National Cancer Center Hospital East, Kashiwa, Japan
Kohei Shitara , Ben George , Julien Taieb , Raghav Sundar , Marwan Fakih , Lukas Makris , Karim A. Benhadji , Michele Ghidini
Background: It is unclear whether prior treatment with ramucirumab (RAM) or RAM plus paclitaxel (PAC), standard second-line treatments for metastatic gastric or gastroesophageal junction cancer (mGC/GEJC), can influence outcomes with third-line chemotherapy in this patient (pt) population (pop). In the phase 3 TAGS trial, FTD/TPI showed a survival benefit vs placebo (PBO) in pts with mGC/GEJC who had received ≥2 prior chemotherapy regimens. Post hoc analyses were performed to assess the impact of prior RAM, PAC or RAM+PAC treatment on the efficacy and safety of FTD/TPI in TAGS. Methods: Pts in the TAGS trial were categorized into 5 subgroups based on prior treatment received as follows: A) RAM (alone or combined with other agents), B) no RAM, C) PAC (but no RAM), D) RAM+PAC (sequentially or in combination) and E) neither PAC nor RAM. While subgroups A and B were prespecified, all other subgroups were identified post hoc. Efficacy (overall survival [OS] and progression-free survival [PFS]) and safety were assessed in these subgroups. Results: In the overall pop (N=507), 33% had received prior RAM (alone/combined); 30% prior RAM+PAC; 27% prior PAC but no RAM; and 40% had received neither PAC nor RAM. As only 3% of all pts received prior RAM but no PAC, that subgroup was not considered in this analysis. FTD/TPI treatment was consistently associated with benefits in OS and PFS vs placebo across all pt subgroups (Table). Among pts randomized to FTD/TPI, OS benefit was similar between pts who received RAM+PAC vs those who received neither (HR, 1.15; 95% CI, 0.84–1.58) and between pts who received PAC (but no RAM) vs those who received neither (HR, 0.91; 95% CI, 0.66–1.25). The FTD/TPI safety profile was consistent across all subgroups, with similar overall incidences of grade ≥3 adverse events (AEs). Minor variations in hematologic toxicities were noted (Table). Conclusions: In the phase 3 TAGS trial, FTD/TPI treatment in the third or later line provided efficacy benefits vs PBO and demonstrated a consistent safety profile in pts with mGC/GEJC regardless of prior treatments. Clinical trial information: NCT02500043
All pts | Prior RAM | No prior RAM | Prior Pac (no RAM) | Prior RAM+PAC | No prior RAM or PAC | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FTD/ TPI | PBO | HR (95% CI) | FTD/ TPI | PBO | HR (95% CI) | FTD/ TPI | PBO | HR (95% CI) | FTD/ TPI | PBO | HR (95% CI) | FTD/ TPI | PBO | HR (95% CI) | FTD/ TPI | PBO | HR (95% CI) | |
ITT pop, n | 337 | 170 | 114 | 55 | 223a | 115 | 99 | 37 | 106 | 48 | 124 | 78 | ||||||
Median OS, mo | 5.7 | 3.6 | 0.69 (0.56-0.85) | 5.0 | 3.8 | 0.76 (0.53–1.08) | 6.0 | 3.3 | 0.66 (0.51–0.85) | 5.7 | 3.0 | 0.47 (0.31–0.73) | 4.6 | 3.6 | 0.73 (0.50–1.05) | 6.1 | 3.7 | 0.83 (0.60–1.16) |
Median PFS, mo | 2.0 | 1.8 | 0.57 (0.47-0.70) | 1.9 | 1.7 | 0.54 (0.38–0.77) | 2.2 | 1.8 | 0.58 (0.46–0.75) | 1.9 | 1.8 | 0.57 (0.37–0.85) | 1.9 | 1.7 | 0.51 (0.36–0.74) | 2.3 | 1.8 | 0.62 (0.46–0.84) |
Safety pop, n | 335 | 168 | 109 | 55 | 226a | 113 | 99 | 36 | 105 | 48 | 123 | 77 | ||||||
Grade ≥3 AE, % | ||||||||||||||||||
Any | 80 | 58 | 76 | 56 | 81 | 58 | 80 | 61 | 76 | 60 | 83 | 56 | ||||||
Neutropenia | 34 | 0 | 38 | 0 | 32 | 0 | 32 | 0 | 37 | 0 | 32 | 0 | ||||||
Anemia | 19 | 8 | 19 | 11 | 19 | 6 | 26 | 8 | 17 | 10 | 15 | 5 |
aSlightly different source parameters accounted for minor variations in pt numbers.
Taiho Oncology, Inc.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Arvind Dasari
2022 ASCO Annual Meeting
First Author: Alla Paskovaty
2023 ASCO Genitourinary Cancers Symposium
First Author: Yann-Alexandre Vano
2023 ASCO Genitourinary Cancers Symposium
First Author: Yann-Alexandre Vano