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Speeding Access to Precision Oncology Drugs: How Are We Doing With Biomarker-Driven Drug Approvals?

Tianhong Li

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Exploring Pharmacy and Drug Policy Concerns

Edward C. Li

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Will Risk Evaluation and Mitigation Strategies Ever Be Accepted?

Edward C. Li

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A Quick REMS Update and a Clinical Focus

Edward C. Li

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Letter to the Editor: Re: “Mortality After Invasive Second Breast Cancers Following Prior Radiotherapy for DCIS”

Wu Ding and Zhian Li

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Preliminary Report: The Development of the NCCN Comparative Therapeutic Index™ as a Clinical Evaluative Process for Existing Data in Oncology

Edward C. Li and Jessica DeMartino

The National Comprehensive Cancer Network (NCCN) develops and communicates the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to oncologists and other clinicians. The NCCN Guidelines are widely recognized and applied as the standard for clinical policy in the United States. These guidelines and related documents, such as the NCCN Drugs & Biologics Compendium (NCCN Compendium), are used extensively by public and private payors as the basis for the setting of coverage policies. Given the demand for comparative effectiveness (CE) analyses, as described and discussed in this report, the NCCN has begun work on a paradigm to integrate evidence-based CE analysis into the NCCN Guidelines deliberative process. This report presents NCCN's initial thinking on the use of NCCN expert panel members in developing a process that can be used to compare health care technologies (e.g., radiation modalities, chemotherapy regimens) in a formal, systematic way. Draft considerations are provided to stimulate discussion and feedback, particularly in the oncology community, as NCCN moves through processes such as methodologic review, validation of rating scales, and review of implications for public policy, toward finalization of an NCCN CE analytic paradigm.

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HSR19-078: Human Papillomavirus Status and Survival Among Patients With Oropharyngeal Cancer: Analyses of a United States Health System

Himani Aggarwal, Li Li, Gebra Cuyun Carter, Kathy Fraeman, and Ariel Berger

Background: The incidence of oropharyngeal cancer (OPC) due to tobacco and alcohol, respectively, has been declining, while that linked to human papilloma virus (HPV) has been rising. Epidemiologic, biologic, and prognostic characteristics of OPC differ by HPV-status. This study compared overall survival (OS) among HPV-positive and -negative patients with OPC in a real-world setting. Methods: This retrospective observational study used electronic medical records data from the Geisinger Health System to select patients diagnosed with OPC between January 1, 2010 and September 30, 2015. Patients were designated as HPV-positive if the HPV or P16 test closest to the diagnosis date was positive. All other patients were deemed HPV-negative. Descriptive statistics and relevant statistical tests were used to compare baseline characteristics by HPV status; survival by HPV status was examined using Kaplan–Meier methods and multivariable Cox models. Results: In this study, 152 patients met all selection criteria; 110 (72.4%) were HPV-positive. HPV-positive patients were more likely to be men (89.1% vs 73.8%; P=.019) and to have lymph node involvement (88.2% vs 59.5%; P=.0008); they were less likely to have cerebrovascular disease (6.9% vs. 23.5%; P=.01), or distant metastases (1.8% vs 9.5%; P=.029) vs HPV-negative patients. Among HPV-positive patients, 75.5%, 12.7%, and 10.9% had squamous cell carcinoma NOS, basaloid squamous cell carcinoma, and squamous cell carcinoma large cell non-keratinizing, respectively; corresponding values for HPV-negative patients were 85.7%, 0.0%, and 2.4%, respectively (P=.0013). HPV-positive patients were nominally younger than HPV-negative patients (median: 58 vs 61 years; P=.085). Log-rank test showed OS of HPV-positive patients (median OS from treatment initiation: not reached) is higher than of HPV-negative patients (median OS: 3.7 years; P=.002). In multivariable analyses, HPV-negative status was associated with increased mortality risk (P=.0035); other significant risk factors included alcohol use, diabetes, and distant metastases. Conclusions: HPV-positive status was associated with a decreased risk of mortality among OPC patients in this study. Despite the small sample size and potential violation of assumption of proportional hazard rate, this study underscores the prognostic implication of HPV status in OPC, which may have important ramifications in optimizing treatment decisions among this patient population.

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Implications of the FDA Draft Guidance on Biosimilars for Clinicians: What We Know and Don't Know

Edward Li and James M. Hoffman

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HSR19-077: Primary Tumor Location (PTL) and Survival Outcomes in a Real World Cohort of KRAS Wild-Type (WT) Metastatic Colorectal Cancer (mCRC) Patients in the United States

Himani Aggarwal, Kristin M. Sheffield, Li Li, David Lenis, Rachael Sorg, and Rebecca Miksad

Background: PTL is a prognostic factor for mCRC. Recent data suggest PTL is also predictive of survival benefit with cetuximab (CET) and bevacizumab (BEV). This study evaluated the prognostic and predictive effect of PTL in patients with KRAS WT mCRC who initiated first-line (1L) therapy with CET vs BEV in the real world. Methods: This retrospective study selected patients with KRAS WT mCRC who initiated 1L therapy with CET or BEV + FOLFIRI or FOLFOX between January 2013 and April 2017 from Flatiron Health’s electronic health record-derived database. PTL was abstracted from patients’ charts. Left-sided PTL (LPTL): splenic flexure to rectum; right-sided PTL (RPTL): cecum to splenic flexure. Propensity score matching was used to balance treatment cohorts on baseline characteristics. Kaplan Meier and Cox regression methods were used for survival analyses. Results: 1,312 patients met the selection criteria. Of 248 CET + FOLFIRI or FOLFOX patients, 164 had LPTL and 84 had RPTL; of 1,064 BEV + FOLFIRI or FOLFOX patients, 679 had LPTL and 385 had RPTL. CET LPTL and RPTL patients were more likely to receive FOLFIRI vs BEV patients (LPTL: 64.0% vs 24.3%; P<.001; RPTL: 76.2% vs 24.9%; P<.001). Stage at initial diagnosis was different between CET RPTL vs BEV RPTL patients (P<.001). CET RPTL patients were more likely to be stage III (44.0% vs 22.6%) while BEV RPTL patients were more likely to be stage IV (48.8% vs 65.7%) at initial diagnosis. CET RPTL patients were more likely to have a history of adjuvant chemotherapy vs BEV RPTL patients (47.6% vs 22.3%; P<.001). In the matched sample, median overall survival (OS) was 29.7 months (95% CI, 26.9–35.2) for LPTL patients vs 18.3 months (95% CI, 15.8–21.3) for RPTL patients (P<.001). Median OS was 29.7 months (95% CI, 27.4–NA) for CET LPTL vs 29.1 months (95% CI, 26.6–35.6) for BEV LPTL patients (HR, 0.87; 95% CI, 0.63–1.19; P=.378), and 17.0 months (95% CI, 12.0–32.6) for CET RPTL vs 18.8 months (95% CI, 15.8–22.3) for BEV RPTL patients (HR, 1.00; 95% CI, 0.68–1.46; P=.996). The interaction of treatment and PTL was not significant in the Cox regression. Conclusions: This study found a prognostic effect of PTL but not a predictive effect. LPTL patients had significantly longer OS vs RPTL patients. However, the treatment effect for CET vs BEV by PTL was not significantly different. Future research is needed to examine differences between real-world and clinical trial populations that may have contributed to divergent results.

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HSR22-180: Real-World Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy in BRAF+ Cutaneous Melanoma Patients Treated in the Adjuvant Setting

Sanjay Chandrasekaran, You-Li Ling, Jackson Tang, Deborah Norton, and Rohan Shah