Quality of life, effectiveness, and safety of aflibercept plus FOLFIRI in older patients with metastatic colorectal cancer: An analysis of the prospective QoLiTrap study.

Colorectal cancer (CRC) mainly affects older patients. The pivotal VELOUR phase III trial of aflibercept plus FOLFIRI in metastatic CRC (mCRC) included only 5.9% of patients aged ≥75 years. Herein, we report a preplanned analysis from QoLiTrap, a large prospective observational study evaluating the impact of age on quality of life (QoL), effectiveness, and safety of aflibercept plus FOLFIRI in daily clinical practice in Europe. Enrolled patients had progressive mCRC, had failed a prior oxaliplatin-based regimen, and had received aflibercept (4 mg/kg) plus FOLFIRI every two weeks until disease progression, death, unacceptable toxicity, or physician/patient decision. Analyses were performed by age classes (<60, 60-64, 65-69, 70-74, and ≥ 75 years). The primary endpoint was the percentage of patients whose global health status (GHS) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was maintained (i.e., no worsening from baseline by at least 5% over a 12-week treatment). Secondary endpoints included tumor objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Overall, 1277 patients (<60 years, n = 327; 60-64 years, n = 231; 65-69 years, n = 227; 70-74 years, n = 259; and ≥ 75 years, n = 233) were treated, of whom 872 were evaluable for QoL. GHS was maintained in 36.5%, 41.6%, 38.9%, 41.8%, and 44.8% of patients aged <60, 60-64, 65-69, 70-74, and ≥ 75 years, respectively. Age did not influence PFS (median 7.8 months), OS (median 14.4 months), or ORR (20.8%). Number of cycles, dose delays for any cause, and dose reductions for adverse events (AEs) were comparable between age classes. Grade ≥ 3 AEs occurred in 47.7%, 51.9%, 51.5%, 55.2%, and 55.8% of patients aged <60, 60-64, 65-69, 70-74, and ≥ 75 years, respectively. The main grade ≥ 3 AEs were hypertension (11.2%) and diarrhea (9%) in patients aged ≥75 years. The results suggest that aflibercept plus FOLFIRI maintains QoL and retains its activity, including a high objective tumor response, regardless of age and treatment line. In fit older patients, the safety profile seems manageable, with no new safety signals.

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Declaration of Competing Interest Christine Geffriaud-Ricouard and Max Gueldner are employees of Sanofi and may hold shares and/or stock options in the company. Leonora Schwarz is an employee of Alcedis GmbH, which was contracted for statistical analysis by Sanofi-Aventis. Sandro Anchisi received funding from Merck, Janssen-Cilag and Gilead Sciences Switzerland Sàrl for participation in an advisory board; support from Celgene, Janssen-Cilag AG, Merck, MSD, and Roche for attending meetings; and honoraria for lectures from Sanofi-Aventis (Suisse). Pierre Bohanes received honoraria from Bayer and MSD. Birgit Grünberger received honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly, MSD, Pfizer, Pierre Fabre, Sanofi, and Servier; support for attending meetings from Merck, MSD, and Roche; and payment for participation in an advisory board from Bayer, Eli Lilly, MSD, Pfizer, and Roche. Ralf-Dieter Hofheinz received funding from Amgen, Deutsche Krebshilfe, Merck, and Sanofi; honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daichi, Eli Lilly, Medac, Merck, MSD, Pierre Fabre, Roche, Saladax, Servier and Sanofi-Aventis; and support for attending meetings from Amgen, AstraZeneca, Bayer, Bristol- Myers Squibb, Boehringer, Eli Lilly, Merck, MSD, Pierre Fabre, Roche, Sanofi, and Servier; as well as consulted for Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer, Daiichi, Eli Lilly, Merck, MDS, Pierre Fabre, Roche, Sanofi, and Servier. Felicitas Scholten received support for attending meetings from AbbVie, Glaxo-Smith Kline, Janssen, Novartis, and Servier, and for participation in an advisory board from Glaxo-Smith Kline. Roger von Moos received honoraria from Sanofi; consulted for Roche and Sanofi; and was paid for participation in advisory boards by Amgen, Merck Serono, MSD, and the Annals of Oncology. Hans-Günter Derigs, Josef Thaler, and Gudrun Piringer declared no conflicts of interest.