Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma - A Randomized phase III trial

Objective: Combination therapies of fluorouracil ( FU) with irinotecan ( CPT- 11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin 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), leucovorin (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). All 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 experimental arm of an ongoing multicenter trial. Copyright (C) 2006 S. Karger AG, Basel.