Since 2010, the beginning of this blog, I have been YELLING that interferon provides little to no help in stopping the progression of melanoma and NO effect on overall survival at all!!! (That's from the real live DATA people!) It WILL, however, make you extremely ill! The problem has always been the presence of anecdotal "evidence" and the desire of folks to believe. We've all heard this story, "Well, I'm Stage III and I took interferon and MY melanoma hasn't recurred!" In melanoma world, when ANYONE fails to recur, that is WONDERFUL news!!! However, these stories were never proof that interferon had ANYTHING to do with failure to progress. Research has been lacking because, with no effective drugs for use as adjuvant, no one was really paying attention, AND - many folks with Stage II/III melanoma never progress even with no treatment!!! Now there's this.....
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, Lee...Sosman, Flaherty, Sondak, ….Kirkwood. J Clin Oncol. 2017 Jan 30.
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 for OBS and 0.70 for IFN. The 5-year overall survival rate was 0.83 for OBS and 0.83 for IFN. Treatment-related grade 3 and higher toxicity was 4.6% versus 57.9% for OBS and IFN, respectively. 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.