Abstract 493P
Background
Median ages at CRC diagnosis and death are 67 and 72 years, respectively. Older patients (pts) are underrepresented in clinical trials and often undertreated in daily practice. Here, we report the impact of age on effectiveness, quality of life (QoL) and safety of aflibercept plus FOLFIRI in mCRC pts previously treated with an oxaliplatin-containing regimen.
Methods
QoLiTrap was a large international, non-interventional study. The primary endpoint was QoL assessed by EORTC QLQ-C30. Secondary endpoints included overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and safety. Effectiveness was analyzed in pts with a QoL scale available at baseline and ≥2 post-baseline. Safety was analyzed in all pts exposed to study drug.
Results
1277 pts were treated with FOLFIRI plus aflibercept (males: 64.8%; right colon tumor: 27.6%; liver metastasis: 53.2%; RAS mutant: 50.7%; ECOG 0-1: 84.7%; age <60 years, n=327; 60-64, n=231; 65-69, n=227; 70-74, n=259; ≥75, n=233). Aflibercept was mainly given in 2nd-line (50.3%). Median duration of therapy was 12 weeks. 872 pts were evaluable for effectiveness analysis. At baseline, the mean global health score (GHS) was 58.7. Key results by age class are provided in the table below. Main grade ≥3 adverse events (AEs) were hypertension (9.2%), diarrhea (6.7%), general physical health deterioration (4.9%), decreased white blood cell count (3.4%) and stomatitis (3.9%). Table: 493P
| Age (years) | ||||||
| <60 | 60-64 | 65-69 | 70-74 | ≥75 | Overall | |
| GHS* Mean change (95% CI) | -5.2 (-10.6 to 0.2) | -2.0 (-10.5 to 6.5) | -3.0 (-10.9 to 4.9) | -8.0 (-13.7 to -2.3) | -4.3 (-11.7 to 3.1) | -4.6 (-7.7 to -1.6) |
| ORR | 21% | 24% | 22% | 22% | 24% | 22% |
| PFS† Median (95% CI) | 8.8 (7.5-10.6) | 8.1 (7.0-11.6) | 9.0 (7.7-11.8) | 9.5 (7.8-12.6) | 7.7 (6.3-9.6) | 8.8 (8.0-9.4) |
| OS† Median (95% CI) | 19.4 (14.3-NR$) | 31.6 (12.5-36.3) | 18.1 (12.2-27.0) | 20.6 (14.4-33.7) | 10.8 (9.0-14.7) | 19.5 (14.4-23.6) |
| Pts with AE Grade ≥1, % | 81.0 | 82.3 | 83.3 | 83.4 | 84.1 | 82.7 |
| Pts with AE Grade ≥3, % | 47.7 | 51.9 | 51.5 | 55.2 | 55.8 | 52.2 |
*% Change from baseline to week 12; †months; $not reached
Conclusions
FOLFIRI plus aflibercept administered in daily practice is associated with an acceptable QoL and retains its activity regardless of age. Safety profile was manageable regardless of age.
Clinical trial identification
AIO Arbeitsgemeinschaft Internistische Onkologie (AIO-LQ-0113).
Editorial acknowledgement
Legal entity responsible for the study
Sanofi Aventis Deutschland GmbH.
Funding
Sanofi.
Disclosure
F. Scholten: Other, Personal and Institutional, Other, Honoraria: Janssen; Other, Personal and Institutional, Other, Travel, accomodation and expenses: Novartis, Sanofi, Janssen, Celgene, BMS, Pfizer, Pharmatias and Riore. H. Derigs: Other, Personal and Institutional, Other, Honoraria: Janssen and AstraZeneca; Financial Interests, Personal and Institutional, Other, Travel, accomodations and expenses: BMS. S. Pederiva: Other, Personal and Institutional, Other, Travel, accomodations and expenses: Roche, Bayer and Celgene. S. Anchisi: Other, Personal and Institutional, Other, Travel, accomodations and expenses: Roche, Celgene, Merck, Janssen-Cilag AG. P. Bohanes: Other, Personal, Other, Honoraria: MSD and Bayer; Other, Personal, Other, Travel, accomodations and expenses: Janssen. C. Windemuth-Kieselbach: Financial Interests, Personal, Other, Employment: CRO Alcedis GMbH. R. von Moos: Other, Personal, Advisory Role: Amgen, AstraZeneca, BMS, Celgene, MSD, Pierre Fabre, Pharmamar, Polyphor, Roche, Vifor. R. Hofheinz: Other, Personal, Advisory Role: o Amgen, AstraZeneca, Bayer, BMS, Boehringer, Merck, MSD Roche, Sanofi; Other, Personal, Other, Honorary for lectures: o Amgen, AstraZeneca, Bayer, BMS, Boehringer, Lilly, medac, Merck, MSD, Roche, Saladax, Sanofi, Daichi Sankyo, Servier, Pierre Fabre. All other authors have declared no conflicts of interest.