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Cancer ; 115(22): 5339-48, 2009 Nov 15.
Article in English | MEDLINE | ID: mdl-19637348

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.


Subject(s)
Acetylmuramyl-Alanyl-Isoglutamine/analogs & derivatives , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bone Neoplasms/drug therapy , Immunologic Factors/administration & dosage , Osteosarcoma/drug therapy , Phosphatidylethanolamines/administration & dosage , Acetylmuramyl-Alanyl-Isoglutamine/administration & dosage , Adolescent , Adult , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bone Neoplasms/mortality , Bone Neoplasms/pathology , Child , Child, Preschool , Disease-Free Survival , Drug Administration Schedule , Female , Humans , Infant , Infant, Newborn , Male , Neoplasm Metastasis , Osteosarcoma/mortality , Osteosarcoma/pathology , Survival Analysis
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