Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, MBA, PhD, PA-C
Objective: The objective of this selective EBM review is to determine whether or not temozolomide in combination with interferon alpha-2b a safe and effective treatment for malignant melanoma.
Study Design: Review of three randomized controlled trials published in the United States and Britain between 2003 and 2005.
Data Sources: Three non-blind randomized controlled trials were found via Cochrane library and PubMed.
Outcomes Measured: Efficacy was measured by survival greater than or equal to 12 months, with one (experimental) group receiving treatment with oral temozolomide (TMZ) and subcutaneous interferon alpha-2b (IFN-∝2b) and the other (control) group receiving oral TMZ alone. Safety was measured by rates of nausea with the same experimental and control groups. Safety was also measured by adverse event rates, with one group receiving combination treatment with IFN-∝2b in a body surface area-based (BSA) dose, and the other group receiving combination treatment with IFN-∝2b in a fixed dose.
Results: Kaufman et al and Danson et al demonstrated increased survival at 12 months when comparing treatment with TMZ + IFN-∝ to TMZ monotherapy (ABI 9.7% and 8%, respectively). Danson et al also found increased rates of nausea with combination treatment compared to TMZ alone (ARI 11%, NNH 10). Ritchtig et al showed a slightly increased rate of adverse events with an increased dose of IFN-∝2b when combined with TMZ (ARI 1.1%, NNH 90). No statistical analyses were performed on the data.
Conclusions: Based on these results, it is inconclusive if TMZ + IFN-∝2b is a safe and effective treatment for malignant melanoma. Although results on survival suggest a benefit to combination treatment, statistical analysis is required. Results for safety demonstrated increased adverse event and nausea rates both with the addition of IFN-∝2b and at increased doses of IFN-∝2b, however small sample size and lack of statistical analysis make it difficult to assume the safety of combination treatment.
Vincento, Kathleen, "Is Temozolomide in Combination With Interferon Alpha-2b a Safe and Effective Treatment for Malignant Melanoma?" (2015). PCOM Physician Assistant Studies Student Scholarship. 253.