A phase III randomized trial of cisplatin plus vindesine versus cisplatin plus vindesine plus mitomycin C versus cisplatin plus vindesine plus ifosfamide for advanced non‐small‐cell lung cancer
作者:
Masayuki MASUTANI,
Hiroshi AKUSAWA,
Astushi KADOTA,
Yasushi OHCHI,
Noriaki TAKAHASHI,
Satoshi TANIGAWA,
Yoshiaki KOYA,
Takashi HORIE,
期刊:
Respirology
(WILEY Available online 1996)
卷期:
Volume 1,
issue 1
页码: 49-54
ISSN:1323-7799
年代: 1996
DOI:10.1111/j.1440-1843.1996.tb00010.x
出版商: Blackwell Publishing Ltd
关键词: cisplatin;ifosfamide;mitomycin C;NSCLC;randomized trial;vindesine
数据来源: WILEY
摘要:
AbstractA randomized trial of chemotherapy in 105 patients with advanced and metastatic nonsmall‐cell lung cancer (NCSLC) was conducted in order to compare the effect of the additional drug mitomycin C (PVM) or ifosfamide (PVI), to the combination of cisplatin plus vindesine (PV). An objective response rate was observed in 42.8% of the patients treated with PVM, 42.4% with PVI and 28.6% with PV and these response rates were not statistically significant (P>0.20). No patient achieved the complete response with either of the three regimens. Comparison of the median response durations among the three regimens showed an advantage of PVI over PVM (P<0.02) and PV (P<0.05). The median survival times (MST) were similar for all three regimens (PVM, 33.5; PVI, 40.0 and PV, 36.5 weeks); moreover, the difference in survival time between the three regimens of responders was not statistically significant. The univariate analysis showed that significant predictors of survival were performance status (PS) zero (P = 0.0002), limited disease (P = 0.004), no previous weight loss (P = 0.01) and normal serum albumin (P = 0.016), and in multivariate analysis by a stepwise Cox proportional hazard model, these were PS zero (a hazard ratio of 2.3, P = 0.0001) and limited disease (a hazard ratio of 1.9, P = 0.048). Toxicity did not differ among the three treatment regimen
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