Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer: Korean Cancer Study Group experience

Jee Hyun Kim, Si Young Kim, Kyung Hae Jung, Keunchil Park, Cheol Won Suh, Ho Young Lim, Yeul Hong Kim, Baek Yeol Ryoo, Eun Kyung Cho, Byung Joo Park, Dae Seog Heo

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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/m 2 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.

Original languageEnglish
Pages (from-to)75-81
Number of pages7
JournalLung Cancer
Volume52
Issue number1
DOIs
Publication statusPublished - 2006 Apr 1

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gemcitabine
Etoposide
Non-Small Cell Lung Carcinoma
Cisplatin
Neoplasms
Platinum
Therapeutics
Neutropenia
Population
Survival Rate

Keywords

  • Cisplatin
  • Clinical trials
  • Etoposide
  • Gemcitabine
  • Non-small cell lung cancer
  • Phase II

ASJC Scopus subject areas

  • Oncology

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Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer : Korean Cancer Study Group experience. / 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.

In: Lung Cancer, Vol. 52, No. 1, 01.04.2006, p. 75-81.

Research output: Contribution to journalArticle

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. / Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer : Korean Cancer Study Group experience. In: Lung Cancer. 2006 ; Vol. 52, No. 1. pp. 75-81.
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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/m 2 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.",
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author = "Kim, {Jee Hyun} and Kim, {Si Young} and Jung, {Kyung Hae} and Keunchil Park and Suh, {Cheol Won} and Lim, {Ho Young} and Kim, {Yeul Hong} and Ryoo, {Baek Yeol} and Cho, {Eun Kyung} and Park, {Byung Joo} and Heo, {Dae Seog}",
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T1 - Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer

T2 - Korean Cancer Study Group experience

AU - Kim, Jee Hyun

AU - Kim, Si Young

AU - Jung, Kyung Hae

AU - Park, Keunchil

AU - Suh, Cheol Won

AU - Lim, Ho Young

AU - Kim, Yeul Hong

AU - Ryoo, Baek Yeol

AU - Cho, Eun Kyung

AU - Park, Byung Joo

AU - Heo, Dae Seog

PY - 2006/4/1

Y1 - 2006/4/1

N2 - 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/m 2 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.

AB - 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/m 2 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.

KW - Cisplatin

KW - Clinical trials

KW - Etoposide

KW - Gemcitabine

KW - Non-small cell lung cancer

KW - Phase II

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