Results of a Phase II study of weekly docetaxel and carboplatin in stage IIIB (with effusion) or stage IV non-small cell lung cancer patients age ≤65 and performance status 2

This study explores if advanced NSCLC patients with ECOG PS 2 and age <= 65 years can benefit from weekly docetaxel. + carboplatin, with acceptable toxicities. Fifty-nine eligible patients with Stage IIIB (effusion) or Stage IV NSCLC were registered. Patients received docetaxel 35 mg/m(2) and carboplatin AUC = 2 on Days 1, 8, and 15 every 28-day cycle (maximum 8 cycles). Endpoints were 1-year survival, tumor response, PFS, and safety. Among the 59 eligible patients, the 1-year survival. was 28% and median survival was 6 months (range: 1-24.3). The median duration of response for CR + PR was 5.4 months (range: 2.3-9.7), 1-year progression-free survival. was 14% (median of 3.7 months, range < 1-22.8). Patients received a median of 3 cycles (range: 1-9); 14 patients (24%) had toxicity-related reductions. Responses were: 1 CR (2%), 5 PR (10%), 22 SD (45%), and 21 PD (43%). Forty-nine patients were evaluable for response; 10 patients were non-evaluable due to: radiotherapy (1), withdrew consent (3), insurance issues (1), and early toxicity (1 each; dyspnea, weakness, and rash), and other illness (2). Fifty-eight patients were evaluable for safety. The primary Grade 3 or 4 toxicities were neutropenia and fatigue (10% each), nausea (9%), dehydration (7%), and vomiting (5%). A 12% response rate (plus 45% SD) confirms the relatively poor outcome of patients with advanced NSCLC who are PS 2. Toxicities of docetaxel. + carboplatin are comparable to other regimens and this combination may provide an alternative for this group of patients. Further studies correlating patient characteristics with response are necessary. (C) 2006 Elsevier Ireland Ltd. All rights reserved.