Perioperative chemotherapy with ECX +/- panitumumab in locally advanced gastroesophageal adenocarcinomas (GEA): A randomized study of the Arbeitsgemeinschaft Internistische Onkologie and the Chirurgische Arbeitsgemeinschaft Onkologie of the German Cancer Society.

Medientyp: E-Artikel

Titel: Perioperative chemotherapy with ECX +/- panitumumab in locally advanced gastroesophageal adenocarcinomas (GEA): A randomized study of the Arbeitsgemeinschaft Internistische Onkologie and the Chirurgische Arbeitsgemeinschaft Onkologie of the German Cancer Society

Beteiligte: Stahl, Michael; Mihaljevic, Andre L.; Moehler, Markus; Kanzler, Stephan; Hoehler, Thomas; Thuss-Patience, Peter C.; Moenig, Stefan Paul; Kunzmann, Volker; Schroll, Sebastian; Lordick, Florian; Meyer, Hans-Joachim; Sandermann, Andreas; Schumacher, Christoph; Wilke, Hansjochen

Erschienen: American Society of Clinical Oncology (ASCO), 2015

Sprache: Englisch

DOI: 10.1200/jco.2015.33.3_suppl.104

ISSN: 0732-183X; 1527-7755

Schlagwörter: Cancer Research ; Oncology

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Beschreibung: 104 Background: Perioperative chemotherapy represents the European standard of care in locally advanced GEA. Efficacy may be improved by combining chemotherapy and molecular targeted drugs. Due to overexpression of epidermal growth factor receptor (EGFR) in most GEA EGFR-inhibitors may be candidates for such improvement. Methods: To evaluate the role of EGFR-antibodies in the perioperative treatment we performed a multicenter randomized phase II study. Patients with locally advanced (cT3-4 N0-3 M0) adenocarcinomas of the stomach or gastro-esophageal junction (GEJ) were eligible. Patients were treated with ECX with (arm 1 ) or without (arm 2) panitumumab (P, 9 mg/kg body weight iv, q 3 weeks). Three cycles were planned prior to and after surgery. The primary endpoint was to prove a reduction in ypT3-4 categories by adding P to ECX. Results: From 11/2010 to 7/2013 a total of 171 pts. were randomized, and 163 pts. (83 arm 1, 80 arm 2) were eligible. Prior to therapy 29% of the pts. in both arms had T4 tumors (CT scan and EUS) and 82% vs. 78% showed lymph node involvement. In 42% vs. 45% the primary tumour was located in the GEJ. 68 pts. (82%) vs. 68 pts. (85%) completed 3 preoperative cycles. The mean total dose of preoperative chemotherapy related to the planned dose reached 90% for panitumumab (arm 1 only), 91% vs. 92% for cisplatin, and 81% vs. 85% for capecitabine. R0-resection was achieved in 90% vs. 89% of the patients. The rate of pts. without downstaging (ypT3-4 at surgery) was statistically not significant higher in the experimental arm (73% vs. 66%, p=0.23), as was the overall treatment failure in the ITT analysis (odds ratio 1.37 (0.65-2.86)). The PCR-rate (ypT0N0) was comparable (3% vs. 5%, p=0.43). One toxic death was observed during chemotherapy (arm 2) and 1 pt. of both arms died due to complications after surgery. Conclusions: The study failed to reach its primary endpoint. The addition of P to ECX was not able to improve downstaging of locally advanced GEA. Survival data and results of translational research will be available during the course of 2015. Clinical trial information: NCT01234324.

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