Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer

West Japan Thoracic Oncology Group (WJTOG) 0104

Nobuyuki Yamamoto, Kazuhiko Nakagawa, Hisao Uejima, Takahiko Sugiura, Yoshiki Takada, Shun Ichi Negoro, Kaoru Matsui, Tatsuhiko Kashii, Minoru Takada, Yoichi Nakanishi, Terufumi Kato, Masahiro Fukuoka

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Abstract

BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity. METHODS. One hundred twenty-eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day 1 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m2 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) every 3 weeks. RESULTS. Response rates were 20.3% for the GC patients and 21.0% for the GV patients. In the GC arm, the median survival was 432 days, and the a 1-year survival rate was 57.6%; in the GV arm, the median survival was 385 days, and the 1-year survival rate was 53.3% in the GV arm. The median progression-free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3% vs. 25.8% in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3% vs. 6.5% in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8% vs. 19.4% in the GC arm; P = .057). CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study.

Original languageEnglish
Pages (from-to)599-605
Number of pages7
JournalCancer
Volume107
Issue number3
DOIs
Publication statusPublished - Aug 1 2006
Externally publishedYes

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gemcitabine
Carboplatin
Non-Small Cell Lung Carcinoma
Japan
Thorax
vinorelbine

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer : West Japan Thoracic Oncology Group (WJTOG) 0104. / Yamamoto, Nobuyuki; Nakagawa, Kazuhiko; Uejima, Hisao; Sugiura, Takahiko; Takada, Yoshiki; Negoro, Shun Ichi; Matsui, Kaoru; Kashii, Tatsuhiko; Takada, Minoru; Nakanishi, Yoichi; Kato, Terufumi; Fukuoka, Masahiro.

In: Cancer, Vol. 107, No. 3, 01.08.2006, p. 599-605.

Research output: Contribution to journalArticle

Yamamoto, N, Nakagawa, K, Uejima, H, Sugiura, T, Takada, Y, Negoro, SI, Matsui, K, Kashii, T, Takada, M, Nakanishi, Y, Kato, T & Fukuoka, M 2006, 'Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer: West Japan Thoracic Oncology Group (WJTOG) 0104', Cancer, vol. 107, no. 3, pp. 599-605. https://doi.org/10.1002/cncr.22024
Yamamoto, Nobuyuki ; Nakagawa, Kazuhiko ; Uejima, Hisao ; Sugiura, Takahiko ; Takada, Yoshiki ; Negoro, Shun Ichi ; Matsui, Kaoru ; Kashii, Tatsuhiko ; Takada, Minoru ; Nakanishi, Yoichi ; Kato, Terufumi ; Fukuoka, Masahiro. / Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer : West Japan Thoracic Oncology Group (WJTOG) 0104. In: Cancer. 2006 ; Vol. 107, No. 3. pp. 599-605.
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abstract = "BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity. METHODS. One hundred twenty-eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day 1 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m2 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) every 3 weeks. RESULTS. Response rates were 20.3{\%} for the GC patients and 21.0{\%} for the GV patients. In the GC arm, the median survival was 432 days, and the a 1-year survival rate was 57.6{\%}; in the GV arm, the median survival was 385 days, and the 1-year survival rate was 53.3{\%} in the GV arm. The median progression-free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3{\%} vs. 25.8{\%} in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3{\%} vs. 6.5{\%} in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8{\%} vs. 19.4{\%} in the GC arm; P = .057). CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study.",
author = "Nobuyuki Yamamoto and Kazuhiko Nakagawa and Hisao Uejima and Takahiko Sugiura and Yoshiki Takada and Negoro, {Shun Ichi} and Kaoru Matsui and Tatsuhiko Kashii and Minoru Takada and Yoichi Nakanishi and Terufumi Kato and Masahiro Fukuoka",
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T1 - Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer

T2 - West Japan Thoracic Oncology Group (WJTOG) 0104

AU - Yamamoto, Nobuyuki

AU - Nakagawa, Kazuhiko

AU - Uejima, Hisao

AU - Sugiura, Takahiko

AU - Takada, Yoshiki

AU - Negoro, Shun Ichi

AU - Matsui, Kaoru

AU - Kashii, Tatsuhiko

AU - Takada, Minoru

AU - Nakanishi, Yoichi

AU - Kato, Terufumi

AU - Fukuoka, Masahiro

PY - 2006/8/1

Y1 - 2006/8/1

N2 - BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity. METHODS. One hundred twenty-eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day 1 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m2 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) every 3 weeks. RESULTS. Response rates were 20.3% for the GC patients and 21.0% for the GV patients. In the GC arm, the median survival was 432 days, and the a 1-year survival rate was 57.6%; in the GV arm, the median survival was 385 days, and the 1-year survival rate was 53.3% in the GV arm. The median progression-free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3% vs. 25.8% in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3% vs. 6.5% in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8% vs. 19.4% in the GC arm; P = .057). CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study.

AB - BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity. METHODS. One hundred twenty-eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day 1 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m2 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) every 3 weeks. RESULTS. Response rates were 20.3% for the GC patients and 21.0% for the GV patients. In the GC arm, the median survival was 432 days, and the a 1-year survival rate was 57.6%; in the GV arm, the median survival was 385 days, and the 1-year survival rate was 53.3% in the GV arm. The median progression-free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3% vs. 25.8% in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3% vs. 6.5% in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8% vs. 19.4% in the GC arm; P = .057). CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study.

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