Efficacy of irinotecan in combination with 5-fluorouracil (FOLFIRI) for metastatic gastric or gastroesophageal junction adenocarcinomas (MGA) treatment - 31/01/11

Doi : 10.1016/j.gcb.2010.06.010

E. Samalin ^a,^⁎ , P. Afchain ^b, S. Thézenas ^a, F. Abbas ^c, O. Romano ^d, R. Guimbaud ^e, Y. Bécouarn ^f, F. Desseigne ^g, J. Edeline ^h, E. Mitry ⁱ, O. Bouché ^j, A. Adenis ^k, T. Aparicio ^l, E. Dorval ^m, A. Kramar ^k, M. Ychou ^a
^a CRLC Val d’Aurelle, 208, rue des Apothicaires, 34298 Montpellier cedex 5, France
^b Hôpital Saint-Antoine, Assistance publique–Hôpitaux de Paris, Paris, France
^c Hôpital Tenon, Assistance publique–Hôpitaux de Paris, Paris, France
^d CHU de Lille, Lille, France
^e CHU de Toulouse, Toulouse, France
^f Institut Bergonié, Bordeaux, France
^g Centre Léon-Bérard, Lyon, France
^h Centre Eugène-Marquis, Rennes, France
ⁱ Hôpital Ambroise-Paré, Assistance publique–Hôpitaux de Paris, Boulogne, France
^j CHU Robert-Debré, Reims, France
^k Centre Oscar-Lambret, Lille, France
^l Hôpital Bichat, Assistance publique–Hôpitaux de Paris, Paris, France
^m Hôpital Trousseau, Tours, France

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Summary

Objectives

The most commonly used schedules are 5-FU in combination with CDDP with or without epirubicin (ECF) or docetaxel (TCF) in treatment of MGA patients (pts), independently of HER status. We evaluated the efficacy of FOLFIRI regimen in a large retrospective series of MGA pts.

Methods

Two hundred and twelve pts from 13 French centers were treated with at least one cycle of FOLFIRI (irinotecan 180mg/m² intravenous (i.v.) over 90 minutes on day 1 with folinic acid (FA) 400mg/m² i.v. over two hours followed by 5-FU 400mg/m² i.v. bolus then 5-FU 2400mg/m² continuous infusion over 46 hours on day 1, repeated every 14 days). Primary tumour sites were 120 (58%) stomach and 92 (42%) gastroesophageal junction. FOLFIRI was administered as first-line in 137 (65%) pts and as later-line in 75 (35%) pts for MGA.

Results

There was no difference between chemonaive and not chemonaive pts treated as first-line in terms of response rate 37% (95% CI: 25–50) vs 44% (95% CI: 21–69), median PFS, 6.7 (95% CI: 5.5–9.9) vs 5.3 months (95% CI: 3.6–6.9) (P=0.25), and OS, 13.1 (95% CI: 11.7–18.7) vs 8.8 months (95% CI: 7.3–15.6) (P=0.19), respectively. There was no difference between pts treated as second or later-line in terms of response rate 20% (95% CI: 8–39) vs 22% (95% CI: 6–48), median PFS, four months (95% CI: 2.8–5.4) vs 3.5 months (95% CI: 2.3–4.5) (P=0.56), and OS, 10.4 months (95% CI: 5.4–14.4) vs 5.3 months (95% CI: 3.5–11.3) (P=0.58), respectively. The global grade 3–4 toxicities were: diarrhea 11%, vomiting 9%, neutropenia 18%, febril neutropenia 4% (one toxic death).