Al-Batran, Salah-Eddin, Homann, Nils, Pauligk, Claudia, Illerhaus, Gerald, Martens, Uwe M., Stoehlmacher, Jan, Schmalenberg, Harald, Luley, Kim B., Prasnikar, Nicole, Egger, Matthias, Probst, Stephan, Messmann, Helmut, Moehler, Markus, Fischbach, Wolfgang, Hartmann, Joerg T., Mayer, Frank, Hoeffkes, Heinz-Gert, Koenigsmann, Michael, Arnold, Dirk ORCID: 0000-0002-5325-8182, Kraus, Thomas W., Grimm, Kersten, Berkhoff, Stefan, Post, Stefan, Jager, Elke, Bechstein, Wolf ORCID: 0000-0002-3267-8145, Ronellenfitsch, Ulrich, Moenig, Stefan and Hofheinz, Ralf D. (2017). Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer The AIO-FLOT3 Trial. JAMA Oncol., 3 (9). S. 1237 - 1245. CHICAGO: AMER MEDICAL ASSOC. ISSN 2374-2445

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Abstract

IMPORTANCE Surgical resection has a potential benefit for patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. OBJECTIVE To evaluate outcome in patients with limited metastatic disease who receive chemotherapy first and proceed to surgical resection. DESIGN, SETTING, AND PARTICIPANTS The AIO-FLOT3 (Arbeitsgemeinschaft Internistische Onkologie-fluorouracil, leucovorin, oxaliplatin, and docetaxel) trial is a prospective, phase 2 trial of 252 patients with resectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients were enrolled from 52 cancer care centers in Germany between February 1, 2009, and January 31, 2010, and stratified to 1 of 3 groups: resectable (arm A), limited metastatic (arm B), or extensive metastatic (arm C). Data cutoff was January 2012, and the analysis was performed in March 2013. INTERVENTIONS Patients in arm A received 4 preoperative cycles of fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) followed by surgery and 4 postoperative cycles. Patients in arm B received at least 4 cycles of neoadjuvant FLOT and proceeded to surgical resection if restaging (using computed tomography and magnetic resonance imaging) showed a chance of margin-free (RO) resection of the primary tumor and at least a macroscopic complete resection of the metastatic lesions. Patients in arm C were offered FLOT chemotherapy and surgery only if required for palliation. Patients received a median (range) of 8 (1-15) cycles of FLOT. MAIN OUTCOMES AND MEASURES The primary end point was overall survival. RESULTS In total, 238 of 252 patients (94.4%) were eligible to participate. The median (range) age of participants was 66 (36-79) years in arm A(n = 51), 63 (28-79) years in arm B (n = 60), and 65 (23-83) years in arm C (n = 127). Patients in arm B (n = 60) had only retroperitoneal lymph node involvement (27 patients [45%]), liver involvement (11 [18.3%]), lung involvement (10 [16.7%]), localized peritoneal involvement (4 [6.7%]), or other (8 [13.3%]) incurable sites. Median overall survival was 22.9 months (95% CI, 16.5 to upper level not achieved) for arm B, compared with 10.7 months (95% CI, 9.1-12.8) for arm C (hazard ratio, 0.37; 95% CI, 0.25-0.55) (P < .001). The response rate for arm B was 60%(complete, 10%; partial, 50%), which is higher than the 43.3% for arm C. In arm B, 36 of 60 patients (60%) proceeded to surgery. The median overall survival was 31.3 months (95% CI, 18.9-upper level not achieved) for patients who proceeded to surgery and 15.9 months (95% CI, 7.1-22.9) for the other patients. CONCLUSIONS AND RELEVANCE Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival. The AIO-FLOT3 trial provides a rationale for further randomized clinical trials.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Al-Batran, Salah-EddinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Homann, NilsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pauligk, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Illerhaus, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martens, Uwe M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stoehlmacher, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmalenberg, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luley, Kim B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Prasnikar, NicoleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Egger, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Probst, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Messmann, HelmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moehler, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischbach, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hartmann, Joerg T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mayer, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeffkes, Heinz-GertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koenigsmann, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arnold, DirkUNSPECIFIEDorcid.org/0000-0002-5325-8182UNSPECIFIED
Kraus, Thomas W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grimm, KerstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berkhoff, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Post, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jager, ElkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bechstein, WolfUNSPECIFIEDorcid.org/0000-0002-3267-8145UNSPECIFIED
Ronellenfitsch, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moenig, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hofheinz, Ralf D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-219830
DOI: 10.1001/jamaoncol.2017.0515
Journal or Publication Title: JAMA Oncol.
Volume: 3
Number: 9
Page Range: S. 1237 - 1245
Date: 2017
Publisher: AMER MEDICAL ASSOC
Place of Publication: CHICAGO
ISSN: 2374-2445
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ARBEITSGEMEINSCHAFT INTERNISTISCHE ONKOLOGIE; ESOPHAGOGASTRIC CANCER; CURATIVE RESECTION; PERIOPERATIVE CHEMOTHERAPY; PHASE-II; DOCETAXEL; OXALIPLATIN; ADENOCARCINOMA; LEUCOVORIN; TUMORSMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21983

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