Correction: Lilly Presents Data on Cixutumumab in Five Subtypes o... (oft tissue sarcoma and Ewing family of t...)

Correction: Lilly Presents Data on Cixutumumab in Five Subtypes of Sarcomas

Date:5/27/2011

oft tissue sarcoma and Ewing family of tumors who were treated with cixutumumab. It used the Simon optimal two-stage design, a widely accepted method for determining the sample size in Phase II clinical trials,(4) in which a pre-determined number of patients are treated in the trial's first stage; the trial is then halted and the response rate assessed. If a pre-specified minimal response rate has not been achieved, it is determined that the treatment is not worth pursuing and the trial is ended. Otherwise, the trial proceeds to a second stage, which continues until a pre-determined number of patients are enrolled.

The five tiers evaluated included: those with previously treated, advanced or metastatic rhabdomyosarcoma (tumors in muscles attached to bones); leiomyosarcoma (rare cancerous tumor of the smooth muscle cells); adipocytic sarcoma (rare tumor that develops from fat cells); synovial sarcoma (malignant tumor that develops in the synovial membrane of the joint); and Ewing sarcoma/peripheral primitive neuroectodermal tumor (tumor that forms in bone or soft tissue). Patients received cixutumumab 10 mg/kg intravenously over one hour every other week until disease progression or discontinuation for other reasons.

Patients were assessed at the completion of stage one (12 weeks). Stable disease was seen in 57 percent (n=21) of patients with adipocytic sarcoma and one (n=1) partial response (decrease in the size of a tumor) was seen with this tumor type. The study continued into stage two for the adipocytic sarcoma tier, which was fully enrolled (37 patients total). By contrast, treatment for four of the tiers (rhabdomyosarcoma; leiomyosarcoma; synovial sarcoma and Ewing sarcoma/peripheral primitive neuroectodermal tumor) was ended at the completion of stage one because the pre-specified response rate threshold was not met. The best overall responses were as follows: one partial respon
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