Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study.

Abstract

PURPOSE To compare fotemustine and dacarbazine (DTIC) in terms of overall response rate (ORR) as primary end-point and overall survival, duration of responses, time to progression, time to occurrence of brain metastases (BM), and to assess safety and quality of life in patients with disseminated cutaneous melanoma. PATIENTS AND METHODS Patients received either intravenous fotemustine 100 mg/m2 weekly for 3 weeks or DTIC 250 mg/m2/d for 5 consecutive days every 4 weeks (two cycles). Nonprogressive patients received a maintenance treatment every 4 weeks (fotemustine 100 mg/m2 or DTIC 250 mg/m2 for 5 days). RESULTS Two hundred twenty-nine patients were randomly assigned to fotemustine or DTIC arms. The best ORR was higher in the fotemustine arm than in the DTIC arm in the intent-to-treat population (n=229; 15.2% v 6.8%; P=.043) and in full analysis set (n=221) (15.5% v 7.2%; P=.053). Similar median durations of responses (5.8 months with fotemustine v 6.9 months with DTIC) and time to progression (1.8 v 1.9 months, respectively) were observed. In patients without BM at inclusion, the median time to BM was 22.7 months with fotemustine versus 7.2 months with DTIC (P=.059). Median survival was 7.3 months with fotemustine versus 5.6 months with DTIC (P=.067). The main toxicity was grade 3 to 4 neutropenia (51% with fotemustine v 5% with DTIC) and thrombocytopenia (43% v 6%, respectively). No significant difference was noted for quality of life between arms. CONCLUSION ORR was higher in the fotemustine arm compared to the DTIC arm in first-line treatment of disseminated melanoma. A trend in favor of fotemustine in terms of overall survival and time to BM was evidenced.

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@article{Avril2004FotemustineCW, title={Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study.}, author={M-F Avril and Steinar Aamdal and Jean-Jacques Grob and Axel Hauschild and Peter Mohr and J-J Bonerandi and Michael Weichenthal and Karsten Neuber and Trevor Bieber and Katalin Gilde and Vicente Guillem Porta and Joaqu{\'i}n Fra and Jacques M Bonneterre and Philippe Sa{\"{i}ag and Darab Kamanabrou and Hubert Pehamberger and Jozef Sufliarsky and Jos{\'e} Luis Gonz{\'a}lez Larriba and Alexandra U. Scherrer and Yves Menu}, journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, year={2004}, volume={22 6}, pages={1118-25} }