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
AU - Petersen, Ivy
AU - Shives, Thomas
AU - Mahoney, Michelle
AU - Haddock, Michael
AU - Sim, Franklin
AU - O'Connor, Mary I.
AU - Markovic, Svetomir N.
AU - Maples, William
N1 - Publisher Copyright:
© 2016 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Adjuvant
KW - Chemotherapy
KW - GM-CSF
KW - Radiation
KW - Sarcoma
KW - Surgery
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U2 - 10.1097/COC.0000000000000038
DO - 10.1097/COC.0000000000000038
M3 - Article
C2 - 24487418
AN - SCOPUS:84893165391
SN - 0277-3732
VL - 39
SP - 204
EP - 209
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 2
ER -