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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

1276 - Interim analysis of the non-interventional study QoLiTrap (AIO-LQ-0113) in patients with metastatic colorectal cancer (mCRC) treated with aflibercept (AFL) + FOLFIRI – Efficacy according to age group _65 and >65 years

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Supportive Care and Symptom Management

Tumour Site

Colon and Rectal Cancer

Presenters

Ralf Dieter Hofheinz

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

R.D. Hofheinz1, H. Derigs2, G. Piringer3, R. von Moos4

Author affiliations

  • 1 Interdisciplinary Tumor Center, Universitätsklinikum Mannheim, 68167 - Mannheim/DE
  • 2 Clinic Of Internal Medicine, Klinikum Frankfurt Höchst, 65929 - Frankfurt a. M./DE
  • 3 Palliative Medicine, Klinikum Wels-Grieskirchen GmbH, 4600 - Wels/AT
  • 4 Department Of Oncology/hematology, Kantonsspital Graubünden, 8000 - Chur/CH
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Resources

Abstract 1276

Background

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 DACH region to evaluate Quality-of-life (QoL) 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 according to age groups (≤ 65 and > 65 years / cut-off: 05 Dec 2017) 702 patients (mean age: 64.8 ± 9.9 yrs; 65.0% male, 50.9% with RAS mutation) who completed the baseline and at least 2 additional questionnaires were evaluated. 50% of patients each were ≤65 and >65 yrs old at therapy start. 86.3% and 85.8% of younger and older patients, respectively, had an ECOG of ≤ 1. A median of 7 cycles (range 1 – 65) was given to patients aged ≤65, patients >65 yrs received a median of 6 cycles (range 1 - 54). Mean global health scores at baseline was 55.6 for patients aged ≤65 yrs and 59.1 for patients aged >65 yrs. Mean score decreased slightly in both age groups. 48.4% of younger and 46.7% of older patients received study treatment as second line. More than 75% of patients in both age groups received prior anti-EGFR and / or bevacizumab (BEV) treatment. 89.5% of younger and 92.3% of older patients received prior palliative therapies or prior therapies during metastatic stage. Median PFS of patients pretreated with anti-EGFR or BEV only was 7.6 months (95% CI 3.7- ) and 7.0 months (95% CI 5.6- 8.5), respectively, for younger patients, and 9.4 months (95% CI 5.9- ) and 7.6 months (95% CI 5.8- 9.0), respectively, for older patients. Regarding evaluable patients pretreated with anti-EGFR and/or BEV 11.2% and 10.4% of age group ≤65 and >65 yrs, respectively, exhibited CR+PR.

Conclusions

This interim analysis showed that there are no obvious differences between age groups regarding previous treatment and efficacy in mCRC patients treated with AFL+FOLFIRI under routine conditions. Toxicity was in line with the known safety profile of the study medication. Supported by Sanofi-Aventis Deutschland GmbH.

Clinical trial identification

AIO-LQ-0113.

Legal entity responsible for the study

Sanofi-Aventis Deutschland GmbH.

Funding

Sanofi-Aventis Deutschland GmbH.

Editorial Acknowledgement

Medical writing assistence was provided by Claudia Lorenz-Schlüter (Alcedis GmbH Gießen, Germany), funded by Sanofi-Aventis Deutschland GmbH.

Disclosure

R.D. Hofheinz: Consulting fees, honorarium: Sanofi, Merck, Amgen, Roche, Servier; Grant received/grants pending: Sanofi, Merck, Amgen, Roche. H-G. Derigs: Sponsoring congresses: Roche, Jannsen, Celgene, BMS. R. von Moos: Advisory board: Amgen Roche, Merck und Sanofi; Speaker Honoraria: Roche, Bayer. All other authors have declared no conflicts of interest.

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