Startseite Kongressberichte & Archiv ESMO 2017 Congress Gastrointestinal Carcinoma Highlights Colorectal Cancer 593P - Quality of life (QoL) analyses in patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) treated with first-line FOLFOX-4 ± cetuximab in the phase 3 TAILOR trial

593P - Quality of life analyses in patients with RAS wild-type mCRC treated with first-line FOLFOX-4 ± cetuximab in the phase 3 TAILOR trial

Background

In the phase 3 TAILOR trial, adding cetuximab to first-line FOLFOX-4 significantly improved progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) in patients with RAS wt mCRC. Here we present QoL analyses.

Methods

TAILOR is a randomized phase 3 trial that includes a modified intention-to-treat population of 393 patients from China with RAS wt mCRC treated with FOLFOX-4 ± cetuximab. The primary endpoint of TAILORis PFS based on independent review; secondary endpoints include OS, ORR, and QoL. QoL is investigated using the European Organisation for Research and Treatment of Cancer QoL questionnaire core-30 (EORTC QLQ-C30). QoL assessments were planned to be performed at baseline, every 8 weeks of treatment thereafter, and at the final tumor assessment. Patients with RAS wt tumors are considered evaluable for QoL if they provide ≥ 1 evaluable EORTC QLQ-C30 from screening to end of evaluation. Pattern-mixture modeling is used to compare QoL between treatment groups by taking into account dropout pattern and other covariates.

Results

Among 393 patients with RAS wt tumors, 390 were evaluable for QoL. Before adjustment for several factors (treatment, time, dropout pattern, age, sex, ECOG performance status, number of disease sites, liver-only metastases, and interaction between treatment and dropout pattern), global health status/QoL showed slightly more deterioration in the FOLFOX-4 + cetuximab arm vs FOLFOX-4 arm; however, when these factors were included in the analysis model, the difference between treatment groups was not considered clinically relevant. Similar findings were obtained upon analogous evaluation of social functioning, an individual QoL-related dimension of interest in mCRC.

Conclusions

Adding cetuximab to first-line FOLFOX-4 significantly improved PFS, OS, and ORR without negatively impacting QoL in TAILOR study patients with RAS wt mCRC, consistent with observations from earlier cetuximab pivotal trials. These observations confirm cetuximab in combination with FOLFOX-4 as a standard-of-care first-line treatment regimen for patients with RAS wt mCRC.

Clinical trial identification

NCT01228734

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

J. Li: Research funding: Merck Inc., Roche-Peru. W. Chen, J. Chen: Employment: Merck Serono. C.P. Pescott: Employment: Merck KGaA, Darmstadt, Germany. All other authors have declared no conflicts of interest.