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 language | English |
|---|---|
| Pages (from-to) | 313-319 |
| Number of pages | 7 |
| Journal | Lung Cancer |
| Volume | 36 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2002 |
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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 journal › Article
}
TY - JOUR
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.
KW - Cisplatin
KW - Ifosfamide
KW - Neuron-specific enolase
KW - Non-small-cell lung cancer
KW - Prognostic factor
KW - Vindesine
UR - http://www.scopus.com/inward/record.url?scp=0036248013&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036248013&partnerID=8YFLogxK
U2 - 10.1016/S0169-5002(02)00008-9
DO - 10.1016/S0169-5002(02)00008-9
M3 - Article
C2 - 12009244
AN - SCOPUS:0036248013
VL - 36
SP - 313
EP - 319
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 3
ER -