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Vinorelbine - cisplatin regimen
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Lung Cancer News |
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Lung Cancer |
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Abstract: Randomized trial comparing cisplatin with cisplatin plus vinorelbine
in the treatment of advanced non-small-cell lung cancer: a Southwest Oncology
Group study.
PURPOSE: Cisplatin has played a major role in the treatment of non-small-cell
lung cancer (NSCLC). This randomized trial was performed by the Southwest
Oncology Group (SWOG) to determine whether the combination of vinorelbine
and cisplatin has any advantage with regard to response rate, survival,
and time to treatment failure over single-agent cisplatin in the treatment
of patients with advanced NSCLC. METHODS: Between October 1993 and April
1995, 432 patients with advanced stage NSCLC were randomized to receive
arm I (cisplatin 100 mg/m2 every 4 weeks) or arm II (cisplatin 100 mg/m2
every 4 weeks and vinorelbine 25 mg/m2 weekly). All patients were chemotherapy-naive,
had performance status (PS) 0 or 1, and had adequate hematologic, renal,
and hepatic function. RESULTS: Four hundred fifteen patients were eligible
and assessable. On arm I (cisplatin), there was a 12% partial response rate.
Arm II (cisplatin and vinorelbine) had a 26% response rate (2% complete
responses and 24% partial responses, P = .0002). There was a statistically
significant advantage with regard to progression-free survival (median,
2 v 4 months; P = .0001) and overall survival (median, 6 v 8 months; P =
.0018) for the cisplatin and vinorelbine arm. One-year survival was 20%
for cisplatin alone and 36% for the combination arm. There was more hematologic
toxicity on arm II of the study (81% grades 3 and 4 granulocytopenia v 5%
on arm I). Other toxicities, such as renal insufficiency, ototoxicity, and
nausea and vomiting, and neuropathy were similar. CONCLUSION: The results
of this study indicate that the combination of cisplatin and vinorelbine
is a superior treatment when compared with single-agent cisplatin in the
treatment of advanced NSCLC. Cisplatin and vinorelbine is the new standard
for SWOG against which new therapies will be evaluated.
References
Wozniak AJ, Crowley JJ, Balcerzak SP, Weiss GR, Spiridonidis CH, Baker
LH, Albain KS, Kelly K, Taylor SA, Gandara DR, Livingston RB. Randomized
trial comparing cisplatin with cisplatin plus vinorelbine in the treatment
of advanced non-small-cell lung cancer: a Southwest Oncology Group study.
J Clin Oncol. 1998 Jul;16(7):2459-65.
Le Chevalier T, Brisgand D, Douillard J-Y, et al: J Clin Oncol 12:360-367,
1994.

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Vinorelbine....... 25 mg / M2 IV days 1,8,15,22
Cisplatin....... 100 mg / M2 IV day 1
FREQUENCY every 21 days
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