Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma

Matthew Ladra, Jackie D. Szymonifka, Anita Mahajan, Alison M. Friedmann, Beow Yong Yeap, Claire P. Goebel, Shannon M. MacDonald, David R. Grosshans, Carlos Rodriguez-Galindo, Karen J. Marcus, Nancy J. Tarbell, Torunn I. Yock

Research output: Contribution to journalArticle

Abstract

Purpose This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma (RMS).

Patients and Methods Fifty-seven patients with localized RMS (age 21 years or younger) or metastatic embryonal RMS (age 2 to 10 years) were enrolled between February 2005 and August 2012. All patients were treated with chemotherapy based on either vincristine, actinomycin, and cyclophosphamide or vincristine, actinomycin, and ifosfamide-based chemotherapy and proton radiation. Surgical resection was based on tumor site and accessibility. Common Terminology Criteria for Adverse Events, Version 3.0, was used to assess and grade adverse effects of treatment. Concurrent enrollment onto Children's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed. All pathology and imaging were reviewed at the treating institution.

Results Median follow-up was 47 months (range, 14 to 102 months) for survivors. Five-year event-free survival (EFS), overall survival (OS), and local control (LC) were 69%, 78%, and 81%, respectively, for the entire cohort. The 5-year LC by risk group was 93% for low-risk and 77% for intermediate-risk disease. There were 13 patients with grade 3 acute toxicity and three patients with grade 3 late toxicity. There were no acute or late toxicities higher than grade 3.

Conclusion Five-year LC, EFS, and OS rates were similar to those observed in comparable trials that used photon radiation. Acute and late toxicity rates were favorable. Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS.

Original languageEnglish (US)
Pages (from-to)3762-3770
Number of pages9
JournalJournal of Clinical Oncology
Volume32
Issue number33
DOIs
StatePublished - Nov 20 2014
Externally publishedYes

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Rhabdomyosarcoma
Protons
Radiotherapy
Pediatrics
Radiation
Dactinomycin
Vincristine
Disease-Free Survival
Drug Therapy
Ifosfamide
Photons
Terminology
Sarcoma
Cyclophosphamide
Survivors
Survival Rate
Pathology
Control Groups
Survival
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Ladra, M., Szymonifka, J. D., Mahajan, A., Friedmann, A. M., Yeap, B. Y., Goebel, C. P., ... Yock, T. I. (2014). Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma. Journal of Clinical Oncology, 32(33), 3762-3770. https://doi.org/10.1200/JCO.2014.56.1548

Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma. / Ladra, Matthew; Szymonifka, Jackie D.; Mahajan, Anita; Friedmann, Alison M.; Yeap, Beow Yong; Goebel, Claire P.; MacDonald, Shannon M.; Grosshans, David R.; Rodriguez-Galindo, Carlos; Marcus, Karen J.; Tarbell, Nancy J.; Yock, Torunn I.

In: Journal of Clinical Oncology, Vol. 32, No. 33, 20.11.2014, p. 3762-3770.

Research output: Contribution to journalArticle

Ladra, M, Szymonifka, JD, Mahajan, A, Friedmann, AM, Yeap, BY, Goebel, CP, MacDonald, SM, Grosshans, DR, Rodriguez-Galindo, C, Marcus, KJ, Tarbell, NJ & Yock, TI 2014, 'Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma', Journal of Clinical Oncology, vol. 32, no. 33, pp. 3762-3770. https://doi.org/10.1200/JCO.2014.56.1548
Ladra, Matthew ; Szymonifka, Jackie D. ; Mahajan, Anita ; Friedmann, Alison M. ; Yeap, Beow Yong ; Goebel, Claire P. ; MacDonald, Shannon M. ; Grosshans, David R. ; Rodriguez-Galindo, Carlos ; Marcus, Karen J. ; Tarbell, Nancy J. ; Yock, Torunn I. / Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 33. pp. 3762-3770.
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abstract = "Purpose This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma (RMS).Patients and Methods Fifty-seven patients with localized RMS (age 21 years or younger) or metastatic embryonal RMS (age 2 to 10 years) were enrolled between February 2005 and August 2012. All patients were treated with chemotherapy based on either vincristine, actinomycin, and cyclophosphamide or vincristine, actinomycin, and ifosfamide-based chemotherapy and proton radiation. Surgical resection was based on tumor site and accessibility. Common Terminology Criteria for Adverse Events, Version 3.0, was used to assess and grade adverse effects of treatment. Concurrent enrollment onto Children's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed. All pathology and imaging were reviewed at the treating institution.Results Median follow-up was 47 months (range, 14 to 102 months) for survivors. Five-year event-free survival (EFS), overall survival (OS), and local control (LC) were 69{\%}, 78{\%}, and 81{\%}, respectively, for the entire cohort. The 5-year LC by risk group was 93{\%} for low-risk and 77{\%} for intermediate-risk disease. There were 13 patients with grade 3 acute toxicity and three patients with grade 3 late toxicity. There were no acute or late toxicities higher than grade 3.Conclusion Five-year LC, EFS, and OS rates were similar to those observed in comparable trials that used photon radiation. Acute and late toxicity rates were favorable. Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS.",
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T1 - Preliminary results of a phase II trial of proton radiotherapy for pediatric rhabdomyosarcoma

AU - Ladra, Matthew

AU - Szymonifka, Jackie D.

AU - Mahajan, Anita

AU - Friedmann, Alison M.

AU - Yeap, Beow Yong

AU - Goebel, Claire P.

AU - MacDonald, Shannon M.

AU - Grosshans, David R.

AU - Rodriguez-Galindo, Carlos

AU - Marcus, Karen J.

AU - Tarbell, Nancy J.

AU - Yock, Torunn I.

PY - 2014/11/20

Y1 - 2014/11/20

N2 - Purpose This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma (RMS).Patients and Methods Fifty-seven patients with localized RMS (age 21 years or younger) or metastatic embryonal RMS (age 2 to 10 years) were enrolled between February 2005 and August 2012. All patients were treated with chemotherapy based on either vincristine, actinomycin, and cyclophosphamide or vincristine, actinomycin, and ifosfamide-based chemotherapy and proton radiation. Surgical resection was based on tumor site and accessibility. Common Terminology Criteria for Adverse Events, Version 3.0, was used to assess and grade adverse effects of treatment. Concurrent enrollment onto Children's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed. All pathology and imaging were reviewed at the treating institution.Results Median follow-up was 47 months (range, 14 to 102 months) for survivors. Five-year event-free survival (EFS), overall survival (OS), and local control (LC) were 69%, 78%, and 81%, respectively, for the entire cohort. The 5-year LC by risk group was 93% for low-risk and 77% for intermediate-risk disease. There were 13 patients with grade 3 acute toxicity and three patients with grade 3 late toxicity. There were no acute or late toxicities higher than grade 3.Conclusion Five-year LC, EFS, and OS rates were similar to those observed in comparable trials that used photon radiation. Acute and late toxicity rates were favorable. Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS.

AB - Purpose This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma (RMS).Patients and Methods Fifty-seven patients with localized RMS (age 21 years or younger) or metastatic embryonal RMS (age 2 to 10 years) were enrolled between February 2005 and August 2012. All patients were treated with chemotherapy based on either vincristine, actinomycin, and cyclophosphamide or vincristine, actinomycin, and ifosfamide-based chemotherapy and proton radiation. Surgical resection was based on tumor site and accessibility. Common Terminology Criteria for Adverse Events, Version 3.0, was used to assess and grade adverse effects of treatment. Concurrent enrollment onto Children's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed. All pathology and imaging were reviewed at the treating institution.Results Median follow-up was 47 months (range, 14 to 102 months) for survivors. Five-year event-free survival (EFS), overall survival (OS), and local control (LC) were 69%, 78%, and 81%, respectively, for the entire cohort. The 5-year LC by risk group was 93% for low-risk and 77% for intermediate-risk disease. There were 13 patients with grade 3 acute toxicity and three patients with grade 3 late toxicity. There were no acute or late toxicities higher than grade 3.Conclusion Five-year LC, EFS, and OS rates were similar to those observed in comparable trials that used photon radiation. Acute and late toxicity rates were favorable. Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS.

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