Journal of Clinical Oncology, Vol 17, Issue 1
(January), 1999: 12
© 1999 American Society for Clinical Oncology
Randomized Phase III Study of Gemcitabine-Cisplatin Versus Etoposide-Cisplatin in the Treatment of Locally Advanced or Metastatic Non–Small-Cell Lung Cancer
Felipe Cardenal,
M. Paz López-Cabrerizo,
Antonio Antón,
Vicente Alberola,
Bartomeu Massuti,
Alfredo Carrato,
Isidoro Barneto,
María Lomas,
Margarita García,
Pilar Lianes,
Joaquín Montalar,
Catalina Vadell,
José Luis González-Larriba,
Binh Nguyen,
Angel Artal,
Rafael Rosell
From the Hospital Duran i Reynals, Barcelona; Hospital Germans Trias i Pujol, Badalona; Hospital Miguel Servet, Zaragoza; Hospital Arnau de Vilanova, Valencia; Hospital General de Alicante, Alicante; Hospital General de Elche, Elche; Hospital Universitario Reina Sofia, Cordoba; Hospital Infanta Cristina, Badajoz; Hospital 12 de Octubre, Madrid; Hospital La Fe, Valencia; Hospital del Mar, Barcelona; Hospital Clínico, Madrid, Spain; and Lilly Research Laboratories, Indianapolis, IN.
Address reprint requests to Rafael Rosell, MD, Medical Oncology Service, Hospital Germans Trias i Pujol, Crtra. Canyet s/n, 08916 Badalona, Barcelona, Spain; Email rrosell{at}ns.hugtip.scs.es
PURPOSE: We conducted a randomized trial to compare gemcitabine-cisplatin with etoposide-cisplatin in the treatment of patients with advanced non–small-cell lung cancer (NSCLC). The primary end point of the comparison was response rate.
PATIENTS AND METHODS: A total of 135 chemotherapy-naive patients with advanced NSCLC were randomized to receive either gemcitabine 1,250 mg/m2 intravenously (IV) days 1 and 8 or etoposide 100 mg/m2 IV days 1 to 3 along with cisplatin 100 mg/m2 IV day 1. Both treatments were administered in 21-day cycles. One hundred thirty-three patients were included in the intent-to-treat analysis of response.
RESULTS: The response rate (externally validated) for patients given gemcitabine-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 time to disease progression (6.9 months v 4.3 months; P = .01) without an impairment in quality of life (QOL). There was no statistically significant difference in survival time between both arms (8.7 months for gemcitabine-cisplatin v 7.2 months for etoposide-cisplatin; P = .18). The overall toxicity profile for both combinations of drugs was similar. Nausea and vomiting were reported more frequently in the gemcitabine arm than in the etoposide arm. However, the difference was not significant. Gemcitabine-cisplatin produced less grade 3 alopecia (13% v 51%) and less grade 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 provides a significantly higher response rate and a delay in disease progression without impairing QOL in patients with advanced NSCLC.
This study was supported by grant 17222 from Eli Lilly and Company.
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