MAP (methotrexate, doxorubicin, and cisplatin) and IFN-a-2b (pegylated interferon alfa-2b) did not improve event-free survival (EFS) when compared to MAP alone among patients with osteosarcoma and good histologic response, according to a study published online ahead of print this week in the Journal of Clinical Oncology.
EURAMOS-1 is an international study where the researchers randomly assigned 716 patients to receive four additional cycles of MAP and IFN-a-2b (n=357) or MAP alone (n=359).
The patients enrolled included ≤ 40 years with resectable high-grade osteosarcoma, good histologic response to induction chemotherapy, more than two cycles of preoperative MAP, complete surgery of primary tumor, less than 10% of viable tumor, and no disease progression.
The primary outcome was EFS, and secondary outcomes were overall survival and toxicity. Three-year EFS for 716 patients was 76% (95% CI: 72, 79) during a median follow-up of 44 months.
The number of EFS events reported was 81 for MAP plus IFN-a-2b and 93 for MAP alone (HR=0.82; 95% CI: 0.61, 1.12; P=0.214). Due to refusal and toxicity from IFN-a-2b, a significant proportion of patients either never started IFN-a-2b or stopped prematurely.
The findings suggest that MAP plus IFN-a-2b was not statistically different from MAP monotherapy for resectable high-grade osteosarcoma with a good histologic response.
EURAMOS-1, an international randomized controlled trial, investigated maintenance therapy with pegylated interferon alfa-2b (IFN-α-2b) in patients whose osteosarcoma showed good histologic response (good response) to induction chemotherapy.