Gemcitabine fixed dose rate infusion in combination with cisplation as first-line chemotherapy for advanced non-small cell lung cancer.

Objective:To explore the efficacy and safety of fixed dose rate infusion of gemcitabine in combination with cisplatin as first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Methods: The untreated patients with advanced NSCLC confirmed by pathological examination received gemcitabine plus cisplatin regimen. Gemcitabine 1 200 mg/m2 was infused intravenously at fixed rate (10 mg·m-2·min-1) for 120 min on d 1 and d 8 and cisplatin 80-100 mg/m2 was divided into three parts and each part was administered in 3 days, respectively. Twenty-one days were regarded as one cycle.Clinical efficacy was evaluated after two-cycle therapy. If the disease progressed, the patients were excluded.If the disease had no progression after 6 cycles of chemotherapy, we stoped the combined chemotherapy for the patients. Time to progression (TTP) and overall survival (OS) time were evaluated. Results: Totally 47 chemotherapy NSCLC patients have been enrolled in the study, including 36 males (76.6%) and 11 females (23.4%), with a median age of 56 years. Eleven (23.4%) subjects had stage ⅢB NSCLC and 36 subjects (76.6%) were at stage Ⅳ. Forty-five subjects were assessed for final response. Two cases had complete response (4.4%) and 15 cases had partial response (33.3%). The overall response rate was 37.7%. The median TTP was 5.0 months (95% CI, 4-6 months), and median OS time was 11 months (95% CI, 9-13 months). One-year survival rate was 48.3% and 2-year survival was 14.5%. Grade 3-4 hematologic toxicities were neutropenia (22%), leucocytopenia (23%), thrombocytopenia (14%), and anemia (16%). Most non-hematologic toxicities were at grade 1-2. Grade 3 adverse reaction mainly occurred in gastrointestinal system. No grade 4 non-hematologic toxicity occurred. Conclusion: Fixed-dose rate infusion of gemicitabine combined with cisplatin is effective for advanced NSCLC. The adverse reactions are tolerated. The response rate and the median survival time have some advantages compared with the formerly clinical data, suggesting that we should make further investigation.