Chemotherapy, irradiation, and surgery for function-preserving curative therapy of primary extremity soft tissue sarcomas

Initial treatment with i-MAP and inhalation GM-CSF during preoperative irradiation and postoperatively

Scott Heitaka Okuno, Ivy A Petersen, Thomas Shives, Michelle Mahoney, Michael Haddock, Franklin Sim, Mary I. O'Connor, Svetomir Nenad Markovic, William Maples

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

PURPOSE: To determine if aerosol granulocyte macrophage-colony-stimulating factor (GM-CSF) decreases the 2-year pulmonary metastasis rate for soft tissue sarcoma. PATIENTS AND METHODS: Patients with high-grade soft tissue sarcomas were treated with 2 cycles of ifosfamide, mitomycin, doxorubicin, and cisplatin plus GM-CSF subcutaneous followed by 45 Gy irradiation with concurrent 2 cycles of mitomycin, doxorubicin, and cisplatin followed by surgery +/- intraoperative radiation or brachytherapy. Aerosol GM-CSF (250 mcg twice a day) was administered for 1 week every other week 3× during neoadjuvant therapy and beginning 4 weeks postoperatively every other week 5×. RESULTS: A total of 39 patients were enrolled between November 2001 and April 2006. The median age was 51 years (range, 19 to 65 y). The median lesion size was 9 cm (range, 2.3 to 26.7 cm). Seventy-six percent experienced grade 3-4 hematologic toxicity. Twenty-four of the first 35 evaluable patients (69%; 95% CI, 41%-84%) were free of pulmonary metastasis at 2 years. A total of 82% (95% CI, 70%-95%) of patients were still alive after 3 years, with a median follow-up of 5.5 years (range, 3.4 to 7.6 y). A total of 58% (95% CI, 44%-76%) of patients remained progression free after 3 years. CONCLUSIONS: The addition of aerosol GM-CSF to combined chemotherapy, irradiation, and surgery for soft tissue sarcomas did not achieve the study endpoint to decrease the 2-year pulmonary metastasis rate.

Original languageEnglish (US)
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
DOIs
StateAccepted/In press - Jan 30 2014

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Granulocyte-Macrophage Colony-Stimulating Factor
Sarcoma
Inhalation
Extremities
Drug Therapy
Aerosols
Mitomycin
Neoplasm Metastasis
Lung
Doxorubicin
Cisplatin
Therapeutics
Ifosfamide
Neoadjuvant Therapy
Brachytherapy
Radiation

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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title = "Chemotherapy, irradiation, and surgery for function-preserving curative therapy of primary extremity soft tissue sarcomas: Initial treatment with i-MAP and inhalation GM-CSF during preoperative irradiation and postoperatively",
abstract = "PURPOSE: To determine if aerosol granulocyte macrophage-colony-stimulating factor (GM-CSF) decreases the 2-year pulmonary metastasis rate for soft tissue sarcoma. PATIENTS AND METHODS: Patients with high-grade soft tissue sarcomas were treated with 2 cycles of ifosfamide, mitomycin, doxorubicin, and cisplatin plus GM-CSF subcutaneous followed by 45 Gy irradiation with concurrent 2 cycles of mitomycin, doxorubicin, and cisplatin followed by surgery +/- intraoperative radiation or brachytherapy. Aerosol GM-CSF (250 mcg twice a day) was administered for 1 week every other week 3× during neoadjuvant therapy and beginning 4 weeks postoperatively every other week 5×. RESULTS: A total of 39 patients were enrolled between November 2001 and April 2006. The median age was 51 years (range, 19 to 65 y). The median lesion size was 9 cm (range, 2.3 to 26.7 cm). Seventy-six percent experienced grade 3-4 hematologic toxicity. Twenty-four of the first 35 evaluable patients (69{\%}; 95{\%} CI, 41{\%}-84{\%}) were free of pulmonary metastasis at 2 years. A total of 82{\%} (95{\%} CI, 70{\%}-95{\%}) of patients were still alive after 3 years, with a median follow-up of 5.5 years (range, 3.4 to 7.6 y). A total of 58{\%} (95{\%} CI, 44{\%}-76{\%}) of patients remained progression free after 3 years. CONCLUSIONS: The addition of aerosol GM-CSF to combined chemotherapy, irradiation, and surgery for soft tissue sarcomas did not achieve the study endpoint to decrease the 2-year pulmonary metastasis rate.",
author = "Okuno, {Scott Heitaka} and Petersen, {Ivy A} and Thomas Shives and Michelle Mahoney and Michael Haddock and Franklin Sim and O'Connor, {Mary I.} and Markovic, {Svetomir Nenad} and William Maples",
year = "2014",
month = "1",
day = "30",
doi = "10.1097/COC.0000000000000038",
language = "English (US)",
journal = "American Journal of Clinical Oncology: Cancer Clinical Trials",
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publisher = "Lippincott Williams and Wilkins",

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TY - JOUR

T1 - Chemotherapy, irradiation, and surgery for function-preserving curative therapy of primary extremity soft tissue sarcomas

T2 - Initial treatment with i-MAP and inhalation GM-CSF during preoperative irradiation and postoperatively

AU - Okuno, Scott Heitaka

AU - Petersen, Ivy A

AU - Shives, Thomas

AU - Mahoney, Michelle

AU - Haddock, Michael

AU - Sim, Franklin

AU - O'Connor, Mary I.

AU - Markovic, Svetomir Nenad

AU - Maples, William

PY - 2014/1/30

Y1 - 2014/1/30

N2 - PURPOSE: To determine if aerosol granulocyte macrophage-colony-stimulating factor (GM-CSF) decreases the 2-year pulmonary metastasis rate for soft tissue sarcoma. PATIENTS AND METHODS: Patients with high-grade soft tissue sarcomas were treated with 2 cycles of ifosfamide, mitomycin, doxorubicin, and cisplatin plus GM-CSF subcutaneous followed by 45 Gy irradiation with concurrent 2 cycles of mitomycin, doxorubicin, and cisplatin followed by surgery +/- intraoperative radiation or brachytherapy. Aerosol GM-CSF (250 mcg twice a day) was administered for 1 week every other week 3× during neoadjuvant therapy and beginning 4 weeks postoperatively every other week 5×. RESULTS: A total of 39 patients were enrolled between November 2001 and April 2006. The median age was 51 years (range, 19 to 65 y). The median lesion size was 9 cm (range, 2.3 to 26.7 cm). Seventy-six percent experienced grade 3-4 hematologic toxicity. Twenty-four of the first 35 evaluable patients (69%; 95% CI, 41%-84%) were free of pulmonary metastasis at 2 years. A total of 82% (95% CI, 70%-95%) of patients were still alive after 3 years, with a median follow-up of 5.5 years (range, 3.4 to 7.6 y). A total of 58% (95% CI, 44%-76%) of patients remained progression free after 3 years. CONCLUSIONS: The addition of aerosol GM-CSF to combined chemotherapy, irradiation, and surgery for soft tissue sarcomas did not achieve the study endpoint to decrease the 2-year pulmonary metastasis rate.

AB - PURPOSE: To determine if aerosol granulocyte macrophage-colony-stimulating factor (GM-CSF) decreases the 2-year pulmonary metastasis rate for soft tissue sarcoma. PATIENTS AND METHODS: Patients with high-grade soft tissue sarcomas were treated with 2 cycles of ifosfamide, mitomycin, doxorubicin, and cisplatin plus GM-CSF subcutaneous followed by 45 Gy irradiation with concurrent 2 cycles of mitomycin, doxorubicin, and cisplatin followed by surgery +/- intraoperative radiation or brachytherapy. Aerosol GM-CSF (250 mcg twice a day) was administered for 1 week every other week 3× during neoadjuvant therapy and beginning 4 weeks postoperatively every other week 5×. RESULTS: A total of 39 patients were enrolled between November 2001 and April 2006. The median age was 51 years (range, 19 to 65 y). The median lesion size was 9 cm (range, 2.3 to 26.7 cm). Seventy-six percent experienced grade 3-4 hematologic toxicity. Twenty-four of the first 35 evaluable patients (69%; 95% CI, 41%-84%) were free of pulmonary metastasis at 2 years. A total of 82% (95% CI, 70%-95%) of patients were still alive after 3 years, with a median follow-up of 5.5 years (range, 3.4 to 7.6 y). A total of 58% (95% CI, 44%-76%) of patients remained progression free after 3 years. CONCLUSIONS: The addition of aerosol GM-CSF to combined chemotherapy, irradiation, and surgery for soft tissue sarcomas did not achieve the study endpoint to decrease the 2-year pulmonary metastasis rate.

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U2 - 10.1097/COC.0000000000000038

DO - 10.1097/COC.0000000000000038

M3 - Article

JO - American Journal of Clinical Oncology: Cancer Clinical Trials

JF - American Journal of Clinical Oncology: Cancer Clinical Trials

SN - 0277-3732

ER -