Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma

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Abstract
BACKGROUND: The addition of liposomal muramyl tripeptide phosphatidylethanolamine (MTP‐PE) to chemotherapy has been shown to improve overall survival in patients with nonmetastatic osteosarcoma (OS). The authors report the results of addition of liposomal MTP‐PE to chemotherapy for patients with metastatic OS.METHODS: Intergroup‐0133 was a prospective randomized phase 3 trial for the treatment of newly diagnosed patients with OS. The authors compared 3‐drug chemotherapy with cisplatin, doxorubicin, and high‐dose methotrexate (Regimen A) to the same 3 drugs with the addition of ifosfamide (Regimen B). The addition of liposomal MTP‐PE to chemotherapy was evaluated.RESULTS: Five‐year event‐free survival (EFS) for patients who received liposomal MTP‐PE (n = 46) was 42% versus 26% for those who did not (n = 45) (relative risk for liposomal MTP‐PE, 0.72; P = .23; 95% confidence interval [CI], 0.42‐1.2). The 5‐year overall survival for patients who received MTP‐PE versus no MTP‐PE was 53% and 40%, respectively (relative risk for liposomal MTP‐PE, 0.72; P = 0.27; 95% CI, 0.40‐1.3). The comparison of Regimen A with Regimen B did not suggest a difference for EFS (35% vs 34%, respectively; relative risk for Regimen B, 1.07; P = .79; 95% CI, 0.62‐1.8) or overall survival (52% vs 43%, respectively; relative risk for Regimen B, 1.1, P = .75; 95% CI, 0.61‐2.0).CONCLUSIONS: When the metastatic cohort was considered in isolation, the addition of liposomal MTP‐PE to chemotherapy did not achieve a statistically significant improvement in outcome. However, the pattern of outcome is similar to the pattern in nonmetastatic patients. Cancer 2009. © 2009 American Cancer Society.