Gemcitabine and docetaxel as second-line chemotherapy for patients with nonsmall cell lung carcinoma who fail prior paclitaxel plus platinum-based regimens

Background. Treatment options for patients with recurrent nonsmall cell lun g carcinoma (NSCLC) remain limited as a result of poor activity of older ag ents after platinum-based therapy. In the current Phase II study, the autho rs evaluated the combination of gemcitabine and docetaxel in patients with recurrent NSCLC. Methods. Patients with advanced NSCLC (Stage IIIB-IV) a World Health Organi zation performance status (PS)less than or equal to2, prior paclitaxel plus platinum-based chemotherapy, and unimpaired hematopoietic and organ functi on were eligible. Chemotherapy was administered as follows: gemcitabine 100 0 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 granu locyte-colony stimulating factor was administer ed on Days 10-14 or until t he patient achieved a white blood cell count greater than or equal to 5000/ muL. Results. Of 43 patients who were entered on the study, 41 patients were eva luable for response, and all were evaluable for toxicity. The median patien t 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 patient s had Stage IIIA disease, 17 patients had Stage IIIB disease, and 22 patien ts had Stage IV disease. Histologies included 19 patients with adenocarcino ma, 18 patients with squamous cell carcinoma, and 3 patients with large cel l 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 pat ients, adrenals in 7 patients, and other sites in 3 patients. All patients had received prior paclitaxel plus platinum-based treatment; 28 patients ha d received prior paclitaxel, ifosfamide, and cisplatin. Objective responses were partial response (PR) in 14 of 43 patients [33%; 95% confidence inter val [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 (r ange, 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 experie ncing febrile neutropenia. Grade 3 thrombocytopenia was experienced by 7% o f patients (no Grade 4), whereas other Grade 3 nonhematologic toxicities we re 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 effect ive combination to apply in the palliative treatment of patients with recur rent NSCLC. Cancer 2001;92:2902-10. (C) 2001 American Cancer Society.