The S-TRAC study reported that adjuvant therapy of renal-cell carcinoma (RCC) with sunitinib after nephrectomy had not improved the overall survival rate. However, distant disease recurrence was decreased with the therapy, and a rate of disease-free survival was increased. The study was reported in European Urology.
The researchers did not find a significant difference in mortality rate after a median follow-up of 6.6 years. Approximately 22% of sunitinib recipients died whereas 24% of the placebo recipients died. However, 32% of sunitinib patients developed distant disease whereas 40% of placebo recipients developed the distant disease.
Previous results, published in The New England Journal of Medicine reported that median disease-free survival was 6.8 years with sunitinib and 5.6 years without sunitinib.
In the 2016 ASSURE study survival benefit was not found and the disease-free survival rate was not increased in 649 volunteers who got sunitinib therapy. The researchers said differences in the two studies might explain the disparity.
The present study involved 615 patients treated at 97 sites in Europe, Asia, and the Americas. Sunitinib was given on a 4-weeks-on and 2-weeks-off schedule, for eight months and 56% of participants received a full year of treatment.
Patients aged <45 years and >64 years and patients with normal body weight showed better disease-free survival with the sunitinib therapy. Better responses were seen when the neutrophil-to-lymphocyte ratio was three or lower; Eastern Cooperative Oncology Group performance status was zero and Fuhrman grade score was three or four.
Among all, because of side effects, 28% of sunitinib recipients discontinued treatment while relapses accounted for 7.2%. However, 5.9% of placebo recipients discontinued therapy due to side effects and 19% because of relapse.
The researchers said supportive care and a dose reduction or interruption managed toxicities associated with adjuvant sunitinib. However, still, an improvement in the management of some side effects in the adjuvant setting needed.
Sunitinib is a potential new option for adjuvant therapy in renal cell carcinoma with increase in disease-free survival and the manageable safety profile.