Adding Evofosfamide to Doxorubicin Fails to Improve OS in Sarcoma
Among patients with advanced soft tissue sarcoma, adding evofosfamide to doxorubicin failed to improve overall survival compared with doxorubicin alone.
Among patients with advanced soft tissue sarcoma, adding evofosfamide to doxorubicin failed to improve overall survival compared with doxorubicin alone, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
A single-arm study previously demonstrated that evofosfamide with doxorubicin may be associated with a longer overall survival versus ifosfamide plus doxorubicin among patients with advanced soft tissue sarcoma. Researchers therefore evaluated the efficacy and safety of evofosfamide and doxorubicin in a phase 3 clinical trial.
For the international, open-label study (ClinicalTrials.gov Identifier: NCT01440088), researchers enrolled 640 patients with locally-advanced, unresectable or metastatic soft tissue sarcoma. Of those, 36% had leiomyosarcoma, 17% had liposarcoma, and 12% had undifferentiated pleomorphic sarcoma. Participants were randomly assigned 1:1 to receive doxorubicin with or without evofosfamide.
Median overall survival was 18.4 months with the combination, versus 19.0 months with doxorubicin alone (hazard ratio [HR], 1.06; 95% CI, 0.88-1.29). It was found, however, that evofosfamide plus doxorubicin was significantly associated with a 77% higher odds of achieving a response (odds ratio [OR], 1.77; 95% CI, 1.20-2.58; P = .003).
Median progression-free survival was 6.3 months and 6.0 months with the combination and doxorubicin alone, respectively (HR, 0.85; 95% CI, 0.70-1.03; P = .099).
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The toxicity profile of evofosfamide and doxorubicin was consistent with previous reports. The most common grade 3-5 adverse events with evofosfamide were anemia, neutropenia, and leukoepenia, with 18% of patients experiencing febrile neutropenia vs 11% in the doxorubicin group.
- Tap W, Papai Z, Van Tine B, et al. Randomized phase 3, multicenter, open-label study comparing evofosfamide (Evo) in combination with doxorubicin (D) vs. D alone in patients (pts) with advanced soft tissue sarcoma (STS): Study TH-CR-406/SARC021. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.