Kim, Jee Hyun; Kim, Si Young; Jung, Kyung Hae; Park, Keunchil; Suh, Cheol Won; Lim, Ho Young; Kim, Yeul Hong; Ryoo, Baek Yeol; Cho, Eun Kyung; Park, Byung Joo; Heo, Dae Seog
Lung cancer (Amsterdam, Netherlands)
2006Apr ; 52 ( 1 ) :75-81.
PMID : 16488054
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Kim, Jee Hyun -
Kim, Si Young -
Jung, Kyung Hae -
Park, Keunchil -
Suh, Cheol Won -
Lim, Ho Young -
Kim, Yeul Hong -
Ryoo, Baek Yeol -
Cho, Eun Kyung -
Park, Byung Joo -
Heo, Dae Seog -
ABSTRACT
BACKGROUND: Several randomized trials have demonstrated superior response rates and survivals for new agent platinum doublets than for older platinum doublets in advanced non-small cell lung cancer (NSCLC), however, few trials have been performed in Asian populations. Thus, we conducted a randomized study to compare gemcitabine-cisplatin (GP) with etoposide-cisplatin (EP) in Korean patients with advanced NSCLC.
METHODS: Patients with histologically confirmed, locally advanced or metastatic NSCLC were randomized to receive either gemcitabine 1250 mg/m2 on days 1 and 8 plus cisplatin 75 mg/m2 on day 1, or etoposide 100 mg/m2 on days 1-3 plus cisplatin 75 mg/m2 on day 1. Treatment was repeated every 21 days in both groups. The primary endpoint was response rate.
RESULTS: Between May 2000 and December 2001, 83 patients at 9 Korean centers were enrolled in this study. The GP arm showed a significantly higher response rate (52.6% versus 19.4%; P = 0.002), a longer time to progression (4.3 months in both arms; P = 0.018) and a marginally significant prolongation of overall survival (18.3 months versus 10.9 months; P = 0.059) than the EP arm. Grades 3 and 4 thrombocytopenia (18% versus 0%) was more common in the GP arm whereas grades 3 and 4 neutropenia was more common in EP arm (48.7% versus 71.8%). Other toxicities were comparable in both arms. CONCLUSION: GP provided a significantly higher response rate and a longer time to progression than EP and should be considered a standard treatment in advanced NSCLC in Korean population.
Non-small cell lung cancer; Gemcitabine; Etoposide; Cisplatin; Clinical trials; Phase II
MESH
Adenocarcinoma/drug therapy/secondary, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use, Carcinoma, Large Cell/drug therapy/secondary, Carcinoma, Non-Small-Cell Lung/*drug therapy/secondary, Carcinoma, Squamous Cell/drug therapy/secondary, Cisplatin/administration & dosage, Deoxycytidine/administration & dosage/analogs & derivatives, Etoposide/administration & dosage, Female, Humans, Korea/epidemiology, Lung Neoplasms/*drug therapy/secondary, Male, Middle Aged, Survival Rate, Treatment Outcome
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