TUESDAY, Nov. 8 (HealthDay News) -- Ridaforolimus treatment is associated with promising clinical benefit response (CBR) and progression-free survival (PFS) for patients with advanced sarcomas, according to a study published online Nov. 7 in the Journal of Clinical Oncology.
Sant P. Chawla, M.D., from the Sarcoma Oncology Center in Santa Monica, Calif., and colleagues assessed the antitumor activity of ridaforolimus in 212 patients with metastatic or unresectable soft tissue or bone sarcomas. The participants of this phase II study received a 30-minute intravenous infusion of ridaforolimus 12.5 mg once daily for five days every two weeks. The primary end point was CBR rate. The participants were also evaluated for safety, PFS, overall survival (OS), time to progression, and duration of response.
The investigators found that 28.8 percent of the patients achieved CBR. The median PFS and OS were 15.3 and 40 weeks, respectively. Four patients (two with osteosarcoma, one with spindle cell sarcoma, and one with malignant fibrous histiocytoma) achieved confirmed partial response. This gave a Response Evaluation Criteria in Solid Tumors-confirmed response rate of 1.9 percent. No correlation was observed between archival tumor protein markers and CBR. Related adverse events included stomatitis, mucosal inflammation, mouth ulceration, rash, and fatigue, and were mainly mild or moderate.
"The results of this phase II trial demonstrate that ridaforolimus is associated with clinical benefit for patients with advanced sarcomas of several histopathologic subtypes," the authors write.
Several study authors disclosed financial relationships with pharmaceutical companies, including ARIAD pharmaceuticals, which funded the study and manufactures ridaforolimus.
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