Comparative effectiveness of everolimus (EVE) and axitinib (AXI) for second-line treatment of metastatic renal cell carcinoma (mRCC) in the United States: A retrospective chart review.
500 Background: EVE and AXI are approved as 2nd-line TTs for mRCC. This study compares OS and PFS among mRCC patients treated with EVE and AXI following 1st TKI. The extent to which the duration of 1st TKI can inform optimal selection of a 2nd-line TT is of interest. Methods: A retrospective patient chart review study was conducted. Medical oncologists or hematologists/oncologists who treated ≥3 mRCC patients in the past year were recruited from a national panel. Patient eligibility criteria included: 1) aged ≥18 years; 2) initiated and discontinued 1st TKI (sunitinib or pazopanib) for medical reasons; 3) initiated 2nd TT between 2/1/2012 and 1/31/2013. OS was defined as time from initiation of 2nd TT to death. PFS was defined as time from initiation of 2nd TT to physician/chart reported progression or death, whichever occurred first. Multivariable Cox proportional hazards models were used to estimate the hazard ratio (HR) for OS and PFS between EVE and AXI, adjusting for age, gender, type and duration of 1st TKI, response to 1st TKI, duration of mRCC at 2nd TT, disease profile, performance status, sites of metastases, and years of physician practice. Comparative effectiveness was also analyzed by the type and duration (<6, 6-12, >12 months) of 1st TKI. Results: A total of 298 and 122 patients received 2nd TT with EVE and AXI. After adjusting for baseline characteristics, there was no statistically significant difference between EVE and AXI in OS [HR (95% CI): 1.10 (0.69-1.75)] or PFS [HR (95% CI): 1.12 (0.81-1.54)]. When stratified by subgroups defined by type and duration of 1st TKI, there was no statistically significant difference in OS between EVE and AXI in all subgroups, except for patients with <6 months on sunitinib as 1st TKI in which AXI had longer OS (HR =3.95). There was no statistically significant difference in PFS between EVE and AXI in all subgroups. Conclusions: In this large, retrospective chart review study, there was no significant difference in OS or PFS between EVE and AXI. Subgroup analyses stratified by duration of 1st TKI did not suggest that longer duration of 1st TKI was associated with better efficacy for 2nd-line AXI vs. EVE.