A randomized study of gemcitabine plus cisplatin and vinorelbine plus cisplatin in patients with advanced non-small-cell lung cancer.
BACKGROUND
Gemcitabine plus cisplatin (GC) and vinorelbine plus cisplatin (VC) are active and well-tolerated regimens for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). We conducted this study to compare the safety and efficacy of these regimens as front-line chemotherapy for patients with NSCLC.


METHODS
Eligible patients were randomized to receive either gemcitabine (1000 mg/m2) on days 1, 8, and 15 plus cisplatin (80 mg/m2) on day 15 (arm GC), or vinorelbine (20 mg/m2) on days 1, 8, and 15 plus cisplatin (80 mg/m2) on day 15 (arm VC). Treatments were repeated every 28 days. The costs of treatment were retrieved from the Health Care Reporting System of Chang Gung Memorial Hospital at the time of final data analysis.


RESULTS
Eighty-three patients (GC, n=39; VC, n=44) were enrolled in the study. Seventy-three patients were analyzed. Response rates were 38% and 31% and median survivals were 12.9 and 9.0 months for the 34 patients in the GC arm and 39 patients in the VC arm, respectively. One-year survival was 55.9% in the GC arm and 33.3% in the VC arm. There was no difference in the response rate (p=0.622), progression free survival (p=0.443) and median survival (p = 0.4197) between the two arms. Grade 3-4 toxicities were vomiting (GC: 16.3% vs. VC: 36.3%), neutropenia (GC: 14.7% vs. VC: 20%), and thrombocytopenia (GC: 8.68% vs. VC: 5%). There was a significant increase in all-grade thrombocytopenia (p=0.002) in the GC arm. The GC arm had higher total expenses than the VC arm (p=0.020).


CONCLUSIONS
Both vinorelbine plus cisplatin and gemcitabine plus cisplatin yielded similar efficacies for NSCLC.
Chang
John Wen-Cheng
JW
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Tsao
Thomas Chang-Yao
TC
Yang
Cheng-Ta
CT
Lin
Meng-Chih
MC
Cheung
Yun-Chung
YC
Liaw
Chung-Chi
CC
Chen
Chih-Hung
CH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
D003841:Deoxycytidine; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine