First line sunitinib in metastatic RCC top everolimus
By Lynda Williams, Senior medwireNews Reporter
Results for the RECORD-3 trial support, strategy current first-line sunitinib followed by second line of everolimus for the treatment of patients with metastatic renal cell carcinoma (mRCC).
As explained in Journal of Clinical Oncology , the phase II study researchers have hypothesized that the first line everolimus sunitinib followed by the second line at the first sign of disease progression would be better tolerated than the opposite and would therefore offer patients a better progression-free survival (PFS).
However, the median PFS in early second-line treatment was significantly lower for the 238 patients who were randomly assigned to receive primary everolimus for the 233 patients who received first-line sunitinib, 7.9 against 10.7 months with a hazard ratio (HR) of 1.4
the HR exceeds the preset value of 1.1 for the primary endpoint. the upper limit of the range of a side confidence 0% was 1.64, beyond the predefined margin of 1.27.
Thus, the study did not demonstrate non-inferiority to everolimus first line from the first line sunitinib, say Robert Motzer, of Memorial Sloan Kettering Cancer Center in New York, USA and co-authors.
"These clinically relevant differences support the standard processing sequence, so that patients suffering from progression (or intolerant) first-line sunitinib are then treated with everolimus" they write .
Overall, 45% of patients who received everolimus first line switched to a second-line treatment, and 43% of those given in first line sunitinib.
The combined median PFS was 21.1 months for patients who received everolimus and sunitinib first line second line compared to 25.8 months for the first-line sunitinib followed by the second line everolimus; the difference was not significant.
The median overall survival was 22.4 months for the first line and second line everolimus and sunitinib 32.0 months for the first-line sunitinib and everolimus second line, and once again the difference between the arm treatment reached statistical significance.
patients in the everolimus first line and first-line sunitinib group reported similar side effects with stomatitis (53 and 57%), fatigue (45 and 51%) and diarrhea ( 38 and 57%), the most common.
"observes [adverse events] were consistent with the known safety profile of everolimus and sunitinib and differentiated by mTOR [mammalian target of rapamycin] respective inhibitor and VEGFR [vascular endothelial growth factor receptor] tyrosine kinase inhibitor class," Motzer and the team observed
They conclude: ".. the test results support the standard treatment paradigm frontline sunitinib followed by everolimus progression"
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