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BACKGROUND The authors conducted a Phase II study to evaluate the activity and toxicity of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma (NSCLC). METHODS Patients with documented recurrent or refractory NSCLC, previously treated with no more than one chemotherapy regimen, were eligible if they had a performance status (PS) of 0–2, measurable or evaluable disease, and adequate organ function. Patients were treated with docetaxel 36 mg/m2/week for 6 consecutive weeks, administered intravenously with dexamethasone premedication. Cycles were repeated every 8 weeks. RESULTS Thirty-one patients were enrolled. One patient was ineligible because of uncontrolled brain metastases. Hematologic toxicity was minimal. Nonhematologic toxicities were modest except for diarrhea and cumulative fatigue. There were no treatment-related deaths. The overall response rate was 10% (95% confidence interval [CI], 1.6–29%). The median survival time (MST) was 8.0 months. and the 1-year survival rate was 31% (95% CI, 17– 58%). Patients with PS 0–1 had a MST of 11.9 months with 1-year survival of 42%. CONCLUSIONS Weekly docetaxel is very well tolerated as second-line therapy for NSCLC. The activity of this regimen appears to be comparable to the standard 3-week schedule. This regimen offers new opportunities for combination regimens, both as first- and second-line therapy for NSCLC. Cancer 2001;92:2158–63. © 2001 American Cancer Society.

BACKGROUND The authors conducted a Phase II study to evaluate the activity of the combination of gemcitabine and vinorelbine in patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS Patients were eligible if they had Stage IIIB (malignant pleural effusion) or Stage IV NSCLC, no prior chemotherapy, and Cancer and Leukemia Group B performance status (PS) 0–2. Patients with brain metastases were eligible if they were neurologically stable after brain irradiation. Thirty-three patients from participating institutions were enrolled. One patient was ineligible due to untreated brain metastases. Patients were treated with gemcitabine 1250 mg/m2 over 30 minutes (1000 mg/m2 for the first 6 patients) and vinorelbine 25 mg/m2 over 6 minutes, both administered intravenously on Days 1 and 8 every 21 days. Treatment was planned for a total of six cycles or more if the patient had persistent benefit. Growth factors were not allowed. RESULTS Among all 32 eligible patients, there were 8 partial responses, for an overall response rate of 25% (95% confidence interval [CI], 11.5–43.4%). The median survival time was 8.3 months and the 1-year survival rate was 38% (95% CI, 24–59%). Patients with PS 0–1 had a median survival of 11.7 months and a 1-year survival rate of 48%. Grade 3 and 4 neutropenia was observed in 13% and 25% of the 148 treatment cycles, respectively. One patient died of neutropenic sepsis. Only 2 episodes of Grade 3 and 4 thrombocytopenia were observed. Nonhematologic toxicity was minimal. CONCLUSIONS Gemcitabine and vinorelbine is an active and well-tolerated regimen in patients with advanced NSCLC, with response and survival rates at least comparable to those achieved with standard platinum-based regimens. This combination may be particularly suitable for the elderly or for patients who cannot tolerate more toxic platinum-based regimens. Cancer 2000;88:557–62. © 2000 American Cancer Society.