In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e15044-e15044
Abstract:
e15044 Background: Everolimus (EVE, Afinitor) is approved for the treatment of metastatic renal cell cancer (mRCC) after failure of VEGF-targeted therapy. The option to treat mRCC with six approved targeted agents has sparked debate on proper sequencing of these agents. However, data beyond clinical trials is limited. Here, we report prospective non-interventional data on EVE in routine use after failure of the 1 st VEGFR-TKI. Methods: A prospective, single arm non-interventional study for patients with mRCC enrolled 383 patients in Germany between 08/2009 and 01/2012 to determine effectiveness defined as time between first EVE intake until disease progression due to any cause (TTP) and treatment duration. A first interim analysis was previously conducted and presented (Bergmann et al., J Clin Oncol 29: 2011 [suppl; abstr 4552]). Here we present a second interim analysis which was carried out 10 months after the first to corroborate the previous results. Results: 196 pts were included at 79 sites between 08/2009 and 07/2011 and had been followed for a median of 4.5 months at the time of analysis. The safety population (pts with information on EVE treatment) and efficacy population (pts who fulfilled all criteria per observational plan) consisted of 195 pts and 165 pts, respectively. At the cut-off date for the interim analysis, 136 pts (69%) had discontinued the study. Median treatment duration was 7.3 months (95% CI: 4.7 mo; 10.9 mo) and median time to progression (TTP) was 7.0 months (95% CI: 5.1 mo; 9.0 mo) for the efficacy population. A total of 600 AEs were reported in 70% of pts of the safety population including 148 SAEs in 67 pts (34%). Subgroup analysis according to duration of prior VEGF-targeted treatment 〈 6 months and ≥6 months revealed median TTPs of 6.8 months (95% CI: 4.4 mo; 13.4 mo) and 7.4 months (95% CI: 4.6 mo; 10.1 mo), respectively. Conclusions: This 2 nd interim analysis of a non-interventional study on EVE in treatment of mRCC after prior failure of the 1 st VEGFR-TKI confirms the longer TTP reported in the 1 st interim analysis compared to the pivotal trial. The results also provide evidence that TTP under EVE does not necessarily correlate with time on prior treatment.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.e15044
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
