Phase III Randomized Study of 4 Weeks of High-Dose Interferon-α-2b in Stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) Melanoma: A Trial of the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group (E1697)
| Autor: | Jeffrey A. Sosman, Gary I. Cohen, Lawrence E. Flaherty, Robert M. Conry, Alberto S. Pappo, Richard F. Kefford, Joanna M. Brell, Michael Smylie, Douglas S. Reintgen, John M. Kirkwood, William E. Carson, Sandra J. Lee, Sanjiv S. Agarwala, Shaker R. Dakhil, Terry L. Evans, Mark R. Albertini, Uma N. M. Rao, Wai-Ki Yip, Michael B. Atkins, Vernon K. Sondak, Ahmad A. Tarhini |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology Cancer Research medicine.medical_specialty Skin Neoplasms medicine.medical_treatment Alpha interferon Kaplan-Meier Estimate Interferon alpha-2 Drug Administration Schedule law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Original Reports medicine Clinical endpoint Humans Melanoma Lymph node Survival rate Aged Neoplasm Staging Aged 80 and over Chemotherapy business.industry Interferon-alpha Middle Aged medicine.disease Recombinant Proteins Regimen 030104 developmental biology medicine.anatomical_structure Chemotherapy Adjuvant 030220 oncology & carcinogenesis Female Lymph Nodes business |
| Zdroj: | Journal of Clinical Oncology. 35:885-892 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2016.70.2951 |
| Popis: | Purpose To test the efficacy of 4 weeks of intravenous (IV) induction with high-dose interferon (IFN) as part of the Eastern Cooperative Oncology Group regimen compared with observation (OBS) in patients with surgically resected intermediate-risk melanoma. Patients and Methods In this intergroup international trial, eligible patients had surgically resected cutaneous melanoma in the following categories: (1) T2bN0, (2) T3a-bN0, (3) T4a-bN0, and (4) T1-4N1a-2a (microscopic). Patients were randomly assigned to receive IFN α-2b at 20 MU/m2/d IV for 5 days (Monday to Friday) every week for 4 weeks (IFN) or OBS. Stratification factors were pathologic lymph node status, lymph node staging procedure, Breslow depth, ulceration of the primary lesion, and disease stage. The primary end point was relapse-free survival. Secondary end points included overall survival, toxicity, and quality of life. Results A total of 1,150 patients were randomly assigned. At a median follow-up of 7 years, the 5-year relapse-free survival rate was 0.70 (95% CI, 0.66 to 0.74) for OBS and 0.70, (95% CI, 0.66 to 0.74) for IFN ( P = .964). The 5-year overall survival rate was 0.83 (95% CI, 0.79 to 0.86) for OBS and 0.83 (95% CI, 0.80 to 0.86) for IFN ( P = .558). Treatment-related grade 3 and higher toxicity was 4.6% versus 57.9% for OBS and IFN, respectively ( P < .001). Quality of life was worse for the treated group. Conclusion Four weeks of IV induction as part of the Eastern Cooperative Oncology Group high-dose IFN regimen is not better than OBS alone for patients with intermediate-risk melanoma as defined in this trial. |
| Databáze: | OpenAIRE |
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