PMID- 33636693 OWN - NLM STAT- MEDLINE DCOM- 20220321 LR - 20220321 IS - 1540-1413 (Electronic) IS - 1540-1405 (Linking) VI - 19 IP - 7 DP - 2021 Feb 26 TI - Reassessing the Net Benefit of Cancer Drugs With Evolution of Evidence Using the ASCO Value Framework. PG - 815-820 LID - jnccn20498 [pii] LID - 10.6004/jnccn.2020.7677 [doi] AB - BACKGROUND: Regulatory approval of oncology drugs is often based on interim data or surrogate endpoints. However, clinically relevant data, such as long-term overall survival and quality of life (QoL), are often reported in subsequent publications. This study evaluated the ASCO-Value Framework (ASCO-VF) net health benefit (NHB) at the time of approval and over time as further evidence arose. METHODS: FDA-approved oncology drug indications from January 2006 to December 2016 were reviewed to identify clinical trials scorable using the ASCO-VF. Subsequent publications of clinical trials relevant for scoring were identified (until December 2019). Using ASCO-defined thresholds (/=45 for substantial benefit), we assessed changes in classification of benefit at 3 years postapproval. RESULTS: Fifty-five eligible indications were included. At FDA approval, 40.0% were substantial, 10.9% were intermediate, and 49.1% were low benefit. We then identified 90 subsequent publications relevant to scoring, including primary (28.9%) and secondary endpoint updates (47.8%), safety updates (31.1%), and QoL reporting (47.8%). There was a change from initial classification of benefit in 27.3% of trials (10.9% became substantial, 9.1% became low, and 7.3% became intermediate). These changes were mainly due to updated hazard ratios (36.4%), toxicities (56.4%), new tail-of-the-curve bonus (9.1%), palliation bonus (14.5%), or QoL bonus (18.2%). Overall, at 3 years postapproval, 40.0% were substantial, 9.1% were intermediate, and 50.9% were low benefit. CONCLUSIONS: Because there were changes in classification for more than one-quarter of indications, in either direction, reassessing the ASCO-VF NHB as more evidence becomes available may be beneficial to inform clinical shared decision-making. On average, there was no overall improvement in the ASCO-VF NHB with longer follow-up and evolution of evidence. FAU - Delos Santos, Seanthel AU - Delos Santos S AD - Evaluative Clinical Sciences, Odette Cancer Centre Research Program, Sunnybrook Research Institute, Toronto, Ontario. FAU - Witzke, Noah AU - Witzke N AD - Evaluative Clinical Sciences, Odette Cancer Centre Research Program, Sunnybrook Research Institute, Toronto, Ontario. FAU - Gyawali, Bishal AU - Gyawali B AD - Cancer Centre of Southeastern Ontario, Kingston Health Sciences Centre, Kingston, Ontario. AD - School of Medicine, Queen's University, Kingston, Ontario. FAU - Arciero, Vanessa Sarah AU - Arciero VS AD - Evaluative Clinical Sciences, Odette Cancer Centre Research Program, Sunnybrook Research Institute, Toronto, Ontario. AD - Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario. FAU - Rahmadian, Amanda Putri AU - Rahmadian AP AD - Evaluative Clinical Sciences, Odette Cancer Centre Research Program, Sunnybrook Research Institute, Toronto, Ontario. FAU - Everest, Louis AU - Everest L AD - Evaluative Clinical Sciences, Odette Cancer Centre Research Program, Sunnybrook Research Institute, Toronto, Ontario. FAU - Cheung, Matthew C AU - Cheung MC AD - Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario. AD - Department of Medicine, University of Toronto, Toronto, Ontario; and. FAU - Chan, Kelvin K AU - Chan KK AD - Evaluative Clinical Sciences, Odette Cancer Centre Research Program, Sunnybrook Research Institute, Toronto, Ontario. AD - Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario. AD - Department of Medicine, University of Toronto, Toronto, Ontario; and. AD - Canadian Centre for Applied Research in Cancer Control, Toronto, Ontario, Canada. LA - eng PT - Journal Article DEP - 20210226 PL - United States TA - J Natl Compr Canc Netw JT - Journal of the National Comprehensive Cancer Network : JNCCN JID - 101162515 RN - 0 (Antineoplastic Agents) SB - IM MH - *Antineoplastic Agents/therapeutic use MH - Humans MH - *Neoplasms/drug therapy MH - Quality of Life EDAT- 2021/02/27 06:00 MHDA- 2022/03/22 06:00 CRDT- 2021/02/26 20:19 PHST- 2020/09/16 00:00 [received] PHST- 2020/10/26 00:00 [accepted] PHST- 2021/02/27 06:00 [pubmed] PHST- 2022/03/22 06:00 [medline] PHST- 2021/02/26 20:19 [entrez] AID - jnccn20498 [pii] AID - 10.6004/jnccn.2020.7677 [doi] PST - epublish SO - J Natl Compr Canc Netw. 2021 Feb 26;19(7):815-820. doi: 10.6004/jnccn.2020.7677.