Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer

Phase 3 Completed 82 enrolled Gustave Roussy, Cancer Campus, Grand Paris Ligue contre le cancer, France · collab Merck Serono International SA · collab National Cancer Institute, France · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC. Efficacy assessed by failure free survival

Timeline

Start: 2013-11-06
Primary completion: 2021-10-12
Completion: 2021-10-12

Outcome

Missed primary endpoint

paper The study showed no improvement in failure-free survival with cetuximab versus methotrexate. PMID 38432247 ↗

paper adjusted HR 1·03 [95% CI 0·66-1·61], p=0·89 PMID 38432247 ↗

Publications

Guigay J, Ortholan C, Vansteene D, Cupissol D, Even C, Kaminsky MC, Sire C, Blot E, Debourdeau P, Bozec L, Saada-Bouzid E, Fayette J, Dalloz P, Pointreau Y, Caer HL, Falandry C, Digue L, Braccini A, Lopez S, Guillet P, Michel C, Cheurfa N, Schwob D, Bourhis J, Mertens C, Auperin A; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups and the GORTEC. Cetuximab versus methotrexate in first-line treatment of older, frail patients with inoperable recurrent or metastatic head and neck cancer (ELAN UNFIT): a randomised, open-label, phase 3 trial. Lancet Healthy Longev. 2024 Mar;5(3):e182-e193. doi: 10.1016/S2666-7568(23)00284-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous
Comparator	Methotrexate	Small molecule	40 mg/m2	Intravenous