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The purpose of the study was to evaluate the combination of gemcitabine and vinorelbine in the treatment of patients with relapsed or refractory small cell lung cancer. Between March 1998 and February 1999, 30 patients with relapsed or refractory small cell lung cancer who had received treatment with one previous combination chemotherapy regimen entered this multicenter, community-based clinical trial. All patients had received previous platinum/etoposide combination chemotherapy; in addition, 12 patients had received paclitaxel as part of their first-line therapy. All patients received gemcitabine 1000 mg/m2 and vinorelbine 20 mg/m2 on days 1, 8, and 15 of each 28-day cycle. Patients were reevaluated for response after two cycles of therapy; those with objective response or stable disease continued treatment for six courses or until disease progression. Three of 28 evaluable patients (10%) had partial responses to treatment. None of the 17 patients with refractory disease responded, while 3 of 12 patients (25%) with relapsed disease had partial responses. Median survival was 5 months. Treatment was generally well tolerated; myelosuppression was the major toxicity, but only two patients developed febrile neutropenia, and there were no treatment-related deaths. Non-hematologic toxicity was uncommon; alopecia did not occur with this regimen. The activity of gemcitabine and vinorelbine in patients with previously treated small cell lung cancer is modest and is limited to patients with relapsed (versus refractory) disease. In patients with relapsed small cell lung cancer, this regimen provides an additional treatment option, with decreased toxicity when compared to other second-line options. However, novel treatment approaches are necessary before substantial improvements in treating this patient population will be realized. [ABSTRACT FROM AUTHOR]

Background: The effect of using fixed versus weight-based doses for erythropoietic agents has not been reported previously. To investigate this issue, the authors conducted a randomized Phase II study of darbepoetin alfa administered as either a fixed dose or a weight-based dose using an accelerated correction and maintenance dosing regimen (front-loading)., Methods: During the correction phase, patients with anemia (hemoglobin < 11.0 g/dL) who had nonmyeloid malignancies and who were receiving chemotherapy were given darbepoetin alfa at a fixed dose of 325 microg (n = 122) or at a weight-based dose of 4.5 microg/kg (n = 120) once weekly until they achieved a hemoglobin concentration > or = 12.0 g/dL. Patients then received darbepoetin alfa (325 microg or 4.5 microg/kg) once every 3 weeks for the remainder of the 16-week treatment period (maintenance phase)., Results: Darbepoetin alfa resulted in high Kaplan-Meier rates of hematopoietic response (> or = 2 g/dL increase from the baseline level or a hemoglobin level > or = 12 g/dL) in both the fixed-dose group (86%; 95% confidence interval [95% CI], 78- 94%) and the weight-based dose group (84%; 95% CI, 76-92%). The median time to hematopoietic response was 34 days (95% CI, 28-44 days) for the fixed-dose group and 36 days (95% CI, 30-45 days) for the weight-based dose group. Hemoglobin concentrations were maintained at target levels for up to 16 weeks in both groups. Darbepoetin alfa was well tolerated, and no clinically significant differences between fixed doses and weight-based doses were observed., Conclusions: Darbepoetin alfa was effective when administered as either a fixed dose or a weight-based dose using a front-loading approach to rapidly correct anemia and effectively maintain hemoglobin levels in patients with anemia who had malignant disease., (Copyright 2004 American Cancer Society.)