Publications by authors named "James D Murphy"

169 Publications

Evaluation of Insurance Coverage and Cancer Stage at Diagnosis Among Low-Income Adults With Renal Cell Carcinoma After Passage of the Patient Protection and Affordable Care Act.

JAMA Netw Open 2021 Jul 1;4(7):e2116267. Epub 2021 Jul 1.

Department of Urology, University of California, San Diego, School of Medicine, La Jolla.

Importance: The association of the Patient Protection and Affordable Care Act (ACA) with insurance status and cancer stage at diagnosis among patients with renal cell carcinoma (RCC) is unknown.

Objective: To test the hypothesis that the ACA may be associated with increased access to care through expansion of insurance, which may vary based on income.

Design, Setting, And Participants: This retrospective cohort analysis included patients diagnosed with RCC from January 1, 2010, to December 31, 2016, in the National Cancer Database. Data were analyzed from July 1 to December 31, 2020. The periods from 2010 to 2013 and from 2014 to 2016 were defined as pre- and post-ACA implementation, respectively. Patients were categorized as living in a Medicaid expansion state or not.

Exposures: Implementation of the ACA.

Main Outcomes And Measures: The absolute percentage change (APC) of insurance coverage was calculated before and after ACA implementation in expansion and nonexpansion states. Secondary outcomes included change in stage at diagnosis, difference in the rate of insurance change, and change in localized disease between expansion and nonexpansion states. Adjusted difference-in-difference modeling was performed.

Results: The cohort included 78 099 patients (64.7% male and 35.3% female; mean [SD] age, 54.66 [6.46] years), of whom 21.2% had low, 46.2% had middle, and 32.6% had high incomes. After ACA implementation, expansion states had a lower proportion of uninsured patients (adjusted difference-in-difference, -1.14% [95% CI, -1.98% to -1.41%]; P = .005). This occurred to the greatest degree among low-income patients through the acquisition of Medicaid (APC, 11.0% [95% CI, 8.6%-13.3%]; P < .001). Implementation of the ACA was also associated with an increase in detection of stage I and II disease (APC, 4.0% [95% CI, 1.6%-6.3%]; P = .001) among low-income patients in expansion states.

Conclusions And Relevance: Among patients with RCC, ACA implementation was associated with an increase in insurance coverage status in both expansion and nonexpansion states for all income groups, but to a greater degree in expansion states. The proportion of patients with localized disease increased among low-income patients in both states. These data suggest that ACA implementation is associated with earlier RCC detection among lower-income patients.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.16267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285737PMC
July 2021

Wide-Scale Clinical Implementation of Knowledge-Based Planning: An Investigation of Workforce Efficiency, Need for Post-automation Refinement, and Data-Driven Model Maintenance.

Int J Radiat Oncol Biol Phys 2021 Jul 1. Epub 2021 Jul 1.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. Electronic address:

Purpose: Our purpose was to investigate the effect of automated knowledge-based planning (KBP) on real-world clinical workflow efficiency, assess whether manual refinement of KBP plans improves plan quality across multiple disease sites, and develop a data-driven method to periodically improve KBP automated planning routines.

Methods And Materials: Using clinical knowledge-based automated planning routines for prostate, prostatic fossa, head and neck, and hypofractionated lung disease sites in a commercial KBP solution, workflow efficiency was compared in terms of planning time in a pre-KBP (n = 145 plans) and post-KBP (n = 503) patient cohort. Post-KBP, planning was initialized with KBP (KBP-only) and subsequently manually refined (KBP + human). Differences in planning time were tested for significance using a 2-tailed Mann-Whitney U test (P < .05, null hypothesis: planning time unchanged). Post-refinement plan quality was assessed using site-specific dosimetric parameters of the original KBP-only plan versus KBP + human; 2-tailed paired t test quantified statistical significance (Bonferroni-corrected P < .05, null hypothesis: no dosimetric difference after refinement). If KBP + human significantly improved plans across the cohort, optimization objectives were changed to create an updated KBP routine (KBP'). Patients were replanned with KBP' and plan quality was compared with KBP + human as described previously.

Results: KBP significantly reduced planning time in all disease sites: prostate (median: 7.6 hrs → 2.1 hrs; P < .001), prostatic fossa (11.1 hrs → 3.7 hrs; P = .001), lung (9.9 hrs → 2.0 hrs; P < .001), and head and neck (12.9 hrs → 3.5 hrs; P <.001). In prostate, prostatic fossa, and lung disease sites, organ-at-risk dose changes in KBP + human versus KBP-only were minimal (<1% prescription dose). In head and neck, KBP + human did achieve clinically relevant dose reductions in some parameters. The head and neck routine was updated (KBP') to incorporate dose improvements from manual refinement. The only significant dosimetric differences to KBP + human after replanning with KBP' were in favor of the new routine.

Conclusions: KBP increased clinical efficiency by significantly reducing planning time. On average, human refinement offered minimal dose improvements over KBP-only plans. In the single disease site where KBP + human was superior to KBP-only, differences were eliminated by adjusting optimization parameters in a revised KBP routine.
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http://dx.doi.org/10.1016/j.ijrobp.2021.06.028DOI Listing
July 2021

Disentangling Racial, Ethnic, and Socioeconomic Disparities in Treatment for Colorectal Cancer.

Cancer Epidemiol Biomarkers Prev 2021 Jun 9. Epub 2021 Jun 9.

School of Public Health, San Diego State University, San Diego, California.

Background: Colorectal cancer is curable if diagnosed early and treated properly. Black and Hispanic patients with colorectal cancer are more likely to experience treatment delays and/or receive lower standards of care. Socioeconomic deprivation may contribute to these disparities, but this has not been extensively quantified. We studied the interrelationship between patient race/ethnicity and neighborhood socioeconomic status (nSES) on receipt of timely appropriate treatment among patients with colorectal cancer in California.

Methods: White, Black, and Hispanic patients (26,870) diagnosed with stage I-III colorectal cancer (2009-2013) in the California Cancer Registry were included. Logistic regression models were used to examine the association of race/ethnicity and nSES with three outcomes: undertreatment, >60-day treatment delay, and >90-day treatment delay. Joint effect models and mediation analysis were used to explore the interrelationships between race/ethnicity and nSES.

Results: Hispanics and Blacks were at increased risk for undertreatment [Black OR = 1.39; 95% confidence interval (CI) = 1.23-1.57; Hispanic OR = 1.17; 95% CI = 1.08-1.27] and treatment delay (Black/60-day OR = 1.78; 95% CI = 1.57-2.02; Hispanic/60-day OR = 1.50; 95% CI = 1.38-1.64) compared with Whites. Of the total effect (OR = 1.15; 95% CI = 1.07-1.24) of non-white race on undertreatment, 45.71% was explained by nSES.

Conclusions: Lower nSES patients of any race were at substantially higher risk for undertreatment and treatment delay, and racial/ethnic disparities are reduced or eliminated among non-white patients living in the highest SES neighborhoods. Racial and ethnic disparities persisted after accounting for neighborhood socioeconomic status, and between the two, race/ethnicity explained a larger portion of the total effects.

Impact: This research improves our understanding of how socioeconomic deprivation contributes to racial/ethnic disparities in colorectal cancer.
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http://dx.doi.org/10.1158/1055-9965.EPI-20-1728DOI Listing
June 2021

The influence of patient-provider language concordance in cancer care: results of the Hispanic Outcomes by Language Approach (HOLA) randomized trial.

Int J Radiat Oncol Biol Phys 2021 May 28. Epub 2021 May 28.

Department of Radiation Medicine and Applied Sciences, University of California, San Diego. Electronic address:

Purpose: Delivering linguistically competent care is critical to serving limited English proficiency (LEP) patients, and represents a key national strategy to help reduce health disparities. Current acceptable standards of communication with LEP patients include providers communicating through professional interpretive services, or bilingual providers speaking the patients' preferred language directly. This randomized clinical trial tests the impact of patient-provider language concordance on patient satisfaction.

Methods: Eighty-three adult Spanish-speaking cancer patients were randomized to receive care from either 1) a bilingual physician speaking to the patient directly in Spanish or 2) the same physicians speaking English and using a professional interpreter service. Validated questionnaires were administered to assess patient-reported satisfaction with both provider communication and overall care. Transcripts of initial consultations were analyzed for content variations.

Results: Compared to patients receiving care through professional interpretive services, patients cared for in direct Spanish reported significantly improved general satisfaction, technical quality of care (MCS 4.41 vs 4.06, p = 0.005), care team interpersonal manner (MCS 4.37 vs 3.88, p=0.004), communication (MCS 4.50 vs 4.25, p=0.018), and time spent with patient (MCS 4.30 vs 3.92, p=0.028). Specific to physician communication, patients rated direct Spanish care more highly in perceived opportunity to disclose concerns (MCS 4.91 vs 4.62, p=0.001), physician empathy (MCS 4.94 vs 4.59, p<0.001), confidence in physician abilities (MCS 4.84 vs 4.51, p=0.001), and general satisfaction with their physician (MCS 4.88 vs 4.59, p<0.001). Analyzing the content of consultation encounters revealed differences between study arms, with the direct Spanish arm having more physician speech related to patient history verification (mean utterances 13 vs 8.9, p=0.01) and partnering activities (mean utterances 16 vs 5, p<0.001). Additionally, patients in the direct-Spanish arm were more likely to initiate unprompted speech (mean utterances 11 vs 3.1, p<0.001), and asked their providers more questions (mean utterances 11 vs 4, p=0.007).

Conclusion: This study demonstrates improved patient-reported satisfaction among LEP cancer patients cared for in direct Spanish compared to interpreter-based communication. Further research into interventions to mitigate this patient-provider language barrier is necessary to optimize care for this minority population.
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http://dx.doi.org/10.1016/j.ijrobp.2021.05.122DOI Listing
May 2021

Radiation Recall Pneumonitis After Treatment With Checkpoint Blockade Immunotherapy: A Case Series and Review of Literature.

Front Oncol 2021 30;11:662954. Epub 2021 Apr 30.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA, United States.

Background: Radiation recall pneumonitis (RRP) is a poorly understood clinical syndrome in which patients develop radiation pneumonitis triggered by a systemic agent, often years after the completion of radiation therapy. Immune checkpoint blockade agents have only recently been posited as a trigger for RRP. Here, we present three cases of immunotherapy-induced RRP.

Case Presentation: Our first patient was diagnosed with primary lung adenocarcinoma, and 4.5 years after completing radiation therapy developed symptomatic RRP immediately following a second dose of nivolumab-containing immunotherapy regimen. Our second patient was diagnosed with primary bladder cancer metastatic to the mediastinum, which was treated twice with radiation therapy. He developed RRP in the days following his second course of ipilimumab-pembrolizumab which was months after his second course of radiation that he received. Our final patient was diagnosed with metastatic small cell lung cancer and received local consolidative radiation therapy in addition to whole-brain radiation. He developed RRP on the 11 day after concluding his 4 cycle of nivolumab-ipilimumab, approximately 7 months after having had completed chest radiation therapy.

Conclusions: Immunotherapy-induced RRP is a rare diagnosis which can present more focally than traditional immunotherapy pneumonitis and which must be clinically differentiated from other local processes such as pneumonia. Further research should explore the mechanisms underlying these radiation recall reactions as many patients receive radiation and immunotherapy during the course of their cancer treatment.
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http://dx.doi.org/10.3389/fonc.2021.662954DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8121173PMC
April 2021

Malignancies diagnosed before and after anal squamous cell carcinomas: A SEER registry analysis.

Cancer Med 2021 Jun 7;10(11):3575-3583. Epub 2021 May 7.

Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, Rutgers University, New Brunswick, NJ, USA.

Background: Increased risk of a second primary malignancy (SPM) before or after diagnosis of anal squamous cell carcinoma (ASCC) has been reported in a previous single-institution study. We hypothesize that patients diagnosed with ASCC are at increased risk for developing SPMs before or after the diagnosis of ASCC. The primary objective of this study was to identify the diagnoses of cancer most likely to occur as SPMs before or after ASCC.

Methods: This work employs the Surveillance, Epidemiology, and End Results (SEER) Program registry data to conduct a US-population-based study of patients diagnosed with ASCC between 1975 and 2016. In patients diagnosed with ASCC, we evaluated the risk of SPMs and the risk of developing ASCC as an SPM after another cancer using standardized incidence ratios (SIR) for all SPMs by calculating the ratio of observed events in the ASCC cohort compared to expected (O/E) events in a matched reference cohort of the general population.

Results: A total of 7,594 patients with primary ASCC were included. Patients with ASCC were at increased risk of the diagnosis of an SPM (SIR = 1.45), particularly cancers of the lung, vulva, oropharynx, or colon. Patients with ASCC had an increased rate of previous malignancy (SIR = 1.23), especially Kaposi sarcoma or vulvar cancer. Overall elevated incidence of SPMs was unrelated to prior radiation treatment. Radiation treatment was associated with increased risk for SPMs in the female genital system but appeared protective against prostate cancer as SPMs.

Conclusions: Our findings support increased surveillance and screening for second malignancies in patients with these diagnoses, as patients with ASCC are often either survivors of a prior cancer diagnosis or are at increased risk of developing later malignancies.
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http://dx.doi.org/10.1002/cam4.3909DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178496PMC
June 2021

Cost-effectiveness of Nivolumab-Ipilimumab Combination Therapy for the Treatment of Advanced Non-Small Cell Lung Cancer.

JAMA Netw Open 2021 May 3;4(5):e218787. Epub 2021 May 3.

University of California, San Diego School of Medicine, La Jolla.

Importance: Treatment with nivolumab-ipilimumab combination therapy was found to improve overall survival compared with chemotherapy among patients with advanced non-small cell lung cancer (NSCLC) in the CheckMate 227 clinical trial. However, these drugs are substantially more expensive than chemotherapy and, given the high incidence of advanced NSCLC, the incorporation of dual immune checkpoint inhibitors into the standard of care could have substantial economic consequences.

Objective: To assess whether nivolumab-ipilimumab combination therapy is a cost-effective first-line treatment for patients with advanced NSCLC.

Design, Setting, And Participants: This economic evaluation designed a Markov model to compare the cost-effectiveness of nivolumab-ipilimumab combination therapy with platinum-doublet chemotherapy as first-line treatment for patients with advanced NSCLC. The Markov model was created to simulate patients with advanced NSCLC who were receiving either nivolumab-ipilimumab combination therapy or platinum-doublet chemotherapy. Transition probabilities, including disease progression, survival, and treatment toxic effects, were derived using data from the CheckMate 227 clinical trial. Costs and health utilities were obtained from published literature. Data analyses were conducted from November 2019 to September 2020.

Exposures: Nivolumab-ipilimumab combination therapy.

Main Outcomes And Measures: The primary study outcomes were quality-adjusted life-years (QALYs) and cost in 2020 US dollars. Cost-effectiveness was measured using an incremental cost-effectiveness ratio (ICER), with an ICER less than $100 000 per QALY considered cost-effective. Model uncertainty was assessed with 1-way and probabilistic sensitivity analyses.

Results: Treatment with nivolumab-ipilimumab combination therapy was associated with an increase in overall cost of $201 900 and improved effectiveness of 0.50 QALYs compared with chemotherapy, yielding an ICER of $401 700 per QALY. The study model was sensitive to the cost and duration of immunotherapy. Treatment with nivolumab-ipilimumab combination therapy became cost-effective when monthly treatment costs were reduced from $26 425 to $5058 (80.9% reduction) or when the maximum duration of immunotherapy was reduced from 24.0 months to 1.4 months. The model was not sensitive to assumptions about survival or programmed cell death 1 ligand 1 status. A probabilistic sensitivity analysis indicated that, at a willingness-to-pay threshold of $100 000 per QALY, nivolumab-ipilimumab combination therapy was less cost-effective than chemotherapy 99.9% of the time.

Conclusions And Relevance: In this study, first-line treatment with nivolumab-ipilimumab combination therapy was not found to be cost-effective at current prices despite clinical trial data indicating that this regimen increases overall survival among patients with advanced NSCLC.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.8787DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094011PMC
May 2021

Association of Health-Care System with Prostate Cancer-Specific Mortality in African American and Non-Hispanic White Men.

J Natl Cancer Inst 2021 Apr 21. Epub 2021 Apr 21.

Department of Radiation Medicine and Applied Sciences, University of California San Diego School of Medicine, La Jolla, California.

Background: Disparities in prostate cancer-specific mortality (PCSM) between African American and non-Hispanic White (White) patients have been attributed to biological and systemic factors. We evaluated drivers of these disparities in the Surveillance, Epidemiology and End Results (SEER) national registry and an equal-access system, the Veterans Health Administration (VHA).

Methods: We identified African American and White patients diagnosed with prostate cancer between 2004-2015 in SEER (N = 311,691) and the VHA (N = 90,749). We analyzed the association between race and metastatic disease at presentation using multivariable logistic regression adjusting for sociodemographic factors, and PCSM using sequential competing-risks regression adjusting for disease and sociodemographic factors.

Results: The median follow-up was 5.3 years in SEER and 4.7 years in the VHA. African American men were more likely than White men to present with metastatic disease in SEER (adjusted odds ratio = 1.23, 95% confidence interval [CI] = 1.17-1.30), but not in the VHA (adjusted odds ratio = 1.07, 95% CI = 0.98-1.17). African American versus White race was associated with an increased risk of PCSM in SEER (subdistribution hazard ratio [SHR] = 1.32, 95% CI = 1.10-1.60), but not in the VHA (SHR = 1.00, 95% CI: 0.93-1.08). Adjusting for disease extent, PSA, and Gleason score eliminated the association between race and PCSM in SEER (aSHR 1.04, 95% CI 0.93-1.16).

Conclusions: Racial disparities in PCSM were present in a nationally representative registry, but not in an equal-access healthcare system, due to differences in advanced disease at presentation. Strategies to increase healthcare access may bridge the racial disparity in outcomes. Longer follow-up is needed to fully assess mortality outcomes.Disparities between African American and non-Hispanic White (White) patients in cancer-specific mortality have been described across numerous cancer types and healthcare systems[1-5]. The survival gap between African American and White patients with prostate cancer has been well-characterized, with two-fold higher prostate cancer-specific mortality (PCSM) rates among African American patients depending on the setting[1, 6-10]. This disparity has been attributed to differences in prostate cancer biology in African American men, in addition to systemic factors in mediating this disparity, such as differential access to healthcare, Prostate-Specific Antigen (PSA) screening, and distrust in the healthcare system[1, 11-16].The Veterans Health Administration (VHA) is a relatively equal-access healthcare system that treats a large, ethnically diverse population of veterans. The Surveillance, Epidemiology and End Results (SEER) program is a national cancer registry program that collects data from the general United States (US) population. The goals of the present investigation were to 1) Compare PCSM between African American and White men within SEER and the VHA and 2) Identify modifiable system-level contributors to these disparities. We hypothesized that PCSM would be comparable among African American and White men in an equal-access setting, the VHA, but not in a national registry, SEER, and that this disparity in SEER would be in part driven by more advanced disease at presentation.
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http://dx.doi.org/10.1093/jnci/djab062DOI Listing
April 2021

Impact of Radiation on Cardiovascular Outcomes in Older Resectable Esophageal Cancer Patients With Medicare.

Am J Clin Oncol 2021 06;44(6):275-282

University of California San Diego School of Medicine.

Objectives: Preoperative radiotherapy improves outcomes for operable esophageal cancer patients, though the proximity of the heart to the esophagus puts patients at risk of radiation-induced cardiovascular disease. This study characterizes the impact of radiotherapy and different radiation techniques on cardiovascular morbidity among a cohort of esophageal cancer patients.

Materials And Methods: We identified 1125 patients aged 65 and older diagnosed between 2000 and 2011 with esophageal cancer who received surgery alone, or surgery preceded by either preoperative chemotherapy or preoperative chemoradiation from the Surveillance Epidemiology and End Results (SEER)-Medicare database. We used Medicare claims to identify severe perioperative and late cardiovascular events. Multivariable logistic regression and Fine-Gray models were used to determine the effect of presurgery treatment on the risk of perioperative and late cardiovascular disease.

Results: Preoperative chemotherapy or chemoradiation did not significantly increase the risk of perioperative cardiovascular complications compared with surgery alone. Patients treated with preoperative chemoradiation had a 36% increased risk of having a late cardiovascular event compared with patients treated with surgery alone (subdistribution hazard ratio [SDHR]: 1.36; P=0.035). There was no significant increase in late cardiovascular events among patients treated with preoperative chemotherapy (SDHR: 1.18; P=0.40). Among patients treated with preoperative chemoradiation, those receiving intensity modulated radiotherapy had a 68% decreased risk of having a late cardiovascular event compared with patients receiving conventional radiation (SDHR: 0.32; P=0.007).

Conclusions: This study demonstrates an increased risk of cardiovascular complications among operative esophageal cancer patients treated with preoperative chemoradiation, though these risks might be reduced with more cardioprotective radiation techniques such as intensity modulated radiotherapy.
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http://dx.doi.org/10.1097/COC.0000000000000815DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141011PMC
June 2021

Clinical Data Prediction Model to Identify Patients With Early-Stage Pancreatic Cancer.

JCO Clin Cancer Inform 2021 03;5:279-287

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA.

Purpose: Pancreatic cancer is an aggressive malignancy with patients often experiencing nonspecific symptoms before diagnosis. This study evaluates a machine learning approach to help identify patients with early-stage pancreatic cancer from clinical data within electronic health records (EHRs).

Materials And Methods: From the Optum deidentified EHR data set, we identified early-stage (n = 3,322) and late-stage (n = 25,908) pancreatic cancer cases over 40 years of age diagnosed between 2009 and 2017. Patients with early-stage pancreatic cancer were matched to noncancer controls (1:16 match). We constructed a prediction model using eXtreme Gradient Boosting (XGBoost) to identify early-stage patients on the basis of 18,220 features within the EHR including diagnoses, procedures, information within clinical notes, and medications. Model accuracy was assessed with sensitivity, specificity, positive predictive value, and the area under the curve.

Results: The final predictive model included 582 predictive features from the EHR, including 248 (42.5%) physician note elements, 146 (25.0%) procedure codes, 91 (15.6%) diagnosis codes, 89 (15.3%) medications, and 9 (1.5%) demographic features. The final model area under the curve was 0.84. Choosing a model cut point with a sensitivity of 60% and specificity of 90% would enable early detection of 58% late-stage patients with a median of 24 months before their actual diagnosis.

Conclusion: Prediction models using EHR data show promise in the early detection of pancreatic cancer. Although widespread use of this approach on an unselected population would produce high rates of false-positive tests, this technique may be rapidly impactful if deployed among high-risk patients or paired with other imaging or biomarker screening tools.
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http://dx.doi.org/10.1200/CCI.20.00137DOI Listing
March 2021

The Landmark Series: Locally Advanced Pancreatic Cancer and Ablative Therapy Options.

Ann Surg Oncol 2021 Aug 14;28(8):4173-4180. Epub 2021 Feb 14.

Department of Surgery, University of Louisville, Louisville, KY, USA.

Locally advanced pancreatic cancer (LAPC) is a challenging disease to treat. There is consensus that systemic chemotherapy should be the first line of therapy for most patients. However, there is no consensus on how to manage those patients who do not have sufficient response to become candidates for resection but also do not have distant progression after weeks or months of systemic therapy. Radiation therapy is the most commonly used and best-studied local ablative therapy. One recent randomized controlled trial (LAP-07) failed to demonstrate an overall survival benefit for conventional chemoradiation therapy after induction chemotherapy versus chemotherapy alone. This study had several limitations, and ongoing studies are re-evaluating the role of chemoradiation after more effective chemotherapy regimens as well as more advanced radiation techniques. In parallel, there has been increasing interest in other thermal and non-thermal methods of ablation. In particular, irreversible electroporation has gained traction for treatment of LAPC, with at least one ongoing randomized controlled trial designed to address its role compared with systemic chemotherapy alone. Multiple preclinical and clinical studies are investigating combinations of local ablation and immunotherapy with the goal of generating immune responses that will meaningfully improve outcomes.
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http://dx.doi.org/10.1245/s10434-021-09662-zDOI Listing
August 2021

Phase I Trial of Stereotactic Body Radiation Therapy Dose Escalation in Pancreatic Cancer.

Int J Radiat Oncol Biol Phys 2021 Jul 8;110(4):1003-1012. Epub 2021 Feb 8.

University of California San Diego School of Medicine, La Jolla, California; Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. Electronic address:

Purpose: Stereotactic body radiation therapy (SBRT) has demonstrated encouraging local tumor control rates in the treatment of pancreatic cancer, yet we lack prospective clinical trials evaluating dose-escalation strategies among patients treated with 5-fraction SBRT. This phase 1 dose-escalation trial was conducted to determine the maximum tolerated dose of SBRT in patients with pancreatic cancer.

Methods And Materials: Thirty patients with pancreatic cancer were enrolled and treated with 40, 45, or 50 Gy SBRT in 5 fractions with doses determined using a time-to-event continual reassessment method trial design. Systemic therapy was permitted before and after SBRT, but not mandated by the study protocol. Toxicity was the primary study endpoint, and any grade ≥3 acute or late toxicity potentially attributable to SBRT was considered a dose-limiting toxicity. Secondary endpoints included local progression, distant progression, and overall survival.

Results: The median follow up from SBRT was 8.9 months (range, 1.7-62.6 months). Nineteen patients (63%) had locally advanced disease, 3 patients (10%) had metastatic disease, and 8 patients (27%) had medically unresectable disease. Three patients (10%) received 40 Gy, 16 patients (53%) received 45 Gy, and 11 patients (37%) received 50 Gy. Seven patients (23%) experienced grade ≤2 acute toxicity, and 2 patients (6.7%) experienced grade 4 to 5 late toxicity, both of which occurred in the 45 Gy group. Median survival time was 17.1 months from the time of diagnosis and 9.8 months from SBRT. The 1-year cumulative incidence of local progression was 14.2% (95% confidence interval, 4.2%-30%).

Conclusions: This dose-escalation trial evaluated high-dose SBRT delivered in 5 fractions, and overall demonstrated favorable local control and survival, but was associated with nontrivial rates of severe late gastrointestinal toxicity potentially attributable to radiation. Further prospective studies are needed to define the safety and efficacy of high-dose SBRT in patients with pancreatic cancer.
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http://dx.doi.org/10.1016/j.ijrobp.2021.02.008DOI Listing
July 2021

Surgical revascularization for Moyamoya disease in the United States: A cost-effectiveness analysis.

J Cerebrovasc Endovasc Neurosurg 2021 Mar 5;23(1):6-15. Epub 2021 Feb 5.

Department of Neurological Surgery, University of California, San Diego, CA, USA.

Objective: Moyamoya disease (MMD) is a vasculopathy of the internal carotid arteries with ischemic and hemorrhagic sequelae. Surgical revascularization confers upfront peri-procedural risk and costs in exchange for long-term protective benefit against hemorrhagic disease. The authors present a cost-effectiveness analysis (CEA) of surgical versus non-surgical management of MMD.

Methods: A Markov Model was used to simulate a 41-year-old suffering a transient ischemic attack (TIA) secondary to MMD and now faced with operative versus nonoperative treatment options. Health utilities, costs, and outcome probabilities were obtained from the CEA registry and the published literature. The primary outcome was incremental cost-effectiveness ratio which compared the quality adjusted life years (QALYs) and costs of surgical and nonsurgical treatments. Base-case, one-way sensitivity, two-way sensitivity, and probabilistic sensitivity analyses were performed with a willingness to pay threshold of $50,000.

Results: The base case model yielded 3.81 QALYs with a cost of $99,500 for surgery, and 3.76 QALYs with a cost of $106,500 for nonsurgical management. One-way sensitivity analysis demonstrated the greatest sensitivity in assumptions to cost of surgery and cost of admission for hemorrhagic stroke, and probabilities of stroke with no surgery, stroke after surgery, poor surgical outcome, and death after surgery. Probabilistic sensitivity analyses demonstrated that surgical revascularization was the cost-effective strategy in over 87.4% of simulations.

Conclusions: Considering both direct and indirect costs and the postoperative QALY, surgery is considerably more cost-effective than non-surgical management for adults with MMD.
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http://dx.doi.org/10.7461/jcen.2021.E2020.07.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8041505PMC
March 2021

Racial, Ethnic, and Socioeconomic Discrepancies in Opioid Prescriptions Among Older Patients With Cancer.

JCO Oncol Pract 2021 06 3;17(6):e703-e713. Epub 2021 Feb 3.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA.

Purpose: Minority race and lower socioeconomic status are associated with lower rates of opioid prescription and undertreatment of pain in multiple noncancer healthcare settings. It is not known whether these differences in opioid prescribing exist among patients undergoing cancer treatment.

Methods And Materials: This observational cohort study involved 33,872 opioid-naive patients of age > 65 years undergoing definitive cancer treatment. We compared rates of new opioid prescriptions by race or ethnicity and socioeconomic status controlling for differences in baseline patient, cancer, and treatment factors. To evaluate downstream impacts of opioid prescribing and pain management, we also compared rates of persistent opioid use and pain-related emergency department (ED) visits.

Results: Compared with non-Hispanic White patients, the covariate-adjusted odds of receiving an opioid prescription were 24.9% (95% CI, 16.0 to 33.9, < .001) lower for non-Hispanic Blacks, 115.0% (84.7 to 150.3, < .001) higher for Asian-Pacific Islanders, and not statistically different for Hispanics (-1.0 to 14.0, = .06). There was no significant association between race or ethnicity and persistent opioid use or pain-related ED visits. Patients living in a high-poverty area had higher odds (53.9% [25.4 to 88.8, < .001]) of developing persistent use and having a pain-related ED visit (39.4% [16.4 to 66.9, < .001]).

Conclusion: For older patients with cancer, rates of opioid prescriptions and pain-related outcomes significantly differed by race and area-level poverty. Non-Hispanic Black patients were associated with a significantly decreased likelihood of receiving an opioid prescription. Patients from high-poverty areas were more likely to develop persistent opioid use and have a pain-related ED visit.
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http://dx.doi.org/10.1200/OP.20.00773DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8258011PMC
June 2021

ORBIT-RT: A Real-Time, Open Platform for Knowledge-Based Quality Control of Radiotherapy Treatment Planning.

JCO Clin Cancer Inform 2021 01;5:134-142

University of California, San Diego, CA.

Purpose: Access to knowledge-based treatment plan quality control has been hindered by the complexity of developing models and integration with different treatment planning systems (TPS). Online Real-time Benchmarking Information Technology for RadioTherapy (ORBIT-RT) provides a free, web-based platform for knowledge-based dose estimation that can be used by clinicians worldwide to benchmark the quality of their radiotherapy plans.

Materials And Methods: The ORBIT-RT platform was developed to satisfy four primary design criteria: web-based access, TPS independence, Health Insurance Portability and Accountability Act compliance, and autonomous operation. ORBIT-RT uses a cloud-based server to automatically anonymize a user's Digital Imaging and Communications in Medicine for RadioTherapy (DICOM-RT) file before upload and processing of the case. From there, ORBIT-RT uses established knowledge-based dose-volume histogram (DVH) estimation methods to autonomously create DVH estimations for the uploaded DICOM-RT. ORBIT-RT performance was evaluated with an independent validation set of 45 volumetric modulated arc therapy prostate plans with two key metrics: (i) accuracy of the DVH estimations, as quantified by their error, DVH - DVH and (ii) time to process and display the DVH estimations on the ORBIT-RT platform.

Results: ORBIT-RT organ DVH predictions show < 1% bias and 3% error uncertainty at doses > 80% of prescription for the prostate validation set. The ORBIT-RT extensions require 3.0 seconds per organ to analyze. The DICOM upload, data transfer, and DVH output display extend the entire system workflow to 2.5-3 minutes.

Conclusion: ORBIT-RT demonstrated fast and fully autonomous knowledge-based feedback on a web-based platform that takes only anonymized DICOM-RT as input. The ORBIT-RT system can be used for real-time quality control feedback that provides users with objective comparisons for final plan DVHs.
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http://dx.doi.org/10.1200/CCI.20.00093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240787PMC
January 2021

Association Between the Use of Non-benzodiazepine Hypnotics and Cognitive Outcomes: A Systematic Review.

Curr Sleep Med Rep 2020 Mar 28;6(1):11-20. Epub 2020 Jan 28.

Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.

Purpose Of Review: Adverse effects of sedative-hypnotic medications on cognition are concerning. Past studies have examined benzodiazepine (BZD) use and cognitive outcomes; however, few studies have examined newer non-BZD hypnotic agents (nBHs; e.g. zolpidem). This systematic review examined observational studies assessing the association between nBH use and cognitive outcomes.

Recent Findings: Five studies met eligibility requirements and were included in the review. Most studies did not find an association between nBH use and dementia diagnosis; however, we found no studies assessing other cognitive outcomes such as cognitive performance (e.g., word recall tasks). Characterization of nBH use mostly consisted of incident new use; one study assessed nBH dosing; none examined duration of use. Studies included were of strong quality.

Summary: This review found no association between nBH use and dementia diagnosis, although there is a need for more research on more cognitive outcomes and nBH use patterns.
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http://dx.doi.org/10.1007/s40675-020-00163-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810183PMC
March 2020

Cost Savings Associated With Palliative Care Among Older Adults With Advanced Cancer.

Am J Hosp Palliat Care 2021 Jan 11:1049909120986800. Epub 2021 Jan 11.

Department of Radiation Medicine and Applied Science, Moores Cancer Center, University of California San Diego, La Jolla, CA, USA.

Background: There is inconsistent evidence that palliative care intervention decreases total healthcare expenditure at end-of-life for oncology patients. This inconsistent evidence may result from small sample sizes at single institution studies and disparate characterization of costs across studies. Comprehensive studies in population-based datasets are needed to fully understand the impact of palliative care on total healthcare costs. This study analyzed the impact of palliative care on total healthcare costs in a nationally representative sample of advanced cancer patients.

Methods: We conducted a matched cohort study among Medicare patients with metastatic lung, colorectal, breast and prostate cancers. We matched patients who received a palliative care consultation to similar patients who did not receive a palliative care consultation on factors related to both the receipt of palliative care and end of life costs. We compared direct costs between matched patients to determine the per-patient economic impact of a palliative care consultation.

Results: Patients who received a palliative care consultation experienced an average per patient cost of $5,834 compared to $7,784 for usual care patients (25% decrease; p < 0.0001). Palliative care consultation within 7 days of death decreased healthcare costs by $451, while palliative care consultation more than 4 weeks from death decreased costs by $4,643.

Conclusion: This study demonstrates that palliative care has the capacity to substantially reduce healthcare expenditure among advanced cancer patients. Earlier palliative care consultation results in greater cost reductions than consultation in the last week of life.
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http://dx.doi.org/10.1177/1049909120986800DOI Listing
January 2021

Validation of an oncology-specific opioid risk calculator in cancer survivors.

Cancer 2021 May 30;127(9):1529-1535. Epub 2020 Dec 30.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.

Background: Clinical guidelines recommend that providers risk-stratify patients with cancer before prescribing opioids. Prior research has demonstrated that a simple cancer opioid risk score might help identify to patients with cancer at the time of diagnosis with a high likelihood of long-term posttreatment opioid use. This current project validates this cancer opioid risk score in a generalizable, population-based cohort of elderly cancer survivors.

Methods: This study identified 44,932 Medicare beneficiaries with cancer who had received local therapy. Longitudinal opioid use was ascertained from Medicare Part D data. A risk score was calculated for each patient, and patients were categorized into low-, moderate-, and high-risk groups on the basis of the predicted probability of persistent opioid use. Model discrimination was assessed with receiver operating characteristic curves.

Results: In the study cohort, 5.2% of the patients were chronic opioid users 1 to 2 years after the initiation of cancer treatment. The majority of the patients (64%) were at low risk and had a 1.2% probability of long-term opioid use. Moderate-risk patients (33% of the cohort) had a 5.6% probability of long-term opioid use. High-risk patients (3.5% of the cohort) had a 75% probability of long-term opioid use. The opioid risk score had an area under the receiver operating characteristic curve of 0.869.

Conclusions: This study found that a cancer opioid risk score could accurately identify individuals with a high likelihood of long-term opioid use in a large, generalizable cohort of cancer survivors. Future research should focus on the implementation of these scores into clinical practice and how this could affect prescriber behavior and patient outcomes.

Lay Summary: A novel 5-question clinical decision tool allows physicians treating patients with cancer to accurately predict which patients will persistently be using opioid medications after completing therapy.
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http://dx.doi.org/10.1002/cncr.33410DOI Listing
May 2021

Association Between African American Race and Clinical Outcomes in Men Treated for Low-Risk Prostate Cancer With Active Surveillance.

JAMA 2020 11;324(17):1747-1754

VHA San Diego Health Care System, La Jolla, California.

Importance: There is concern that African American men with low-risk prostate cancer may harbor more aggressive disease than non-Hispanic White men. Therefore, it is unclear whether active surveillance is a safe option for African American men.

Objective: To compare clinical outcomes of African American and non-Hispanic White men with low-risk prostate cancer managed with active surveillance.

Design, Setting, And Participants: Retrospective cohort study in the US Veterans Health Administration Health Care System of African American and non-Hispanic White men diagnosed with low-risk prostate cancer between January 1, 2001, and December 31, 2015, and managed with active surveillance. The date of final follow-up was March 31, 2020.

Exposures: Active surveillance was defined as no definitive treatment within the first year of diagnosis and at least 1 additional surveillance biopsy.

Main Outcomes And Measures: Progression to at least intermediate-risk, definitive treatment, metastasis, prostate cancer-specific mortality, and all-cause mortality.

Results: The cohort included 8726 men, including 2280 African American men (26.1%) (median age, 63.2 years) and 6446 non-Hispanic White men (73.9%) (median age, 65.5 years), and the median follow-up was 7.6 years (interquartile range, 5.7-9.9; range, 0.2-19.2). Among African American men and non-Hispanic White men, respectively, the 10-year cumulative incidence of disease progression was 59.9% vs 48.3% (difference, 11.6% [95% CI, 9.2% to 13.9%); P < .001); of receipt of definitive treatment, 54.8% vs 41.4% (difference, 13.4% [95% CI, 11.0% to 15.7%]; P < .001); of metastasis, 1.5% vs 1.4% (difference, 0.1% [95% CI, -0.4% to 0.6%]; P = .49); of prostate cancer-specific mortality, 1.1% vs 1.0% (difference, 0.1% [95% CI, -0.4% to 0.6%]; P = .82); and of all-cause mortality, 22.4% vs 23.5% (difference, 1.1% [95% CI, -0.9% to 3.1%]; P = 0.09).

Conclusions And Relevance: In this retrospective cohort study of men with low-risk prostate cancer followed up for a median of 7.6 years, African American men, compared with non-Hispanic White men, had a statistically significant increased 10-year cumulative incidence of disease progression and definitive treatment, but not metastasis or prostate cancer-specific mortality. Longer-term follow-up is needed to better assess the mortality risk.
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http://dx.doi.org/10.1001/jama.2020.17020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610194PMC
November 2020

Outcomes of Black men with prostate cancer treated with radiation therapy in the Veterans Health Administration.

Cancer 2021 Feb 9;127(3):403-411. Epub 2020 Oct 9.

Department of Radiation Medicine and Applied Sciences, University of California San Diego School of Medicine, La Jolla, California.

Background: Population-based studies demonstrate that Black men in the United States have an increased risk of death from prostate cancer. Determinants of racial disparities are multifactorial, including socioeconomic and biologic factors.

Methods: The authors conducted a pooled analysis of patients derived from 152 centers within the Veterans Health Administration. The cohort included men who had nonmetastatic prostate diagnosed between 2001 and 2015 and received definitive radiation therapy. The primary endpoint was prostate cancer-specific mortality (PCSM). Secondary endpoints included all-cause mortality (ACM) and the time from a prostate-specific antigen level ≥4 ng/mL to biopsy and radiation therapy. A Cox regression model was performed to adjust for differences between clinical parameters.

Results: Among the 31,131 patients included in the cohort, 9584 (30.8%) were Black. The 10-year cumulative incidence of death from prostate cancer was lower in Black men compared with White men (4.0% vs 4.8%; P = .004). In a competing risk model, Black race was associated with a decreased risk of PCSM (subdistribution hazard ratio, 0.79; 95% CI, 0.69-0.92; P = .002). Similarly, the 10-year cumulative incidence of death from any cause was lower in Black men (27.6% vs 31.8%; P < .001). In multivariable analysis, Black men had a 10% decreased risk of ACM (hazard ratio, 0.90; 95% CI, 0.85-0.95; P < .001).

Conclusions: The current results indicate relatively lower PCSM and ACM among Black men who were included in a large Veterans Health Administration cohort and received radiation therapy as primary treatment for nonmetastatic prostate cancer. There is an ongoing need to continue to understand and mitigate the factors associated with disparities in health care outcomes.
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http://dx.doi.org/10.1002/cncr.33224DOI Listing
February 2021

Cost-Effectiveness Analysis of Stereotactic Ablative Radiation Therapy in Patients With Oligometastatic Cancer.

Int J Radiat Oncol Biol Phys 2021 04 28;109(5):1185-1194. Epub 2020 Sep 28.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. Electronic address:

Purpose: The Stereotactic Ablative Radiation therapy for Comprehensive Treatment of Oligometastatic Tumors phase 2 randomized clinical trial found that stereotactic ablative radiation therapy (SABR) improved outcomes among cancer patients with oligometastatic disease. Yet, the cost of SABR along with the large number of patients with oligometastatic disease raises the important question of value. This study sought to evaluate the cost-effectiveness of the addition of SABR compared with standard therapy alone among cancer patients with oligometastatic disease.

Methods And Materials: We constructed a Markov model to simulate treatment with stereotactic ablative radiation therapy or standard therapy among patients with oligometastatic cancers. The model derived transition probabilities from Stereotactic Ablative Radiation therapy for Comprehensive Treatment of Oligometastatic Tumors clinical trial data to estimate risks of toxicity, disease progression and survival. Health care costs and health utilities were estimated from the literature. Probabilistic and one-way sensitivity analyses evaluate model uncertainty. Cost-effectiveness was estimated from both the health care sector and societal perspectives with an incremental cost-effectiveness ratio (ICER) defined as dollars per quality-adjusted life year (QALY). An ICER less than $100,000/QALY was considered cost-effective. One-way and probabilistic sensitivity analyses were used to examine model uncertainty.

Results: The addition of SABR increased total costs by $54,260 (health care sector perspective) or $72,799 (societal perspective) and improved effectiveness by 1.88 QALYs compared with standard therapy, leading to an ICER of $28,906/QALY (health care sector perspective) or $38,783/QALY (societal perspective). The model was modestly sensitive to assumptions about tumor progression, although the model was not sensitive to assumptions about survival or cost of treatment. Probabilistic sensitivity analyses demonstrated that SABR was the cost-effective treatment option 99.8% (health care sector perspective) or 98.7% (societal perspective) of the time.

Conclusions: The addition of SABR increased costs and improved quality adjusted survival, overall leading to a cost-effective treatment strategy for patients with oligometastatic cancer.
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http://dx.doi.org/10.1016/j.ijrobp.2020.09.045DOI Listing
April 2021

Cost-effectiveness Analysis of Genetic Testing and Tailored First-Line Therapy for Patients With Metastatic Gastrointestinal Stromal Tumors.

JAMA Netw Open 2020 09 1;3(9):e2013565. Epub 2020 Sep 1.

Department of Surgery, Division of Surgical Oncology, University of California, San Diego.

Importance: Gastrointestinal stromal tumor (GIST) is frequently driven by oncogenic KIT variations. Imatinib targeting of KIT marked a new era in GIST treatment and ushered in precision oncological treatment for all solid malignant neoplasms. However, studies on the molecular biological traits of GIST have found that tumors respond differentially to imatinib dosage based on the KIT exon with variation. Despite this knowledge, few patients undergo genetic testing at diagnosis, and empirical imatinib therapy remains routine. Barriers to genetic profiling include concerns about the cost and utility of testing.

Objective: To determine whether targeted gene testing (TGT) is a cost-effective diagnostic for patients with metastatic GIST from the US payer perspective.

Design, Setting, And Participants: This economic evaluation developed a Markov model to compare the cost-effectiveness of TGT and tailored first-line therapy compared with empirical imatinib therapy among patients with a new diagnosis of metastatic GIST. The main health outcome, quality-adjusted life years (QALYs), and costs were obtained from the literature, and transitional probabilities were modeled from disease progression and survival estimates from randomized clinical trials of patients with metastatic GIST. Data analyses were conducted October 2019 to January 2020.

Exposure: TGT and tailored first-line therapy.

Main Outcomes And Measures: The primary outcome was QALYs and cost. Cost-effectiveness was defined using an incremental cost-effectiveness ratio, with an incremental cost-effectiveness ratio less than $100 000/QALY considered cost-effective. One-way and probabilistic sensitivity analyses were conducted to assess model stability.

Results: Therapy directed by TGT was associated with an increase of 0.10 QALYs at a cost of $9513 compared with the empirical imatinib approach, leading to an incremental cost-effectiveness ratio of $92 100. These findings were sensitive to the costs of TGT, drugs, and health utility model inputs. Therapy directed by TGT remained cost-effective for genetic testing costs up to $3730. Probabilistic sensitivity analysis found that TGT-directed therapy was considered cost-effective 70% of the time.

Conclusions And Relevance: These findings suggest that using genetic testing to match treatment of KIT variations to imatinib dosing is a cost-effective approach compared with empirical imatinib.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.13565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7522695PMC
September 2020

Quality of care at safety-net hospitals and the impact on pay-for-performance reimbursement.

Cancer 2020 10 11;126(20):4584-4592. Epub 2020 Aug 11.

Department of Radiation Medicine and Applied Sciences, University of California San Diego School of Medicine, La Jolla, California.

Background: Pay-for-performance reimbursement ties hospital payments to standardized quality-of-care metrics. To the authors' knowledge, the impact of pay-for-performance reimbursement models on hospitals caring primarily for uninsured or underinsured patients remains poorly defined. The objective of the current study was to evaluate how standardized quality-of-care metrics vary by a hospital's propensity to care for uninsured or underinsured patients and demonstrate the potential impact that pay-for-performance reimbursement could have on hospitals caring for the underserved.

Methods: The authors identified 1,703,865 patients with cancer who were diagnosed between 2004 and 2015 and treated at 1344 hospitals. Hospital safety-net burden was defined as the percentage of uninsured or Medicaid patients cared for by that hospital, categorizing hospitals into low-burden, medium-burden, and high-burden hospitals. The authors evaluated the impact of safety-net burden on concordance with 20 standardized quality-of-care measures, adjusting for differences in patient age, sex, stage of disease at diagnosis, and comorbidity.

Results: Patients who were treated at high-burden hospitals were more likely to be young, male, Black and/or Hispanic, and to reside in a low-income and low-educated region. High-burden hospitals had lower adherence to 13 of 20 quality measures compared with low-burden hospitals (all P < .05). Among the 350 high-burden hospitals, concordance with quality measures was found to be lowest for those caring for the highest percentage of uninsured or Medicaid patients, minority patients, and less educated patients (all P < .001).

Conclusions: Hospitals caring for uninsured or underinsured individuals have decreased quality-of-care measures. Under pay-for-performance reimbursement models, these lower quality-of-care scores could decrease hospital payments, potentially increasing health disparities for at-risk patients with cancer.
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http://dx.doi.org/10.1002/cncr.33137DOI Listing
October 2020

Impact of positive surgical margins on survival after partial nephrectomy in localized kidney cancer: analysis of the National Cancer Database.

Minerva Urol Nephrol 2021 Apr 4;73(2):233-244. Epub 2020 Aug 4.

Department of Urology, University of California San Diego School of Medicine, La Jolla, CA, USA -

Background: The impact of positive surgical margins (PSM) on outcomes in partial nephrectomy (PN) is controversial. We investigated impact of PSM for patients undergoing PN on overall survival (OS) in different stages of renal cell carcinoma (RCC).

Methods: Retrospective analysis of patients from the US National Cancer Database who underwent PN for cT1a-cT2b N0M0 RCC between 2004-13. Patients were stratified by pathological stage (pT1a, pT1b, pT2a, pT2b, and pT3a [upstaged]) and analyzed by margin status. Cox Regression multivariable analysis (MVA) was performed to investigate associations of PSM and covariates on all-cause mortality (ACM). Kaplan-Meier analysis (KMA) of OS was performed for PSM versus negative margin (NSM) by pathological stage. Sub-analysis of Charlson Comorbidity Index 0 (CCI=0) subgroup was conducted to reduce bias from comorbidities.

Results: We analyzed 42,113 PN (pT1a: 33,341 [79.2%]; pT1a, pT1b: 6689 [15.9%]; pT2a: 757 [1.8%]; pT2b: 165 [0.4%]; and pT3a: upstaged 1161 [2.8%]). PSM occurred in 6.7% (2823) (pT1a: 6.5%, pT1b: 6.3%, pT2a: 5.9%, pT2b: 6.1%, pT3a: 14.1%, P<0.001). On MVA, PSM was associated with 31% increase in ACM (HR 1.31, P<0.001), which persisted in CCI=0 sub-analysis (HR: 1.25, P<0.001). KMA revealed negative impact of PSM vs. NSM on 5-year OS: pT1 (87.3% vs. 90.9%, P<0.001), pT2 (86.7% vs. 82.5%, P=0.48), and upstaged pT3a (69% vs. 84.2%, P<0.001).

Conclusions: PSM after PN was independently associated with across-the-board decrement in OS, which worsened in pT3a disease and persisted in sub-analysis of patients with CCI=0. PSM should prompt more aggressive surveillance or definitive resection strategies.
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http://dx.doi.org/10.23736/S0393-2249.20.03728-5DOI Listing
April 2021

Evaluation of the Use of Cancer Registry Data for Comparative Effectiveness Research.

JAMA Netw Open 2020 07 1;3(7):e2011985. Epub 2020 Jul 1.

School of Medicine, University of California, San Diego, La Jolla.

Importance: Researchers often analyze cancer registry data to assess for differences in survival among cancer treatments. However, the retrospective, nonrandomized design of these analyses raises questions about study validity.

Objective: To examine the extent to which comparative effectiveness analyses using observational cancer registry data produce results concordant with those of randomized clinical trials.

Design, Setting, And Participants: In this comparative effectiveness study, a total of 141 randomized clinical trials referenced in the National Comprehensive Cancer Network Clinical Practice Guidelines for 8 common solid tumor types were identified. Data on participants within the National Cancer Database (NCDB) diagnosed between 2004 and 2014, matching the eligibility criteria of the randomized clinical trial, were obtained. The present study was conducted from August 1, 2017, to September 10, 2019. The trials included 85 118 patients, and the corresponding NCDB analyses included 1 344 536 patients. Three Cox proportional hazards regression models were used to determine hazard ratios (HRs) for overall survival, including univariable, multivariable, and propensity score-adjusted models. Multivariable and propensity score analyses controlled for potential confounders, including demographic, comorbidity, clinical, treatment, and tumor-related variables.

Main Outcomes And Measures: The main outcome was concordance between the results of randomized clinical trials and observational cancer registry data. Hazard ratios with an NCDB analysis were considered concordant if the NDCB HR fell within the 95% CI of the randomized clinical trial HR. An NCDB analysis was considered concordant if both the NCDB and clinical trial P values for survival were nonsignificant (P ≥ .05) or if they were both significant (P < .05) with survival favoring the same treatment arm in the NCDB and in the randomized clinical trial.

Results: Analyses using the NCDB-produced HRs for survival were concordant with those of 141 randomized clinical trials in 79 univariable analyses (56%), 98 multivariable analyses (70%), and 90 propensity score models (64%). The NCDB analyses produced P values concordant with randomized clinical trials in 58 univariable analyses (41%), 65 multivariable analyses (46%), and 63 propensity score models (45%). No clinical trial characteristics were associated with concordance between NCDB analyses and randomized clinical trials, including disease site, type of clinical intervention, or severity of cancer.

Conclusions And Relevance: The findings of this study suggest that comparative effectiveness research using cancer registry data often produces survival outcomes discordant with those of randomized clinical trial data. These findings may help provide context for clinicians and policy makers interpreting observational comparative effectiveness research in oncology.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.11985DOI Listing
July 2020

Evaluation of a Patient Communication Skills Training Program for Medical Physicists.

Int J Radiat Oncol Biol Phys 2020 12 23;108(5):1284-1291. Epub 2020 Jul 23.

Department of Radiation Medicine and Applied Sciences, UC San Diego, Moores Cancer Center, La Jolla, California.

Purpose: To evaluate the efficacy of a training program designed to teach medical physicists how to communicate with patients effectively in the clinical environment.

Methods And Materials: The training program was offered 3 times between 2016 and 2019. Participants were asked to rank their level of confidence in 5 categories relevant to patient communication on a 5-point Likert scale at 3 separate time points over the course of the training program. Participants were also asked to provide written responses to 5 common questions from patients at 2 separate time points, and these responses were numerically scored using the Constant Comparative Method. Competency in patient communication was assessed during simulated patient consults using a 9-element clinical competency assessment form. Changes in participants' stated level of confidence over the course of the training program and differences between faculty and residents were analyzed using the Student t test, and participants' scored responses to common questions were analyzed using analysis of variance.

Results: Fifteen medical physicists participated in the training program: 6 resident physicists (4 first year and 2 second year) and 9 faculty physicists. Mean participant-stated level of confidence increased significantly across all categories (P < .05) between the first and second training intervention and between the second and third training intervention. There was no significant difference in mean participant-stated level of confidence between faculty and resident medical physicists. We observed statistically significant improvements in scored responses to common patient questions between the 2 assessment time points (P < .05). Of the 15 participants, 14 met competency assessment goals during simulated patient consults.

Conclusions: The patient communication skills training program increases medical physicists' level of confidence across 5 patient communication categories and improves their responses to common questions from patients. In addition, the program can discern differences in communication competency between physicists.
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http://dx.doi.org/10.1016/j.ijrobp.2020.07.028DOI Listing
December 2020

A review of patient questions from physicist-patient consults.

J Appl Clin Med Phys 2020 Aug 9;21(8):305-308. Epub 2020 Jun 9.

Department of Radiation Medicine & Applied Sciences, UC San Diego, La Jolla, CA, USA.

Purpose: To provide insight into the types of questions asked to medical physicists by patients during one-on-one physicist-patient consults at one institution.

Materials And Methods: Medical physicists trained in patient communication techniques met with patients to provide an overview of the treatment planning and delivery processes, discuss the patient's treatment plan, and answer any technical questions. From August 2016 to December 2019, 152 physicist-patient consults were conducted. In the initial months of the study (August 2016-December 2017), following each physicist-patient consult, all patient questions were documented by the physicists. For the remaining time period (January 2018-December 2019), any newly encountered questions were periodically added to the list. The questions were compiled into a comprehensive list and organized into categories.

Results: There were a total of 88 unique patient questions. These questions fit into four topical categories. Fifty-four questions (61.4%) were in the "Treatment Planning and Delivery Questions" category, 15 questions (17.1%) were in the "General Radiation Questions or Concerns" category, 13 questions (14.8%) were in the "Safety and Quality Assurance Questions" category, and 6 questions (6.8%) were in the "Medical Questions" category. Overall, patients were primarily concerned about how radiation works, the treatment planning and delivery processes, and what is being done to keep them safe throughout their treatment.

Conclusion: Physicist-patient consults provided an opportunity to address the technical aspects of radiation therapy with patients in greater detail. The fact that patient questions could be conveniently grouped into only four topical categories indicates that it may be straightforward for other medical physicists to prepare for effectively addressing technical questions during physicist-patient consults.
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http://dx.doi.org/10.1002/acm2.12942DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484844PMC
August 2020

Testosterone therapy does not increase the risks of prostate cancer recurrence or death after definitive treatment for localized disease.

Prostate Cancer Prostatic Dis 2020 12 8;23(4):689-695. Epub 2020 Jun 8.

Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA, 92093, USA.

Background: The safety of testosterone therapy (TT) after definitive treatment for localized prostate cancer remains undefined. We analyzed the risks of biochemical recurrence and mortality in men receiving TT after treatment for localized prostate cancer.

Methods: Cohort analysis using the national US Veterans Affairs Informatics and Computing Infrastructure. We identified 69,984 patients with localized prostate cancer diagnosed from 2001 to 2015 treated with surgery or radiation. We coded receipt of TT after treatment as a time-dependent covariate; used the National Death Index to identify cause of death; and defined biochemical recurrence as PSA > 0.2 ng/mL after surgery and nadir + 2 ng/mL after radiation. We analyzed recurrence and mortality using cumulative incidence curves, Fine-Gray competing risk regression, and Cox regression.

Results: This cohort included 28,651 surgery patients and 41,333 radiation patients, of whom 469 (1.64%) and 543 (1.31%), respectively, received TT with a median follow-up of 6.95 years. Comparing testosterone users to nonusers, there were no between-group differences in biochemical recurrence, prostate cancer-specific mortality, or overall mortality after surgery [hazard ratios (HR): 1.07; HR: 0.72 (p = 0.43); and HR: 1.11 (p = 0.43), respectively] or radiation [HR: 1.07; HR: 1.02 (p = 0.95); and HR: 1.02 (p = 0.86), respectively]. Limitations included lack of detailed data on TT duration and serum testosterone concentrations.

Conclusions: In this multi-ethnic national cohort, TT did not increase the risks of biochemical recurrence or prostate cancer-specific or overall mortality after surgery or radiation. These data suggest that TT is safe in appropriate men after definitive treatment of localized prostate cancer.
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http://dx.doi.org/10.1038/s41391-020-0241-3DOI Listing
December 2020

Palliative Radiotherapy Versus Esophageal Stent Placement in the Management of Patients With Metastatic Esophageal Cancer.

J Natl Compr Canc Netw 2020 05;18(5):569-574

Department of Radiation Medicine and Applied Sciences, University of California, San Diego, San Diego, California.

Background: Patients with advanced esophageal cancer often experience pain and dysphagia, yet the optimal palliative management remains unclear. This retrospective study evaluated outcomes and adverse effects of palliative radiotherapy (RT) compared with esophageal stenting among a cohort of U.S. veterans with metastatic esophageal cancer.

Patients And Methods: We identified 1,957 veterans in the United States with metastatic esophageal cancer who received palliative RT to the esophagus or esophageal stenting, and assessed the risks of severe adverse effects, including esophageal fistula formation, perforation, obstruction, hemorrhage, and esophagitis. We determined palliative efficacy by evaluating pain and dysphagia scores before and after intervention. Multivariable analyses were used to control for potential confounding factors.

Results: In our cohort, 1,593 patients underwent RT and 364 underwent esophageal stenting. The cumulative incidence of any severe adverse effect at 6 months was higher among patients who received stents compared with those who received RT (21.7% vs 12.4%; P<.0010). In multivariable analysis, patients who received stents had an increased risk of any severe adverse effect, including fistula, perforation, and hemorrhage (all P<.0500). Multivariable analysis also showed that, compared with stenting, RT was associated with more rapid and durable pain relief (P<.0010) with no difference in relief of dysphagia over time when accounting for pretreatment dysphagia scores (P=.1029).

Conclusions: Compared with esophageal stenting, RT was associated with a decreased risk of adverse effects, greater pain relief, and equivalent relief of moderate to severe dysphagia over time. Unmeasured patient- or tumor-related factors could have influenced the choice of intervention, thereby impacting our study outcomes. To our knowledge, this is the largest study to date analyzing the comparative risks and benefits of palliative RT and esophageal stenting among patients with metastatic esophageal cancer.
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http://dx.doi.org/10.6004/jnccn.2019.7524DOI Listing
May 2020

Managing Cancer Pain During the Opioid Epidemic-Balancing Caution and Compassion.

JAMA Oncol 2020 07;6(7):1103-1104

Department of Radiation Medicine and Applied Sciences, School of Medicine, University of California San Diego, La Jolla, California.

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http://dx.doi.org/10.1001/jamaoncol.2020.0779DOI Listing
July 2020
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