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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 03/04/2008

Experimental Drug for Osteosarcoma Improves Overall Survival

Adapted from the NCI Cancer Bulletin.

Patients with osteosarcoma who received the experimental drug mifamurtide (L-MTP-PE) along with chemotherapy fared better than patients who received chemotherapy alone, according to the Feb. 1, 2008, Journal of Clinical Oncology (see the journal abstract). Osteosarcoma is a rare but often fatal cancer of the bone. The disease typically affects children and young adults, and no new therapies have been introduced in two decades.

The study - conducted by the Children's Oncology Group - was the largest final-stage randomized trial in this disease and included 662 patients with newly diagnosed nonmetastatic osteosarcoma.

After six years of follow-up, overall survival was 78 percent in the group receiving mifamurtide plus chemotherapy compared with 70 percent in the group receiving chemotherapy alone. "This is an almost one-third reduction in the risk of death," write Dr. Paul A. Meyers of the Memorial Sloan-Kettering Cancer Center and his colleagues.

A second goal of the National Cancer Institute-sponsored study was to evaluate the addition of ifosfamide to the three chemotherapy drugs used in the study (cisplatin, doxorubicin, and methotrexate). Adding this agent did not enhance event-free survival or overall survival for patients in the trial.

As an experimental agent, mifamurtide is available only through clinical trials. In 2006, its manufacturer, IDM Pharma, sought approval for its use in treating osteosarcoma from the U.S. Food and Drug Administration, but the agency requested more information. The company plans to submit new data showing an overall survival benefit in the disease this year.