A phase III randomized trial comparing vindesine and cisplatin with or without ifosfamide in patients with advanced non-small-cell lung cancer: Long-term follow-up results and analysis of prognostic factors

Tsuyoshi Kodani, Hiroshi Ueoka, Katsuyuki Kiura, Masahiro Tabata, Nagio Takigawa, Yoshihiko Segawa, Tomonori Moritaka, Shunkichi Hiraki, Mine Harada, Mitsune Tanimoto

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Abstract

In order to evaluate the activity and toxicity of a three-drug combination of vindesine, ifosfamide and cisplatin (VIP) for inoperable non-small-cell lung cancer (NSCLC), we conducted a randomized trial comparing VIP with a two-drug combination of cisplatin and vindesine (VP). Between September 1987 and March 1992, a total of 132 patients with stage III or IV NSCLC were randomly allocated to either VIP or VP. The VIP regimen consisted of vindesine (VDS 3 mg/m2 on days 1 and 8), ifosfamide (IFX 1300 mg/m2 on days 1-5), and cisplatin (CDDP 20 mg/m2 on days 1-5). The VP regimen consisted of VDS and CDDP with the same dose and schedule as the VIP regimen. Both regimens were repeated every 4 weeks. Objective response rates were 49.3% (95% confidence interval: 95%CI, 43.1-55.4%) in the VIP arm and 44.6% (95%CI, 38.4-50.2%) in the VP arm; the difference was not significant (P=0.5390). Median response duration, median survival time, and two-year survival rates were 26.5 weeks, 49.6 weeks, and 14.9% in the VIP arm and 28.7 weeks, 37.1 weeks, and 12.3% in the VP arm, respectively. There were also no significant differences between these two treatment arms. In comparison with the VP regimen, however, a survival advantage of the VIP regimen could be confirmed when the data were evaluated with Cox's multivariate analysis (P=0.0131). In both arms, the principal toxicity was myelosuppression, which was significantly more frequent in the VIP arm, although generally well tolerated. Conclusion: This study suggested the survival advantage of the VIP regimen over the VP regimen for treatment of patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)313-319
Number of pages7
JournalLung Cancer
Volume36
Issue number3
DOIs
Publication statusPublished - 2002

Fingerprint

Vindesine
Ifosfamide
Non-Small Cell Lung Carcinoma
Cisplatin
Drug Combinations
Survival
Appointments and Schedules
Multivariate Analysis
Survival Rate
Confidence Intervals
ICE protocol 1
Therapeutics
VDA-P protocol

Keywords

  • Cisplatin
  • Ifosfamide
  • Neuron-specific enolase
  • Non-small-cell lung cancer
  • Prognostic factor
  • Vindesine

ASJC Scopus subject areas

  • Oncology

Cite this

A phase III randomized trial comparing vindesine and cisplatin with or without ifosfamide in patients with advanced non-small-cell lung cancer : Long-term follow-up results and analysis of prognostic factors. / Kodani, Tsuyoshi; Ueoka, Hiroshi; Kiura, Katsuyuki; Tabata, Masahiro; Takigawa, Nagio; Segawa, Yoshihiko; Moritaka, Tomonori; Hiraki, Shunkichi; Harada, Mine; Tanimoto, Mitsune.

In: Lung Cancer, Vol. 36, No. 3, 2002, p. 313-319.

Research output: Contribution to journalArticle

Kodani, Tsuyoshi ; Ueoka, Hiroshi ; Kiura, Katsuyuki ; Tabata, Masahiro ; Takigawa, Nagio ; Segawa, Yoshihiko ; Moritaka, Tomonori ; Hiraki, Shunkichi ; Harada, Mine ; Tanimoto, Mitsune. / A phase III randomized trial comparing vindesine and cisplatin with or without ifosfamide in patients with advanced non-small-cell lung cancer : Long-term follow-up results and analysis of prognostic factors. In: Lung Cancer. 2002 ; Vol. 36, No. 3. pp. 313-319.
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abstract = "In order to evaluate the activity and toxicity of a three-drug combination of vindesine, ifosfamide and cisplatin (VIP) for inoperable non-small-cell lung cancer (NSCLC), we conducted a randomized trial comparing VIP with a two-drug combination of cisplatin and vindesine (VP). Between September 1987 and March 1992, a total of 132 patients with stage III or IV NSCLC were randomly allocated to either VIP or VP. The VIP regimen consisted of vindesine (VDS 3 mg/m2 on days 1 and 8), ifosfamide (IFX 1300 mg/m2 on days 1-5), and cisplatin (CDDP 20 mg/m2 on days 1-5). The VP regimen consisted of VDS and CDDP with the same dose and schedule as the VIP regimen. Both regimens were repeated every 4 weeks. Objective response rates were 49.3{\%} (95{\%} confidence interval: 95{\%}CI, 43.1-55.4{\%}) in the VIP arm and 44.6{\%} (95{\%}CI, 38.4-50.2{\%}) in the VP arm; the difference was not significant (P=0.5390). Median response duration, median survival time, and two-year survival rates were 26.5 weeks, 49.6 weeks, and 14.9{\%} in the VIP arm and 28.7 weeks, 37.1 weeks, and 12.3{\%} in the VP arm, respectively. There were also no significant differences between these two treatment arms. In comparison with the VP regimen, however, a survival advantage of the VIP regimen could be confirmed when the data were evaluated with Cox's multivariate analysis (P=0.0131). In both arms, the principal toxicity was myelosuppression, which was significantly more frequent in the VIP arm, although generally well tolerated. Conclusion: This study suggested the survival advantage of the VIP regimen over the VP regimen for treatment of patients with advanced NSCLC.",
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T1 - A phase III randomized trial comparing vindesine and cisplatin with or without ifosfamide in patients with advanced non-small-cell lung cancer

T2 - Long-term follow-up results and analysis of prognostic factors

AU - Kodani, Tsuyoshi

AU - Ueoka, Hiroshi

AU - Kiura, Katsuyuki

AU - Tabata, Masahiro

AU - Takigawa, Nagio

AU - Segawa, Yoshihiko

AU - Moritaka, Tomonori

AU - Hiraki, Shunkichi

AU - Harada, Mine

AU - Tanimoto, Mitsune

PY - 2002

Y1 - 2002

N2 - In order to evaluate the activity and toxicity of a three-drug combination of vindesine, ifosfamide and cisplatin (VIP) for inoperable non-small-cell lung cancer (NSCLC), we conducted a randomized trial comparing VIP with a two-drug combination of cisplatin and vindesine (VP). Between September 1987 and March 1992, a total of 132 patients with stage III or IV NSCLC were randomly allocated to either VIP or VP. The VIP regimen consisted of vindesine (VDS 3 mg/m2 on days 1 and 8), ifosfamide (IFX 1300 mg/m2 on days 1-5), and cisplatin (CDDP 20 mg/m2 on days 1-5). The VP regimen consisted of VDS and CDDP with the same dose and schedule as the VIP regimen. Both regimens were repeated every 4 weeks. Objective response rates were 49.3% (95% confidence interval: 95%CI, 43.1-55.4%) in the VIP arm and 44.6% (95%CI, 38.4-50.2%) in the VP arm; the difference was not significant (P=0.5390). Median response duration, median survival time, and two-year survival rates were 26.5 weeks, 49.6 weeks, and 14.9% in the VIP arm and 28.7 weeks, 37.1 weeks, and 12.3% in the VP arm, respectively. There were also no significant differences between these two treatment arms. In comparison with the VP regimen, however, a survival advantage of the VIP regimen could be confirmed when the data were evaluated with Cox's multivariate analysis (P=0.0131). In both arms, the principal toxicity was myelosuppression, which was significantly more frequent in the VIP arm, although generally well tolerated. Conclusion: This study suggested the survival advantage of the VIP regimen over the VP regimen for treatment of patients with advanced NSCLC.

AB - In order to evaluate the activity and toxicity of a three-drug combination of vindesine, ifosfamide and cisplatin (VIP) for inoperable non-small-cell lung cancer (NSCLC), we conducted a randomized trial comparing VIP with a two-drug combination of cisplatin and vindesine (VP). Between September 1987 and March 1992, a total of 132 patients with stage III or IV NSCLC were randomly allocated to either VIP or VP. The VIP regimen consisted of vindesine (VDS 3 mg/m2 on days 1 and 8), ifosfamide (IFX 1300 mg/m2 on days 1-5), and cisplatin (CDDP 20 mg/m2 on days 1-5). The VP regimen consisted of VDS and CDDP with the same dose and schedule as the VIP regimen. Both regimens were repeated every 4 weeks. Objective response rates were 49.3% (95% confidence interval: 95%CI, 43.1-55.4%) in the VIP arm and 44.6% (95%CI, 38.4-50.2%) in the VP arm; the difference was not significant (P=0.5390). Median response duration, median survival time, and two-year survival rates were 26.5 weeks, 49.6 weeks, and 14.9% in the VIP arm and 28.7 weeks, 37.1 weeks, and 12.3% in the VP arm, respectively. There were also no significant differences between these two treatment arms. In comparison with the VP regimen, however, a survival advantage of the VIP regimen could be confirmed when the data were evaluated with Cox's multivariate analysis (P=0.0131). In both arms, the principal toxicity was myelosuppression, which was significantly more frequent in the VIP arm, although generally well tolerated. Conclusion: This study suggested the survival advantage of the VIP regimen over the VP regimen for treatment of patients with advanced NSCLC.

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KW - Prognostic factor

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