Fotemustine Compared With Dacarbazine in Patients With Disseminated Malignant Melanoma: A Phase III Study
| Autor: | D. Kamanabrou, J. Bonneterre, Philippe Saiag, J. Fra, V. Guillem Porta, A. Scherrer, Y. Menu, J. L.Gonzalez Larriba, Michael Weichenthal, Marie-Françoise Avril, Jean-Jacques Grob, T. Bieber, K. Neuber, J. Sufliarsky, Jean Jacques Bonerandi, Hubert Pehamberger, K. Gilde, Peter Mohr, Steinar Aamdal, Axel Hauschild |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Skin Neoplasms Dacarbazine Population Antineoplastic Agents Gastroenterology Disease-Free Survival Nitrosourea Compounds Statistics Nonparametric law.invention Organophosphorus Compounds Randomized controlled trial law Internal medicine Humans Medicine In patient education Melanoma Survival analysis Aged education.field_of_study Brain Neoplasms business.industry Middle Aged medicine.disease Survival Analysis Surgery Europe Oncology Cutaneous melanoma Quality of Life Fotemustine Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 22:1118-1125 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2004.04.165 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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