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Cisplatin Plus Gemcitabine or Vinorelbine for Elderly Patients With Advanced Non–Small-Cell Lung Cancer: The MILES-2P Studies

Cesare Gridelli, Paolo Maione, Alfonso Illiano, Franco Vito Piantedosi, Adolfo Favaretto, Alessandra Bearz, Sergio Federico Robbiati, Virginio Filipazzi, Vito Lorusso, Francesco Carrozza, Rosario Vincenzo Iaffaioli, Luigi Manzione, Ciro Gallo, Alessandro Morabito, Francesco Perrone

From the Division of Medical Oncology, S. Giuseppe Moscati Hospital, Avellino; the Chemotherapy Unit and the Department of Pneumooncology, Monaldi Hospital, the Division of Medical Oncology B and the Clinical Trials Unit, National Cancer Institute, and the Department of Medicine and Public Health, Second University, Naples; the Division of Medical Oncology II, Istituto Oncologico Veneto, Padua; the Division of Medical Oncology A, CRO, Aviano; the Division of Medical Oncology, S. Maria del Carmine Hospital, Rovereto; the Division of Medical Oncology, L. Sacco Hospital, Milan; the Division of Medical Oncology, Oncologic Hospital, Bari; Medical Oncology, S. Carlo Hospital, Potenza; and the Division of Medical Oncology, A.Cardarelli Hospital, Campobasso, Italy

Address reprint requests to Cesare Gridelli, MD, Division of Medical Oncology, S.G. Moscati Hospital, Via Circumvallazione, 68, Contrada Amoretta, 83100 Avellino, Italy; e-mail: cgridelli{at}libero.it

Purpose: Two phase I/II trials were done to evaluate the feasibility of cisplatin combined with gemcitabine or vinorelbine in elderly patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods: Patients with advanced NSCLC who were older than 70 years of age and who had a performance status of 0 to 1 were eligible. Cisplatin was given on day 1 (a starting dose of 50 mg/m² with increasing increments of 10 mg/m² at each level) and gemcitabine (1,000 mg/m²) or vinorelbine (25 mg/m²) on days 1 and 8. Cycles were repeated every 21 days. A two-stage flexible optimal design was applied in the phase II study, and unacceptable toxicity was the primary end point.

Results: Overall, 159 patients were enrolled: 38 in phase I and 121 in phase II studies. Cisplatin was feasible at 60 mg/m² with gemcitabine and at 40 mg/m² with vinorelbine. With the former combination, 50 of 60 (83.3%) patients were treated without unacceptable toxicity; objective responses were reported in 26 of 60 patients (43.5%; 95% CI, 30.6 to 56.8); median progression-free and overall survivals were 25.3 and 43.6 weeks, respectively. With the latter combination, 50 (82.0%) of 61 patients were treated without unacceptable toxicity; objective responses were reported in 22 of 61 patients (36.1%; 95% CI, 24.2 to 49.4); median progression-free and overall survivals were 21.1 and 33.1 weeks, respectively.

Conclusion: Both cisplatin (60 mg/m²) plus gemcitabine and cisplatin (40 mg/m²) plus vinorelbine are feasible and active in the treatment of elderly patients with advanced NSCLC. The former combination, which provides a higher dose of cisplatin, deserves comparison versus single-agent chemotherapy in this setting of patients.

The Clinical Trials Unit of the National Cancer Institute, Naples is supported in part by the nonprofit group Associazione Italiana per la Ricerca sul Cancro.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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