Phase III Trial Comparing Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, Interleukin-2, and Interferon Alfa-2b With Cisplatin, Vinblastine, and Dacarbazine Alone in Patients With Metastatic Malignant Melanoma (E3695): A Trial Coordinated by the Eastern Cooperative Oncology Group Export

@article{citeulike:4117827, abstract = {PurposePhase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit. In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup. Patients and MethodsPatients were randomly assigned to receive cisplatin, vinblastine, and dacarbazine (CVD) either alone or concurrent with interleukin-2 and interferon alfa-2b (BCT). Treatment cycles were repeated at 21-day intervals for a maximum of four cycles. Tumor response was assessed after cycles 2 and 4, then every 3 months. ResultsFour hundred fifteen patients were enrolled, and 395 patients (CVD, n = 195; BCT, n = 200) were deemed eligible and assessable. The two study arms were well balanced for stratification factors and other prognostic factors. Response rate was 19.5\% for BCT and 13.8\% for CVD (P = .140). Median progression-free survival was significantly longer for BCT than for CVD (4.8 v 2.9 months; P = .015), although this did not translate into an advantage in either median overall survival (9.0 v 8.7 months) or the percentage of patients alive at 1 year (41\% v 36.9\%). More patients experienced grade 3 or worse toxic events with BCT than CVD (95\% v 73\%; P = .001). ConclusionAlthough BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses. Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma. 10.1200/JCO.2008.17.5448}, author = {Atkins, Michael B. and Hsu, Jessie and Lee, Sandra and Cohen, Gary I. and Flaherty, Lawrence E. and Sosman, Jeffrey A. and Sondak, Vernon K. and Kirkwood, John M.}, citeulike-article-id = {4117827}, citeulike-linkout-0 = {http://dx.doi.org/10.1200/JCO.2008.17.5448}, citeulike-linkout-1 = {http://jco.ascopubs.org/cgi/content/abstract/26/35/5748}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/19001327}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=19001327}, day = {10}, doi = {10.1200/JCO.2008.17.5448}, journal = {J Clin Oncol}, keywords = {melanoma}, month = {December}, number = {35}, pages = {5748--5754}, posted-at = {2009-03-02 01:39:16}, priority = {2}, title = {Phase III Trial Comparing Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, Interleukin-2, and Interferon Alfa-2b With Cisplatin, Vinblastine, and Dacarbazine Alone in Patients With Metastatic Malignant Melanoma (E3695): A Trial Coordinated by the Eastern Cooperative Oncology Group}, url = {http://dx.doi.org/10.1200/JCO.2008.17.5448}, volume = {26}, year = {2008} }

TY - JOUR ID - citeulike:4117827 L3 - citeulike-article-id:4117827 N2 - PurposePhase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit. In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup. Patients and MethodsPatients were randomly assigned to receive cisplatin, vinblastine, and dacarbazine (CVD) either alone or concurrent with interleukin-2 and interferon alfa-2b (BCT). Treatment cycles were repeated at 21-day intervals for a maximum of four cycles. Tumor response was assessed after cycles 2 and 4, then every 3 months. ResultsFour hundred fifteen patients were enrolled, and 395 patients (CVD, n = 195; BCT, n = 200) were deemed eligible and assessable. The two study arms were well balanced for stratification factors and other prognostic factors. Response rate was 19.5% for BCT and 13.8% for CVD (P = .140). Median progression-free survival was significantly longer for BCT than for CVD (4.8 v 2.9 months; P = .015), although this did not translate into an advantage in either median overall survival (9.0 v 8.7 months) or the percentage of patients alive at 1 year (41% v 36.9%). More patients experienced grade 3 or worse toxic events with BCT than CVD (95% v 73%; P = .001). ConclusionAlthough BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses. Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma. 10.1200/JCO.2008.17.5448 IS - 35 JF - J Clin Oncol EP - 5754 TI - Phase III Trial Comparing Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, Interleukin-2, and Interferon Alfa-2b With Cisplatin, Vinblastine, and Dacarbazine Alone in Patients With Metastatic Malignant Melanoma (E3695): A Trial Coordinated by the Eastern Cooperative Oncology Group VL - 26 SP - 5748 KW - melanoma AU - Atkins, Michael AU - Hsu, Jessie AU - Lee, Sandra AU - Cohen, Gary AU - Flaherty, Lawrence AU - Sosman, Jeffrey AU - Sondak, Vernon AU - Kirkwood, John PY - 2008/12/10/ UR - http://dx.doi.org/10.1200/JCO.2008.17.5448 ER -