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Phase III Randomized Study of 4 Weeks of High-Dose Interferon-?-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).

ABSTRACT: 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 ?-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.

SUBMITTER: Agarwala SS

PROVIDER: S-EPMC5455684 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Publications

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).

Agarwala Sanjiv S SS Lee Sandra J SJ Yip Waiki W Rao Uma N UN Tarhini Ahmad A AA Cohen Gary I GI Reintgen Douglas S DS Evans Terry L TL Brell Joanna M JM Albertini Mark R MR Atkins Michael B MB Dakhil Shaker R SR Conry Robert M RM Sosman Jeffrey A JA Flaherty Lawrence E LE Sondak Vernon K VK Carson William E WE Smylie Michael G MG Pappo Alberto S AS Kefford Richard F RF Kirkwood John M JM

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20170130 8

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 randoml ...[more]

PMID: 28135150

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Project description:BackgroundIt is known that not all chiropractors follow mainstream guidelines on the use of diagnostic ionising radiation. Various reasons have been discussed in the literature, including using radiography to screen for congenital anomalies, to perform postural analysis, to search for contraindications to spinal manipulation, and to document chiropractic subluxations, i.e., tiny anatomical displacements of vertebrae thought to affect nerves and health. The visualisation of subluxations was the reason chiropractic first adopted the x-ray in 1910. There has never been a study of the influence of this historical paradigm of radiography on the practices of chiropractic radiologists (DACBRs or Diplomates of the American Chiropractic College of Radiology).MethodsA survey was administered with a modified Dillman method using SurveyMonkey and supplemented by hard copies distributed at a professional conference. The target population was all active DACBRs. There were 34 items, which consisted of multiple choice and open-ended interrogatives on all three areas in which chiropractic radiologists work: education, clinical practice, and radiology practice.ResultsThe response rate was 38% (73 of 190 DACBRs). Respondents reported that the historical paradigm of radiography was found in all areas of practice, but not as a major aspect. The majority of respondents did not condone that historical paradigm, but many tolerated it, particularly from referring chiropractors. Radiographic subluxation analysis was reportedly perpetuated by private clinical practitioners as well as technique instructors and supervising clinicians in the teaching institutions.ConclusionsWithin the chiropractic profession, there is a continuing belief in radiographically visible subluxations as a cause of suboptimal health. This situation is sustained in part due to the reticence of other chiropractors to report these practices to licensing and registration boards. Investigation into other structures supporting a vitalistic belief system over science in chiropractic is recommended. In addition, it may be useful to explore remunerative systems that move beyond the inherently conflicted fee-for-service model.

Dataset Information

Phase III Randomized Study of 4 Weeks of High-Dose Interferon-?-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).

Publications

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).

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