Potential ‘risk of harm’ for older women with adjuvant sunitinib for RCC
medwireNews: Adjuvant treatment with sunitinib may be associated with an increased mortality risk for older female patients with renal cell carcinoma (RCC), suggests a post-hoc analysis of the ASSURE trial that compared sunitinib and sorafenib with placebo.
As reported in Cancer, sunitinib-treated women who were older than 56 years of age had a significant 2.21-fold worse overall survival (OS) relative to placebo, whereas no such relationship was observed for women aged 56 years or younger or men in either age group.
A similar pattern was observed for disease-free survival (DFS) among older women (hazard ratio=1.41), but the finding did not reach statistical significance, and age and sex did not appear to modify the outcomes of sorafenib treatment.
These results therefore show that “certain groups of patients, such as older women, may be at risk of harm with adjuvant sunitinib,” say Ronac Mamtani (University of Pennsylvania, Philadelphia, USA) and co-researchers.
The team stresses the need for further research, noting that adjuvant sunitinib was recently approved for high-risk patients by the US FDA “in a controversial decision” based on improved DFS in the S-TRAC trial, even though a previous analysis of ASSURE found no significant improvement in either OS or DFS with sunitinib or sorafenib.
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