Publications by authors named "Alfred I Neugut"

512 Publications

Racial Disparities in Children, Adolescents, and Young Adults with Hodgkin Lymphoma Enrolled in the New York State Medicaid Program.

J Adolesc Young Adult Oncol 2021 Oct 8. Epub 2021 Oct 8.

Center for Oncology Hematology Outcomes Research and Training (COHORT) and Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento, California, USA.

We examined the impact of race/ethnicity and age on survival in a publicly insured cohort of children and adolescent/young adults (AYA; 15-39 years) with Hodgkin lymphoma, adjusting for chemotherapy using linked Medicaid claims. We identified 1231 Medicaid-insured patients <1-39 years diagnosed with classical Hodgkin lymphoma between 2005 and 2015, in the New York State Cancer Registry. Chemotherapy regimens were based on contemporary therapeutic regimens. Cox proportional hazards regression models quantified associations of patient, disease, and treatment variables with overall survival (OS) and disease-specific survival (DSS), and are presented as hazard ratios (HR) with confidence intervals (95% CIs). At median follow-up of 6.6 years,  = 1108 (90%) patients were alive; 5-year OS was 92% in children <15 years. In multivariable models, Black (vs. White) patients had 1.6-fold increased risk of death (HR: 1.58, 95% CI: 1.02-2.46;  = 0.042). Stage III/IV (vs. I/II) was associated with 1.9-fold increased risk of death (HR: 1.86, 95% CI: 1.25-2.78;  = 0.002) and treatment at a non-National Cancer Institute (NCI) affiliate was associated with worse DSS (HR: 2.71, 95% CI: 1.47-4.98;  = 0.001). In this Medicaid-insured cohort of children and AYAs with Hodgkin lymphoma, Black race/ethnicity remained associated with inferior OS in multivariable models adjusted for disease, demographic, and treatment data. Further work is needed to identify dimensions of health care access not mediated by insurance, as findings suggest additional factors are contributing to observed cancer disparities in vulnerable pediatric and AYA populations.
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http://dx.doi.org/10.1089/jayao.2021.0131DOI Listing
October 2021

The Impact of HIV on Non-AIDS defining gastrointestinal malignancies: A review.

Semin Oncol 2021 Sep 22. Epub 2021 Sep 22.

Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York NY; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York NY; Herbert Irving Comprehensive Cancer Center, Vagelos College of Physicians and Surgeons, Columbia University, New York NY.

Background: Cancer is the leading cause of morbidity and mortality among people living with HIV (PLWH). Although gastrointestinal (GI) cancers are not associated with HIV, their incidence is rising among PLWH, and yet little is known about how HIV affects their presentation, treatment and outcomes.

Methods: We searched PubMed using "HIV" and "cancer", "esophageal cancer", "gastric cancer", "stomach cancer", "gastroesophageal cancer", "colorectal cancer", "colon cancer", or "rectal cancer". We included studies comparing an HIV-positive group (n ≥ 4) to an HIV-negative group, with respect to clinical presentation, treatment, or mortality of GI cancers.

Results: Of 18 articles that met inclusion criteria, 17 were retrospective, and 13 described patients in the United States. At diagnosis with colorectal, but not pancreatic, gastric, or esophageal cancer, PLWH were younger than patients who were HIV-negative. PLWH did not present with more advanced stage GI cancers than patients who were HIV-negative. Compared to HIV-negative controls, PLWH with colorectal cancer had a higher proportion of right-sided versus left-sided colon cancers and a higher proportion of rectal versus colon cancers. Among patients diagnosed with colorectal or pancreatic cancer, PLWH were less likely to receive cancer treatment than other patients; no studies examined the association of HIV status with treatment for esophageal or gastric cancer. PLWH with GI malignancies had higher all-cause mortality compared to patients who were HIV-negative, but evidence for cancer-specific mortality was limited and mixed.

Conclusion: PLWH with GI malignancies were less likely to receive cancer treatment and had higher all-cause mortality than patients who were HIV-negative. Most of the studies focused on colorectal cancer; more studies are needed in pancreatic, gastric and esophageal cancer. Future studies should investigate the effects of HIV on cancer-specific mortality, especially among patients in low- and middle-income countries, including those with high HIV prevalence.
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http://dx.doi.org/10.1053/j.seminoncol.2021.09.001DOI Listing
September 2021

The Looming Threat: Cancer in Sub-Saharan Africa.

Oncologist 2021 Sep 2. Epub 2021 Sep 2.

Division of Medical Oncology, University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa.

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http://dx.doi.org/10.1002/onco.13963DOI Listing
September 2021

Survival of south african women with breast cancer receiving anti-retroviral therapy for HIV.

Breast 2021 Oct 3;59:27-36. Epub 2021 Jun 3.

Non-Communicable Diseases Research Division, Wits Health Consortium (PTY) Ltd, 31 Princess of Wales Building, Johannesburg, 2193 South Africa; Department of Medicine, University of Witwatersrand Faculty of Health Sciences, 7 York Road Johannesburg, South Africa.

Purpose: Breast cancer outcomes in sub-Saharan Africa is reported to be poor, with an estimated five-year survival of 50% when compared to almost 90% in high-income countries. Although several studies have looked at the effect of HIV in breast cancer survival, the effect of ARTs has not been well elucidated.

Methods: All females newly diagnosed with invasive breast cancer from May 2015-September 2017 at Charlotte Maxeke Johannesburg Academic and Chris Hani Baragwanath Academic Hospital were enrolled. We analysed overall survival and disease-free survival, comparing HIV positive and negative patients. Kaplan-Meier survival curves were generated with p-values calculated using a log-rank test of equality while hazard ratios and their 95% confidence intervals (CIs) were estimated using Cox regression models.

Results: Of 1019 patients enrolled, 22% were HIV positive. The overall survival (95% CI) was 53.5% (50.1-56.7%) with a disease-free survival of 55.8% (52.1-59.3) after 4 years of follow up. HIV infection was associated with worse overall survival (HR (95% CI): 1.50 (1.22-1.85), p < 0.001) and disease-free survival (OR (95% CI):2.63 (1.71-4.03), p < 0.001), especially among those not on ART at the time of breast cancer diagnosis. Advanced stage of the disease and hormone-receptor negative breast cancer subtypes were also associated with poor survival.

Conclusion: HIV infection was associated with worse overall and disease-free survival. HIV patients on ARTs had favourable overall and disease-free survival and with ARTs now being made accessible to all the outcome of women with HIV and breast cancer is expected to improve.
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http://dx.doi.org/10.1016/j.breast.2021.05.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8209274PMC
October 2021

Impact of HIV infection on overall survival among women with stage IV breast cancer in South Africa.

Breast Cancer Res Treat 2021 Aug 14;189(1):285-296. Epub 2021 Jun 14.

Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.

Purpose: Advanced breast cancer (BC) at diagnosis is common in sub-Saharan Africa (SSA), including among women living with HIV (WLWH). In public hospitals across South Africa (SA), 10-15% of women present with stage IV BC, compared to < 5% in the United States (US); 20% of new BC diagnoses in SA are in WLWH. We evaluated the impact of HIV on overall survival (OS) among women with stage IV BC.

Methods: We conducted a prospective cohort study of women diagnosed with stage IV BC between February 2, 2015 and September 18, 2019 at six public hospitals in SA. Multivariate Cox regression models were used to estimate the association between HIV status and OS.

Results: Among 550 eligible women, 147 (26.7%) were WLWH. Compared to HIV-negative BC patients, WLWH were younger (median age 45 vs. 60 years, p < 0.001), predominantly black (95.9% vs. 77.9%, p < 0.001), and more likely to have hormone receptor-negative (hormone-negative) BC (32.7% vs. 22.6%, p = 0.016). Most women received systemic cancer-directed therapy (80.1%). HIV status was not associated with treatment or OS (Hazard Ratio (HR) 1.13 [95%CI 0.89-1.44]). On exploratory subgroup analysis, WLWH and hormone-negative BC had shorter OS compared to HIV-uninfected women (1-year OS: 27.1% vs. 48.8%, p = 0.003; HR 1.94 [95%CI 1.27-2.94]; p = 0.002), which was not observed for hormone receptor-positive BC.

Conclusion: HIV status was not associated with worse OS in women with stage IV BC in SA and cannot account for the poor survival in this cohort. Subgroup analysis revealed that WLWH with hormone-negative BC had worse OS, which warrants further investigation.
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http://dx.doi.org/10.1007/s10549-021-06265-wDOI Listing
August 2021

Efficacy and cost of high-frequency IGRT in elderly stage III non-small-cell lung cancer patients.

PLoS One 2021 27;16(5):e0252053. Epub 2021 May 27.

Department of Radiation Oncology, New York Presbyterian Hospital, New York, New York, United States of America.

Background: High-frequency image-guided radiotherapy (hfIGRT) is ubiquitous but its benefits are unproven. We examined the cost effectiveness of hfIGRT in stage III non-small-cell lung cancer (NSCLC).

Methods: We selected stage III NSCLC patients ≥66 years old who received definitive radiation therapy from the Surveillance, Epidemiology, and End-Results-Medicare database. Patients were stratified by use of hfIGRT using Medicare claims. Predictors for hfIGRT were calculated using a logistic model. The impact of hfIGRT on lung toxicity free survival (LTFS), esophageal toxicity free survival (ETFS), cancer-specific survival (CSS), overall survival (OS), and cost of treatment was calculated using Cox regressions, propensity score matching, and bootstrap methods.

Results: Of the 4,430 patients in our cohort, 963 (22%) received hfIGRT and 3,468 (78%) did not. By 2011, 49% of patients were receiving hfIGRT. Predictors of hfIGRT use included treatment with intensity-modulated radiotherapy (IMRT) (OR = 7.5, p < 0.01), recent diagnosis (OR = 51 in 2011 versus 2006, p < 0.01), and residence in regions where the Medicare intermediary allowed IMRT (OR = 1.50, p < 0.01). hfIGRT had no impact on LTFS (HR 0.97; 95% CI 0.86-1.09), ETFS (HR 1.05; 95% CI 0.93-1.18), CSS (HR 0.94; 95% CI 0.84-1.04), or OS (HR 0.95; 95% CI 0.87-1.04). Mean radiotherapy and total medical costs six months after diagnosis were $17,330 versus $15,024 (p < 0.01) and $71,569 versus $69,693 (p = 0.49), respectively.

Conclusion: hfIGRT did not affect clinical outcomes in elderly patients with stage III NSCLC but did increase radiation cost. hfIGRT deserves further scrutiny through a randomized controlled trial.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252053PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8158910PMC
October 2021

Patient perspectives on treatment decision-making under clinical uncertainty: chemotherapy treatment decisions among stage II colon cancer patients.

Transl Behav Med 2021 Oct;11(10):1905-1914

Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, NY, USA.

The decision to use adjuvant chemotherapy (ACT) after surgical resection for stage II colon cancer remains an area of clinical uncertainty. Many patients diagnosed with stage II colon cancer receive ACT, despite inconclusive evidence of long-term clinical benefit. This study investigates patient experiences and perceptions of treatment decision-making and shared decision making (SDM) for ACT among patients diagnosed with stage II colon cancer. Stage II colon cancer patients engaged in treatment or follow-up care aged >18 years were recruited from two large NYC health systems. Patients participated in 30-60-min semi-structured interviews. All interviews were transcribed, translated, coded, and analyzed using a thematic analysis approach. We interviewed 31 patients, of which 42% received ACT. Overall, patient perspectives indicate provider inconsistency in communicating ACT harms, benefits, and uncertainties, and poor elicitation of patient preferences and values. Patients reported varying perceptions and understanding of personal risk and clinical benefits of ACT. For many patients, receiving a clear treatment recommendation from the provider limited their participation in the decision-making process, whether it aligned with their decisional support preferences or not. Findings advance understanding of perceived roles and preferences of patients in SDM processes for cancer treatment under heightened clinical uncertainty, and indicate a notable gap in understanding for decisions made using SDM models in the context of clinical uncertainty. Educational and communication strategies and training are needed to support providers in communicating uncertainty, risk, treatment options, and implementing clinical guidelines to support patient awareness and informed decisions.
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http://dx.doi.org/10.1093/tbm/ibab040DOI Listing
October 2021

PAM50- and immunohistochemistry-based subtypes of breast cancer and their relationship with breast cancer mortality in a population-based study.

Breast Cancer 2021 Nov 18;28(6):1235-1242. Epub 2021 May 18.

Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, Box 1057, New York, NY, 10029 , USA.

Purpose: We evaluated the prognostic ability of immunohistochemistry (IHC)-based vs. PAM50-based subtypes for breast cancer mortality in a population-based study of breast cancer.

Methods: We included a total of 463 breast cancer cases from the population-based Long Island Breast Cancer Study Project (LIBCSP). IHC-based markers were abstracted from the medical records, while the PAM50-based intrinsic subtypes were assessed from tumor tissues using NanoString nCounter Analysis System. Cox proportional hazards models were used to estimate hazards ratios (HRs) for breast cancer-specific mortality associated with subtypes.

Results: For IHC-based hormone receptor-positive (HR+) tumors (n = 361), 68.7% were classified as luminal subtypes by PAM50; for HR- tumors (n = 102), 95.1% were classified as non-luminal subtypes. Compared to HR+/HER2- subtype, HR- patients had significantly higher breast cancer mortality (HR-/HER2+: HR = 2.84, 95% CI = 1.58-5.11; triple-negative breast cancer: HR = 2.42, 95% CI = 1.44-4.06). Compared to luminal A, a higher mortality rate was observed for all other PAM50-based subtypes: luminal B (HR = 4.03, 95% CI = 1.97-8.22), HER2-enriched (HR = 6.82, 95% CI = 3.29-14.14) and basal-like (HR = 4.71, 95% CI = 2.24-9.93). Additional subtyping of HR+ patients by PAM50 provided future risk stratification where luminal B patients in this group had significant higher mortality than luminal A patients (HR = 3.93, 95% CI = 1.92-8.03). Similar results were also observed among 291 HR+/HER2- patients, but not among the HR- patients.

Conclusions: Our study suggests that for HR+ patients, especially HR+/HER2- patients, additional PAM50-based subtyping would provide better prognostic stratification and improve disease management.
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http://dx.doi.org/10.1007/s12282-021-01261-wDOI Listing
November 2021

Patient-Reported Outcomes and Long-Term Nonadherence to Aromatase Inhibitors.

J Natl Cancer Inst 2021 Aug;113(8):989-996

SWOG Statistics and Data Management Center, Seattle, WA, USA.

Background: Nonadherence to aromatase inhibitors (AIs) is common and increases risk of breast cancer (BC) recurrence. We analyzed factors associated with nonadherence among patients enrolled in S1105, a randomized trial of text messaging.

Methods: At enrollment, patients were required to have been on an adjuvant AI for at least 30 days and were asked about financial, medication, and demographic factors. They completed patient-reported outcomes (PROs) representing pain (Brief Pain Inventory), endocrine symptoms (Functional Assessment of Cancer Therapy-Endocrine Symptoms), and beliefs about medications (Treatment Satisfaction Questionnaire for Medicine; Brief Medication Questionnaire). Our primary endpoint was AI nonadherence at 36 months, defined as urine AI metabolite assay of less than 10 ng/mL or no submitted specimen. We evaluated the association between individual baseline characteristics and nonadherence with logistic regression. A composite risk score reflecting the number of statistically significant baseline characteristics was examined.

Results: We analyzed data from 702 patients; median age was 60.9 years. Overall, 35.9% patients were nonadherent at 36 months. Younger patients (younger than age 65 years) were more nonadherent (38.8% vs 28.6%, odds ratio [OR] = 1.51, 95% confidence interval [CI] = 1.05 to 2.16; P = .02). Fourteen baseline PRO scales were each statistically significantly associated with nonadherence. In a composite risk model categorized into quartile levels, each increase in risk level was associated with a 46.5% increase in the odds of nonadherence (OR = 1.47, 95% CI =1.26 to 1.70; P < .001). The highest-risk patients were more than 3 times more likely to be nonadherent than the lowest-risk patients (OR = 3.14, 95% CI = 1.97 to 5.02; P < .001).

Conclusions: The presence of multiple baseline PRO-specified risk factors was statistically significantly associated with AI nonadherence. The use of these assessments can help identify patients for targeted interventions to improve adherence.
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http://dx.doi.org/10.1093/jnci/djab022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8328987PMC
August 2021

Emergency Department Visits for Emesis Following Chemotherapy: Guideline Nonadherence, OP-35, and a Path Back to the Future.

Oncologist 2021 04 4;26(4):274-276. Epub 2021 Mar 4.

Department of Medicine and Herbert Irving Comprehensive Cancer Center, Columbia University, New York, New York, USA.

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http://dx.doi.org/10.1002/onco.13681DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018296PMC
April 2021

Association of Neoadjuvant Chemotherapy With Overall Survival in Women With Metastatic Endometrial Cancer.

JAMA Netw Open 2020 12 1;3(12):e2028612. Epub 2020 Dec 1.

Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.

Importance: Although primary debulking surgery (PDS) is often considered the criterion standard for treatment of stage IV endometrial cancer, PDS is associated with significant morbidity and poor survival. Neoadjuvant chemotherapy (NACT) has been proposed as an alternative treatment strategy.

Objective: To determine the use of and outcomes associated with NACT for women with stage IV endometrial cancer.

Design, Setting, And Participants: This cohort study used the National Cancer Database to identify women with stage IV endometrial cancer treated from January 1, 2010, to December 31, 2015. The cohort was limited to women aged 70 years or younger with minimal comorbidity (comorbidity score = 0). Women were stratified based on receipt of NACT or PDS. A propensity score analysis with inverse probability weighting was performed to balance the clinical characteristics of the groups. Survival was examined using flexible parametric Royston-Parmer models to account for time-varying hazards associated with use of NACT. An intention-to-treat (ITT) analysis was performed, as was a per-protocol (PP) analysis that included only women who received treatment with both chemotherapy and surgery (in either sequence). Data were analyzed from March 15, 2018, to July 20, 2018.

Main Outcomes And Measures: Use of NACT and overall survival.

Results: Of a total of 4890 women (median age, 60 years [interquartile range, 54-65 years]) with stage IV endometrial cancer, NACT was used in 952 women (19.5%). Use of NACT increased from 106 of 661 women (16.0%; 95% CI, 13.2%-18.8%) in 2010 to 224 of 938 women (23.9%; 95% CI, 21.2%-26.6%) in 2015 (P < .001). In a multivariate model, more recent year of diagnosis (risk ratio [RR], 1.42; 95% CI, 1.21-1.79 for 2015 vs 2010), stage IVB disease (RR, 1.31; 95% CI, 1.03-1.67 for stage IVB vs IVA), and serous histology (RR, 1.38; 95% CI, 1.13-1.69 for serous vs endometrioid histology) were associated with use of NACT. In a propensity score-balanced cohort, use of NACT displayed a time-varying association with survival. In the ITT analysis, use of NACT was associated with decreased mortality for the first 3 months after diagnosis (hazard ratio [HR] at 2 months, 0.81; 95% CI, 0.66-0.99). After 4 months, the survival curves crossed, and receipt of NACT was associated with increased mortality (HR at 6 months, 1.23; 95% CI, 1.09-1.39). In the PP analysis, use of NACT was associated with decreased mortality for the first 8 months after diagnosis (HR at 6 months, 0.79; 95% CI, 0.63-0.98). After 9 months, the survival curves crossed, and receipt of NACT was associated with increased mortality (HR at 12 months, 1.22; 95% CI, 1.04-1.43).

Conclusions And Relevance: The results of this cohort study suggest that women treated with PDS are at increased risk of early death but have a more favorable long-term prognosis. In contrast, results suggest that women treated with NACT, particularly if they ultimately undergo surgery, may have superior survival in the short term. Based on these findings, NACT may be appropriate for select patients with advanced uterine serous carcinoma.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.28612DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726635PMC
December 2020

A joint industry-sponsored data monitoring committee model for observational, retrospective drug safety studies in the real-world setting.

Pharmacoepidemiol Drug Saf 2021 01 24;30(1):9-16. Epub 2020 Nov 24.

Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, New York, New York, USA.

Purpose: To share better practice in establishing data monitoring committees (DMCs) for observational, retrospective safety studies with joint-industry sponsorship.

Methods: A DMC model was created to monitor data from an observational, retrospective, post-authorization safety study investigating risk of medullary thyroid cancer in patients treated with long-acting glucagon-like peptide-1 receptor agonists (LA GLP-1RAs) (NCT01511393). Sponsors reviewed regulatory guidelines, best practice and sponsors' standard operation procedures on DMCs. Discussions were held within the four-member consortium, assessing applicability to observational, retrospective, real-world studies. A DMC charter was drafted based on a sponsor-proposed, adapted DMC model. Thereafter, a kick-off meeting between sponsors and DMC members was held to receive DMC input and finalize the charter.

Results: Due to this study's observational, retrospective nature, assuring participant safety - central for traditional explanatory clinical trial models - was not applicable to our DMC model. The overall strategy and key indication for our real-world model included preserving study integrity and credibility. Therefore, DMC member independence and their contribution of expert knowledge were essential. To ensure between-sponsor data confidentiality, all study committees/corporations and sponsors, besides the DMC, received blinded data only (adapted to refer to data blinding that revealed the specific marketed LA GLP-1RA/sponsor). Communication and blinding/unblinding of these data were facilitated by the contract research organization, which also provided crucial operational oversight.

Conclusions: To our knowledge, we have established the first DMC model for joint industry-sponsored, observational, retrospective safety studies. This model could serve as a precedent for others performing similar post-marketing, joint industry-sponsored pharmacovigilance activities.
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http://dx.doi.org/10.1002/pds.5172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247341PMC
January 2021

Low Subcutaneous Adiposity and Mortality in Esophageal Cancer.

Cancer Epidemiol Biomarkers Prev 2021 01 2;30(1):114-122. Epub 2020 Oct 2.

Department of Medicine, Columbia University Irving Medical Center, New York, New York.

Background: Recent data suggest that subcutaneous adiposity represents an independent prognostic marker in cancer. We aimed to determine whether subcutaneous adiposity estimated by the subcutaneous adiposity tissue index (SATI) was associated with mortality in esophageal cancer.

Methods: We conducted a retrospective analysis of a prospectively enrolled cohort from 2009 to 2015 with esophageal cancer at two major cancer centers. CT scans for initial staging were used to quantify adiposity and skeletal muscle areas. Subjects were categorized as above or below median SATI using sex-specific values. Sarcopenia was defined using previously established skeletal muscle area cutoffs. Cox proportional hazards modeling was performed to determine associations between SATI and all-cause mortality.

Results: Of the original 167 patients, 78 met inclusion criteria and had CT images available. Mean age was 67 years, 81.8% had adenocarcinoma, and 58.9% had stage 3 or 4 disease. Median follow-up time was 29.5 months. Overall 5-year survival was 38.9% [95% confidence interval (CI), 26.8-50.7]. Lower body mass index, higher Charlson comorbidity score, and more advanced stage were independently associated with low SATI. Patients with low SATI had increased mortality (unadjusted HR 2.23; 95% CI, 1.20-4.12), even when adjusted for sarcopenia or for percent weight loss. In a multivariable model including age, histology, stage, and receipt of curative surgery, the association between low SATI and mortality was attenuated (adjusted HR 1.64; 95% CI, 0.81-3.34).

Conclusions: Low subcutaneous adiposity as estimated by SATI may be associated with increased mortality in esophageal cancer.

Impact: Interventions to reduce loss of subcutaneous fat may improve survival in esophageal cancer.
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http://dx.doi.org/10.1158/1055-9965.EPI-20-0737DOI Listing
January 2021

A comparison of complete pathologic response rates following neoadjuvant chemotherapy among South African breast cancer patients with and without concurrent HIV infection.

Breast Cancer Res Treat 2020 Dec 1;184(3):861-872. Epub 2020 Sep 1.

Department of Surgery, Faculty of Health Sciences, University of Witwatersrand, 7 York Rd, Parktown, Johannesburg, 2193, Gauteng, South Africa.

Purpose: Among patients diagnosed with breast cancer (BC), women also living with HIV (WLWH) have worse survival than women without HIV. Chronic HIV infection may interfere with the effectiveness of BC treatment, contributing to this disparity. We attempted to determine the impact of HIV infection on response to neoadjuvant chemotherapy (NACT) among South African women with BC.

Methods: We evaluated women from the South African Breast Cancer and HIV Outcomes cohort study who had stage I-III disease, initiated NACT, underwent definitive breast surgery, and had available surgical pathology reports. We compared pathologic complete response (pCR) rates among women with and without HIV infection, using multivariable logistic regression to control for differences in tumor characteristics. We also evaluated the impact of HIV infection on pCR within subgroups based on patient and tumor factors.

Results: Of 715 women, the 173 (24.2%) WLWH were less likely to achieve pCR than women without HIV (8.7% vs 16.4%, [odds ratio (OR) 0.48, 95% confidence interval (95% CI) 0.27-0.86]). WLWH continued to have lower likelihood of achieving pCR on multivariable analysis (OR 0.52, 95% CI 0.28-0.98). A similar pattern was seen within subgroups, although HIV infection appeared to affect pCR more in ER/PR-positive BC (OR 0.24, 95% CI 0.08-0.71) than in ER/PR-negative BC (OR 0.94, 95% CI 0.39-2.29).

Conclusion: WLWH were less like to achieve pCR following NACT for BC than women without HIV. This reduced response to systemic therapy may contribute to the poorer BC outcomes seen in WLWH.
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http://dx.doi.org/10.1007/s10549-020-05889-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7658037PMC
December 2020

Cost of care for the initial management of cervical cancer in women with commercial insurance.

Am J Obstet Gynecol 2021 03 17;224(3):286.e1-286.e11. Epub 2020 Aug 17.

Columbia University College of Physicians and Surgeons, New York, NY; Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY; NewYork-Presbyterian Hospital, New York, NY. Electronic address:

Background: Women with newly diagnosed cervical cancer are often treated with extensive, multimodal therapies that may include a combination of surgery, radiation, and chemotherapy. Little is known about the cost of treatment or how these costs are passed on to the patients.

Objective: The objectives of this study were to examine the cost of care during the first year after a diagnosis of cervical cancer, to estimate the sources of the costs, and to explore the out-of-pocket costs.

Study Design: We performed a study of women with commercial insurance who received a new diagnosis of cervical cancer, and whose cases were recorded in the MarketScan database from 2008 to 2016. Patients were categorized based on the primary treatment received being either surgery (hysterectomy with or without adjuvant radiation or chemotherapy) or radiation. The inflation-adjusted medical expenditures for a 12-month period beginning on the date of the first treatment were estimated. The payments were divided into the expenditures of inpatient care, outpatient care (including chemotherapy), and outpatient pharmacy costs. The out-of-pocket costs incurred by the patients in the form of copayments, coinsurance, and deductibles were estimated.

Results: A total of 4495 patients, including 3014 (67%) who underwent surgery and 1481 (33%) who primarily underwent radiotherapy, were identified. The median total expenditure per patient during the first year after the diagnosis was $56,250 (interquartile range, $25,767-$107,532). The median total expenditure for patients with surgery as the primary treatment was $37,222 (interquartile range, $20,957-$75,555). The median total expenditure for patients treated primarily with radiotherapy was $101,266 (interquartile range, $63,155-$160,760). For patients treated primarily with surgery, inpatient services accounted for $15,145 (interquartile range, $0-$26,898), outpatient services accounted for $18,430 (interquartile range, $5354-$48,047), and outpatient pharmacy costs accounted for $628 (interquartile range, $141-$1847). The median cost for those women who did not require adjuvant therapy was $26,164 compared with $89,760 for women treated with adjuvant radiation. The median out-of-pocket costs for the cohort was $2253 (interquartile range, $1137-$3990) or 3.9% of the total costs.

Conclusion: The cost of care for women with newly diagnosed cervical cancer is substantial. Overall, patients are responsible for approximately 3.9% of the costs in the form of out-of-pocket expenditures.
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http://dx.doi.org/10.1016/j.ajog.2020.08.039DOI Listing
March 2021

Insurance-Associated Disparities in Opioid Use and Misuse Among Patients Undergoing Gynecologic Surgery for Benign Indications.

Obstet Gynecol 2020 09;136(3):565-575

Columbia University Vagelos College of Physicians and Surgeons, the Joseph L. Mailman School of Public Health and the Herbert Irving Comprehensive Cancer Center, Columbia University, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, New York, New York; and Rutgers Robert Wood Johnson Medical School, New Brunswick, and the Environmental and Occupational Health Sciences Institute (EOHSI), Rutgers, Piscataway, New Jersey.

Objective: To compare perioperative use and persistent postoperative opioid use among Medicaid-insured women and commercially insured women who underwent gynecologic surgery for benign indications.

Methods: The Truven Health MarketScan database, a nationwide data source collecting commercial insurance claims across all states and Medicaid insurance claims from 12 states, was used to identify opioid-naïve women without cancer aged 18-64 years who underwent common gynecologic surgeries from 2012 to 2016 and filled a prescription for an opioid perioperatively. Persistent opioid use was defined as filling an opioid prescription 90-180 days after the surgery. Opioid use disorder (OUD) was defined as hospitalizations or emergency department visits for opioid dependence, misuse, or overdose. Multivariable models were developed to examine the insurance-associated disparity in persistent opioid use and OUD.

Results: A total of 31,155 Medicaid-insured women and 270,716 commercially insured women were identified. Medicaid-insured women received greater quantities of opioids and for longer durations than did commercially insured women. Persistent postoperative opioid use was identified in 14.1% of Medicaid-insured women and 5.8% of commercially insured women (P<.001). More opioid prescriptions filled, longer days supplied, and higher total doses perioperatively contributed most to the prediction of persistent opioid use. Medicaid-insured patients who persistently used opioids were two times more likely to develop OUD than commercially insured patients (16.8% vs 5.1% adjusted relative risk 1.99; 99% CI 1.26-3.15).

Conclusion: Medicaid-insured women received larger quantities of opioids perioperatively, were more likely to use them persistently, and were more likely to develop OUD than commercially insured women.
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http://dx.doi.org/10.1097/AOG.0000000000003948DOI Listing
September 2020

Hepatitis B virus-associated hepatocellular carcinoma in South Africa in the era of HIV.

BMC Gastroenterol 2020 Jul 13;20(1):226. Epub 2020 Jul 13.

Division of Medical Virology, Stellenbosch University, Faculty of Medicine and Health Sciences, Cape Town, South Africa.

Background: Patients co-infected with hepatitis B virus (HBV) and the human immunodeficiency virus (HIV) are at risk of developing hepatocellular carcinoma (HCC). In sub-Saharan Africa, the overlap between high HIV and HBV prevalence may increase the incidence of HCC. This study investigated the impact of HBV/HIV co-infection on age at presentation and survival of HCC.

Methods: Ethical approval was obtained to recruit, following informed written consent, patients diagnosed with HCC at oncology units at four South African hospitals. Between December 2012 and August 2015, patients newly diagnosed with HCC were recruited and provided demographic and clinical data and blood specimens. Patients were tested for HBV, hepatitis C virus (HCV) and HIV. Survival data was available for a subset of patients.

Results: Of 107 HCC cases, 83 (78%) were male. Median age was 46 years (range 18 to 90 years), 68/106 (64%) were HBsAg-positive, and 22/100 (22%) were HIV infected. Among HBV surface antigen (HBsAg)-positive HCC cases, 18/66 (27%) were HIV-infected compared to 3/34 (9%) among those that were HBsAg-negative (p = 0.04). A greater proportion of HBV/HIV co-infected cases were female than HBV mono-infected (6/18, 33% vs 6/47, 13%; p = 0.005). In addition, HBV/HIV co-infected females presented at a younger mean age (36.8 years) than HBV mono-infected women (50.5 years) (p = 0.09). Median survival was 82 days among the HIV-infected HCC patients compared to 181 days among those without HIV (p = 0.15).

Conclusions: HCC is an important complication in the HIV/HBV infected patient. HIV-positive patients presented with HCC at a younger age than HIV-negative patients, this effect appears to be greater in women. These data provide more evidence supporting the call to address. HCC as a cause of morbidity and mortality in the HBV/HIV co-infected patient population. (281 words).
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http://dx.doi.org/10.1186/s12876-020-01372-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359588PMC
July 2020

Incidence and Predictors of Diabetes Mellitus after a Diagnosis of Early-Stage Breast Cancer in the Elderly Using Real-World Data.

Breast Cancer Res Treat 2020 Aug 26;183(1):201-211. Epub 2020 Jun 26.

Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA.

Purpose: The incidence and predictors of diabetes (DM) in patients with breast cancer (BC) were evaluated. We compared DM incidence and physician access in BC patients to matched controls.

Methods: We identified women with stage I-III BC diagnosed from 2005 to 2013 in the SEER-Medicare database, with ≥ 2 years of follow-up after diagnosis, without previous DM claims. Incident DM was determined by ≥ 1 DM claims after BC diagnosis. Multivariable analysis was used to identify factors associated with incident DM. Age- and race-matched non-cancer controls were obtained from a 5% random sample and assigned an index date. Physician and PCP visits per-patient-per-year were compared between cases and controls in the two-year period prior to and after the index date.

Results: Among 14,506 eligible BC patients, 3234 (22.3%) developed DM versus 16.5% of controls. Among BC patients, factors associated with incident DM included race (Black OR 1.63 95% CI 1.39-1.93, Hispanic OR 3.03 95% CI 1.92-4.81; vs. Caucasians), SES (Quintile 0 vs. Quintile 4 OR 1.55 95% CI 1.33-1.78), and receipt of chemotherapy (vs. none OR 1.19 95% CI 1.08-1.31). Among cases and controls, respectively, median physician visits per-patient-per-year were 19 and 17 prior to the index date, and 46 and 19 after the index date; median PCP visits were 2 for both groups in both periods.

Conclusion: About 22% of BC patients developed DM, more than controls in the same period. While there were differences in healthcare access, there weren't differences in PCP access between groups. This represents an opportunity for better comorbidity management in BC patients.
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http://dx.doi.org/10.1007/s10549-020-05756-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8403515PMC
August 2020

Menopausal hormone therapy use and long-term all-cause and cause-specific mortality in the Long Island Breast Cancer Study Project.

Int J Cancer 2020 12 30;147(12):3404-3415. Epub 2020 Jul 30.

Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.

Previous studies have observed a reduced mortality risk associated with menopausal hormone therapy (MHT) use among breast cancer survivors. We sought to clarify whether such association could be explained by tumor heterogeneity, specific causes of death, confounding from comorbidities or health behaviors, and a comparison group of women without breast cancer. We interviewed 1508 women newly diagnosed with first primary breast cancer in 1996 to 1997 (~3 months after diagnosis), and 1556 age-matched women without breast cancer, about MHT use history. The National Death Index was used to ascertain vital status after a median of 17.6 years of follow-up (N = 597 deaths for breast cancer subjects). Multivariable-adjusted Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (95%CIs) for all-cause mortality, and cause-specific HR (cHR) for breast cancer and cardiovascular disease (CVD). The Fine-Gray model was used to account for competing causes of death. Among women with breast cancer, ever vs never MHT use was inversely associated with all-cause (HR = 0.77, 95%CI = 0.62-0.95), breast cancer-specific (cHR = 0.69, 95%CI = 0.48-0.98), and CVD-specific mortality (cHR = 0.57, 95%CI = 0.38-0.85). Difference of the association was observed in breast cancer-specific mortality according to hormone receptor status (negative tumors: cHR = 0.44, 95%CI = 0.19-1.01; positive tumors: cHR = 0.96, 95%CI = 0.60-1.53). Among the comparison group, we observed similar, but more modest inverse associations for all-cause and CVD-specific mortality. MHT use was inversely associated with mortality after breast cancer, even after accounting for competing causes of death and multiple confounders, and was evident among women without breast cancer. Potential heterogeneity by hormone receptor status requires more study.
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http://dx.doi.org/10.1002/ijc.33174DOI Listing
December 2020

Racial and ethnic disparities in mortality from gastric and esophageal adenocarcinoma.

Cancer Med 2020 08 23;9(15):5678-5686. Epub 2020 Jun 23.

Division of Digestive and Liver Diseases, Department of Medicine, Vagelos College of Physicians & Surgeons, Columbia University, New York, NY, USA.

Background: Racial/ethnic differences in mortality have not been well studied for either non-cardia gastric cancer (NCGC) or cardia gastric cancer (CGC). The aim of this study was to examine the US mortality rates for these cancer subtypes, as well as esophageal adenocarcinoma (EAC) as a comparator.

Methods: We identified 14 164 individuals who died from NCGC, 5235 from CGC, and 13 982 from EAC in the Surveillance, Epidemiology, and End Results database between 2004 and 2016. Age-adjusted incidence-based mortality rates and corresponding annual percent changes (APCs) were calculated. Analyses were stratified by race/ethnicity, age, and stage of disease at diagnosis.

Results: The mortality rate in NCGC was two- to threefold higher in blacks, Hispanics, and Asians/Pacific Islanders (PI) than non-Hispanic whites, and was significant across all age groups and stages of disease (P < .01). Mortality in CGC was higher in non-Hispanic whites than blacks and Asians/PI, particularly in individuals in the 50-64 year age group and those with stage IV disease. Mortality in EAC was two- to sixfold higher in non-Hispanic whites than all other groups across all age groups and stages of disease. From 2004 to 2016, mortality rates were stable across all racial/ethnic groups in NCGC and CGC, and in minority groups with EAC, but have been rising in non-Hispanic whites with EAC (APC 3.03, 95% CI 0.17-5.96).

Conclusions: This is the largest study of incidence-based mortality in CGC and NCGC and demonstrates racial/ethnic differences in mortality between these subtypes. Mortality rates for NCGC are highest in minority groups, and have been stable in recent years despite declining incidence. Mortality rates for CGC are marginally higher in middle-aged non-Hispanic whites with advanced disease, though have remained stable. In contrast, mortality in EAC has been rising for non-Hispanic whites, in parallel to incidence. Further studies are needed to refine prevention strategies for high-risk individuals dying from these specific cancer subtypes.
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http://dx.doi.org/10.1002/cam4.3063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7402817PMC
August 2020

Travel distance, hospital volume and their association with ovarian cancer short- and long-term outcomes.

Gynecol Oncol 2020 08 23;158(2):415-423. Epub 2020 May 23.

Columbia University College of Physicians and Surgeons, United States of America; Herbert Irving Comprehensive Cancer Center, United States of America; New York Presbyterian Hospital, United States of America. Electronic address:

Objective: To examine patterns of patient travel among women with ovarian cancer and to explore the association between travel distance and short and long-term outcomes.

Methods: Women with stage II-IV epithelial ovarian cancer diagnosed from 2004 to 2016 who underwent primary surgery were identified in the National Cancer Database. Mixed-effect log-linear models and proportional hazards models were developed to evaluate the association between travel distance and short and long-term outcomes after propensity score weighting. A further analysis was performed to compare patients who traveled a short distance to a low volume center (Local) to patients who traveled farther to a high volume hospital (Travel).

Results: We identified 56,834 patients treated in 1201 hospitals. Hispanic women were 58% and black women 64% less likely than white women to travel to a center in the greatest distance quartile for care. Similarly, Medicaid recipients (vs. commercially insured) were less likely to travel to a quartile four hospital (compared to Q1 of distance traveled). Of all patients, 90-day mortality was significantly lower in patients who traveled farther (Q4 vs. Q1; P < 0.0001). Compared to women in the Local group, patients in the Travel group had a decreased 30-day readmission rate. There was no difference in 30-day, 90-day, or 5-year mortality when comparing the Local to the Travel group.

Conclusions: Travel distance for ovarian cancer surgery has increased over time. While there may be some short-term benefits in traveling to a regional center for care, there was little difference in long term outcomes based on travel distance.
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http://dx.doi.org/10.1016/j.ygyno.2020.05.017DOI Listing
August 2020

Urinary Estrogen Metabolites and Long-Term Mortality Following Breast Cancer.

JNCI Cancer Spectr 2020 Jun 2;4(3):pkaa014. Epub 2020 Mar 2.

Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA.

Background: Estrogen metabolite concentrations of 2-hydroxyestrone (2-OHE) and 16-hydroxyestrone (16-OHE) may be associated with breast carcinogenesis. However, no study has investigated their possible impact on mortality after breast cancer.

Methods: This population-based study was initiated in 1996-1997 with spot urine samples obtained shortly after diagnosis (mean = 96 days) from 683 women newly diagnosed with first primary breast cancer and 434 age-matched women without breast cancer. We measured urinary concentrations of 2-OHE and 16-OHE using an enzyme-linked immunoassay. Vital status was determined via the National Death Index (n = 244 deaths after a median of 17.7 years of follow-up). We used multivariable-adjusted Cox proportional hazards to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the estrogen metabolites-mortality association. We evaluated effect modification using likelihood ratio tests. All statistical tests were two-sided.

Results: Urinary concentrations of the 2-OHE to 16-OHE ratio (>median of 1.8 vs ≤median) were inversely associated with all-cause mortality (HR = 0.74, 95% CI = 0.56 to 0.98) among women with breast cancer. Reduced hazard was also observed for breast cancer mortality (HR = 0.73, 95% CI = 0.45 to 1.17) and cardiovascular diseases mortality (HR = 0.76, 95% CI = 0.47 to 1.23), although the 95% confidence intervals included the null. Similar findings were also observed for women without breast cancer. The association with all-cause mortality was more pronounced among breast cancer participants who began chemotherapy before urine collection (n = 118, HR = 0.42, 95% CI = 0.22 to 0.81) than among those who had not (n = 559, HR = 0.98, 95% CI = 0.72 to 1.34; = .008).

Conclusions: The urinary 2-OHE to 16-OHE ratio may be inversely associated with long-term all-cause mortality, which may depend on cancer treatment status at the time of urine collection.
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http://dx.doi.org/10.1093/jncics/pkaa014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236781PMC
June 2020

Attitudes toward tobacco cessation and lung cancer screening in two South African communities.

Glob Public Health 2020 10 14;15(10):1537-1550. Epub 2020 May 14.

Non-Communicable Diseases Research (NCDR) Division of the Wits Health Consortium, University of Witwatersrand, Johannesburg, South Africa.

Among men in South Africa, the prevalence of tobacco smoking is as high as 33%. Although smoking is responsible for most lung cancer in South Africa, occupational and environmental exposures contribute greatly to risk. We conducted a tobacco and lung cancer screening needs assessment and administered surveys to adults who smoked >100 cigarettes in their lifetime in Johannesburg (urban) and Kimberley (rural). We compared tobacco use, risk exposure, attitudes toward and knowledge of, and receptivity to cessation and screening, by site. Of 324 smokers, nearly 85% of current smokers had a <30 pack-year history of smoking; 58.7% had tried to stop smoking ≥1 time, and 78.9% wanted to quit. Kimberley smokers more often reported being advised by a healthcare provider to stop smoking (56.5% vs. 37.3%, =0.001) than smokers in Johannesburg but smokers in Johannesburg were more willing to stop smoking if advised by their doctor (72.9% vs. 41.7%, <0.001). Findings indicate that tobacco smokers in two geographic areas of South Africa are motivated to stop smoking but receive no healthcare support to do so. Developing high risk criteria for lung cancer screening and creating tobacco cessation infrastructure may reduce tobacco use and decrease lung cancer mortality in South Africa.
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http://dx.doi.org/10.1080/17441692.2020.1761425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529843PMC
October 2020

A Custom Genotyping Array Reveals Population-Level Heterogeneity for the Genetic Risks of Prostate Cancer and Other Cancers in Africa.

Cancer Res 2020 07 11;80(13):2956-2966. Epub 2020 May 11.

Thermo Fisher Scientific, Santa Clara, California.

Although prostate cancer is the leading cause of cancer mortality for African men, the vast majority of known disease associations have been detected in European study cohorts. Furthermore, most genome-wide association studies have used genotyping arrays that are hindered by SNP ascertainment bias. To overcome these disparities in genomic medicine, the Men of African Descent and Carcinoma of the Prostate (MADCaP) Network has developed a genotyping array that is optimized for African populations. The MADCaP Array contains more than 1.5 million markers and an imputation backbone that successfully tags over 94% of common genetic variants in African populations. This array also has a high density of markers in genomic regions associated with cancer susceptibility, including 8q24. We assessed the effectiveness of the MADCaP Array by genotyping 399 prostate cancer cases and 403 controls from seven urban study sites in sub-Saharan Africa. Samples from Ghana and Nigeria clustered together, whereas samples from Senegal and South Africa yielded distinct ancestry clusters. Using the MADCaP array, we identified cancer-associated loci that have large allele frequency differences across African populations. Polygenic risk scores for prostate cancer were higher in Nigeria than in Senegal. In summary, individual and population-level differences in prostate cancer risk were revealed using a novel genotyping array. SIGNIFICANCE: This study presents an Africa-specific genotyping array, which enables investigators to identify novel disease associations and to fine-map genetic loci that are associated with prostate and other cancers.
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http://dx.doi.org/10.1158/0008-5472.CAN-19-2165DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335354PMC
July 2020

Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.

J Clin Oncol 2020 07 5;38(19):2122-2129. Epub 2020 May 5.

Columbia University Medical Center, New York, NY.

Purpose: Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions.

Methods: We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed.

Results: In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; = .57) and site-reported time to AF (21.9% 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; = .21) also did not differ by arm.

Conclusion: To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.
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http://dx.doi.org/10.1200/JCO.19.02699DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325363PMC
July 2020

Analyses of Employer Medical Claims Data to Assess Receipt of High-Priority Preventive Health Services.

Am J Prev Med 2020 05 12;58(5):715-723. Epub 2020 Mar 12.

EHE Health, New York, New York.

Introduction: The Affordable Care Act mandated that health plans cover preventive health services without patient cost sharing. A process, based on the analyses of medical claims data, is presented that allows companies to assess whether their healthcare plans are providing employees and dependents with age- and sex-appropriate high-priority preventive healthcare services.

Methods: High-priority preventive healthcare services are defined as, a physical examination; type 2 diabetes screening; blood lipid screening; cervical, breast, and colon cancer screening; and osteoporosis screening. Current Procedural Terminology codes reflecting billing for these screening services were identified. Receipt of these age- and sex-appropriate services in rolling 3-year windows from 2010 to 2016 was assessed in 86,895,424 person-years of medical claims data from the IBM Watson Health MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefit Database. Data were analyzed in 2018 and 2019.

Results: In the 2014-2016 period, 29% of men and 36% of women received the complete set of age- and sex-appropriate preventive health services, whereas 33% of men and 13% of women received none of these services.

Conclusions: Only a minority of individuals received a complete set of the defined high-priority preventive healthcare services. The process presented here allows employers to routinely analyze their medical claims data to assess the performance of their health and wellness plans in delivering these preventive services. The strengths and weaknesses of this approach are also described.
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http://dx.doi.org/10.1016/j.amepre.2019.12.016DOI Listing
May 2020

Cost-Effectiveness Analysis of Biomarker-Guided Treatment for Metastatic Gastric Cancer in the Second-Line Setting.

J Oncol 2020 17;2020:2198960. Epub 2020 Feb 17.

Columbia University Medical Center, New York, NY, USA.

Background: The 5-year survival rate of patients with metastatic gastric cancer (GC) is only 5%. However, trials have demonstrated promising antitumor activity for targeted therapies/immunotherapies among chemorefractory metastatic GC patients. Pembrolizumab has shown particular efficacy among patients with programmed death ligand-1 (PD-L1) expression and high microsatellite instability (MSI-H). The aim of this study was to assess the effectiveness and cost-effectiveness of biomarker-guided second-line GC treatment.

Methods: We constructed a Markov decision-analytic model using clinical trial data. Our model compared pembrolizumab monotherapy and ramucirumab/paclitaxel combination therapy for all patients and pembrolizumab for patients based on MSI status or PD-L1 expression. Paclitaxel monotherapy and best supportive care for all patients were additional comparators. Costs of drugs, treatment administration, follow-up, and management of adverse events were estimated from a US payer perspective. The primary outcomes were quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold of $100,000/QALY over 60 months. Secondary outcomes were unadjusted life years (survival) and costs. Deterministic and probabilistic sensitivity analyses were performed to evaluate model uncertainty.

Results: The most effective strategy was pembrolizumab for MSI-H patients and ramucirumab/paclitaxel for all other patients, adding 3.8 months or 2.0 quality-adjusted months compared to paclitaxel. However, this strategy resulted in a prohibitively high ICER of $1,074,620/QALY. The only cost-effective strategy was paclitaxel monotherapy for all patients, with an ICER of $53,705/QALY.

Conclusion: Biomarker-based treatments with targeted therapies/immunotherapies for second-line metastatic GC patients substantially improve unadjusted and quality-adjusted survival but are not cost-effective at current drug prices.
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http://dx.doi.org/10.1155/2020/2198960DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048937PMC
February 2020

Diabetes and cardiovascular disease mortality among a population-based cohort of women with and without breast cancer.

Cancer Causes Control 2020 May 7;31(5):517-524. Epub 2020 Mar 7.

Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA.

Purpose: We investigated whether the relationship between diabetes and all-cause and CVD-related mortality differed between women with and without breast cancer among a cohort drawn from the same source population.

Methods: We interviewed 1,363 women newly diagnosed with breast cancer in 1996-1997, and 1,358 age-matched women without breast cancer, to assess history of physician-diagnosed diabetes. All-cause (n = 631) and CVD-specific mortality (n = 234) was determined by the National Death Index through 2009. We estimated multivariable-adjusted hazard ratios (HRs) for the rates of all-cause and CVD-specific mortality and, to account for competing causes of death, and subdistribution HRs (sHRs) for risk of CVD-related death.

Results: Among women with and without breast cancer, respectively, diabetes was associated with: all-cause mortality [HR (95% CI) 1.52 (1.13, 2.05) and 2.17 (1.46, 3.22)]; CVD-specific deaths [1.74 (1.06, 2.84) and 2.06 (1.11, 3.84)]; and risk of CVD-related death [sHR 1.36 (0.81, 2.27) and 1.79 (0.94, 3.40)]. Differences in effect estimates between women with and without breast cancer did not reach statistical significance (p-interaction > 0.10).

Conclusion: We found that the positive association between a history of physician-diagnosed diabetes and risk of all-cause and CVD-related mortality is of similar magnitude among a population-based cohort of women with or without breast cancer.
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http://dx.doi.org/10.1007/s10552-020-01292-2DOI Listing
May 2020

Impact of quality of care on racial disparities in survival for endometrial cancer.

Am J Obstet Gynecol 2020 09 25;223(3):396.e1-396.e13. Epub 2020 Feb 25.

Vagelos College of Physicians and Surgeons, New York, NY; Columbia University, the Herbert Irving Comprehensive Cancer Center, New York, NY; NewYork-Presbyterian Hospital, New York, NY. Electronic address:

Background: Black women experience poorer survival compared with white women across all endometrial cancer stages and histologies. The incidence of endometrial cancer is 30% lower in black women compared with white women, yet mortality is 80% higher in black women. Differences in adherence to evidence-based guidelines have been proposed to be major contributors to this disparity.

Objectives: We examined whether adherence to evidence-based treatment recommendations for endometrial cancer could mitigate survival disparities between black and white women.

Study Design: The National Cancer Database was used to identify women with endometrial cancer treated from 2004 through 2016. We established 5 evidence-based quality metrics based on review of primary literature and accepted guidelines: surgical treatment within 6 weeks of diagnosis (Q1), use of minimally invasive surgery (stage I-IIIC; Q2), pelvic nodal assessment (high-risk tumors; Q3), adjuvant radiation (high intermediate risk; Q4), and systemic chemotherapy (stage III-IV; Q5). The rates of 30 and 90 day mortality and 5 year survival were compared between black and white women. To determine the influence of quality on outcomes, we compared outcomes among perfectly adherent black and white women with stage I and III endometrial cancer.

Results: We identified 310,208 women including 35,035 (11.3%) black women and 275,173 (88.3%) white women. Black women were less likely than white women to receive Q1 (65.8 vs 75.6%), Q2 (58.5 vs 72.9%), Q3 (71.3 vs 74.2%), and Q5 (72.7 vs 73.2%) (P < .05 for all). Adherence to each quality metrics was associated with improved survival. Among women with stage I disease, perfect adherence to the relative quality metrics was seen in 53.1% of white and 41.5% of black women. Among perfectly adherent stage I patients, outcomes in black women improved relative to unselected black women; however, they still experienced higher risk of 30 day (adjusted relative risk, 2.25; 95% confidence interval, 1.30-3.90), 90 day (adjusted relative risk, 1.84; 95% confidence interval, 1.23-2.76), and 5 year mortality (adjusted hazard ratio, 1.42; 95% confidence interval, 1.26-1.59) compared with similar white women. Among women with stage III tumors, perfect adherence to the relative quality metrics was seen in 56.6% of white and 44.1% of black women. Perfectly adherent black women with stage III disease had improved outcomes but remained at increased risk of 30 day (adjusted relative risk, 1.86; 95% confidence interval, 1.01-3.44) and 5 year mortality (adjusted hazard ratio, 1.35; 95% confidence interval, 1.22-1.50) compared with white women.

Conclusion: Black women are less likely than white women with endometrial cancer to receive evidence-based care. However, receipt of evidence-based care mitigates but does not eliminate racial disparities in outcomes and black women remain at greater risk of death from endometrial cancer.
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http://dx.doi.org/10.1016/j.ajog.2020.02.021DOI Listing
September 2020
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