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

• Verfasst von: Hofheinz, Ralf-Dieter [VerfasserIn]
• Verfasst von: Hegewisch-Becker, Susanne [VerfasserIn]
• Verfasst von: Kunzmann, Volker [VerfasserIn]
• Verfasst von: Thuss-Patience, Peter [VerfasserIn]
• Verfasst von: Fuchs, Martin [VerfasserIn]
• Verfasst von: Homann, Nils [VerfasserIn]
• Verfasst von: Graeven, Ullrich [VerfasserIn]
• Verfasst von: Schulte, Nadine [VerfasserIn]
• Verfasst von: Merx, Kirsten [VerfasserIn]
• Verfasst von: Pohl, Michael [VerfasserIn]
• Verfasst von: Held, Swantje [VerfasserIn]
• Verfasst von: Keller, Ralph [VerfasserIn]
• Verfasst von: Tannapfel, Andrea [VerfasserIn]
• Verfasst von: Al-Batran, Salah-Eddin [VerfasserIn]
• Titel: 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
• Titelzusatz: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie Gastric Cancer Study Group
• Körperschaft: Deutsche Krebsgesellschaft / Arbeitsgemeinschaft für Internistische Onkologie [VerfasserIn]
• Verf.angabe: 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
• Jahr: 2021
• Umfang: 11 S.
• Fussnoten: Gesehen am 26.10.2023
• Titel Quelle: Enthalten in: International journal of cancer
• Ort Quelle: Bognor Regis : Wiley-Liss, 1966
• Jahr Quelle: 2021
• Band/Heft Quelle: 149(2021), 6, Seite 1322-1331
• ISSN Quelle: 1097-0215
• DOI: doi:10.1002/ijc.33696
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: docetaxel
• Sach-SW: esophagogastric adenocarcinoma
• Sach-SW: perioperative treatment
• Sach-SW: trastuzumab
• K10plus-PPN: 186812133X
• K10plus-PPN:
  Universitätsbibliothek
• Lokale URL UB: Zum Volltext

Abstract

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.