Overall survival (OS) results from a pooled dataset of 7688 patients (pts) with mCRC treated with Bev in 5 prospective phase-4 or observational studies (ARIES [USA], NIS [Germany], BEAT [ex-USA], BRiTE [USA], and CONCERT [France]) were consistent with those reported in randomized trials of Bev in first-line mCRC (Grothey, Ann Oncol;25[suppl 4]:520P). Because published data on treatment of elderly pts are limited, we present herein pooled efficacy outcomes by age.
The regimen and dose of first-line Bev with chemotherapy were administered to pts at the discretion of the treating physician. Quartiles and Kaplan-Meier estimates at given timepoints with corresponding 95% confidence intervals (CIs) were provided for progression-free survival (PFS) and OS by 5-year (y) pt age groups and descriptive statistics for baseline (BL) characteristics. The 5-y age grouping was selected as the minimum age grouping providing sufficient pts per subgroup.
Most pts (range, 81.5–96.8%) within each 5-y age group had a BL Eastern Oncology Cooperative Oncology Group (ECOG) status of ≤1, with a trend towards higher BL ECOG in the elderly pts. Median PFS and OS outcomes by age groups are shown in the table. Among age groups between 20 to <90 y, median PFS and OS outcomes ranged from 8.3–10.9 and 16.7–25.2 months, respectively.
Among pts receiving first-line Bev and chemotherapy in phase-4 or observational trials for mCRC, PFS was mostly consistent across all age groups, including those between 80 and <90 y. OS was consistent among pts aged 30 to <70 y, with a numerical decline observed in age groups >80 y. Conclusions could not be drawn from age extremes (<20 and >90 y) due to low pt numbers. Results of this pooled analysis suggest bevacizumab efficacy is consistent across most age groups, a finding that aligns with results for elderly pts in the randomized trial AVEX (Cunningham D, et al. Lancet Oncol. 2013).
Median PFS and OS Outcomes by Age
|Age group, y||PFS pts, n||Median PFS (95% CI), mo||OS pts, n||Median OS (95% CI), mo|
|20– <25||13||8.3 (3.0; 14.3)||13||19.0 (10.4; 35.3)|
|25– <30||31||10.0 (6.5; 13.6)||30||18.7 (14.4; 22.7)|
|30– <35||90||9.0 (7.7; 12.1)||90||22.6 (15.2; 26.9)|
|35– <40||169||10.5 (8.5; 11.6)||166||22.1 (17.7; 26.8)|
|40– <45||342||9.9 (8.8; 11.0)||339||22.9 (19.2; 25.1)|
|45– <50||519||9.9 (9.0; 10.7)||514||24.8 (21.9; 27.5)|
|50– <55||862||10.6 (9.8; 11.2)||854||24.5 (22.6; 26.3)|
|55– <60||1140||10.7 (10.2; 11.3)||1133||23.0 (21.8; 25.0)|
|60– <65||1210||10.9 (10.4; 11.7)||1204||25.2 (23.8; 27.0)|
|65– <70||1274||10.8 (10.4; 11.4)||1272||22.7 (21.8; 24.4)|
|70– <75||1015||10.6 (9.9; 11.1)||653||22.1 (20.3; 23.8)|
|75– <80||647||10.0 (9.5; 10.5)||640||19.9 (18.2; 21.0)|
|80– <85||300||9.5 (8.5; 10.2)||296||17.0 (15.5; 18.7)|
|85– <90||67||10.2 (7.8; 11.5)||67||16.7 (11.5; 19.6)|
Clinical trial identification
ARIES: NCT00388206; BRiTE: NCT00862342; BEAT: MO18024; NIS: ML18664 (German registry); CONCERT: ML21696
J. Hubbard: research funding (to Mayo Clinic) from Genentech. A. Grothey: consulting/advisory role: Genentech, F. Hoffmann-La Roche, Bayer, Sanofi, Bristol-Myers Squibb, Eli-Lilly, Boston Biomedicals, Amgen; research funding: Genentech, F. Hoffmann-La Roche, Bayer, Pfizer, Eisai, Eli-Lilly, Boston Biomedicals. E. Van Cutsem: research grants: F. Hoffmann-La Roche. H. Hurwitz: consultant to and research support from: Genentech, F. Hoffmann-La Roche, Pfizer, Sanofi, Regeneron, Bristol-Myers Squibb, Eli Lilly, Merck KGA, Novartis, Incyte, GSK, and Threshold. M.F. Kozloff: consultant and speakers' bureau: Genentech, F. Hoffmann-La Roche. T. Bekaii-Saab: consultant: Genentech and F. Hoffmann-La Roche. J. Bennouna: Advisory board: Roche, Boehringer-Ingelheim, Novartis, and CelgÃ¨ne. Y. Zafar: travel support: GNE/Roche; employment (spouse): Novartis. C. Revil, S. Srock: employment and stock ownership: F. Hoffmann-La Roche. N. Sommer: employment: Genentech; stock ownership: F. Hoffman-La Roche. D. Arnold: compensation for advisory board and lectures: F. Hoffmann-La Roche, Merck Serono, Amgen, Bayer; compensation for lectures: Terumo, Sirtex, and Sanofi.
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