FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of HER-2 Expressing Gastric or GEJ Cancer

Phase 2/3 Completed 81 enrolled Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Trium Analysis Online GmbH · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or GEJ.

Timeline

Start: 2016-06
Primary completion: 2020-07-17
Completion: 2020-07-17

Outcome

Met primary endpoint

paper The pCR rate was significantly improved with the trastuzumab/pertuzumab treatment (A: 12%/B: 35%; P = .02). PMID 35709415 ↗

Publications

Hofheinz RD, Merx K, Haag GM, Springfeld C, Ettrich T, Borchert K, Kretzschmar A, Teschendorf C, Siegler G, Ebert MP, Goekkurt E, Mahlberg R, Homann N, Pink D, Bechstein W, Reichardt P, Flach H, Gaiser T, Battmann A, Oduncu FS, Loose M, Sookthai D, Pauligk C, Goetze TO, Al-Batran SE. FLOT Versus FLOT/Trastuzumab/Pertuzumab Perioperative Therapy of Human Epidermal Growth Factor Receptor 2-Positive Resectable Esophagogastric Adenocarcinoma: A Randomized Phase II Trial of the AIO EGA Study Group. J Clin Oncol. 2022 Nov 10;40(32):3750-3761. doi: 10.1200/JCO.22.00380. Epub 2022 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pertuzumab	Monoclonal antibody	840 mg	—
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	—
Background	Docetaxel	Small molecule	50 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2600 mg/m2	Intravenous