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Efficacy outcomes by age from 5 observational or phase-4 studies of bevacizumab (Bev) in metastatic colorectal cancer (mCRC)

Date

20 Dec 2015

Session

Gastrointestinal tumours 1

Presenters

Joleen Hubbard

Citation

Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523

Authors

J. Hubbard1, A. Grothey1, E. van Cutsem2, H. Hurwitz3, M.F. Kozloff4, T. Bekaii-Saab5, J. Bennouna6, Y. Zafar3, C. Revil7, N. Sommer8, S. Srock9, D. Arnold10

Author affiliations

  • 1 Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 2 Oncology, University Hospitals Leuven, Leuven/BE
  • 3 Medicine, Duke University Medical Center, Durham/US
  • 4 Medicine, Ingalls Hospital and University of Chicago, 60426 - Harvey/US
  • 5 Internal Medicine, The Ohio State University James Cancer Hospital, Columbus/US
  • 6 Oncology, Institut de Cancérologie de l'Ouest, 44805 - St. Herblain/FR
  • 7 Global Medical Affairs, Genentech, Inc, South San Francisco/US
  • 8 Medical Affairs, F. Hoffmann-La Roche, Ltd, Basel/CH
  • 9 Global Product Development, F. Hoffman-La Roche, Ltd, 4070 - Basel/CH
  • 10 Medical Oncology, Klinik fuer Tumorbiologie, 79106 - Freiburg/DE
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Abstract 1200

Aim/Background

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.

Methods

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.

Results

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.

Conclusions

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

Disclosure

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 Celgène. 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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