1 / 18

Abstract

Benefits and adverse events in younger (age <50) vs older patients receiving adjuvant chemotherapy for colon cancer: Findings from the 33,574 patient ACCENT dataset.

emma-hinton
Télécharger la présentation

Abstract

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Benefits and adverse events in younger (age <50) vs older patients receiving adjuvant chemotherapy for colon cancer: Findings from the 33,574 patient ACCENT dataset Daniel Sargent, Greg Yothers, Erin Green, Charles Blanke, Michael O’Connell, R Labianca, Archie Bleyer, A DeGramont, and David Thomas as a joint project of the LIVESTRONG Young Adult Alliance and the ACCENT collaborative group

  2. Abstract Background Limited data exists regarding outcomes and AT benefit/toxicity in Y pts with stage II and III CC. We examined overall survival (OS), disease free survival (DFS), recurrence free interval (RFI) and AEs in the 33,574 pt ACCENT dataset. Methods Individual pt data from 24 randomized Phase III clinical trials (CT) was obtained for survival outcomes, and 10 CT for AE outcomes. Two age-based cut-offs were used to define Y pts, age < 40 and < 50. Cox models stratified by study and adjusted for gender and stage. AT benefit analyses were limited to 9 CT testing 5-FU/LV or Lev vs control (7 CT) or oxaliplatin+5-FU/LV vs 5-FU/LV (2 CT). Results 1758 (5.2%) pts were age < 40; 5817 (17.3%) were < 50; only 299 (0.9%) were age < 30. No differences in gender or stage were present in Y vs older pts. Y and older pts did not differ in RFI (HR=1.02 for each age cutpoint, p>0.35). Y pts had improved OS and DFS (Table), even when restricting to age < 50 vs 50-60 (HR = 1.08, p=0.0061 for DFS comparing < 50 to 50-59). In trials demonstrating AT benefit, similar benefit was observed in Y and older pts (DFS HR for AT benefit 0.66 for pts < 50, 0.76 for pts >50, interaction p=0.19). No clinically meaningful differences in AEs were observed between ages. Conclusions Among pts on CT, Y (age 30-50) stage II and III CC pts had similar RFI and AT benefit as older pts, with no clinically meaningful differences in AEs. Y pts have improved OS and DFS, likely primarily due to to fewer competing causes of death. Adjuvant therapy is beneficial for CC pts aged 30-50 meeting typical CT eligibility criteria.

  3. ACCENT • Initially established in 2003, to validate disease-free survival (DFS) as an endpoint in adjuvant colon cancer • Individual patient data from 24 large adjuvant randomized clinical trails, 33,574 patients • Jointly owned by all contributors

  4. Methods • Analyses of individual patient data • Endpoints: • Primary: Disease Free Survival (PFS) • Secondary: Overall Survival (OS), grade ≥ 3 adverse events (AE) • Cox regression models adjusted by age and gender, stratified by study: • Effect of age with cut points of < 40 and < 50 • Age-by-treatment interaction to assess relative benefit in 9 trials that demonstrated adjuvant therapy benefit

  5. ACCENT: Trials included *Trials included in adjuvant therapy benefit analysis

  6. Baseline Characteristics by Age

  7. Disease Free SurvivalAll Studies, Age Cutoff - 40

  8. Disease Free SurvivalAll Studies, Age Cutoff - 50

  9. Time to Recurrence & Overall SurvivalAll Studies, Age Cutoff - 40

  10. Time to Recurrence & Overall SurvivalAll Studies, Age Cutoff - 50

  11. DFS: Experimental vs Control 9 Studies w/ Treatment Benefit Age < 40 Age > 40 Interaction p-value = 0.78

  12. DFS: Experimental vs Control 9 Studies w/ Treatment Benefit Age < 50 Age > 50 Interaction p-value = 0.19

  13. OS: Experimental vs Control 9 Studies w/ Treatment Benefit Age < 40 Age > 40 Interaction p-value = 0.49

  14. OS: Experimental vs Control 9 Studies w/ Treatment Benefit Age < 50 Age > 50 Interaction p-value = 0.97

  15. Adverse Events by Age

  16. Discussion • Even restricting comparison to patients < 50 vs 50-60, p = 0.0061 (HR=1.08) for improved DFS for < 50 • Detailed data on dosing not available

  17. Conclusions • Among patients on clinical trials, younger (age 30-50) stage II and III colon cancer pts had similar adjuvant therapy benefit as older patients • No clinically meaningful differences in AEs were present between age groups • Younger pts have improved OS and DFS, likely primarily due to fewer competing causes of death • Adjuvant therapy is beneficial for colon cancer patients aged 30-50 meeting typical clinical trials eligibility criteria

  18. ACCENT collaborators S Wieand, G Yothers, M O’Connell, N Wolmark – NSABP J Benedetti, C Blanke – SWOG R Labianca – Ospedali Riuniti (Italy) D Haller, P Catalano, A Benson – ECOG C O’Callaghan – NCIC JF Seitz – University of the Mediterranean (France) G Francini – University of Siena (Italy) A de Gramont, T Andre – GERCOR R Goldberg, L Saltz, J Meyerhardt, N Jackson – CALGB M Buyse – IDDI (Belgium) R Gray, D Kerr – QUASAR A Grothey, S Alberts, B Bot, E Green, Q Shi –Mayo Clinic C Twelves -University of Bradford (UK) J Cassidy – University of Glasgow (UK) F Sirzen – Roche ; L Cisar - Pfizer E Van Cutsem –University Hospital Gasthuisberg (Belgium); A Sobrero - Ospedale San Martino (Italy)

More Related