According to a new study, topotecan and Nexavar (generic Sorafenib) when combined, and there after used as a maintenance therapy has significantly improve the survival outcomes in women who are suffering from platinum-resistant ovarian cancer.
According to a study, led by Radoslav Chekerov, MD, of Charité–Universitätsmedizin Berlin, Germany, particularly poor prognosis was represented in a population where the disease relapses within 6 months of completing the platinum therapy, which is classified as a platinum-refractory or platinum-resistant ovarian cancer. And data from previous researches has proved that angiogenesis inhibition could be effective in this setting.
A total of 174 women suffering from platinum resistant ovarian cancer were recruited in the new TRIAS trial. The patients were to receive either placebo + topotecan or sorafenib + topotecan. Among the 174 women, 85 were given sorafenib + topotecan and 89 were given placebo + topotecan. The completion of 6 cycles, patients were to received either sorafenib or placebo for next 1 year as a maintenance therapy.
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In the pool of patients, characteristics of the patients in the group were well balanced. Majority of the patients has had an ECOG performance score of either 0 or 1 and one or two prior chemotherapy lines.
The mean progression free survival (PFS) for sorafenib using patients was significantly higher than placebo using patients. The median was 3.7 months for placebo group and almost double for sorafenib group i.e. 6.7 months. After the completion of chemotherapy sessions, 38% of placebo group received a median of 1.4 months of maintenance treatment as compared to 42% of sorafenib group receiving a median of 1.6 months of maintenance treatment.
The authors of the study believed that PFS is a very meaning full outcome as most of the death that occurred during the trial was due to the fact that the disease was progressing. Due to the use of sorafenib, the overall survival has also improved. Placebo group had a median overall survival of 10.1 months as compared to 17.1 months of overall survival in sorafenib group.
With the help of multivariate analysis, it was observed that sorafenib treatment and International Federation of Gynaecology (FIGO) stage were the main forecaster of Progression free survival (PFS), and in case of Overall survival (OS), the main forecasters were sorafenib treatment, FIGO stage and patient's age.
The frequency of serious hostile events was similar for both sorafenib and placebo group with 51% in placebo and 59% in sorafenib. Most common hostile events were abdominal pain (10% in sorafenib and 5% in placebo), neutropenia (7% in sorafenib and 3% in placebo) and, dyspnea (7% in sorafenib and 4% in placebo). Grade 3 events like hand-foot skin reaction, Leukopenia, and other dermatologic symptoms were more likely to occur in sorafenib group than the placebo group. According to Radoslav Chekerov, TRIAS study is the only study that proves improvement in both Progression free survival and Overall survival for platinum ovarian cancer patients. Above findings can further support for the effect of antiangiogenic agents in ovarian cancer and further investigation into platinum-resistant ovarian cancer.
The only strength available for Nexavar is Nexavar 200 mg.
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