Daniel J. George, MD
Findings from the phase III S-TRAC trial led to the FDA approval of sunitinib (Sutent) in November 2017 as an adjuvant therapy for patients with renal cell carcinoma (RCC) who are at high risk for recurrence. In a prospective study presented at the 2018 ASCO Annual Meeting, Daniel J. George, MD, reported on the disease-free survival (DFS) of patients at the highest risk of recurrence from S-TRAC.1
, George, professor of Medicine at Duke Cancer Center, discussed the analysis of RCC patients in the S-TRAC trial with the highest risk of recurrence, and potential prognostic factors of DFS that emerged from the study.
OncLive: Can you share some background on the rationale for the S-TRAC study?
S-TRAC was a phase III, prospective, multicenter study looking at the effectiveness of sunitinib versus placebo in patients at high risk for disease recurrence, particularly T3 or node-positive kidney cancer. In that prospective study, what we found [in the overall population] was that treatment with sunitinib for up to 1 year delayed DFS by about 24% with a hazard ratio of 0.76 and a P
value of .03. This was a 615-patient study.
As we enrich for patients at greater risk for disease recurrence, the benefit of sunitinib doesn't go away—if anything, it increases. To me, it reinforces that in our high-risk patients, particularly those T4 node-positive patients, we see a benefit. Even though those numbers are decreased, the statistical significance was sustained. That is really important.
What is the significance of these findings?
Clinically, when we are thinking about who to treat with sunitinib, we want to pick the patients who we think are most likely to benefit. By enriching for these highest-risk patients, we can focus further on the patients wo are most likely to benefit. When I see a patient in my clinic who has node-positive disease, T4 disease, or poor-performance status, that is going to be a patient who I am more inclined to offer sunitinib to, even if I think they might be on the fence medically. This means that they are older, or have other issues that question whether they can tolerate sunitinib for 1 year. That is a patient who I still want to have a conversation with, because there is a greater risk of them recurring and a greater benefit associated with that adjuvant therapy.
Were these findings expected?
[It was only expected in] that this is consistent with the overall population. We are not saying that this is the only subset that is benefitting—we are seeing the overall population benefit—but we are seeing an enrichment in the higher-risk patients. We're not pigeonholing the drug to only those patients, we are saying especially
in those patients.
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