Résumé
Abstract only 509
Background: In the RECORD-1 study, only 22% of the mRCC patients (pts) received eve in pure 2
nd
line. Thus more data in real world are needed. A retrospective French survey, on a large patient population, was designed to evaluate efficacy for the sequence TKI-eve and/or TKI-eve-TKI in mRCC. Methods: Between 10/08 and 10/12, 164 mRCC pts from 26 french centers, who progressed on initial TKI and received eve as 2
nd
line were recorded. In these pts, 3
rd
line TKI was recorded. Primary endpoint was Duration of Treatment (DT) of each sequence. Secondary endpoints were best radiological response for eve evaluated by 2 independent radiologists, tolerability, dose reduction, overall survival from the start of first TKI (OS). Patients characteristics: Amongst 164 pts, 144 pts with follow-up > 4 months since initiation of eve were evaluated, 59/144 pts received TKI-eve-TKI. Before eve initiation: median age was 65 yrs, most pts were male (70.3%), had clear cell histology (92.3%), had received sunitinib as first TKI (94.4%). Main comorbidities were: hypertension (43.8%), diabetes (15.3%), and hypercholesterolemia (19.4%). At the time of eve initiation, MSKCC classification was good (24.4%), intermediate (61.5%) or poor (14.1%). Results: median DT of eve was 4 months and 21% pts were treated >9 months with 2.9% PR and 67.6% SD by central review. Correlation between response to first TKI and eve was observed. Dose reduction of eve for toxicity was 23.2%. The most common toxicities (all grades) were: stomatitis (25.3%), PNI (13%), fatigue (40.7%), hyperglycemia (9.3%), hypercholesterolemia (17.3%) and hypertriglyceridemia (22.8%). Median duration of TKI-eve sequence was 18 months (IC95%: 15-20), and OS was 36 months (IC95%: 27-56). For TKI-eve-TKI sequence (59 pts), sorafenib was mostly used (76.3%) with dose reduction and clinical benefit rate of 26.7% and 42.2% respectively. Median DT and OS were 24 and 41 months (IC95%: 19-29; 25-57) respectively. Conclusions: In real world experience, for mRCC pts receiving TKI-eve sequence, median DT of eve is 4 months with OS of 36 months which compares favorably with RECORD1 and RECORD 3 trials respectively.