KEY TAKEAWAYS
- The phase II trial aimed to evaluate the safety and effectiveness of FLOT plus nivolumab.
- The primary endpoint was PFS. Secondary endpoints were safety, OS, and ORR.
- The study found that FLOT and nivolumab may be good options for aggressive gastric cancer pts.
FOLFOX plus nivolumab is now the standard first-line treatment for aggressive esophagogastric adenocarcinomas. Researchers aimed to assess the safety and efficacy of FLOT plus nivolumab.
In Arm C, they assessed using FLOT combined with nivolumab (240 mg) q2w as the initial treatment for all pts. The primary endpoint was to determine the progression-free survival at 6 months (PFS@6), with the key secondary endpoints being the evaluation of safety, overall survival (OS), and overall response rate (ORR).
The study included 52 pts, with baseline characteristics indicating a median age of 61 years and 65% of pts with gastroesophageal junction (GEJ) tumors. A majority (65%) had PD-L1 CPS≥1(available in 96% of pts). Pts received an average of 8 cycles of FLOT and nivolumab, with 42% receiving additional treatment. The combination therapy was generally well-tolerated, with the most common grade 3 or higher adverse events(AEs) being decreased neutrophils (40.4%), anemia (5.8%), and thromboembolic events (7.7%).
After a median follow-up of 9.4 months, the 3-month and 6-month progression-free survival(PFS) rates were 85% and 42%, respectively. The median PFS was 6.6 months, and the median OS was 10.8 months.ORR was 54%, and the disease control rate (DCR) was 87%. Comparing this cohort (FLOT plus nivo) to the pooled cohorts A and A1 (utilizing mFOLFOX plus nivo and ipilimumab) with a non-randomized comparison of pts (n=90pts), FLOT plus nivo demonstrated higher DCR (87% vs. 78%) and a better 3-month PFS (85% vs. 72%).
The study found that FLOT and nivolumab may be a good option for select patients with aggressive gastric cancer.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.4045
Clinical Trial: https://www.clinicaltrials.gov/study/NCT03647969
Sylvie Lorenzen, Thorsten Oliver Goetze, Ralf Dieter Hofheinz, Peter C. Thuss-Patience, Tobias Nicolaas Dechow, Jorge Riera-Knorrenschild, Gunter Schuch, Kim Barbara Luley, Christine Koch, Eray Goekkurt, Harald Schmalenberg, Thomas Jens Ettrich, Udo Lindig, Daniel Pink, Michael Bitzer, Claus Bolling, Nils Homann, Sabine Junge, Claudia Pauligk, and Salah-Eddin Al-Batran. DOI: 10.1200/JCO.2023.41.16_suppl.4045 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 4045-4045.
