Hand-foot syndrome (HFS) and asthenia/fatigue (A/F) as biomarkers of sunitinib efficacy in Chinese patients (pts) with metastatic renal cell carcinoma (mRCC).

e15622 Background: In an open-label phase IV study of sunitinib as 1st-line treatment (Tx) in Chinese pts with mRCC, median progression-free survival (PFS) and overall survival (OS) were 61.7 and 133.4 wk, respectively; objective response rate (ORR) was 31.1% (Ann Oncol 2012;23:851P). We retrospectively investigated correlations between on-Tx HFS or A/F and efficacy endpoints in pts from this trial. Methods: AEs were recorded and graded using NCI CTCAE v3. Median PFS and OS were estimated by Kaplan−Meier method. The log-rank test was used to compare PFS and OS between groups with and without HFS or A/F. Fisher’s exact test was used for ORR. Multivariate and time-dependent covariate analyses were conducted to assess the influence of various prognostic factors on the association between AEs and efficacy and to address potential bias from longer drug exposure, respectively. Landmark analyses were used to compare outcomes in pts with and without HFS or A/F after 6 and 12 wk of Tx. Results: Of 103 pts included...