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Cisplatin, Gemcitabine, and Vinorelbine Combination Therapy in Advanced Non–Small-Cell Lung Cancer: A Phase II Randomized Study of the Southern Italy Cooperative Oncology Group

From the Division of Medical Oncology A, National Tumor Institute, Naples; Divisions of Medical Oncology and Pneumology, Cardarelli Hospital, Naples; Division of Medical Oncology, San Carlo Hospital, Potenza; Division of Medical Oncology, Oncology Institute, Bari; Division of Thoracic Surgery, San Paolo Hospital, Bari; Division of Pneumology, General Hospital, Caserta; Unit of Medical Oncology, Da Procida Hospital, Salerno; Unit of Medical Oncology, San Gennaro Hospital, Naples; and Department of Respiratory Diseases, School of Medicine, Second University of Naples, Italy; email pcomella@sirio-oncology.it.

Address reprint requests to Pasquale Comella, MD, Division of Medical Oncology A, via M. Semmola 80131, Naples, Italy.

PURPOSE: In a previous phase I study cisplatin (CDDP), gemcitabine (GEM), and vinorelbine (VNR) combination therapy was safe and very active in patients with non–small-cell lung cancer (NSCLC). This study was aimed at better defining the activity and toxicity of this regimen.

PATIENTS AND METHODS: One hundred eleven chemotherapy-naive patients, age 70 years, with stage IIIB or IV NSCLC and a performance status of 0 or 1 (Eastern Cooperative Oncology Group scale) were randomized to two treatment arms. Patients on arm A received CDDP 50 mg/m², GEM 1,000 mg/m², and VNR 25 mg/m² on days 1 and 8 of an every-3-weeks cycle (57 patients). Patients on arm B received CDDP 80 mg/m², epirubicin 80 mg/m², and vindesine 3 mg/m², all delivered on day 1 every 4 weeks, plus lonidamine orally 150 mg three times daily (54 patients). In December 1996, randomization was stopped early, and an additional 30 patients were treated with the experimental regimen to obtain a more accurate estimation of its activity rate.

RESULTS: Among 87 patients who received the CDDP-GEM-VNR combination, four complete responses (CRs) and 46 partial responses (PRs) were observed, for an overall response rate of 57% (95% confidence interval [CI], 46% to 68%). Two CRs and 18 PRs were recorded among 54 patients on arm B, giving a 37% activity rate (95% CI , 24% to 51%). After a median follow-up duration of 19 months, the median progression-free and overall survival durations were 32 and 50 weeks in arm A, and 18 and 33 weeks in arm B, respectively. World Health Organization grade 3 to 4 neutropenia and thrombocytopenia occurred in 46% and 14% of patients in arm A and in 22% and 11% of those in arm B, respectively. Severe nonhematologic toxicity was uncommon in both arms.

CONCLUSION: The CDDP-GEM-VNR combination is a highly effective treatment for patients with advanced NSCLC and has a manageable toxicity. A phase III trial comparing this new combination with both CDDP-VNR and CDDP-GEM regimens is underway.

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