Use of Recentin Helps Stabilize Rare Sarcoma Subset

The use of Recentin (cediranib) can play an important role in long-term disease control for patients with alveolar soft-part sarcoma, according to a study.

Alveolar soft-part sarcoma (ASPS) is a subset of soft-tissue sarcoma, in which tumors grow in the bones or soft tissue, including fat or muscle. This type of rare cancer is accounted for in less than 0.5% of all soft-tissue sarcomas, does not respond to chemotherapy and commonly occurs in people younger than age 30, as stated in the respective study.

Recentin inhibits the action of enzymes called tyrosine kinase. High levels of these enzymes may be present in cancer cells; however, blocking the enzymes prevents cancer cells from growing further.

In a study published in The Lancet, the authors stated that patients who receive a diagnosis of metastatic ASPS typically have a median survival rate of three years.

There was a total of 48 patients with ASPS who participated in the study and were randomly assigned across two groups. In the Recentin group, there were 32 patients and in the placebo group, there were 16 patients. At 24 weeks, 14 patients from the Recentin group and seven patients from the placebo group had stable disease. With this finding, the authors noted that patients most benefited from Recentin at 24 weeks.

Because of the nature of ASPS and its higher risk of recurrence, the authors’ primary endpoint (the main result that measures a treatment’s efficacy in a study) was how the use of Recentin alone made a significant difference with reducing tumor size and thus stabilizing the disease.

“This endpoint was considered a more reliable index of treatment effect than progression-free survival in light of known (slow) progression, spontaneous stabilization, and spontaneous regression in this disease,” said the study authors. “Additionally, this unconventional endpoint was considered more sensitive than progression-free survival and thus required fewer participants to show a significant difference between the two groups — an important consideration for a trial in such a rare disease.”

The median progression-free survival (PFS, the period during and after treatment of cancer when the disease does not get worse) for patients with ASPS was 10.1 months for patients in the Recentin group and 4.9 months for patients in the placebo group. Regarding overall survival (OS, the period from diagnosis or treatment where patients are still alive), the authors found that estimates at 12 months were 90.3% and 68.8% for patients in the Recentin and placebo groups, respectively.

The authors also monitored side effect in both groups during different phases of the study. During the masked (double-blind, meaning both patients and researchers were unaware of the treatment types that patients receive) portion of the study, common side effects in the Recentin group included high blood pressure and diarrhea. However, these side effects were managed when the dose was reduced. In the open-label (treatment type known by the patients and researchers) Recentin phase, 12 patients experienced side effects such as protein in urine, vomiting and dehydration when treated.

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