Multicenter phase III randomized trial of polychemotherapy (CVD regimen) versus the same chemotherapy (CT) plus subcutaneous interleukin-2 and interferon-alpha2b in metastatic melanoma
| Autor: | Alberto Fusi, Emilio Bajetta, Mario Roberto Sertoli, Barbara Formisano, Paola Taveggia, M. Del Vecchio, P. Nova, S. S. Legha, A. Daponte, Paola Queirolo, Natale Cascinelli, Maria Grazia Bernengo |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization medicine.medical_treatment Dacarbazine Injections Subcutaneous Interferon alpha-2 Vinblastine Gastroenterology law.invention Randomized controlled trial Aldesleukin law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Melanoma Aged Chemotherapy business.industry Interferon-alpha Hematology Middle Aged Chemotherapy regimen Recombinant Proteins Surgery CVD Regimen Oncology Vindesine Interleukin-2 Female Cisplatin business medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 17(4) |
| ISSN: | 0923-7534 |
| Popis: | Background: The addition of cytokines to chemotherapy (CT) has obtained encouraging but contradictory results in metastatic melanoma. In this phase III trial, we compared the effects of CT [cisplatin, vindesine and dacarbazine (CVD)] with those of concurrent biochemotherapy (bioCT) consisting of CVD plus interleukin-2 and interferon-a2b. Patients and methods: A total of 151 untreated metastatic melanoma patients were randomized, 75 on arm A (cisplatin 30 mg/m 2 on days 1–3, vindesine 2.5 mg/m 2 on day 1 and dacarbazine 250 mg/m 2 on days 1–3), and 76 on arm B (same CVD scheme plus interferon-a2b on days 1–5 and interleukin-2 on days 1–5 and 8–15, both administered subcutaneously), either recycled every 3 weeks. Response was assessed every two cycles. Results: Ten percent of the patients were alive at a median of 52 months from start of therapy. We observed a response rate (RR) of 21% on arm A versus 33% on arm B; three patients (4%) given bioCT had complete responses (CRs). Median time to progression (TTP) was identical; median overall survival (OS) time was 12 months on arm A and 11 months on arm B. Conclusions: BioCT is not better than CT alone; the trend in favor of the bioCT in terms of RR did not translate into better TTP or OS. Therefore, bioCT cannot be recommended as standard first-line therapy for metastatic melanoma. |
| Databáze: | OpenAIRE |
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