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/m2 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.