Publications by authors named "Ray Page"

39 Publications

Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial.

Clin Lung Cancer 2021 Jan 18;22(1):6-15.e4. Epub 2020 Sep 18.

Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg, Heidelberg, Germany.

Background: We evaluated maintenance nanoparticle albumin-bound (nab) paclitaxel in the treatment of advanced squamous non-small-cell lung cancer.

Patients And Methods: Patients with treatment-naive squamous non-small-cell lung cancer received four 21-day cycles of nab-paclitaxel 100 mg/m on days 1, 8, 15 plus carboplatin area under the curve 6 on day 1 as induction therapy. Patients without disease progression after induction were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m (days 1 and 8 every 21 days) plus best supportive care (BSC) or BSC alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included safety and overall survival (OS).

Results: Overall, 420 patients had received induction therapy; 202 (nab-paclitaxel plus BSC, 136; BSC, 66) had received maintenance therapy. Enrollment was discontinued after a preplanned interim futility analysis (patients could remain in the study at the investigator's discretion). The median PFS was 3.12 months for nab-paclitaxel plus BSC and 2.60 months for BSC; the difference was not statistically significant (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.19; P = .36). The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07). An updated analysis (median follow-up, 28.4 months) revealed a median OS of 17.61 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.68; 95% CI, 0.47-0.98; nominal P = .037). The most frequent grade 3 and 4 treatment-emergent adverse events for the entire study were neutropenia (53.1% [nab-paclitaxel plus BSC] vs. 50.0% [BSC]) and anemia (33.1% [nab-paclitaxel plus BSC] vs. 32.3% [BSC]). Only peripheral neuropathy had occurred in ≥ 5% of patients during maintenance therapy (13.1%; nab-paclitaxel plus BSC).

Conclusions: The results of the ABOUND.sqm did not meet the primary endpoint of PFS. An updated OS analysis revealed a trend favoring nab-paclitaxel plus BSC.
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http://dx.doi.org/10.1016/j.cllc.2020.09.007DOI Listing
January 2021

Prevalence and predictors of patients reporting adverse drug reactions to health care providers during oral targeted cancer treatment.

J Am Pharm Assoc (2003) 2021 Jan-Feb;61(1):53-59. Epub 2020 Oct 5.

Background: Pharmacovigilance is a critical component to facilitate clinicians' decision-making to alter or discontinue therapy. However, self-administration of oral targeted therapy (OTT) requires fewer clinical visits than parenteral infusions, potentially leading to an increase in the under-reporting of adverse drug reactions (ADRs).

Objective(s): To identify factors associated with patients reporting ADRs to their health care provider (HCP) and to identify the prevalence of unreported ADRs while on OTT.

Methods: Patients aged ≥18 years who received care from a community oncology clinic and newly prescribed an OTT between August 1, 2018, and October 31, 2018, were included. Six-monthly follow-up calls were conducted by the pharmacy staff to assess for gradable ADRs-validated by the NCI Common Terminology Criteria for Adverse Events-and ungradable ADRs. Descriptive analysis was used to analyze the prevalence of unreporting ADRs, and a multivariate logistic regression model was utilized to evaluate predictors of reporting ADRs to an HCP. Predictors included sociodemographic factors, severity of ADRs, insurance type, pharmacy setting, type of OTT, and the number of prescribed medications RESULTS: Of the 76 patients analyzed, the mean age was 63.32 ±11.55 years, 84.2% were women, 68.8% were non-Hispanic white, and 76.3% had breast cancer. During the follow-up calls, 306 ADRs were identified and 22.2% were not previously reported to an HCP. Of the unreported gradable ADRs, 63.2% were grade 1, 19.3% were grade 2, and 17.5% were grade 3. We found that for every 1-year increase in age, there was a 5% decrease in the likelihood of reporting ADRs (95% CI, 0.91-0.99), and men were 11.4 times more likely to report ADRs (95% CI, 1.29-100.8).

Conclusion: Follow-up calls served as an outlet to collect pharmacovigilance data by identifying over 20% of unreported ADRs to HCPs, in which over one-third were moderate to severe. However, future studies are needed to further understand the statistically significant differences found in under-reporting for women and the older population.
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http://dx.doi.org/10.1016/j.japh.2020.09.001DOI Listing
October 2020

Factors associated with adherence to follow-up calls in cancer patients receiving care at a community oncology practice.

J Oncol Pharm Pract 2020 Aug 20:1078155220950003. Epub 2020 Aug 20.

SaferCare Texas, University of North Texas Health Science Center, Fort Worth, TX, USA.

Background: Follow-up calls in the oncology setting are frequently used to augment care and encourage oral antineoplastic adherence. However, limited data are available on patient populations that would benefit from this intervention versus populations that may require alternative interventions. The purpose of this study was to identify characteristics among patients on oral antineoplastic agents that influence their likelihood to respond to follow-up calls.

Methods: Patients receiving care from one of the eight community oncology clinics within the same branch were analyzed. Patients were included if they were ≥18 years, received a new oral antineoplastic agent that was electronically prescribed between August 2018-October 2018, and picked up their first fill from their pharmacy of choice. Patients received up to six follow-up calls after picking up their first prescription. Calls were categorized as adherent (≥3 monthly interactions) or non-adherent (<3 monthly interactions). Logistic regression models were used to evaluate factors associated with follow-up call adherence. Factors included demographics, cancer stage, marital status, employment, pharmacy setting (internal pharmacy versus external pharmacy), and insurance used by the patient. Descriptive analysis was performed to analyze response rates, cancer diagnosis, and to determine the best time and day patients responded to follow-up calls.

Results: Data from 125 patients were analyzed, of which 65 patients (52%) were adherent to follow-up calls and the mean response rate over six months was 45% (range: 35% -- 54%). High success rates for follow-up calls were seen between 12-3 pm and on Tuesdays and Thursdays. After adjusting for covariates, patients with stage III-IV were 89% less likely to respond to follow-up calls compared to those with stage 0-II (95% CI: 0.02-0.64; p = 0.01), patients with commercial insurance were 79% less likely to adhere to follow-up calls compared to those on government insurance (95% CI: 0.06-0.71; p = 0.01), and patients using an external pharmacy had a 2.8 times increase odds of being adherent (95% CI 0.98-8.34; p = 0.05). All other factors were not significant.

Conclusions: For patients taking oral antineoplastics, non-adherence to follow-up calls was observed in more than 45% of patients receiving care from a community oncology clinic. Findings demonstrated that those with advanced stages of cancer, on commercial insurance, and going to an internal pharmacy were at higher risk for not adhering to follow up calls. Therefore, alternative methods for managing adherence and side effects in these populations are warranted.
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http://dx.doi.org/10.1177/1078155220950003DOI Listing
August 2020

Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study.

Clin Genitourin Cancer 2020 Dec 14;18(6):469-476.e4. Epub 2020 Jun 14.

US Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas, NV.

Background: The open-label, phase IIIb/IV CheckMate 374 study (NCT02596035) was conducted to validate the safety and efficacy of flat-dose nivolumab monotherapy 240 mg every 2 weeks (Q2W) in previously treated advanced/metastatic renal cell carcinoma (RCC). Three cohorts included patients with predominantly clear cell histology, non-clear cell histologies, or brain metastases. We report safety and efficacy from the CheckMate 374 advanced clear cell RCC (ccRCC) cohort.

Patients And Methods: Eligible patients received prior treatment regimens (1-2 antiangiogenic; 0-3 systemic) with progression on/after last treatment and ≤ 6 months of enrollment. Patients received nivolumab 240 mg Q2W for ≤ 24 months or until confirmed progression/unacceptable toxicity. The primary endpoint was incidence of high-grade (grade 3-5) immune-mediated adverse events (IMAEs). Exploratory endpoints included objective response rate, progression-free survival, and overall survival.

Results: Ninety-seven patients had advanced predominantly ccRCC; 75.3% received only 1 prior systemic regimen in the advanced/metastatic setting. After a median follow-up of 17 months (range, 0.4-26.9 months), no grade 5 IMAEs occurred, and 9.3% of patients reported grade 3/4 IMAEs (hepatitis, 4.1%; diabetes mellitus, 2.1%; nephritis and renal dysfunction, 1.0%; rash, 1.0%; adrenal insufficiency, 1.0%). The objective response rate was 22.7% (95% confidence interval [CI], 14.8%-32.3%). Three patients had a complete response; 19 had partial responses. The median progression-free survival was 3.6 months (95% CI, 2.0-5.5 months). The median overall survival was 21.8 months (95% CI, 17.4 months to not estimable).

Conclusions: This study validates the safety and efficacy of nivolumab 240 mg Q2W flat-dose monotherapy for previously treated advanced ccRCC and adds to previous safety and efficacy data using the 3 mg/kg Q2W dose.
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http://dx.doi.org/10.1016/j.clgc.2020.06.002DOI Listing
December 2020

Updates to the ASCO Patient-Centered Oncology Payment Model.

JCO Oncol Pract 2020 05 17;16(5):263-269. Epub 2020 Apr 17.

American Society of Clinical Oncology, Alexandria, VA.

The past decade has seen considerable innovation in the delivery of care and payment in oncology. Key initiatives have included the development of oncology medical home care delivery standards, the Medicare Oncology Care Model, and multiple commercial payer initiatives. Looking forward, our next challenge is to reflect on lessons learned from these limited-scale demonstration projects and work toward models that are scalable and sustainable and reflect true collaboration between payers and providers sharing common objectives and methods to advance cancer care delivery. To this end, ASCO continues its work on care delivery standards, quality measurement, and alternative payment models. Over the past year, ASCO has received input from physicians, administrators, payers, and employers to update its Patient-Centered Oncology Payment (PCOP) model. PCOP incorporates current work on provider-payer collaboration, the oncology medical home, and the value of clinical pathways and recognizes the need for common quality measurement, performance methodology, and payment structure across multiple sources of payment. The following represents a summary of the entire model. The model includes chapters on PCOP communities, clinical practice transformation, payment methodology, consolidated payments for oncology care, performance methodology, and implementation considerations. In future work, ASCO will continue its support of the PCOP model, including further development of care delivery standards, quality measures, and technology solutions (eg, CancerLinQ).
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http://dx.doi.org/10.1200/JOP.19.00776DOI Listing
May 2020

A Randomized, Double-Blinded, Phase II Trial of Carboplatin and Pemetrexed with or without Apatorsen (OGX-427) in Patients with Previously Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer: The SPRUCE Trial.

Oncologist 2019 12 16;24(12):e1409-e1416. Epub 2019 Aug 16.

Sarah Cannon Research Institute, Nashville, Tennessee, USA.

Background: This randomized, double-blinded, phase II trial evaluated the efficacy of carboplatin and pemetrexed plus either apatorsen, an antisense oligonucleotide targeting heat shock protein (Hsp) 27 mRNA, or placebo in patients with previously untreated metastatic nonsquamous non-small cell lung cancer (NSCLC).

Methods: Patients were randomized 1:1 to Arm A (carboplatin/pemetrexed plus apatorsen) or Arm B (carboplatin/pemetrexed plus placebo). Treatment was administered in 21-day cycles, with restaging every two cycles, until progression or intolerable toxicity. Serum Hsp27 levels were analyzed at baseline and during treatment. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate, and toxicity.

Results: The trial enrolled 155 patients (median age 66 years; 44% Eastern Cooperative Oncology Group performance status 0). Toxicities were similar in the 2 treatment arms; cytopenias, nausea, vomiting, and fatigue were the most frequent treatment-related adverse events. Median PFS and OS were 6.0 and 10.8 months, respectively, for Arm A, and 4.9 and 11.8 months for Arm B (differences not statistically significant). Overall response rates were 27% for Arm A and 32% for Arm B. Sixteen patients (12%) had high serum levels of Hsp27 at baseline. In this small group, patients who received apatorsen had median PFS of 10.8 months, and those who received placebo had median PFS 4.8 months.

Conclusion: The addition of apatorsen to carboplatin and pemetrexed was well tolerated but did not improve outcomes in patients with metastatic nonsquamous NSCLC cancer in the first-line setting.

Implications For Practice: This randomized, double-blinded, phase II trial evaluated the efficacy of carboplatin and pemetrexed plus either apatorsen, an antisense oligonucleotide targeting heat shock protein 27 mRNA, or placebo in patients with previously untreated metastatic nonsquamous non-small cell lung cancer (NSCLC). The addition of apatorsen to carboplatin and pemetrexed was well tolerated but did not improve outcomes in patients with metastatic nonsquamous NSCLC cancer in the first-line setting.
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http://dx.doi.org/10.1634/theoncologist.2018-0518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6975937PMC
December 2019

Opioids and Cancer Pain: Patients' Needs and Access Challenges.

J Oncol Pract 2019 05 23;15(5):229-231. Epub 2019 Apr 23.

2 Southcoast Physicians Group, Fairhaven, MA.

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http://dx.doi.org/10.1200/JOP.19.00081DOI Listing
May 2019

Clinical Utility of Comprehensive Cell-free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-small Cell Lung Cancer.

Clin Cancer Res 2019 Aug 15;25(15):4691-4700. Epub 2019 Apr 15.

MD Anderson Comprehensive Cancer Center, Houston, Texas.

Purpose: Complete and timely tissue genotyping is challenging, leading to significant numbers of patients with newly diagnosed metastatic non-small cell lung cancer (mNSCLC) being undergenotyped for all eight genomic biomarkers recommended by professional guidelines. We aimed to demonstrate noninferiority of comprehensive cell-free DNA (cfDNA) relative to physician discretion standard-of-care (SOC) tissue genotyping to identify guideline-recommended biomarkers in patients with mNSCLC.

Patients And Methods: Prospectively enrolled patients with previously untreated mNSCLC undergoing physician discretion SOC tissue genotyping submitted a pretreatment blood sample for comprehensive cfDNA analysis (Guardant360).

Results: Among 282 patients, physician discretion SOC tissue genotyping identified a guideline-recommended biomarker in 60 patients versus 77 cfDNA identified patients (21.3% vs. 27.3%; < 0.0001 for noninferiority). In tissue-positive patients, the biomarker was identified alone (12/60) or concordant with cfDNA (48/60), an 80% cfDNA clinical sensitivity for any guideline-recommended biomarker. For FDA-approved targets () concordance was >98.2% with 100% positive predictive value for cfDNA versus tissue (34/34 or -positive patients). Utilizing cfDNA, in addition to tissue, increased detection by 48%, from 60 to 89 patients, including those with negative, not assessed, or insufficient tissue results. cfDNA median turnaround time was significantly faster than tissue (9 vs. 15 days; < 0.0001). Guideline-complete genotyping was significantly more likely (268 vs. 51; < 0.0001).

Conclusions: In the largest cfDNA study in previously untreated mNSCLC, a validated comprehensive cfDNA test identifies guideline-recommended biomarkers at a rate at least as high as SOC tissue genotyping, with high tissue concordance, more rapidly and completely than tissue-based genotyping..
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http://dx.doi.org/10.1158/1078-0432.CCR-19-0624DOI Listing
August 2019

Implementing an Electronic End-of-Life Chemotherapy Utilization Measure.

J Oncol Pract 2019 04 18;15(4):220-223. Epub 2019 Mar 18.

1 Flatiron Health, New York, NY.

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http://dx.doi.org/10.1200/JOP.18.00408DOI Listing
April 2019

Safe Handling of Hazardous Drugs: ASCO Standards.

J Clin Oncol 2019 03 8;37(7):598-609. Epub 2019 Jan 8.

7 Michiana Hematology Oncology, Mishiwaka, IN.

Purpose: To provide 2019 ASCO standards on the safe handling of hazardous drugs.

Methods: An Expert Panel was formed, and a systematic review of the literature on closed system transfer devices was performed to May 2017 using PubMed. The Cochrane Database of Systematic Reviews, PubMed, and Google Scholar were used to search for studies of medical surveillance and external ventilation/health effects of exposure to vapors to November 2017. Available standards were considered for endorsement. Public comments were solicited and considered in preparation of the final manuscript.

Results: The search for primary research found no studies that addressed health outcomes as they relate to the identified interventions of interest. The ASCO Expert Panel endorses the best practices for safe handling of hazardous drugs as issued by the Occupational Safety and Health Administration, US Pharmacopeia Chapter 800, and Oncology Nursing Society with clarifications in four key areas: medical surveillance, closed system transfer devices, external ventilation of containment secondary engineering controls or containment segregated compounding areas, and alternative duties.

Conclusion: The ASCO standards address the need for clear standards concerning safe handling of hazardous oncology drugs. More research is needed in several key areas to quantify the level of risk associated with handling hazardous drugs in current workplace settings where the hierarchy of controls is consistently applied. Additional information is available at www.asco.org/safe-handling-standards .
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http://dx.doi.org/10.1200/JCO.18.01616DOI Listing
March 2019

Reducing Cancer Costs Through Symptom Management and Triage Pathways.

J Oncol Pract 2019 02 21;15(2):e91-e97. Epub 2018 Dec 21.

4 Center for Cancer and Blood Disorders, Fort Worth, TX.

Purpose: Value-based care infers care that is high quality at a comparatively low total cost. A key strategy for value-based oncology care is to avoid unnecessary emergency room (ER) visits and associated hospitalizations of patients receiving treatment for cancer. Early experience with this strategy showed that symptom management in patients with cancer can result in the reduction of ER events and hospitalizations. However, quantifying the actual savings achieved has been elusive. In this article, we present the impact of symptom management and triage pathways programs deployed at two midsize community oncology practices. We then quantify the actual dollar saving in their Medicare and commercial populations.

Methods: Symptom management records generated through the ER triage programs at the two practices were screened to identify avoided ER events. This approach was validated with an independent analysis using Medicare claim data from the Oncology Care Model program in which both practices participate. Bootstrap simulations were used to test for statistical significance of the ER event rate changes before and after the launch of the program. Average event and annual total cost savings from avoided ER incidents and ER-related hospitalizations were then calculated.

Results: Two hundred twenty-two avoided ER events were identified, for an estimated net annualized savings generated by the two practices of $3.85 million. Although the ER rate reduction was not statistically significant, these findings are consistent with the observed reduction of ER event rates among a subset of Oncology Care Model beneficiaries at the two practices.

Conclusion: ER events and associated hospitalizations can be avoided as well as quantified as a result of the deployment of a practice-level integrated platform that incorporates physician-scripted symptom management protocols and telephone triage pathways.
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http://dx.doi.org/10.1200/JOP.18.00082DOI Listing
February 2019

Impact on Oncology Practices of Including Drug Costs in Bundled Payments.

J Oncol Pract 2018 05 12;14(5):e259-e268. Epub 2018 Apr 12.

Swedish Cancer Institute, Edmonds, WA; American Society of Clinical Oncology, Alexandria, VA; Center for Cancer and Blood Disorders, Weatherford, TX; WellRithms, Portland, OR; Parkland Health System; University of Texas Southwestern, Dallas; University of Texas MD Anderson Cancer Center, Houston, TX; and University of Chicago, Chicago, IL.

Introduction: This analysis evaluates the impact of bundling drug costs into a hypothetic bundled payment.

Methods: An economic model was created for patient vignettes from: advanced-stage III colon cancer and metastatic non-small-cell lung cancer. First quarter 2016 Medicare reimbursement rates were used to calculate the average fee-for-service (FFS) reimbursement for these vignettes. The probabilistic risk faced by practices was captured by the type of patients seen in practices and randomly assigned in a Monte Carlo simulation on the basis of the given distribution of patient types within each cancer. Simulations were replicated 1,000 times. The impact of bundled payments that include drug costs for various practice sizes and cancer types was quantified as the probability of incurring a loss at four magnitudes: any loss, > 10%, > 20%, or > 30%. A loss was defined as receiving revenue from the bundle that was less than what the practice would have received under FFS; the probability of loss was calculated on the basis of the number of times a practice reported a loss among the 1,000 simulations.

Results: Practices that treat a substantial proportion of patients with complex disease compared with the average patient in the bundle would have revenue well below that expected from FFS. Practices that treat a disproportionate share of patients with less complex disease, as compared with the average patient in the bundle, would have revenue well above the revenue under FFS. Overall, bundled payments put practices at greater risk than FFS because their patient case mix could greatly skew financial performance.

Conclusion: Including drug costs in a bundle is subject to the uncontrollable probabilistic risk of patient case mixes.
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http://dx.doi.org/10.1200/JOP.17.00036DOI Listing
May 2018

When Investment Meets Return.

Authors:
Robin Zon Ray Page

J Oncol Pract 2018 03 7;14(3):147-148. Epub 2018 Feb 7.

Michiana Hematology Oncology, Mishawaka, IN; Center for Cancer and Blood Disorders, Fort Worth, TX.

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http://dx.doi.org/10.1200/JOP.2017.027060DOI Listing
March 2018

Oncology Clinical Pathways: Charting the Landscape of Pathway Providers.

J Oncol Pract 2018 03 7;14(3):e194-e200. Epub 2018 Feb 7.

Memorial Sloan Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; Michiana Hematology-Oncology, Mishawaka, IN; Center for Cancer and Blood Disorders, Fort Worth, TX; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA; American Society of Clinical Oncology, Alexandria, VA; and City of Hope, Rancho Cucamonga, CA.

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http://dx.doi.org/10.1200/JOP.17.00033DOI Listing
March 2018

Patterns of Biomarker Testing Rates and Appropriate Use of Targeted Therapy in the First-Line, Metastatic Non-Small Cell Lung Cancer Treatment Setting.

J Clin Pathw 2018 Jan-Feb;4(1):49-54

Florida Hospital Cancer Institute, Orlando, FL.

Despite clear clinical benefit and guideline recommendations for predictive biomarker testing and subsequent first-line targeted therapy treatment in patients with non-small cell lung cancer (NSCLC), there is evidence that testing has not been widely embraced in the clinical setting. This study uses clinical pathways to understand biomarker testing patterns and ensuing first-line treatment decisions. Data of patients with metastatic NSCLC were analyzed for testing rates and treatment selection at 7 cancer programs using data input by providers into the pathways software. Findings were analyzed by type of provider (community or academic). Among providers using clinical pathways, biomarker testing rates were high and appropriate selection of targeted therapy was observed. Clinical pathways can act as a tool to assist oncology practices to promote testing of key biomarkers and subsequent selection of appropriate therapy.
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http://dx.doi.org/10.25270/jcp.2018.02.00001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709712PMC
August 2019

Financial Conflicts of Interest Among Oncology Clinical Pathway Vendors.

JAMA Oncol 2018 Feb;4(2):255-257

The Center for Cancer and Blood Disorders, Ft Worth, Texas.

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http://dx.doi.org/10.1001/jamaoncol.2017.4473DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838596PMC
February 2018

Measuring Quality Is Complicated.

Authors:
Debra Patt Ray Page

J Oncol Pract 2018 01 6;14(1):1-2. Epub 2017 Dec 6.

Texas Oncology, Austin; and The Center for Cancer and Blood Disorders, Fort Worth, TX.

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http://dx.doi.org/10.1200/JOP.2017.027789DOI Listing
January 2018

-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy.

Lung Cancer (Auckl) 2017 30;8:207-216. Epub 2017 Oct 30.

Department of Oncology/Hematology, S.G. Moscati Hospital, Avellino, Italy.

Background: Longitudinal data on the impact of treatment on quality of life (QoL) in advanced non-small cell lung cancer (NSCLC) are limited. In this palliative setting, treatment that does not deteriorate QoL is key. Here we report longitudinal QoL in patients with squamous NSCLC, receiving ≤4 cycles of -paclitaxel/carboplatin combination chemotherapy.

Methods: Patients received -paclitaxel 100 mg/m days 1, 8, 15 + carboplatin area under the curve 6 mg•min/mL day 1 (q3w) for four cycles. QoL was assessed by the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L) at baseline and each cycle (day 1).

Results: Two-hundred and six lesion-response-evaluable patients completed baseline + ≥1 postbaseline QoL assessment and were QoL evaluable. LCSS average total score and symptom burden index improved from baseline throughout four cycles. In the LCSS pulmonary symptoms score, 46% of patients reported clinically meaningful improvement (≥10 mm visual analog scale) from baseline. Individual EQ-5D-5L dimensions remained stable/improved in ≥83% of patients; ≈33% reported complete resolution of baseline problems at least once during four cycles. Generally, responders (unconfirmed complete/partial response) had higher scores vs nonresponders.

Conclusion: In patients with squamous NSCLC, four cycles of -paclitaxel/carboplatin demonstrated clinically meaningful QoL improvements, with greater benefits in responders vs nonresponders.
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http://dx.doi.org/10.2147/LCTT.S138570DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5679693PMC
October 2017

The Role of Proteomic Testing in Improving Prognosis And Care Planning Quality Measures for Lung Cancer.

Manag Care 2017 09;26(9):37-47

Highlands Oncology Group, Fayetteville, Ark.

Purpose: The Oncology Care Model (OCM) is a payment model from the Centers for Medicare and Medicaid Services designed to reduce costs and improve quality in cancer care. Key components of quality for the OCM originate from the 13-component cancer care plan. We surveyed the literature to understand the value of prognosis in OCM-directed planning for non-small-cell lung cancer (NSCLC) care and to investigate how the results of a prognostic, proteomic biomarker test, the VeriStrat test, can help OCM-participating providers meet the specific quality measures.

Design: A targeted literature review was supplemented by real-world author experience.

Methodology: Available MEDLINE-indexed literature on the topic of lung cancer prognosis and cancer care planning (1997-2017) were reviewed. Authors also included relevant commentary based on their own real-world experience with VeriStrat testing and prognostic conversations.

Results: There was near-universal consensus in guidelines and literature about the critical importance of early, candid, and ongoing physician-patient discussions about prognosis, which informs most components of the OCM care plan. The VeriStrat test has been shown to provide accurate predictions of outcomes in all lines of therapy and in various treatments for patients with NSCLC, including chemotherapies and EGFR-TKI therapies.

Conclusion: Accurate prognostic estimates, such as those provided by the VeriStrat test, are useful for predicting and documenting expected response to treatment, avoiding ineffective and costly overtreatment and for facilitating meaningful conversations with NSCLC patients about the timing of best supportive care and hospice care when appropriate, thereby improving cancer care planning and quality scores.
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September 2017

American Society of Clinical Oncology Criteria for High-Quality Clinical Pathways in Oncology.

J Oncol Pract 2017 03 7;13(3):207-210. Epub 2017 Feb 7.

Michiana Hematology-Oncology PC, Mishawaka, IN; Roswell Park Cancer Institute, Buffalo, NY; The Center for Cancer and Blood Disorders, Fort Worth, TX; Charleston Area Medical Center, Charleston, WV; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA; Cancer Research Advocate, Grand Island, NE; American Society of Clinical Oncology, Alexandria, VA; and City of Hope, Rancho Cucamonga, CA.

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http://dx.doi.org/10.1200/JOP.2016.019836DOI Listing
March 2017

Impact of a multivariate serum-based proteomic test on physician treatment recommendations for advanced non-small-cell lung cancer.

Curr Med Res Opin 2017 06 16;33(6):1091-1097. Epub 2017 Mar 16.

c The Center for Cancer and Blood Disorder , Fort Worth , TX , USA.

Objective: The VeriStrat (VS) test is intended to help guide treatment decisions for patients with advanced non-small-cell lung cancer (NSCLC) without an EGFR-sensitizing mutation, classifying patients into two categories. Patients classified as VSGood have a favorable prognosis and significant clinical response to EGFR tyrosine kinase inhibitors (TKIs). Patients classified as VSPoor have a less favorable prognosis and exhibit no significant response to EGFR-TKIs. The objective of this paper is to assess the real-world impact of VS test results on physicians' treatment recommendations including referrals for best supportive care (BSC).

Methods: Between 1 January 2012 and 1 November 2016, physician respondents were asked to complete standardized questionnaires before and after receiving VS results in patients meeting criteria for the intended use of the VS test. This study evaluated three endpoints: whether physicians followed VS test results in making treatment recommendations, the extent to which tests results changed these treatment recommendations, and the patterns of care subsequent to VS testing.

Results: Of the tests ordered by 989 physicians, 2494 VS tests had completed treatment recommendation questionnaires both prior to and after testing. Prior to VS testing, physicians were considering treatment with EGFR-TKIs for 2250 patients (90%). The VS test classified 1950 patients as VSGood and 544 patients as VSPoor. For patients classified as VSPoor, physicians recommended BSC for 25% of patients and standard systemic treatments such as chemotherapies for 65% of patients. Consistent with previous publications, physicians recommended EGFR-TKI therapy for only 10% of VSPoor patients but for 89% of VSGood patients. Overall, physician's treatment recommendations were consistent with test results in 98% of cases. Availability of test results decreased ineffective treatment recommendations by 89% for VSPoor patients.

Conclusions: Among physicians ordering VS, the test significantly influenced treatment recommendations for patients with NSCLC, reducing ineffective and expensive treatment at the end of life.
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http://dx.doi.org/10.1080/03007995.2017.1301903DOI Listing
June 2017

PD-L1 Expression by Two Complementary Diagnostic Assays and mRNA In Situ Hybridization in Small Cell Lung Cancer.

J Thorac Oncol 2017 01 14;12(1):110-120. Epub 2016 Sep 14.

Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado. Electronic address:

Introduction: Therapeutic antibodies to immune checkpoints show promising results. Programmed death-ligand 1 (PD-L1), an immune checkpoint ligand, blocks the cancer immunity cycle by binding the PD-L1 receptor (programmed death 1). We investigated PD-L1 protein expression and messenger RNA (mRNA) levels in SCLC.

Methods: PD-L1 protein expression and mRNA levels were determined by immunohistochemistry (IHC) with SP142 and Dako 28-8 PD-L1 antibodies and in situ hybridization in primary tumor tissue microarrays in both tumor cells and tumor-infiltrating immune cells (TIICs) obtained from a limited-disease SCLC cohort of 98 patients. An additional cohort of 96 tumor specimens from patients with extensive-disease SCLC was assessed for PD-L1 protein expression in tumor cells with Dako 28-8 antibody only.

Results: The overall prevalence of PD-L1 protein expression in tumor cells was 16.5%. In the limited-disease cohort, the prevalences of PD-L1 protein expression in tumor cells with SP142 and Dako 28-8 were 14.7% and 19.4% (tumor proportion score cutoff ≥1%) and PD-L1 mRNA ISH expression was positive in 15.5% of tumor samples. Increased PD-L1 protein/mRNA expression was associated with the presence of more TIICs (p < 0.05). The extensive-disease cohort demonstrated a 14.9% positivity of PD-L1 protein expression in tumor cells with Dako 28-8 antibody.

Conclusions: A subset of SCLCs is characterized by positive PD-L1 and/or mRNA expression in tumor cells. Higher PD-L1 and mRNA expression correlate with more infiltration of TIICs. The prevalence of PD-L1 in SCLC is lower than that published for NSCLC. The predictive role of PD-L1 expression in SCLC treatment remains to be established.
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http://dx.doi.org/10.1016/j.jtho.2016.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353355PMC
January 2017

A Pathway Through the Bundle Jungle.

J Oncol Pract 2016 06 12;12(6):504-9. Epub 2016 May 12.

The University of Chicago, Chicago, IL; Puget Sound Cancer Centers, Edmonds, WA; University of Texas Southwestern Medical Center, Dallas; The Center for Cancer and Blood Disorders, Fort Worth, TX; Medical Oncology and Hematology Associates, Clive, IA; and Sarah Cannon, Nashville, TN

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http://dx.doi.org/10.1200/JOP.2015.008789DOI Listing
June 2016

Oncology Pathways-Preventing a Good Idea From Going Bad.

JAMA Oncol 2016 Mar;2(3):297-8

Section of Hematology and Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.

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http://dx.doi.org/10.1001/jamaoncol.2015.5778DOI Listing
March 2016

American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology.

J Oncol Pract 2016 Mar 12;12(3):261-6. Epub 2016 Jan 12.

Michiana Hematology-Oncology PC, South Bend, IN Charleston Area Medical Center, Charleston, WV; Vanderbilt-Ingram Cancer Center, Nashville, TN; The Center for Cancer and Blood Disorders, Fort Worth, TX; American Society of Clinical Oncology, Alexandria, VA; Polsinelli Shughart, Washington, DC; and City of Hope, Rancho Cucamonga, CA.

The use of clinical pathways in oncology care is increasingly important to patients and oncology providers as a tool for enhancing both quality and value. However, with increasing adoption of pathways into oncology practice, concerns have been raised by ASCO members and other stakeholders. These include the process being used for pathway development, the administrative burdens on oncology practices of reporting on pathway adherence, and understanding the true impact of pathway use on patient health outcomes. To address these concerns, ASCO's Board of Directors established a Task Force on Clinical Pathways, charged with articulating a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. These recommendations have been approved and adopted by ASCO's Board of Directors on August 12, 2015, and are presented herein.
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http://dx.doi.org/10.1200/JOP.2015.009134DOI Listing
March 2016

Refining the Standard of Care: How Oncology Treatment Pathways Can Make a Difference.

Authors:
Ray D Page

J Oncol Pract 2016 Feb 12;12(2):143-4. Epub 2016 Jan 12.

The Center for Cancer and Blood Disorders, Fort Worth, TX

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http://dx.doi.org/10.1200/JOP.2015.007872DOI Listing
February 2016

The patient-centered medical home in oncology: from concept to reality.

Am Soc Clin Oncol Educ Book 2015 :e82-9

From The Center for Cancer and Blood Disorders, Fort Worth, TX; UnitedHealthcare, Minnetonka, MN; Consultants in Medical Oncology and Hematology, Drexel Hill, PA; New Mexico Cancer Center, Albuquerque, NM.

In recent years, the cost of providing quality cancer care has been subject to an epic escalation causing concerns on the verge of a health care crisis. Innovative patient-management models in oncology based on patient-centered medical home (PCMH) principles, coupled with alternative payments to traditional fee for service (FFS), such as bundled and episodes payment are now showing evidence of effectiveness. These efforts have the potential to bend the cost curve while also improving quality of care and patient satisfaction. However, going forward with FFS alternatives, there are several performance-based payment options with an array of financial risks and rewards. Most novel payment options convey a greater financial risk and accountability on the provider. Therefore, the oncology medical home (OMH) can be a way to mitigate some financial risks by sharing savings with the payer through better global care of the patient, proactively preventing complications, emergency department (ED) visits, and hospitalizations. However, much of the medical home infrastructure that is required to reduced total costs of cancer care comes as an added expense to the provider. As best-of-practice quality standards are being elucidated and refined, we are now at a juncture where payers, providers, policymakers, and other stakeholders should work in concert to expand and implement the OMH framework into the variety of oncology practice environments to better equip them to assimilate into the new payment reform configurations of the future.
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http://dx.doi.org/10.14694/EdBook_AM.2015.35.e82DOI Listing
February 2016

Outcome and economic implications of proteomic test-guided second- or third-line treatment for advanced non-small cell lung cancer: extended analysis of the PROSE trial.

Lung Cancer 2015 May 12;88(2):223-30. Epub 2015 Mar 12.

The Center for Cancer and Blood Disorders, 800W Magnolia Avenue, Fort Worth, TX 76104, USA. Electronic address:

Objectives: Lung cancer accounts for a significant number of new cancer cases and deaths, with the majority of patients presenting with non-small cell lung cancer (NSCLC). Although epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors are recommended as an alternative to chemotherapy for certain patients, challenges exist for clinical utilization. The objective of this analysis was to assess the outcome and economic implications of a clinically validated serum-based proteomic test to guide treatment decisions in patients with advanced NSCLC, who are EGFR-negative or status unknown, and have progressed following at least one chemotherapy regimen.

Methods: This analysis was conducted from a US payer perspective. Clinical outcomes were evaluated over the lifetime of a patient, based on data from randomized trials and clinical studies. The clinical endpoints included treatment utilization, adverse events, survival, and a composite measure of length and quality of life, referred to as the quality-adjusted life year (QALY). Costs for testing, treatment, surveillance, and management of adverse events were analyzed based on publicly available costs of the related procedures. The economic endpoints were cumulative lifetime direct medical costs and cost per QALY gained.

Results: In the base case, treatment recommendation for 27.3% of the patient population changed from erlotinib to chemotherapy after using the proteomic test. Overall survival increased by 0.091 year and QALYs increased by 0.050 year. The total lifetime direct medical cost per patient decreased by $135 with test-guided treatment. The findings were robust over a wide range of variation in the input parameters.

Conclusion: The serum-based proteomic test informed treatment selection for patients with advanced NSCLC who failed previous chemotherapy regimen(s), improving QALYs and saving costs.
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http://dx.doi.org/10.1016/j.lungcan.2015.03.006DOI Listing
May 2015

Reply to M. Thompson et Al.

J Oncol Pract 2015 May 3;11(3):263-4. Epub 2015 Mar 3.

The University of Chicago, Chicago, IL.

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http://dx.doi.org/10.1200/JOP.2015.003897DOI Listing
May 2015

Reply to a. Small et al.

J Oncol Pract 2015 Mar 16;11(2):162. Epub 2014 Dec 16.

Center for Blood and Cancer Disorders, Fort Worth, TX.

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http://dx.doi.org/10.1200/JOP.2014.002071DOI Listing
March 2015