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

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Purpose: To determine if aerosol granulocyte macrophage-colonystimulating 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)
Pages (from-to)204-209
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume39
Issue number2
DOIs
StatePublished - Jan 1 2016

Keywords

  • Adjuvant
  • Chemotherapy
  • GM-CSF
  • Radiation
  • Sarcoma
  • Surgery

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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