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Clinical Trial
. 2009 Nov 15;115(22):5339-48.
doi: 10.1002/cncr.24566.

Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma: a report from the Children's Oncology Group

Alexander J Chou  1 , Eugenie S Kleinerman, Mark D Krailo, Zhengjia Chen, Donna L Betcher, John H Healey, Ernest U Conrad 3rd, Michael L Nieder, Michael A Weiner, Robert J Wells, Richard B Womer, Paul A Meyers; Children's Oncology Group
Affiliations
Clinical Trial

Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma: a report from the Children's Oncology Group

Alexander J Chou et al. Cancer. .

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.

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Figures

Figure 1
Figure 1
Treatment Schema Abbreviations: HDMTX, high dose methotrexate; MTP, muramyl tri-peptide phosphatidylethanolamine *Resection of metastatic lesions, when possible, occurred after definitive surgery
Figure 2A
Figure 2A
Event Free Survival (EFS) by Treatment Regimen Assignment
Figure 2B
Figure 2B
Event Free Survival (EFS) by L-MTP-PE assignment
Figure 2C
Figure 2C
Event Free Survival (EFS) by Chemotherapy Regimen Assignment
Figure 3A
Figure 3A
Overall Survival by Treatment Regimen Assignment
Figure 3B
Figure 3B
Overall Survival by L-MTP-PE Assignment
Figure 3C
Figure 3C
Overall Survival by Chemotherapy Regimen Assignment
See this image and copyright information in PMC

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