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Di Bartolomeo, Maria; Buzzoni, Roberto; Mariani, Luigi; Ferrario, Erminia; Katia, Dotti; Gevorgyan, Arpine; Zilembo, Nicoletta; Bordonaro, Roberto; Bochicchio, Anna Maria; Massidda, Bruno; Ardizzoia, Antonio; Ardizzoni, Antonio; Marini, Giovanni; Aitini, Enrico; Schieppati, Giuseppe; Comella, Giuseppe; Pinotti, Graziella; Palazzo, Salvatore; Cicero, Giovanni; Bajetta, Emilio; Villa, Eugenio; Fagnani, Daniele; Reguzzoni, Giorgio; Agostana, Biagio; Oliani, Cristina; Kildani, Basem; Duro, Maria; Botta, Mario; Mozzana, Ruggiero; Mantovani, Giovanni
Oncology, 01/2006, Volume: 71, Issue: 5-6Journal Article
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. 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 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.
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