Gemcitabine versus gemcitabine-carboplatin for patients with advanced non-small cell lung cancer and a performance status of 2: A prospective randomized phase II study of the Hellenic Cooperative Oncology Group

Background: The purpose of this study was to evaluate gemcitabine-carboplatin (GCb) versus single-agent gemcitabine (G) in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2. The primary endpoint was clinical benefit. Patients and Methods: Patients were randomly assigned to either 1250 mg/m(2) of G (arm A) or 1250 mg/m(2) of G plus carboplatin area under the curve of 3 (arm B). Both treatments were given on days 1 and 14 and were repeated every 28 days for up to four cycles. Results: Among the 90 eligible patients (47 in arm A and 43 in arm B), in arm A, two (4%) had partial responses (95% CI, 0.52%-14.5%) and 10 (21%) had stable disease (95% Cl, 10.7%-35.7%). In arm B, six (14%) had partial responses (95% CI, 5.3%-27.9%) and nine (21%) had stable disease (95% CI, 10%-36%) (p = 0.14). No significant difference was found in terms of clinical benefit between the two treatment groups after two cycles of treatment or at the end of chemotherapy. Furthermore, no association was found between clinical benefit and response to treatment (p > 0.05). Median survival was 4.8 months (95% CI, 2.45-7.25) for arm A and 6.7 months (95% CI, 2.47-10.8) for arm B (p = 0.49). Neutropenia (p = 0.007) and thrombocytopenia (p < 0.001) were more common in group B. Nevertheless, no significant differences were found in terms of severe toxicities (p > 0.05 in all cases). Conclusion: No significant difference was found in terms of clinical benefit in patients with NSCLC and PS 2 who received single-agent G or GCb. Nevertheless, GCb caused more toxicity, particularly neutropenia and thrombocytopenia.