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Clinical Trial
. 2022 Apr:165:48-57.
doi: 10.1016/j.ejca.2022.01.015. Epub 2022 Feb 21.

FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel - results from the phase II RAMIRIS Study of the German Gastric Cancer Study Group at AIO

Sylvie Lorenzen  1 , Peter Thuss-Patience  2 , Claudia Pauligk  3 , Eray Gökkurt  4 , Thomas Ettrich  5 , Florian Lordick  6 , Michael Stahl  7 , Peter Reichardt  8 , Martin Sökler  9 , Daniel Pink  10 , Stefan Probst  11 , Axel Hinke  12 , Thorsten O Goetze  13 , Salah E Al-Batran  13
Affiliations
Clinical Trial

FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel - results from the phase II RAMIRIS Study of the German Gastric Cancer Study Group at AIO

Sylvie Lorenzen et al. Eur J Cancer. 2022 Apr.

Abstract

Background: Ramucirumab and paclitaxel is the standard second-line therapy in patients with metastatic gastroesophageal adenocarcinoma. We report the efficacy and safety analyses of FOLFIRI and ramucirumab versus paclitaxel and ramucirumab after the failure of a platinum- and fluoropyrimidine-containing chemotherapy.

Methods: This multicenter, investigator initiated, phase II trial randomised patients with gastroesophageal adenocarcinoma to either FOLFIRI plus ramucirumab (RAM) (arm A) or paclitaxel plus RAM (arm B). The primary end-point was 6-month overall survival (OS) rate, with a proportion of ≥65% in arm A considered a positive signal for further investigation.

Results: 111 patients (65% of patients had prior docetaxel) were enrolled and 110 patients qualified for ITT population (arm A, 72; arm B, 38). The study did not meet the primary end-point for the comparison with historical control, as 6-month OS rate in the FOLFIRI plus RAM arm was 54% (95% CI 44-67). In between arm comparison, OS was similar (hazard ratio, HR 0.97 [95% CI 0.62-1.52]), while objective response rates (ORRs) and PFS were numerically better in arm A versus arm B (HR for PFS 0.73; ORR, 22% versus 11%). These differences were largely attributed to favourable efficacy results for arm A in docetaxel-pretreated patients (HR, 0.49; ORR, 25% versus 8%). In the safety population (n = 106), grade 3-5 adverse events were similar between arms (arm A, 75%; arm B, 68%).

Conclusion: The RAMIRIS trial demonstrated feasibility of FOLFIRI plus RAM. While the study was formally negative, it provided a signal to further investigate this combination for the group of patients with previous docetaxel therapy.

Trial registration: clinicaltrials.gov identifier: NCT03081143.

Keywords: Advanced gastroesophageal cancer; FOLFIRI; Irinotecan; Paclitaxel; Ramucirumab; Second line; Taxanes.

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Conflict of interest statement

Conflict of interest statement SL reports personal fees from Amgen, AstraZeneca, Eli Lilly, Elsevier, Merck Serono, Merck Sharp & Dohme, Roche, Servier; PTP reports personal fees from AstraZeneca, Lilly, BMS, MSD Merck Serono, Roche, Pfizer, Servier outside the submitted work; EG reports personal fees from Amgen, Merck Sharp & Dohme, Roche, BMS; FL reports personal fees from Amgen, Astellas, AstraZeneca, Bayer, Biontech, Eli Lilly, Elsevier, Imedex, Infomedica, Iomedica, Medscape, MedUpdate, Merck Serono, Merck Sharp & Dohme, Oncovis, Promedicis, Roche, Springer Nature, StreamedUp!, and Zymeworks; grants and personal fees from BMS, outside the submitted work; MS reports personal fees from Amgen, Bristol-Myers Squibb, Lilly, Merck Serono, MSD Sharp & Dohme, Pfizer, Roche, Servier and Sanofi; PR reports honoraria from Bayer, Clinigen, BMS, Roche, MSD, and Deciphera for a position on advisory boards and received honoraria for speaking at symposia from Novartis, Pfizer, PharmaMar, Lilly, and Amgen; DP reports institutional fees from Roche (advisory role), Lilly (advisory role), PharmaMar (advisory role, lecture fee), Blueprint Medicines (lecture fee) and research grants from Lilly, PharmaMar, Novartis, Clinigen, BMS, EUSA Pharma, Roche, outside the submitted work; AH reports Honoraria for lectures from Roche; TOG reports advisory role with Lilly, MSD Sharp & Dohme, Bayer, Bristol-Myers Squibb, Roche and Servier; is a speaker for Lilly, MCI, MSD Sharp & Dohme, Roche and Servier; and has received research grants from AstraZeneca, Lilly, German Cancer Aid (Krebshilfe), German Research Foundation German Research Foundation (DFG) and Joint Federal Committee (Gemeinsamer Bundesausschuss). SA reports advisory role with, Lilly, Bristol-Myers Squibb, MacroGenics, Immutep, and MSD Sharp & Dohme; he is a speaker for Bristol-Myers Squibb, Lilly, AIO Studien gGmbH, MCI Deutschland GmbH; He is CEO/founder of Institute of Clinical Cancer Research IKF at Northwest Hospital. He received research grants from Sanofi, Roche, Celgene, Vifor, Medac, Hospira, Lilly, Eurozyto, Immutep, Ipsen, Bristol-Myers Squibb, MSD Sharp & Dohme, AstraZeneca, German Cancer Aid (Krebshilfe), German Research Foundation and the Federal Ministry of Education and Research. All other authors declare no competing interests.

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