Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre phase II study Cesare Gridelli a, *, Antonio Rossi b , Emiddio Barletta a , Nicola Panza c , Luigi Brancaccio d , Riccardo Cioffi e , Tonino Pedicini f , Giovanni Pietro Ianniello g , Elena Piazza h , Nestore Rossi i , Rosario Vincenzo Iaffaioli a , Paolo Maione a , Massimo Di Maio k , Ciro Gallo j , Francesco Perrone k a Oncologia Medica B, Istituto Nazionale Tumori, Napoli, Italy b Oncologia Medica, Ospedale S. Carlo, Potenza, Italy c Oncologia Medica, Ospedale Cardarelli, Napoli, Italy d Oncologia Pneumologica V, Ospedale Monaldi, Napoli, Italy e Pneumologia Oncologica, Ospedale Civile, Caserta, Italy f Oncologia Medica, Ospedale Fatebenefratelli, Benevento, Italy g Oncologia Medica, Az. Ospedaliera Rummo, Benevento, Italy h Oncologia Medica, Ospedaliera Sacco, Milano, Italy i Day-Hospital di Oncologia, Ospedale Civile, Polla (SA), Italy j Statistica Medica, Seconda Universita `, Napoli, Italy k Ufficio Sperimentazioni Cliniche Controllate, Istituto Nazionale Tumori, Napoli (Coordinating Centre), Italy Received 17 October 2001; received in revised form 4 January 2002; accepted 9 January 2002 Abstract Purpose and methods: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m 2 days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end- point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. Results: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5  /59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3  /6.7). Median survival was 7.9 months (95% CI: 4.8 /14.4). Conclusion: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC. # 2002 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Small-cell lung cancer; Elderly; Chemotherapy; Phase II study; Carboplatin; Vinorelbine 1. Introduction About the half of small-cell lung cancer (SCLC) cases are diagnosed among elderly people, over 65 years. Elderly patients poorly tolerate chemotherapy because of comorbidities and progressive reduction of organ function related to age. Consequently, they often receive untested or inadequate treatments [1] and are excluded from clinical trials [2]. When they receive the same chemotherapy combinations used in the younger pa- tients, empirical dose-reductions are frequently applied. Nevertheless, several retrospective studies have shown that this strategy is not successful, severe toxicity being frequently observed [3  /7]. In order to develop active * Corresponding author. Address: Medical Oncology, S. Giuseppe Moscati Hospital, via Circumvallazione, 83100 Avellino, Italy. E-mail address: cgridelli@sirio-oncology.it (C. Gridelli). Lung Cancer 36 (2002) 327  /332 www.elsevier.com/locate/lungcan 0169-5002/02/$ - see front matter # 2002 Elsevier Science Ireland Ltd. All rights reserved. PII:S0169-5002(02)00003-X