Gemcitabine plus docetaxel was associated with a nonsignificant lower hospitalization rate compared with doxorubicin plus ifosfamide in patients with localized, high grade soft tissue sarcoma, a study published this month in the European Journal of Cancer has shown.1
The American Cancer Society estimates about 11,930 new soft tissue sarcomas will be diagnosed in the United States in 2015 and approximately 4,870 Americans will die from the disease.
Because doxorubicin plus ifosfamide, a standard therapy for patients with high-risk soft tissue sarcoma, often causes severe toxicities resulting in hospitalization, researchers sought to determine whether gemcitabine plus docetaxel would be better tolerated.
For the open-label, phase 2 study, researchers enrolled 80 patients with localized, resectable, high grade soft tissue sarcoma and randomly assigned them to receive neo/adjuvant doxorubicin 75 mg/m2 plus ifosfamide 2.5 g/m2/day on days 1 to 3 with mesna 500 mg/m2/dose or gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8. All patients received filgrastim as well.
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Results showed that the hospitalization rate was 35% in the doxorubicin plus ifosfamide arm and 26% in the gemcitabine plus docetaxel arm (P = .25).
In regard to efficacy, the 2-year disease-free survival was 57% with doxorubicin and ifosfamide and 74% with gemcitabine plus docetaxel. The median disease-free survival was 37 months and not yet reached, respectively.
The findings suggest that gemcitabine plus docetaxel warrants further study in patients with localized, resectable, high grade soft tissue sarcoma.
- Davis EJ, Chugh R, Zhao L, et al. A randomised, open-label, phase II study of neo/adjuvant doxorubicin and ifosfamide versus gemcitabine and docetaxel in patients with localised, high-risk, soft tissue sarcoma. Eur J Cancer. 2015;51(13):1794-1802.