ObjectiveTo determine the differences between recommendations by the National Comprehensive Cancer Network (NCNN) guidelines and Food and Drug Administration approvals of anticancer drugs, and the evidence cited by the NCCN to justify recommendations where differences exist.DesignRetrospective observational study.SettingNational Comprehensive Cancer Network and FDA.Participants47 new molecular entities approved by the FDA between 2011 and 2015.Main outcome measuresComparison of all FDA approved indications (new and supplemental) with all NCCN recommendations as of 25 March 2016. When the NCCN made recommendations beyond the FDA’s approvals, the recommendation was classified and the cited evidence noted.Results47 drugs initially approved by the FDA between 2011 and 2015 for adult hematologic or solid cancers were examined. These 47 drugs were authorized for 69 FDA approved indications, whereas the NCCN recommended these drugs for 113 indications, of which 69 (62%) overlapped with the 69 FDA approved indications and 44 (39%) were additional recommendations. The average number of recommendations beyond the FDA approved indications was 0.92. 23% (n=10) of the additional recommendations were based on evidence from randomized controlled trials, and 16% (n=7) were based on evidence from phase III studies. During 21 months of follow-up, the FDA granted approval to 14% (n=6) of the additional recommendations.ConclusionThe NCCN frequently recommends beyond the FDA approved indications even for newer, branded drugs. The strength of the evidence cited by the NCCN supporting such recommendations is weak. Our findings raise concern that the NCCN justifies the coverage of costly, toxic cancer drugs based on weak evidence.

Introduction: Patients with advanced lung cancer have a poor prognosis, but both chemotherapy and early palliative care (EPC) have been shown to improve survival and quality of life (QOL). The relationship between palliative care and receipt of chemotherapy receipt is understudied. We sought to determine if EPC is associated with chemotherapy receipt and intensity among patients with advanced stage lung cancer.Methods: Retrospective cohort study of patients in the national Veterans Health Administration (VA) with stage IIIB or IV lung cancer diagnosed between January 2007-December 2013. EPC was defined as a specialist-delivered palliative care received within 90 days of cancer diagnosis. Outcomes included any chemotherapy receipt and high-intensity chemotherapy receipt defined as: i) more than 4 cycles of a platinum-based doublet, ii) 3 lines of chemotherapy, iii) Bevacizumab/Cetuximab triplet therapy, iv) Erlotinib use prior to 2011, and v) chemotherapy in the last days of life. Logistic regression was used to determine the association between EPC and chemotherapy receipt after adjustment for patient and tumor characteristics.Results: Among the entire cohort (N¼23,566), 37% received EPC and 45% received any chemotherapy. Among those with EPC, 34% received chemotherapy compared to 51% among those without EPC (Adjusted Odds Ratio (AOR¼0.55, 95% CI: 0.51-0.58). Patients who received EPC had reduced receipt of high-intensity chemotherapy including >4 cycles of platinum-based doublet (AOR¼0.68, 95% CI: 0.60-0.77), 3 lines of chemotherapy (AOR¼0.61, 95% CI: 0.53-0.71), triplet therapy (AOR¼0.68, 95% CI: 0.56-0.82) and use of erlotinib prior to 2011 (AOR¼0.66, 95% CI: 0.55-0.79). Patients with EPC were more likely to receive chemotherapy in the last 14 (AOR¼1.65, 95% CI: 1.44-1.87) and 30 days (AOR¼1.67, 95% CI: 1.51-1.85) of life compared to those without EPC.Conclusions: EPC was associated with reduced receipt of both any chemotherapy and high-intensity chemotherapy. However, receipt of chemotherapy at the very end-of-life was increased among patients with EPC compared to those without EPC. Among patients with advanced lung cancer, EPC may optimize patient selection for chemotherapy receipt leading to reduced use of high-intensity therapy by focusing on quality of life in accordance with patients' performance, preferences and goals of care.

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