Universität zu Köln

Schuhmacher, Christoph, Gretschel, Stephan, Lordick, Florian, Reichardt, Peter, Hohenberger, Werner, Eisenberger, Claus F., Haag, Cornelie, Mauer, Murielle E., Hasan, Baktiar, Welch, John, Ott, Katja, Hoelscher, Arnulf, Schneider, Paul M., Bechstein, Wolf ORCID: 0000-0002-3267-8145, Wilke, Hans, Lutz, Manfred P., Nordlinger, Bernard, Van Cutsem, Eric, Siewert, Joerg R. and Schlag, Peter M. (2010). Neoadjuvant Chemotherapy Compared With Surgery Alone for Locally Advanced Cancer of the Stomach and Cardia: European Organisation for Research and Treatment of Cancer Randomized Trial 40954. J. Clin. Oncol., 28 (35). S. 5210 - 5219. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

Purpose Patients with locally advanced gastric cancer benefit from combined pre- and postoperative chemotherapy, although fewer than 50% could receive postoperative chemotherapy. We examined the value of purely preoperative chemotherapy in a phase III trial with strict preoperative staging and surgical resection guidelines. Patients and Methods Patients with locally advanced adenocarcinoma of the stomach or esophagogastric junction (AEG II and III) were randomly assigned to preoperative chemotherapy followed by surgery or to surgery alone. To detect with 80% power an improvement in median survival from 17 months with surgery alone to 24 months with neoadjuvant, 282 events were required. Results This trial was stopped for poor accrual after 144 patients were randomly assigned (72: 72); 52.8% patients had tumors located in the proximal third of the stomach, including AEG type II and III. The International Union Against Cancer RO resection rate was 81.9% after neoadjuvant chemotherapy as compared with 66.7% with surgery alone (P = .036). The surgery-only group had more lymph node metastases than the neoadjuvant group (76.5% v 61.4%; P = .018). Postoperative complications were more frequent in the neoadjuvant arm (27.1% v 16.2%; P = .09). After a median follow-up of 4.4 years and 67 deaths, a survival benefit could not be shown (hazard ratio, 0.84; 95% CI, 0.52 to 1.35; P = .466). Conclusion This trial showed a significantly increased RO resection rate but failed to demonstrate a survival benefit. Possible explanations are low statistical power, a high rate of proximal gastric cancer including AEG and/or a better outcome than expected after radical surgery alone due to the high quality of surgery with resections of regional lymph nodes outside the perigastic area (celiac trunc, hepatic ligament, lymph node at a. lienalis; D2).

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schuhmacher, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Gretschel, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Lordick, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Reichardt, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Hohenberger, Werner UNSPECIFIED UNSPECIFIED UNSPECIFIED Eisenberger, Claus F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Haag, Cornelie UNSPECIFIED UNSPECIFIED UNSPECIFIED Mauer, Murielle E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hasan, Baktiar UNSPECIFIED UNSPECIFIED UNSPECIFIED Welch, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Ott, Katja UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoelscher, Arnulf UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneider, Paul M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bechstein, Wolf UNSPECIFIED orcid.org/0000-0002-3267-8145 UNSPECIFIED Wilke, Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED Lutz, Manfred P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nordlinger, Bernard UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Cutsem, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Siewert, Joerg R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schlag, Peter M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-490765
DOI:	10.1200/JCO.2009.26.6114
Journal or Publication Title:	J. Clin. Oncol.
Volume:	28
Number:	35
Page Range:	S. 5210 - 5219
Date:	2010
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ARBEITSGEMEINSCHAFT-INTERNISTISCHE-ONKOLOGIE; ADVANCED GASTRIC-CANCER; PROGNOSTIC-FACTORS; FOLINIC ACID; CARCINOMA; CISPLATIN; RESECTION; ADENOCARCINOMA; FLUOROURACIL; PLUS Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/49076