Objectives: We have carried out a phase II study to evaluate the efficacy and the toxicity associated with the combination of gemcitabine, ifosfamide, and cisplatin (GIP) in chemotherapy-naive patients with advanced nonsmall cell lung cancer (NSCLC).
Methods: Each cycle consisted of treatment with ifosfamide (3000 mg/m2) and gemcitabine (1500 mg/m2) on day 1, followed by cisplatin (100 mg/m2) and gemcitabine (1500 mg/m2) on day 15. Each treatment cycle was repeated every 28 days. A maximum of 6 cycles were administered.
Results: Sixty NSCLC patients (23 stage III and 37 stage IV) were entered in this study. The median survival for all patients is 9 months (stage III: 12.3 months; stage IV: 7.5 months). The overall survival at 1 and 2 years is 38% and 17%, respectively (52% and 30% for stage III; 30% and 8% for stage IV). The median time to progression is 6.3 months (stage III: 8.8 months; stage IV: 3.6 months). Progression free survival at 1 and 2 years for all patients is 22% and 8%. The response rate is 56% for patients with stage III disease and 27% for patients with stage IV disease. Among the grade 3/4 toxicities, hematological toxicity was the most frequent (59% of patients) followed by gastrointestinal toxicity (nausea/vomiting) in 21% of patients.
Conclusion: The GIP combination yields an efficacy, in terms of response and survival, comparable to that reported with other triplet combination treatments for local advanced or metastatic NSCLC, with an acceptable toxicity profile.