PURPOSE: Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both National Cancer Institute (NCI)-designated comprehensive cancer centers and community cancer programs. This report describes the initial experience with clinical trial accrual after next-generation sequencing (NGS) from three affiliated non-NCI-designated cancer programs. MATERIALS AND METHODS: Clinical trial participation was reviewed after enrollment of the first 200 patients undergoing comprehensive genomic profiling by NGS as part of an institutional intuitional review board-approved protocol at three affiliated hospitals in Rhode Island and was compared with published experience from NCI-designated cancer centers. RESULTS: Patient characteristics included a median age of 64 years, a median of two lines of prior therapy, and a predominance of GI carcinomas (58%). One hundred sixty-four of 200 patients (82%) had adequate tumor for NGS, 95% had genomic alterations identified, and 100% had variants of unknown significance. Fifteen of 164 patients (9.2%) enrolled in genotype-directed clinical trials, and three patients (1.8%) received commercially available targeted agents off clinical trials. The reasons for nonreceipt of NGS-directed therapy were no locally available matching trial (48.6%), ineligibility (33.6%) because of comorbidities or interim clinical deterioration, physician's choice of a different therapy (6.8%), or stable disease (11%). CONCLUSION: This experience demonstrates that a program enrolling patients in specific targeted agent clinical trials after NGS can be implemented successfully outside of the NCI-designated cancer program network, with comparable accrual rates. This is important because targetable genes have rare mutation rates and clinical trial accrual after NGS is low.
PURPOSE: Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both National Cancer Institute (NCI)-designated comprehensive cancer centers and community cancer programs. This report describes the initial experience with clinical trial accrual after next-generation sequencing (NGS) from three affiliated non-NCI-designated cancer programs. MATERIALS AND METHODS: Clinical trial participation was reviewed after enrollment of the first 200 patients undergoing comprehensive genomic profiling by NGS as part of an institutional intuitional review board-approved protocol at three affiliated hospitals in Rhode Island and was compared with published experience from NCI-designated cancer centers. RESULTS:Patient characteristics included a median age of 64 years, a median of two lines of prior therapy, and a predominance of GI carcinomas (58%). One hundred sixty-four of 200 patients (82%) had adequate tumor for NGS, 95% had genomic alterations identified, and 100% had variants of unknown significance. Fifteen of 164 patients (9.2%) enrolled in genotype-directed clinical trials, and three patients (1.8%) received commercially available targeted agents off clinical trials. The reasons for nonreceipt of NGS-directed therapy were no locally available matching trial (48.6%), ineligibility (33.6%) because of comorbidities or interim clinical deterioration, physician's choice of a different therapy (6.8%), or stable disease (11%). CONCLUSION: This experience demonstrates that a program enrolling patients in specific targeted agent clinical trials after NGS can be implemented successfully outside of the NCI-designated cancer program network, with comparable accrual rates. This is important because targetable genes have rare mutation rates and clinical trial accrual after NGS is low.
Authors: Katherine C Kurnit; Ecaterina E Ileana Dumbrava; Beate Litzenburger; Yekaterina B Khotskaya; Amber M Johnson; Timothy A Yap; Jordi Rodon; Jia Zeng; Md Abu Shufean; Ann M Bailey; Nora S Sánchez; Vijaykumar Holla; John Mendelsohn; Kenna Mills Shaw; Elmer V Bernstam; Gordon B Mills; Funda Meric-Bernstam Journal: Clin Cancer Res Date: 2018-02-02 Impact factor: 12.531
Authors: Todd C Knepper; Gillian C Bell; J Kevin Hicks; Eric Padron; Jamie K Teer; Teresa T Vo; Nancy K Gillis; Neil T Mason; Howard L McLeod; Christine M Walko Journal: Oncologist Date: 2017-02-08
Authors: Scott M Morris; Janakiraman Subramanian; Esma S Gel; George C Runger; Eric J Thompson; David W Mallery; Glen J Weiss Journal: PLoS One Date: 2018-04-27 Impact factor: 3.240
Authors: Jessica J Tao; Michael H Eubank; Alison M Schram; Nicholas Cangemi; Erika Pamer; Ezra Y Rosen; Nikolaus Schultz; Debyani Chakravarty; John Philip; Jaclyn F Hechtman; James J Harding; Lillian M Smyth; Komal L Jhaveri; Alexander Drilon; Marc Ladanyi; David B Solit; Ahmet Zehir; Michael F Berger; Peter D Stetson; Stuart M Gardos; David M Hyman Journal: JCO Precis Oncol Date: 2019-07-24