Patients (>70 years old) who had pathologically been proven to have a NSCLC and measurable lesions were treated with paclitaxel (175 mg/m2 for 3 h) and carboplatin [area under the concentration–time curve (AUC = 5)] on day 1 every 3 weeks.
Forty patients were enrolled into the study. The median age was 74 years (range, 70–78 years). Approximately 85 % of the patients had stage IV and 80 % had a performance status (PS) of 0–1. Nine of the 40 (22.5 % ; 90 % CI 17.6–28.1) included patients had a partial response; one patient (2.5 % ; 90 % CI 1.7–3.2) achieved a complete response. The overall response rate was 25 % (90 % CI 15.3–38.6). In addition stable disease was observed in 13 patients (32.5 % ; 90 % CI 24.3–40.7). The median survival was 7.8 months (95 % confidence interval, 5.1–11.8 months). The actual 1-year survival was 18 % (95 % confidence interval, 12–29 % ). The median time to disease progression was 4.1 months (95 % CI 2.8–8.5). Overall, 37.5 % of patients experienced grade 3–4 neutropenia of any duration with only two patients (5 % ) developing neutropenic fever. Grade 3 or 4 non-haematological toxicity was uncommon apart alopecia.
In the present phase II study the combination of paclitaxel and carboplatin has demonstrated to be active and safe in an age-selected population.