Gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer.

To evaluate the efficacy and safety of gemcitabine combined with carboplatin for a chemotherapy regimen for patients with metastatic, recurrent, or locally advanced non-small cell lung cancer (NSCLC), 46 chemotherapy-naïve patients with histologically confirmed stage IIIB or IV NSCLC were treated with 1250 mg/m(2) of gemcitabine on d 1 and 8, with carboplatin of AUC 6 additionally applied on d 1. This treatment was repeated every 3 wk. In all, a total of 215 chemotherapy courses were administered. The median age of the patients was 46, ranging from 33 to 83. Ten patients (22%) had an ECOG performance status of 2. Responses were observed objectively in 20 patients (43.5%) and maintained for a median of 7.4 mo. The median duration of progression-free and overall survivals were 5.0 and 12.3 mo, respectively. Neutropenia was frequently encountered, and gastrointestinal side effects, such as anorexia and nausea, were mostly predictable but manageable. One patient died of septic shock due to a complication with pneumonia while simultaneously trying to recover from myelosuppression. A subgroup consisting of patients aged 65 yr or older and/or PS 2 showed a outcome similar with the entire group of all patients involved in the study: response rate (43.5%), median PFS (4.6 months), median OS (12.3 months), and similar toxicity rate. After analyzing all the results, it was evident that a treatment of gemcitabine combined with carboplatin is an active and safe regimen for first-line treatment of advanced NSCLC. The results of the elderly and/or PS 2 patients were similar to those of the entire group of patients.