Background: Treatment options for patients with recurrent nonsmall cell lung carcinoma (NSCLC) remain limited as a result of poor activity of older agents after platinum-based therapy. In the current Phase II study, the authors evaluated the combination of gemcitabine and docetaxel in patients with recurrent NSCLC.
Methods: Patients with advanced NSCLC (Stage IIIB-IV), a World Health Organization performance status (PS) < or = 2, prior paclitaxel plus platinum-based chemotherapy, and unimpaired hematopoietic and organ function were eligible. Chemotherapy was administered as follows: gemcitabine 1000 mg/m(2) was administered on Days 1 and 8 followed by docetaxel 100 mg/m(2) on Day 8, and this regimen was recycled every 21 days. Prophylactic granulocyte-colony stimulating factor was administered on Days 10-14 or until the patient achieved a white blood cell count > or = 5000/microL.
Results: Of 43 patients who were entered on the study, 41 patients were evaluable for response, and all were evaluable for toxicity. The median patient age was 63 years (range, 47-70 years), the median PS was 1 (range, 0-2), there were 38 male patients, and there were 5 female patients. Four patients had Stage IIIA disease, 17 patients had Stage IIIB disease, and 22 patients had Stage IV disease. Histologies included 19 patients with adenocarcinoma, 18 patients with squamous cell carcinoma, and 3 patients with large cell carcinoma. Metastatic sites included lymph nodes in 28 patients, bone in 6 patients, liver in 5 patients, brain in 5 patients, lung nodules in 8 patients, adrenals in 7 patients, and other sites in 3 patients. All patients had received prior paclitaxel plus platinum-based treatment; 28 patients had received prior paclitaxel, ifosfamide, and cisplatin. Objective responses were partial response (PR) in 14 of 43 patients [33%; 95% confidence interval [95%CI], 18.5-46.6%], stable disease (SD) in 16 of 43 patients (37%; 95% CI, 22.8-51.6%), and progressive disease (PD) in 13 of 43 patients (30%; 95% CI, 16.3-43.7%). The median time to disease progression was 6 months (range, 1.0-20.0+ months), and the median survival was 8.5 months (range, 1.5-20.0+ months). The 1-year survival rate was 28%. Grade 3-4 neutropenia was experienced by 53% of patients (30% Grade 4), with 14% of patients experiencing febrile neutropenia. Grade 3 thrombocytopenia was experienced by 7% of patients (no Grade 4), whereas other Grade 3 nonhematologic toxicities were never encountered.
Conclusions: The combination of gemcitabine and docetaxel is active and is well tolerated in patients with advanced NSCLC who have failed prior taxane plus platinum chemotherapy. This regimen represents a tolerable and effective combination to apply in the palliative treatment of patients with recurrent NSCLC.
Copyright 2001 American Cancer Society.