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Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate.
J Clin Oncol. 2005 Mar 20; 23(9):2004-11.JC

Abstract

PURPOSE

To determine whether the addition of ifosfamide and/or muramyl tripeptide (MTP) encapsulated in liposomes to cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) could improve the probability for event-free survival (EFS) in newly diagnosed patients with osteosarcoma (OS).

PATIENTS AND METHODS

Six hundred seventy-seven patients with OS without clinically detectable metastatic disease were treated with one of four prospectively randomized treatments. All patients received identical cumulative doses of cisplatin, doxorubicin, and HDMTX and underwent definitive surgical resection of the primary tumor. Patients were randomly assigned to receive or not to receive ifosfamide and/or MTP in a 2 double dagger 2 factorial design. The primary end point for analysis was EFS.

RESULTS

Patients treated with the standard arm of therapy had a 3-year EFS of 71%. We could not analyze the results by factorial design because we observed an interaction between the addition of ifosfamide and the addition of MTP. The addition of MTP to standard chemotherapy achieved a 3-year EFS rate of 68%. The addition of ifosfamide to standard chemotherapy achieved a 3-year EFS rate of 61%. The addition of both ifosfamide and MTP resulted in a 3-year EFS rate of 78%.

CONCLUSION

The addition of ifosfamide in this dose schedule to standard chemotherapy did not enhance EFS. The addition of MTP to chemotherapy might improve EFS, but additional clinical and laboratory investigation will be necessary to explain the interaction between ifosfamide and MTP.

Authors+Show Affiliations

Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021, USA. meyersp@mskcc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15774791

Citation

Meyers, Paul A., et al. "Osteosarcoma: a Randomized, Prospective Trial of the Addition of Ifosfamide And/or Muramyl Tripeptide to Cisplatin, Doxorubicin, and High-dose Methotrexate." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 23, no. 9, 2005, pp. 2004-11.
Meyers PA, Schwartz CL, Krailo M, et al. Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. J Clin Oncol. 2005;23(9):2004-11.
Meyers, P. A., Schwartz, C. L., Krailo, M., Kleinerman, E. S., Betcher, D., Bernstein, M. L., Conrad, E., Ferguson, W., Gebhardt, M., Goorin, A. M., Harris, M. B., Healey, J., Huvos, A., Link, M., Montebello, J., Nadel, H., Nieder, M., Sato, J., Siegal, G., ... Grier, H. (2005). Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 23(9), 2004-11.
Meyers PA, et al. Osteosarcoma: a Randomized, Prospective Trial of the Addition of Ifosfamide And/or Muramyl Tripeptide to Cisplatin, Doxorubicin, and High-dose Methotrexate. J Clin Oncol. 2005 Mar 20;23(9):2004-11. PubMed PMID: 15774791.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. AU - Meyers,Paul A, AU - Schwartz,Cindy L, AU - Krailo,Mark, AU - Kleinerman,Eugenie S, AU - Betcher,Donna, AU - Bernstein,Mark L, AU - Conrad,Ernest, AU - Ferguson,William, AU - Gebhardt,Mark, AU - Goorin,Allen M, AU - Harris,Michael B, AU - Healey,John, AU - Huvos,Andrew, AU - Link,Michael, AU - Montebello,Joseph, AU - Nadel,Helen, AU - Nieder,Michael, AU - Sato,Judith, AU - Siegal,Gene, AU - Weiner,Michael, AU - Wells,Robert, AU - Wold,Lester, AU - Womer,Richard, AU - Grier,Holcombe, PY - 2005/3/19/pubmed PY - 2005/4/6/medline PY - 2005/3/19/entrez SP - 2004 EP - 11 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J. Clin. Oncol. VL - 23 IS - 9 N2 - PURPOSE: To determine whether the addition of ifosfamide and/or muramyl tripeptide (MTP) encapsulated in liposomes to cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) could improve the probability for event-free survival (EFS) in newly diagnosed patients with osteosarcoma (OS). PATIENTS AND METHODS: Six hundred seventy-seven patients with OS without clinically detectable metastatic disease were treated with one of four prospectively randomized treatments. All patients received identical cumulative doses of cisplatin, doxorubicin, and HDMTX and underwent definitive surgical resection of the primary tumor. Patients were randomly assigned to receive or not to receive ifosfamide and/or MTP in a 2 double dagger 2 factorial design. The primary end point for analysis was EFS. RESULTS: Patients treated with the standard arm of therapy had a 3-year EFS of 71%. We could not analyze the results by factorial design because we observed an interaction between the addition of ifosfamide and the addition of MTP. The addition of MTP to standard chemotherapy achieved a 3-year EFS rate of 68%. The addition of ifosfamide to standard chemotherapy achieved a 3-year EFS rate of 61%. The addition of both ifosfamide and MTP resulted in a 3-year EFS rate of 78%. CONCLUSION: The addition of ifosfamide in this dose schedule to standard chemotherapy did not enhance EFS. The addition of MTP to chemotherapy might improve EFS, but additional clinical and laboratory investigation will be necessary to explain the interaction between ifosfamide and MTP. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/15774791/Osteosarcoma:_a_randomized_prospective_trial_of_the_addition_of_ifosfamide_and/or_muramyl_tripeptide_to_cisplatin_doxorubicin_and_high_dose_methotrexate_ L2 - http://ascopubs.org/doi/full/10.1200/JCO.2005.06.031?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -