1. ¹Division of Oncology, Department of Oncology, UO Oncologia Medica, Presidio Ospedaliero, Azienda USL-6 of Livorno Viale Alfieri 36, Livorno 57100, Italy
2. ²Department of Oncology Civil Hospital, Via Forlanini 22, Piombino 57025, Italy
3. ³Department of Oncology Civil Hospital, Via O. Marrucci 66, Cecina 57023, Italy
4. ⁴Division of Pneumology Civil Hospital, Viale Matteotti 35, Pistoia 51100, Italy
5. ⁵Division of Oncology, Department of Oncology Civil Hospital, Via Aurelia 335, Viareggio 55041, Italy
6. ⁶Department of Oncology, University of Pisa Via Roma 67, Pisa 56100, Italy
7. ⁷Istituto Toscano Tumori (ITT) Via Taddeo Alderotti 26/N, Firenze 50139, Italy

Correspondence: Dr C Tibaldi, E-mail: tiby@katamail.com

Received 2 July 2007; Revised 6 December 2007; Accepted 12 December 2007; Published online 22 January 2008.

Abstract

This multicenter phase II study evaluated, in chemonaive patients with stage IIIB–IV NSCLC, age 70 and with a performance status 0–2, the activity, efficacy and tolerability of planned sequential administration of gemcitabine 1200 mg m^-2 on days 1 and 8 every 3 weeks for three courses followed by three cycles of docetaxel 37.5 mg m^-2 on days 1 and 8 every 3 weeks, provided there was no evidence of disease progression. A total of 56 patients entered the study. According to intention-to-treat analysis, the objective response rate was 16.0% (95% CI 7.6–28.3%); 23 patients (41.0%) had stable disease and 24 patients (43%) had progressive disease. Five patients who had a stable disease after three courses of gemcitabine obtained a conversion to partial response by docetaxel. Median time to progression was 4.8 months (95% CI 3.6–6.0 months) and median duration of survival was 8.0 months (95% CI 5.6–10.5 months). The 1-year survival rate was 34%. No grade 4 haematological toxicity was observed and grade 3 neutropenia and thrombocytopenia were reported in 5.4 and 3.6% of the patients, respectively. Grade 3/4 mucositis and grade 3 diarrhoea, both occurred in 3.6% of the patients and grade 3 asthenia was observed in 9% of patients. One patient reported a grade 4 skin toxicity. No treatment-related deaths occurred. Sequential gemcitabine and docetaxel is a well-tolerated and effective regimen in elderly advanced NSCLC patients.