Combining trabectedin with doxorubicin as first-line treatment for metastatic leiomyosarcoma nearly doubled the time to progression compared with doxorubicin alone, and later showed a survival benefit, making it the first combination to beat single-agent doxorubicin in a sarcoma subtype.
Phase 3 trial of 150 patients with metastatic or unresectable uterine or soft tissue leiomyosarcoma randomised to six cycles of doxorubicin alone or doxorubicin plus trabectedin followed by trabectedin maintenance, with surgery of residual disease allowed.
Median progression-free survival was 12.2 versus 6.2 months (hazard ratio 0.41) and response 36 versus 13 percent; the final analysis showed median overall survival of 33 versus 24 months. Grade 3 to 4 haematological toxicity was much higher with the combination.
Doxorubicin-trabectedin is a first-line standard for fit patients with metastatic leiomyosarcoma, one of the few histology-specific first-line regimens in sarcoma.
Shares LMS-04, Retroperitoneal sarcoma, Leiomyosarcoma, Soft tissue sarcoma of the extremity (localised and advanced).
Shares Leiomyosarcoma, Soft tissue sarcoma of the extremity (localised and advanced), The Lancet Oncology, Doxorubicin.
Shares Trabectedin, Leiomyosarcoma.
Shares Retroperitoneal sarcoma, Leiomyosarcoma, Soft tissue sarcoma of the extremity (localised and advanced).
Shares Trabectedin, Soft tissue sarcoma of the extremity (localised and advanced).
Shares Retroperitoneal sarcoma, Leiomyosarcoma.
Shares Soft tissue sarcoma of the extremity (localised and advanced), The Lancet Oncology.