Gemcitabine (G) vs gemcitabine-carboplatin (GCB) for patients with advanced non-small cell lung cancer (NSCLC) and PS:2. A prospective randomized phase II study of the Hellenic Co-Operative Oncology Group

Abstract

7058 Background: PS:2 is an independent negative prognostic factor for patients(pts) with NSCLC. Most of the information about prognosis, response, survival and treatment options was obtained from subset analysis of large trials. Single agent chemotherapy has been proven superior to best supportive care on survival or quality of life. Purpose was to evaluate prospectively if the combination chemotherapy GCb has superior efficacy compared to single agent G in pts with advanced NSCLC PS:2. Primary end-point was clinical benefit. Methods: Pts received either G: 1250 mg/m2 every 14 days (Arm A) or G: 1250 mg/m2 and Cb: 3AUC every 14 days (Arm B). Both treatments were given in cycles of 28 days. Four were the maximum number of cycles. 102 pts were enrolled. Ten pts were non -eligible. Baseline demographics were comparable for both groups. Median age was 73 and 70.5 for group A and B, male 83% and 72%, stage IV 64% and 72%, two disease sites 36% and 40.5% respectively. Relative dose intensity for G was 76% and 71% for arm A and B. For the clinical benefit, the following factors were evaluated: pain, cough, dyspnea, weight loss, appetite, weakness, nausea, vomiting and overall general feeling. Results: are summarized below. Conclusions: The combination GCb is not superior to G alone in terms of clinical benefit, TTP, m. survival and 1 -year survival. The combination causes more toxicity particularly neutropenia. No significant financial relationships to disclose.