Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lungcancer

Purpose: We conducted a randomized trial to compare gemcitabine-cisplatin w ith etoposide-cisplatin in the treatment of patients with advanced non-smal l-cell lung cancer (NSCLC), The primary end point of the comparison was res ponse rate. Patients and Methods: A total of 135 chemotherapy-naive patients with advan ced NSCLC were randomized to receive either gemcitabine 1,250 mg/m(2) intra venously (IV) days 1 and 8 or etoposide 100 mg/m(2) IV days 1 to 3 along wi th cisplatin 100 mg/m(2) IV day 1. Both treatments were administered in 21- day cycles. One hundred thirty-three patients were included in the intent-t o-treat analysis of response. Results: The response rate (externally validated) for patients given gemcit abine-cisplatin was superior to that for patients given etoposide-cisplatin (40.6% v 21.9%; P = .02), This superior response rate was associated with a significant delay in lime to disease progression (6.9 months v 4.3 months ; P = .01) without an impairment in qualify of life (QOL). There was no sta tistically significant difference in survival time between both arms (8.7 m onths for gemcitabine-cisplatin v 7.2 months far etoposide-cisplatin; P = . 18), The overall toxicity profile for both combinations of drugs was simila r. Nausea and vomiting were reported more frequently in the gemcitabine arm than in the etoposide arm. However, the difference was not significant. Ge mcitabine-cisplatin produced less grade 3 alopecia (13% v 51%) and less gra de 4 neutropenia (28% v 56%) but more grade 3 and 4 thrombocytopenia (56% v 13%) than did etoposide-cisplatin, However, there were no thrombocytopenia -related complications in the gemcitabine arm. Conclusion: Compared with etoposide-cisplatin, gemcitabine-cisplatin provid es a significantly higher response rate and a delay in disease progression without impairing QOL in patients with advanced NSCLC. J Clin Oncol 17:12-18. (C) 1999 by American Society of Clinical Oncology.