Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 2

2589 - Noninferiority on overall survival of every-2-weeks vs weekly schedule of cetuximab for first-line treatment of RAS wild-type metastatic colorectal cancer

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Colon and Rectal Cancer

Presenters

Stefan Kasper

Citation

Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246

Authors

S. Kasper1, A. Cheng2, F. Overkamp3, M. Rouyer4, C. Foch5, F. Lamy6, R. Esser5, D. Messinger7, V. Rothe7, W. Chen8, T. Brodowicz9, C.C. Zielinski10

Author affiliations

  • 1 Medical Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45147 - Essen/DE
  • 2 Department Of Internal Medicine And Oncology, National Taiwan University Cancer Center, 10048 - Taipei/TW
  • 3 Oncology, Oncologianova GmbH, 45657 - Recklinghausen/DE
  • 4 Inserm Cic1401, Bordeaux PharmacoEpi, University of Bordeaux, 33076 - Bordeaux cedex/FR
  • 5 Oncology, Merck Healthcare KGaA, 64293 - Darmstadt/DE
  • 6 Global Epidemiology, Merck Healthcare KGaA, 64293 - Darmstadt/DE
  • 7 Biostatistics, Prometris GmbH, 68219 - Mannheim/DE
  • 8 Biostatistics, Merck Serono, 2000070 - Shanghai/CN
  • 9 Department Of Medical Oncology, Internal Medicine 1, General Hospital – Medical University of Vienna, 1090 - Vienna/AT
  • 10 Oncology, Comprehensive Cancer Center, Vienna General Hospital and Medical University of Vienna, 1090 - Vienna/AT

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2589

Background

Cetuximab (CET) in combination with chemotherapy is approved for a once-weekly (q1w) schedule at an initial dose of 400 mg/m², followed by weekly doses of 250 mg/m², in patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC). However in clinical practice, an off-label schedule of CET 500 mg/m2 every-2-weeks (q2w) is frequently used. This pooled analysis of patient-level data aimed to test the noninferiority of the q2w vs q1w schedule on overall survival (OS).

Methods

All post-authorization studies with patient-level data available to marketing authorization holder at time of study design, in patients with confirmed RAS wt mCRC who received a first-line treatment with CET q1w or q2w in combination with chemotherapy from 2007 to 2018 were included: 2 non-interventional cohort studies (NIS) (EREBUS, ERBITAG) and 3 clinical trials (CEBIFOX, CECOG/CORE 1.2.002, APEC). Patients were categorized into q1w or q2w groups according to the CET schedule planned at initiation. OS was calculated from first CET infusion until all-cause death and censored at the last date patients were known to be alive. The noninferiority of the q2w vs q1w schedule was tested with a hazard ratio (HR) margin of 1.25 using a Cox proportional hazards regression model. Differences in baseline characteristics were accounted for with inverse probability of treatment weighting (IPTW) based on a propensity score.

Results

763 (91% from NIS) and 554 (51% from NIS) patients were included in the q1w and q2w groups, respectively. Median (Q1-Q3) age in years was 66 (57-73) for q1w and 60 (53-69) for q2w. Liver-limited disease concerned 42.6% of patients for q1w and 37.9% for q2w. A baseline ECOG Performance Status of 0-1 was reported in 81.8% of q1w and 90.6% of q2w patients. FOLFIRI was most frequently used in combination with q1w (49.4%) and FOLFOX with q2w (59.2%). IPTW-adjusted HRs for OS were in favor of q2w: 0.83 (95% CI, 0.71-0.96) and 0.73 (95% CI, 0.61-0.88) when restricted to NIS. Other efficacy and safety results will be presented in the future.

Conclusions

This pooled analysis confirmed the noninferiority of CET q2w vs q1w. This result suggests an improved OS with the q2w schedule.

Clinical trial identification

Editorial acknowledgement

ClinicalThinking, Inc, Hamilton, NJ, USA, funded by Merck Healthcare KGaA, Darmstadt, Germany.

Legal entity responsible for the study

Merck Healthcare KGaA.

Funding

Merck Healthcare KGaA.

Disclosure

S. Kasper: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Aventis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Servier; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly. F. Overkamp: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Chugai; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Cellex; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Gilead; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Novonordisc; Honoraria (self), Advisory / Consultancy: Riemser; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Servier. C. Foch: Full / Part-time employment: Merck Healthcare KGaA. F. Lamy: Full / Part-time employment: Merck Healthcare KGaA. R. Esser: Full / Part-time employment: Merck Healthcare KGaA. D. Messinger: Full / Part-time employment, Prometris provides statistical services for Merck Healthcare KGaA: Merck Healthcare KGaA. V. Rothe: Full / Part-time employment, Prometris provides statistical services for Merck Healthcare KGaA: Merck Healthcare KGaA. W. Chen: Full / Part-time employment: Merck Serono. T. Brodowicz: Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: PharmaMar; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Lilly. C.C. Zielinski: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Imugene; Honoraria (self), Advisory / Consultancy: ARIAD; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Merrimack; Honoraria (self), Advisory / Consultancy: Merck Healthcare KGaA; Honoraria (self), Advisory / Consultancy: FibroGen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self), Advisory / Consultancy: Gilead; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self), Advisory / Consultancy: Shire; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Athenex. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.