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

Alexander Ja-Ho Chou, Eugenie S. Kleinerman, Mark D. Krailo, Zhengjia Chen, Donna L. Betcher, John H. Healey, Ernest U. Conrad, Michael L. Nieder, Michael A. Weiner, Robert J. Wells, Richard B. Womer, Paul A. Meyers

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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.

Original languageEnglish (US)
Pages (from-to)5339-5348
Number of pages10
JournalCancer
Volume115
Issue number22
DOIs
StatePublished - Nov 15 2009
Externally publishedYes

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Osteosarcoma
Drug Therapy
Confidence Intervals
Disease-Free Survival
Survival
Pyridinolcarbamate
mifamurtide
Ifosfamide
Methotrexate
Pharmaceutical Preparations
Doxorubicin
Cisplatin
Regimen B

Keywords

  • Children's Oncology Group
  • Metastatic osteosarcoma
  • Muramyl tripeptide
  • Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma : A report from the Children's Oncology Group. / Chou, Alexander Ja-Ho; Kleinerman, Eugenie S.; Krailo, Mark D.; Chen, Zhengjia; Betcher, Donna L.; Healey, John H.; Conrad, Ernest U.; Nieder, Michael L.; Weiner, Michael A.; Wells, Robert J.; Womer, Richard B.; Meyers, Paul A.

In: Cancer, Vol. 115, No. 22, 15.11.2009, p. 5339-5348.

Research output: Contribution to journalArticle

Chou, AJ-H, Kleinerman, ES, Krailo, MD, Chen, Z, Betcher, DL, Healey, JH, Conrad, EU, Nieder, ML, Weiner, MA, Wells, RJ, Womer, RB & Meyers, PA 2009, 'Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma: A report from the Children's Oncology Group', Cancer, vol. 115, no. 22, pp. 5339-5348. https://doi.org/10.1002/cncr.24566
Chou, Alexander Ja-Ho ; Kleinerman, Eugenie S. ; Krailo, Mark D. ; Chen, Zhengjia ; Betcher, Donna L. ; Healey, John H. ; Conrad, Ernest U. ; Nieder, Michael L. ; Weiner, Michael A. ; Wells, Robert J. ; Womer, Richard B. ; Meyers, Paul A. / Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma : A report from the Children's Oncology Group. In: Cancer. 2009 ; Vol. 115, No. 22. pp. 5339-5348.
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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.",
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author = "Chou, {Alexander Ja-Ho} and Kleinerman, {Eugenie S.} and Krailo, {Mark D.} and Zhengjia Chen and Betcher, {Donna L.} and Healey, {John H.} and Conrad, {Ernest U.} and Nieder, {Michael L.} and Weiner, {Michael A.} and Wells, {Robert J.} and Womer, {Richard B.} and Meyers, {Paul A.}",
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T1 - Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma

T2 - A report from the Children's Oncology Group

AU - Chou, Alexander Ja-Ho

AU - Kleinerman, Eugenie S.

AU - Krailo, Mark D.

AU - Chen, Zhengjia

AU - Betcher, Donna L.

AU - Healey, John H.

AU - Conrad, Ernest U.

AU - Nieder, Michael L.

AU - Weiner, Michael A.

AU - Wells, Robert J.

AU - Womer, Richard B.

AU - Meyers, Paul A.

PY - 2009/11/15

Y1 - 2009/11/15

N2 - 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.

AB - 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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KW - Metastatic osteosarcoma

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KW - Survival

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