Participants were randomly assigned to receive either a standard HDI 20 MIU/m2 intravenously from days 1 to 5, 8 to 12, 15 to 19, and 22 to 26, followed by 20 MIU/m2 subcutaneously 3 times weekly for 48 weeks beginning on day 29 of week 5, or 3 courses of IFN-α-2b 20 MUI/m2 administered intravenously 5 days per week for 4 weeks, then every 4 months.1
Results showed that among the 627 evaluable patients, there were no significant differences for distant metastasis-free survival (HR, 1.21; P = .12) or overall survival (HR, 1.01; P = .85); however, there was a significant difference in relapse-free survival in favor of HDI (HR = 1.27; P = .03).
In regard to tolerability, patients in the HDI arm experienced significantly more anemia than in those in the iHDI group (P = .004), while grade 3 or 5 neutropenia was significantly more common in the iHDI group (P = .004).
Significantly more patients receiving HDI terminated treatment early due to adverse events or quality of life than did those receiving iHDI (26.0% vs 12.8%; P < .001).
“The results show that HDI seems to be more effective than iHDI and also once again shows that HDI is an active adjuvant therapy even when not compared to observation. [It] also shows that maintaining patients on therapy is more important than to deliver maximum dose,” Dr. Mohr told Cancer Therapy Advisor.
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Therefore, the investigators anticipate that the approved schedules for adjuvant IFN treatment of patients with melanoma will remain the standard of care until new treatment modalities, such as with ipilimumab or other agents, demonstrate durable improvements in relapse-free or overall survival with acceptable safety profiles.1
“iHDI is better tolerable and patients have a better quality of life but OS is not superior to HDI and PFS is inferior to HDI, so iHDI cannot be recommended,” Dr. Mohr concluded.
- Mohr P, Hauschild A, Trefzer U, et al. Intermittent high-dose intravenous interferon alfa-2b for adjuvant treatment of stage III melanoma: final analysis of a randomized phase III Dermatologic Cooperative Oncology Group trial [published online ahead of print October 26, 2015]. J Clin Oncol. doi: 10.1200/JCO.2014.59.6932.
- What are the key statistics about melanoma skin cancer? American Cancer Society. http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics. Updated March 20, 2015. Accessed October 26, 2015. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Melanoma. Version 1.2016. http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Accessed October 26, 2015.