PURPOSE: To identify sunitinib alternative schedules (AS) that maintained dose intensity while decreasing adverse events (AEs) in patients with metastatic renal cell cancer (mRCC), and to determine impact of AS on clinical outcomes.
PATIENTS AND METHODS: A retrospective review of patients ≥ 18 yr of age with clear-cell mRCC who received first-line sunitinib between 1/26/06 and 3/1/11 at a major Comprehensive Cancer Center. Subset of patients switched at first intolerable AE from traditional schedule (28 d on, 14 d off; TS) to 14 d on/7 d off schedule or other AS. Control group underwent standard dose reduction. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method. Predictors of PFS and OS were analyzed using Cox regression.
RESULTS: One hundred eighty five patients were included for analysis; 87% were on TS at baseline. During treatment, 53% of patients continued TS and 47% initiated or transitioned to AS. Baseline characteristics were similar. AEs prompting schedule modification included fatigue (64%), hand-foot syndrome (38%) and diarrhea (32%). Median time to AS was 5.6 mo. Median OS was 17.7 mo (95% confidence interval [CI], 10.8-22.2) on TS compared to 33.0 mo (95% CI, 29.3- not estimable) on AS (P < 0.0001). By multivariable analysis; poor ECOG PS, increased LDH, decreased albumin, unfavorable Heng criteria, and TS are associated with decreased OS (P < 0.05).
CONCLUSION: Sunitinib administered on AS may mitigate AEs and has comparable outcomes as TS for mRCC patients. Prospective investigations of alternate dosing schemas are warranted.
Written by:
Atkinson BJ, Kalra S, Wang X, Bathala T, Corn P, Tannir NM, Jonasch E. Are you the author?
University of Texas M. D. Anderson Cancer Center, Department of Pharmacy Clinical Programs, Houston, TX, USA.
Reference: J Urol. 2013 Sep 6. pii: S0022-5347(13)05338-X.
doi: 10.1016/j.juro.2013.08.090
PubMed Abstract
PMID: 24018239
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