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. 2022 Jul 20;14(14):3522.
doi: 10.3390/cancers14143522.

Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study

Ralf-Dieter Hofheinz  1 , Sandro Anchisi  2 , Birgit Grünberger  3 , Hans G Derigs  4 , Mark-Oliver Zahn  5 , Christine Geffriaud-Ricouard  6 , Max Gueldner  7 , Christine Windemuth-Kieselbach  8 , Stefanie Pederiva  9 , Pierre Bohanes  10 , Felicitas Scholten  4 , Gudrun Piringer  11   12 , Josef Thaler  11 , Roger von Moos  13
Affiliations

Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study

Ralf-Dieter Hofheinz et al. Cancers (Basel). .

Abstract

Aflibercept plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer after the failure of oxaliplatin-containing therapy. QoLiTrap prospectively evaluated the quality of life (QoL) and effectiveness of this regimen in daily clinical practice, according to RAS status, sex, and prior targeted therapy, especially epidermal growth factor receptor inhibitors (EGFR-I). The primary endpoint was the percentage of patients whose EORTC QLQ-C30 global health status (GHS) improved or reduced by <5% from baseline during the first 12 weeks of therapy. Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. One thousand two hundred and seventy-seven patients were treated with aflibercept plus FOLFIRI and 872 were evaluable for QoL. GHS improved or decreased by <5% in 40.3% of cases. The ORR was 20.8%, the median PFS was 7.8 months (95% confidence interval (CI), 7.3−8.3), and the median OS was 14.4 months (95% CI, 13.1−18.1). After prior EGFR-I, the ORR was 23.7%, median PFS was 9.4 months (95% CI, 6.5−12.9), and median OS was 17.4 months (95% CI, 10.5−33.7). The safety profile was consistent with previously reported data. Aflibercept plus FOLFIRI given in daily practice maintained QoL in mCRC patients, was associated with a high objective tumor response, and retained its activity regardless of sex, RAS status, and prior EGFR-I therapy.

Keywords: EGFR inhibitors; VEGF; aflibercept; anti-angiogenics; colorectal cancer; quality of life.

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Conflict of interest statement

C.G.R. and M.G. are employees of Sanofi and may hold shares and/or stock options in the company. C.W.K. is an employee of Alcedis GmbH; Alcedis was contracted for statistical analysis by Sanofi-Aventis. S.A. received funding from Merck 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). P.B. received honoraria from Bayer and MSD. B.G. received honoraria from Astra Zeneca, 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. R.D.H. received funding from Amgen, Deutsche Krebshilfe, Merck, and Sanofi, honoraria from Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daichi, Lilly, Medac, Merck, MSD, Pierre Fabre, Roche, Saladax, and Sanofi-Aventis, has consulted for Amgen, Astra Zeneca, Bayer, Bristol-Myers Squibb, Boehringer, Daiichi, Lilly, Merck, MDS, Pierre Fabre, Roche, Sanofi, and Servier, and support for attending meetings from Amgen, Astra Zeneca, Bayer, Bristol-Myers Squibb, Boehringer, Lilly, Merck, MSD, Pierre Fabre, Roche, Sanofi, and Servier. F.S. received support for attending meetings from Abbvie, Glaxo-Smith Kline, Janssen, Novartis, and Servier, and for participation on an advisory board from Glaxo-Smith Kline. R.V. has received honoraria from Sanofi, consulted for Roche and Sanofi, and was paid for participation in advisory boards by Amgen, Merck Serono, MSD, and Annals of Oncology. H.G.D., S.P., and M.O.Z. have declared no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT diagram. EORTC QLQ-C30, European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire; FOLFIRI, fluorouracil (5-FU), leucovorin, irinotecan; FOLFOX, fluorouracil (5-FU), leucovorin, oxaliplatin; ITT, intention to treat (population); QoL, Quality of life (population).
Figure 2
Figure 2
Percentage of patients with global health status that was stable or decreased by less than 5% from baseline within the first 12 weeks of treatment by sex, therapy line, RAS status, and prior targeted therapy. 1L, first-line; 2L, second-line; 3L, third-line; EGFR-I, epidermal growth factor receptor inhibitors; VEGF-I, vascular endothelial growth factor inhibitors.
Figure 3
Figure 3
Mean global health status during the first seven cycles in the overall QoL population. Gray marking represents a clinically non-meaningful decline from the baseline value. 1L, first-line; 2L, second-line; 3L, third-line; EORTC QLQ-C30, European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire; QoL, quality of life.
Figure 4
Figure 4
Kaplan–Meier estimates for PFS and OS according to RAS wild-type and RAS mutant patients (A,B), treatment line (C,D) and prior targeted therapy (E,F). EGFR-I, epidermal growth factor receptor inhibitors; CI, confidence interval; ITT, intention to treat (population); mutant; NR, not reported; OS, overall survival; PFS, progression-free survival; VEGF-I, vascular endothelial growth factor inhibitors; wt, wild-type.
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