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Trastuzumab in combination with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel as perioperative treatment for patients with human epidermal growth factor receptor 2-positive locally advanced esophagogastric adenocarcinoma: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie Gastric Cancer Study Group

Perioperative chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) is a mainstay in the treatment of esophagogastric adenocarcinomas (EGA). Trastuzumab improved survival when added to chemotherapy in patients with HER-2-positive metastatic EGA. We investigated the combinati...

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Main Authors: Hofheinz, Ralf-Dieter (Author) , Hegewisch-Becker, Susanne (Author) , Kunzmann, Volker (Author) , Thuss-Patience, Peter (Author) , Fuchs, Martin (Author) , Homann, Nils (Author) , Graeven, Ullrich (Author) , Schulte, Nadine (Author) , Merx, Kirsten (Author) , Pohl, Michael (Author) , Held, Swantje (Author) , Keller, Ralph (Author) , Tannapfel, Andrea (Author) , Al-Batran, Salah-Eddin (Author)
Corporate Author: Deutsche Krebsgesellschaft, Arbeitsgemeinschaft für Internistische Onkologie (Author)
Format: Article (Journal)
Language:English
Published: 2021
In: International journal of cancer
Year: 2021, Volume: 149, Issue: 6, Pages: 1322-1331
ISSN:1097-0215
DOI:10.1002/ijc.33696
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1002/ijc.33696
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/ijc.33696
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Author Notes:Ralf-Dieter Hofheinz, Susanne Hegewisch-Becker, Volker Kunzmann, Peter Thuss-Patience, Martin Fuchs, Nils Homann, Ullrich Graeven, Nadine Schulte, Kirsten Merx, Michael Pohl, Swantje Held, Ralph Keller, Andrea Tannapfel, Salah-Eddin Al-Batran
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Summary:Perioperative chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) is a mainstay in the treatment of esophagogastric adenocarcinomas (EGA). Trastuzumab improved survival when added to chemotherapy in patients with HER-2-positive metastatic EGA. We investigated the combination of trastuzumab and FLOT as perioperative treatment in patients with locally advanced EGA. A multicenter phase II study evaluated the efficacy and toxicity of perioperative FLOT (24-hours 5-FU 2600 mg/m2, leucovorin 200 mg/m2, oxaliplatin 85 mg/mg2, docetaxel 50 mg/m2, trastuzumab 6 mg/kg then 4 mg/kg d1, repeated d15 for four cycles preoperatively and postoperatively followed by 9 cycles of trastuzumab monotherapy) in patients with HER-2 positive EGA. Patients had ≥cT2, any N, M0 EGA. The primary endpoint was the rate of centrally assessed pathological complete response (pCR). Secondary endpoints comprised disease-free (DFS) and overall survival (OS), R0 resection rate, toxicity and surgical morbidity. Fifty-six evaluable patients (median age 62 years) were included; n = 40 had tumors originating from the esophagogastric junction; T stage was (cT2/3/4/unknown): 4/42/8/2; n = 50 patients had cN+ disease. Main adverse events grades 3-4: leukopenia (17.9%), neutropenia (46.6%) and diarrhea (17.0%). All patients underwent tumor resections. R0 resection rate was 92.9%. Eight patients had anastomotic leakage. One postoperative death occurred. pCR was found in 12 patients (21.4%) and a further n = 14 patients (25.0%) had near complete response. Median DFS was 42.5 months and the 3-year OS rate was 82.1%. The primary endpoint of achieving a pCR >20% was reached. No unexpected safety issues were observed. Survival data are promising.
Item Description:Gesehen am 26.10.2023
Physical Description:Online Resource
ISSN:1097-0215
DOI:10.1002/ijc.33696

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