Cetuximab every 2 weeks versus standard weekly dosing administration schedule

Author:

Bokemeyer Carsten1,Ciardiello Fortunato2ORCID,Dubreuil Olivier3ORCID,Guigay Joel4ORCID,Kasper Stefan5ORCID,Pfeiffer Per6ORCID,Pinto Carmine7ORCID,Yamaguchi Kensei8,Yoshino Takayuki9ORCID,Zielinski Christoph10ORCID,Esser Regina11,Tabernero Josep12ORCID

Affiliation:

1. The II Medical Clinic, Department of Oncology, Hematology & BMT with section of Pneumology, University Medical Center of Hamburg-Eppendorf, Hamburg, Germany

2. Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy

3. Medical Oncology Unit, Diaconesses-Croix St Simon Hospital, Paris, France

4. Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC), Tours, France

5. Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany

6. Department of Oncology, Odense University Hospital, Odense, Denmark

7. Medical Oncology, Comprehensive Cancer Center, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy

8. Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan

9. Department of Gastroenterology & Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan

10. Central European Cooperative Oncology Group, Vienna, Austria

11. Merck Healthcare KGaA, Darmstadt, Germany

12. Medical Oncology Department, Vall d'Hebron Hospital Campus & Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain

Abstract

Cetuximab every 2 weeks (Q2W) dosing schedule is approved by the US FDA and by the Japanese Pharmaceuticals and Medical Devices Agency in patients with metastatic colorectal cancer and squamous cell carcinoma of the head and neck. Phase II trials have found comparable efficacy and safety for the weekly (Q1W) and Q2W schedules, and real-world studies have shown noninferiority of the Q2W compared with the Q1W schedule. Several guidelines recommend cetuximab Q2W administration as an alternative to the Q1W dosing schedule. Cetuximab Q2W can be administered with a Q2W dose of chemotherapy, making it a more convenient option to the Q1W schedule, potentially resulting in reduced costs for administration, increased flexibility for clinical staff and improved patient adherence.

Funder

Merck KGaA, Darmstadt, Germany

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Reference72 articles.

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2. European Medicines Agency. Summary of product characteristics, Erbitux (2022). www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf (Accessed 12 November 2022).

3. Japanese Pharmaceuticals and Medical Devices Agency. Package insert, Erbitux (2022).

4. U.S. Food and Drug Administration. FDA approves new dosing regimen for cetuximab (2021). www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-dosing-regimen-cetuximab (Accessed 20 November 2022).

5. Center for Drug Evaluation and Research. Approval package for Erbitux (2021). www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125084Orig1s277,s280.pdf (Accessed: 20 November 2022).

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