1123 - Quality of Life (QoL) in patients with aflibercept (AFL) and FOLFIRI for metastatic colorectal cancer (mCRC) – Interim analysis with focus on mutational status of the non-interventional study QoLiTrap (AIO-LQ-0113)

Background

The anti-angiogenic fusion protein AFL targets VEGF-A, VEGF-B and PlGF. It is approved in combination with FOLFIRI for treatment of mCRC that is resistant to or has progressed after oxaliplatin-containing therapy.

Methods

QoLiTrap is an ongoing non-interventional study conducted in the DACH region to evaluate Quality of Life in 1500 mCRC patients treated with AFL+FOLFIRI using the EORTC-QLQ C30 questionnaire at baseline and before every cycle.

Results

For this interim analysis (cut-off: 02 Jan 2019) 839 patients (mean age: 64.7 ± 9.8 years; 64.4% male, 50.9% with documented RAS mutation, ECOG 0-1: 86.0%) who completed the baseline and at least 2 post-baseline EORTC-QLQ C30 questionnaires were evaluated. AFL was administered for a median of 7 cycles to RAS-wild-type (wt) (range: 1-61) and RAS-mutated (mut) (range 1-44) patients. Of those 772 patients with a previous therapy, 56.7 % received bevacizumab (BEV), 15.3% anti-EGFR antibodies (cetuximab and/or panitumumab) and 14.6 % both agents. 42.1% of RAS-wt and 56.7% of RAS-mut patients received AFL in second line setting. Median global health score at baseline was 58.3 and decreased moderately (mean change -3.4%, p < 0.0001) within the first 12 weeks of therapy. Reduction was greater in RAS-mut compared to RAS-wt (mean change -5.1% vs. -1.1%). Among evaluable patients receiving AFL in second line after anti-EGFR or BEV, 25.0% exhibited CR+PR and 51.6% had SD as best response. RAS mutational status had an impact on the rate of disease control in these patients (85.7% disease control in RAS-wt vs. 69.8% in RAS-mut; p = 0.0242). Median PFS in these patients was 7.6 months (95% CI 6.3- 12.4) for RAS-wt patients and 8.2 months (95% CI 5.9- 9.0) for RAS-mut patients. Toxicity was in line with the known safety profile.

Conclusions

The current interim analysis suggests that FOLFIRI + AFL administered in routine conditions after either BEV or anti-EGFR is an active second-line therapy. Both RAS-wt and RAS-mut patients benefited from this combination. No clinically relevant decrease in global health status was observed during study treatment. Supported by Sanofi-Aventis Deutschland GmbH.

Clinical trial identification

AIO-LQ-0113.

Editorial acknowledgement

Sandra Baumgart (Alcedis GmbH Gießen, Germany), funded by Sanofi-Aventis Deutschland GmbH.

Legal entity responsible for the study

Sanofi-Aventis Deutschland GmbH.

Funding

Sanofi-Aventis Deutschland GmbH.

Disclosure

R. von Moos: Honoraria (self), Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Novartis; Advisory / Consultancy: Sanofi Aventis; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Merck-Serono; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Vifor; Travel / Accommodation / Expenses: Pfizer. F. Scholten: Honoraria (self), Travel / Accommodation / Expenses: Pharmamar; Travel / Accommodation / Expenses: Eli-Lilly; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: Sanofi-Aventis. H. Derigs: Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Roche. R.D. Hofheinz: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Merck; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Sanofi; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Research grant / Funding (self): Medac; Honoraria (self): Boehringer; Honoraria (self): Celgene; Honoraria (self): Saladax; Honoraria (self): AstraZeneca; Speaker Bureau / Expert testimony: Deutsche Krebshilfe. All other authors have declared no conflicts of interest.