Clinical Study Oncology Oncology 2006;71:341-346 Received: May 30, 2007 Accepted: May 31, 2007 DOI: 10.1159/000108575 Published online: September 14, 2007 Feasibility of Sequential Therapy with FOLFIRI Followed by Docetaxel/Cisplatin in Patients with Radically Resected Gastric Adenocarcinoma A Randomized Phase III Trial Maria Di Bartolomeo a Roberto Buzzoni a Luigi Mariani b Erminia Ferrario a Dotti Katia a Arpine Gevorgyan a Nicoletta Zilembo a Roberto Bordonaro c Anna Maria Bochicchio d Bruno Massidda e Antonio Ardizzoni f Giovanni Marini 9 Enrico Aitini h Giuseppe Schieppati i Giuseppe Comella j Graziella Pinotti k Salvatore Palazzo l Giovanni Cicero e Emilio Bajetta a on behalf ofthe Italian Trial in Medicai Oncology (lTMO) Group aMedical Oncology Unit 2 and bStatistics and Biometry Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori of Milano, Milano; cAzienda Ospedaliera S. Luigi Currò, Catania; dCentro Riferimento Oncologico Rionero in Vulture, Potenza; ePoliciinico Universitario, Monserrato; fOspedale S. Gerardo, Monza; 9Spedali civili, Brescia; hAzienda Ospedaliera C. Poma, Mantova; iOspedale Generale Provinciale, Saronno; Jlstituto Tumori, Fondazione G. Pasca le, Napoli; kOspedale di Circolo e Fondazione Macchi, Varese, e IAzienda Ospedaliera di Cosenza, Cosenza, Italia KeyWords Adjuvant chemotherapy • Docetaxel • Gastric cancer • Irinotecan Abstract Objective: Combination therapies of fluorouracil (FU) with irinotecan (CPT-ll) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer.ln this paper, we present the results of a phase III trial in which these two combinations given sequentiallywere compared to mitomy- cin C (MMC) monochemotherapy in an adjuvant setting. Methods: 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m 2 day 1), leu- covorin (100 mg/m 2 days 1-2), FU (400-600 mg/m 2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m 2 day 1), cisplatin (75 mg/m 2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m 2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). Ali patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76% of the patients in arm A and in 70% of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35%, with only 1 febrile patient, and diarrhea in 11% in arm A, and thrombocytopenia in 10% and neutropenia in 7% in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experi- mental arm of an ongoing multicenter trial. Copyright © 2006 S. Karger AG, Basel The following investigators should be considered as coauthors: Eu- genio Villa, IRCCS San Raffaele, Milano; Daniele Fagnani, Azienda Ospedaliera di Vimercate, Vimercate; Giorgio Reguzzoni, Azienda Ospedaliera di Circolo Busto Arsizio, Busto Arsizio; Biagio Agostana, Azienda M. Ascoli, Palermo; Cristina Oliani, Ospedale Civile Maggiore Borgo Trento, Verona; Basem Kildani, Ospedale S. Orsola Fatebene- fratelli, Brescia; Maria Duro, Ospedale Valduce, Como; Mario Botta, Ospedale S. Spirito, Casale Monserrato; Ruggiero Mozzana, Ospeda- leS. Antonio Abate, Gallarate; Giovanni Mantovani, Policlinico Uni- versitario, Monserrato, and Gianfranco Porcile, Azienda Ospedaliera S. Lazzaro, Alba, Italia. KARGER © 2006 S. Karger AG. Base! 0030-2414/06/0716-0341 $23 .50/0 Emilio Bajetta, MD Medica! Onco!ogy Unit 2. Fondazione IRCCS. Istituto Nazionale dei Tumori of Milan Fax +41613061234 Via Venezian l E·Mail karger@karger.ch Accessible on!ine al: IT-20133 Milano (Italy) www.karger.com www.karger.com/ocl Tel. +39 022 390 2500. Fax +39 022 390 2149. E-Mail bajelta@istitulotumori.mi.it