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.