Abstract
16033 Background: Tyrosine kinase inhibitors (TKIs) improve progression free survival in both first line (sunitinib) and second line (sorafenib) treatment of metastatic renal cell carcinoma (mRCC). We performed a Retrospective Population based study to assess the impact of TKIs on overall survival (OS) in patients (pts) treated for mRCC in Alberta, Canada. Methods: 130 pts were identified who commenced either sorafenib, or sunitinib between December 2003 and June 2007 for mRCC at one of two referral cancer centres in Alberta. Survival was compared to that of an earlier cohort of 141 pts treated with Interferon α (IFN) at the same centres between May 1995 and March 2003. Data was collected enabling stratification into risk categories according to the MSKCC prognostic model. The primary endpoint was OS measured from date of commencement of TKI in the recent cohort, and IFN in the earlier cohort. The Kaplan Meier method was used to determine OS, with Cox Regression analysis used to determine hazard ratios (HR) and confidence intervals (CI). Results: Of the 130 pts treated with a TKI, 78 received treatment in the first line setting, whereas 52 received treatment after prior IFN therapy. All 141 pts from the IFN cohort received treatment in the 1st line setting. Patients treated on TKIs had an improved OS compared with the earlier IFN cohort with a HR of 0.621 (95% CI .45–.857, p=0.004). Median OS was 16.5 months and 10.2 months, respectively. There was no significant impact on OS based on whether the TKI was received after prior IFN therapy or in first line (HR .774, 95% CI .451–1.327, p=.351). Survival according to MSKCC risk groups is outlined in Table 1. Factors associated with improved survival on multivariate analysis were treatment with a TKI, time between diagnosis and treatment greater than 12 months, LDH ≤ 1.5 ULN, normal Hb, normal corr. Ca++ and Karnofsky PS ≥80%. Conclusions: TKIs improve OS compared with IFN in mRCC with significant benefits in favourable and intermediate risk groups. Risk Group No. pts TKI/IFN HR 95% CI P value Favourable 46/21 .311 .115-.84 .021 Intermediate 45/66 .559 .332-.94 .028 Poor 28/25 .814 .46-1.442 .559 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer, Pfizer Oncology Pfizer Oncology
Published Version
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