Abstract 1454P
Background
FOLFIRI is a standard second-line (2L) chemotherapy (CT) in metastatic gastric and oeso-gastric junction cancer (mGC) in France. The RAINBOW trial demonstrated a meaningful efficacy of the paclitaxel/ramucirumab (PR) combination with a median overall survival (mOS) of 9.6 months. Since no prospective trial has compared FOLFIRI and PR regimen, this retrospective study was performed.
Methods
Between 2014 and 2018, 194 consecutive Her2 negative mGC patients from 22 centers, previously treated with a first-line chemotherapy (platinum based) and receiving a 2L CT, either PR (n=68) or FOLFIRI (n=126) were included in this retrospective study. Primary objective was to estimate mOS from the beginning of 2L CT with the Kaplan Meier method and to compare PR and FOLFIRI using Log Rank test after matching the two groups by a propensity score.
Results
Median age was 63 years, 73% were men, 67% had an intestinal type mGC, 29% had a surgery of the primary tumor and 50 % had one metastatic site. ECOG performance status (PS) was 0-1 in 82%. Median follow-up time was 37.6 months. There was no significant difference for baseline patient and tumor characteristics, except for age (59 vs 64 years, p<0.01) and median number of metastatic site (2 vs 1, p=0.03) in the PR and FOLFIRI group respectively. There was no statistical difference for 2L mOS, either in the baseline population (9.8 vs 8.3 months, p=0.28) or in the matched population (9.6 vs 8.3 months, p=0.24), as well as in the signet ring cell GC subgroup (7.9 vs 6.6 months, p=0.77). Progression free survival (5.6 vs 4.1 months, p=0.16) and disease control rate (67% vs 59%, p=0.32) were also similar. Overall, grade 3-4 toxicities were similar between the two groups. However, there was more grade 3-4 asthenia (44% vs 5%, p=0.03), nausea (17% vs 0%, p=0.02) and vomiting (17% vs 0%, p=0.02) in the FOLFIRI group.
Conclusions
PR and FOLFIRI regimen show similar efficacy endpoints and overall toxicity, even though FOLFIRI had higher grade 3-4 asthenia and upper GI tract toxicity. These results need to be validated by a phase III prospective trial with analysis of quality of life.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
AGEO.
Funding
Has not received any funding.
Disclosure
J. Vivier-Chicoteau: Travel/Accommodation/Expenses: Amgen. C. Toullec: Travel/Accommodation/Expenses: Merck Serono; Honoraria (self), Travel/Accommodation/Expenses: Sanofi Aventis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS. S. Racine Doat: Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: Merck Serono; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: MSD. A. Turpin: Honoraria (self): Bayer; Honoraria (self): Mylan; Honoraria (self), Travel/Accommodation/Expenses: Merck; Honoraria (self): Amgen; Travel/Accommodation/Expenses: Astra Zeneca; Travel/Accommodation/Expenses: Pfizer. D. Sefrioui: Honoraria (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Sandoz; Travel/Accommodation/Expenses: Pierre Fabre. O. Bouche: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Servier; Honoraria (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Travel/Accommodation/Expenses: Merck Serono; Honoraria (self): MSD; Honoraria (self): Pierre Fabre; Advisory/Consultancy: Astra Zeneca; Advisory/Consultancy: Grunenthal. A. Zaanan: Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Baxter; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Honoraria (self), Advisory/Consultancy: Sanofi Aventis; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: MSD. M. Kroemer: Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Biogen; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: MSD; Travel/Accommodation/Expenses: Astra Zeneca. A. Pellat: Advisory/Consultancy: Servier; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Amgen. A.L. Bignon Bretagne: Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Amgen; Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy: Bayer; Advisory/Consultancy: BMS; Advisory/Consultancy: Sanofi Aventis. C. VITELLIUS: Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Sanofi. J. Lavole: Advisory/Consultancy: Servier. G. Goujon: Honoraria (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): Servier; Honoraria (self), Travel/Accommodation/Expenses: Sanofi Aventis. Y. Touchefeu: Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Advisory/Consultancy: Merck Serono; Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Biocodex. D. Tougeron: Research grant/Funding (institution): Merck Serono; Research grant/Funding (self): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy: Astra Zeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi Aventis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Travel/Accommodation/Expenses: Ipsen. V. Hautefeuille: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AAA; Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Sanofi Aventis; Travel/Accommodation/Expenses: Merck. All other authors have declared no conflicts of interest.