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Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group |
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| Authors: | Pasquale Comella Vito Lorusso Luigi Maiorino Rossana Casaretti Michele Cannone Bruno Massidda Carlo Putzu Silvana Leo Mario Roselli Sergio Mancarella Sergio Palmeri Ettore Greco Giacomo Vessia Claudia Sandomenico Luca Franco |
| Affiliation: | 1. Unit of Medical Oncology, Department of Gastrointestinal Tumours, National Tumour Institute, Via Mariano Semmola, 80131, Naples, Italy 2. Unit of Medical Oncology, Oncology Institute, Bari, Italy 7. Unit of Medical Oncology, City Hospital, Lecce, Italy 3. Unit of Medical Oncology, San Gennaro Hospital, Naples, Italy 4. Unit of Medical Oncology, City Hospital, Canosa, Italy 5. Chair of Medical Oncology, University of Cagliari, Cagliari, Italy 6. Chair of Medical Oncology, University of Sassari, Sassari, Italy 8. Chair of Medical Oncology, Tor Vergata University, Rome, Italy 9. Unit of Medical Oncology, City Hospital, Galatina, Italy 10. Chair of Medical Oncology, University of Palermo, Palermo, Italy 11. Unit of Medical Oncology, City Hospital, Lametia Terme, Italy 12. Unit of Medical Oncology, City Hospital, Altamura, Italy |
| Abstract: | Purpose This phase II trial assessed the tolerability and efficacy of a triplet of oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer. Methods Patients with unresectable or metastatic gastric cancer, unexposed to palliative chemotherapy, received oxaliplatin 85 mg/m2 iv and irinotecan 150 mg/m2 iv on day 1, 6S-folinic acid 250 mg/m2 iv and fluorouracil 750 mg/m2 iv on day 2, every 2 weeks. Response rate (RR) was assessed after a minimum of four cycles, and treatment continued up to 12 cycles. Results Sixty-three patients were treated, with a median of eight (range 1–12) cycles/patient. Two complete and 19 partial responses were registered (RR 33% [95% CI, 22–46%]). Median progression-free survival was 7.5 (95% CI, 5.6–9.4) months, and median overall survival was 12.1 (95% CI, 10.8–13.4) months. Most common grade ≥3 toxicities were neutropenia (59%), febrile neutropenia (7%), vomiting (20%), and diarrhoea (10%). All-grade neurotoxicity affected 33% of patients. Conclusions Oxaliplatin, irinotecan, and fluorouracil/folinic acid administered every 2 weeks are safe and active in advanced gastric cancer. SICOG trial 0405, EudraCT number 2006-0066869-16. |
| Keywords: | Gastric cancer Fluorouracil Irinotecan Oxaliplatin Triplet regimen |
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