A phase II study of combination chemotherapy with docetaxel and carboplatin for elderly patients with advanced non-small cell lung cancer.

BACKGROUND: More than 50% of all advanced non-small cell lung cancer (NSCLC) is diagnosed in patients older than 65 years. Chemotherapy in elderly patients has not been standardized even though cisplatin-based chemotherapy has been used in patients with advanced NSCLC as primary therapy. We investigated the efficacy and safety of combination chemotherapy with docetaxel and carboplatin for elderly patients with advanced NSCLC. METHODS: Chemotherapy-naïve patients (age > or = 65 years) with stage IIIB or IV NSCLC were enrolled. Patients received docetaxel (75 mg/m(2) on D1) and carboplatin (AUC of 5mg/ml/min on D1) every 3 weeks. The end points included the response rate, progression-free survival (PFS), overall survival (OS) and toxicity. RESULTS: A total of 43 patients was enrolled between March 2005 and December 2008, and 38 patients were evaluable. The median age was 74 years old (range, 65-84 years) and 39 patients (90.6%) had an ECOG PS of 0 or 1. Squamous cell carcinoma was observed in 18 patients (41.8%) and 24 patients (55.8%) had an increased Charlson comorbidity index score (CCI > or = 1). The median number of treatment cycles was five (range, 1-8) and the relative dose intensity was 90.4% for docetaxel and 92.7% for carboplatin. The overall response rate was 46.5% (95% CI, 31.6-61.4) for with one complete response and 19 partial responses. The median follow-up duration was 14.4 months. The median PFS was 6.9 months (95% CI, 6.25-7.55) and the median OS was 13.1 months (95% CI, 10.20-16.07). The 1-year survival rate was 60%. In grade 3 or 4 hematological toxicities, neutropenia (37.2%), anemia (18.6%) and thrombocytopenia (4.6%) were shown. The non-hematological toxicities were tolerable. CONCLUSIONS: The combination chemotherapy with docetaxel and carboplatin was effective with tolerable toxicities in elderly patients with advanced non-small cell lung cancer.

A phase II study of single-agent gemcitabine as a second-line treatment in advanced non-small cell lung cancer.

OBJECTIVE: To evaluate the efficacy and safety of the single-agent gemcitabine in advanced non-small cell lung cancer (NSCLC) as second-line chemotherapy. METHODS: Between February 2002 and November 2004, a total of 27 patients, who had previously been treated with paclitaxel and platinum as first line chemotherapy, were enrolled in the study. Patients were treated with gemcitabine (1000 mg/m(2)) on days 1, 8 and 15 in a 28 day cycle. The response was assessed every two cycles. Toxicities were evaluated according to common toxicity criteria (CTC). RESULTS: The median age was 62 (range, 46-79) years old. Among the 27 patients, 26 were male. Twenty-three patients had an ECOG performance status of 0 or 1 and four patients had a status of 2. Pathologically, 24 patients had squamous cell carcinoma and 3 had adenocarcinoma. Partial responses were observed in 15 patients. All patients were evaluated for response and toxicity. The overall response rate was 18.5% (95% confidence interval, 5-33%) and the median response duration was 17 (range, 7.4 to 49+) weeks. The median time to progression was 10 (range, 7 to 34+) weeks. The median overall survival for all patients was 38 (range, 10 to 122+) weeks. During a total of 87 cycles, granulocytopenia greater than CTC grade 2 occurred in 7%, thrombocytopenia in 1% and anemia in 24% of case. Non-hematologic toxicities were minor and easily controlled. CONCLUSION: This study confirms the activity and safety of the single-agent gemcitabine as a second-line therapy in pretreated patients with advanced NSCLC.