Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma: A report from the Children's Oncology Group Journal Article
| Authors: | Chou, A. J.; Kleinerman, E. S.; Krailo, M. D.; Chen, Z.; Betcher, D. L.; Healey, J. H.; Conrad, E. U. 3rd; Nieder, M. L.; Weiner, M. A.; Wells, R. J.; Womer, R. B.; Meyers, P. A. |
| Article Title: | Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma: A report from the Children's Oncology Group |
| 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. © 2009 American Cancer Society. |
| Keywords: | osteosarcoma; survival; adolescent; adult; cancer survival; child; controlled study; preschool child; school child; treatment outcome; bone neoplasms; child, preschool; disease-free survival; survival analysis; clinical trial; cisplatin; doxorubicin; cancer combination chemotherapy; cancer risk; side effect; skin toxicity; methotrexate; drug megadose; metastasis; controlled clinical trial; infection; liver toxicity; nephrotoxicity; blood toxicity; randomized controlled trial; stomatitis; antineoplastic combined chemotherapy protocols; drug administration schedule; ifosfamide; drug fever; infant; infant, newborn; neoplasm metastasis; nausea and vomiting; phase 3 clinical trial; children's oncology group; metastatic osteosarcoma; muramyl tripeptide; phosphatidylethanolamine; hearing; heart rhythm; sensory dysfunction; acetylmuramyl-alanyl-isoglutamine; immunologic factors; phosphatidylethanolamines |
| Journal Title: | Cancer |
| Volume: | 115 |
| Issue: | 22 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2009-11-15 |
| Start Page: | 5339 |
| End Page: | 5348 |
| Language: | English |
| DOI: | 10.1002/cncr.24566 |
| PUBMED: | 19637348 |
| PROVIDER: | scopus |
| PMCID: | PMC2783515 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 7" - "Export Date: 30 November 2010" - "CODEN: CANCA" - "Source: Scopus" |
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