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Tytuł:
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• Pancho trial (p53-adapted neoadjuvant chemotherapy for resectable esophageal cancer) completed-mutation rate of the marker higher than expected.
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Autorzy:
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Kappel-Latif S; 1Division of General Surgery, Department of Surgery, Research Laboratories, Medical University of Vienna, Vienna, Austria.
Zacherl J; 2Division of General Surgery, Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Hejna M; 3Division of Oncology, Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.
Westerhoff M; 4Department of Pathology, University of Michigan, Ann Arbor, MI USA.
Tamandl D; 5Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
Ba-Ssalamah A; 5Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.
Mittlböck M; 6Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
Wolf B; 1Division of General Surgery, Department of Surgery, Research Laboratories, Medical University of Vienna, Vienna, Austria.
Wrba F; 7Department of Pathology, Medical University of Vienna, Vienna, Austria.
Kührer I; 2Division of General Surgery, Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Pluschnig U; 3Division of Oncology, Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.
Schoppmann SF; 2Division of General Surgery, Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Függer R; 8Department of Surgery, Elisabethinen Hospital Linz, Linz, Austria.
Zwrtek R; Department of Surgery, Landesklinikum Mistelbach, Mistelbach, Austria.
Glaser K; 10Department of General‑, Visceral- and Tumor Surgery, Wilhelminenspital, Vienna, Austria.
Karner J; 11Department of Surgery, Kaiser Franz Josef Hospital, Vienna, Austria.
Längle F; Department of Surgery, Landesklinikum Wr. Neustadt, Wr. Neustadt, Austria.
Wenzl E; 13Department of General‑, Visceral- and Thoracic Surgery, Landeskrankenhaus Feldkirch, Feldkirch, Austria.
Roka R; 14Department of Surgery I, Krankenanstalt Rudolfstiftung, Vienna, Austria.
Öfner D; 15Department of Visceral- , Transplant- and Thoracic Surgery, Medical University Innsbruck, Innsbruck, Austria.
Tschmelitsch J; Department of Surgery, Hospital Barmherzige Brüder St. Veit/Glan, St. Veit/Glan, Austria.
Hold M; 17Department of Surgery and Vascular Surgery, Hanusch Hospital, Vienna, Austria.
Keil F; Department of Hematology and Oncology, Landeskrankenhaus Leoben, Leoben, Austria.
Gnant M; 2Division of General Surgery, Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Kandioler D; 2Division of General Surgery, Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
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Corporate Authors:
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Pancho trialists and for the Medical University of Vienna p53research group
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Źródło:
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European surgery : ACA : Acta chirurgica Austriaca [Eur Surg] 2018; Vol. 50 (4), pp. 160-166. Date of Electronic Publication: 2018 Jun 11.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: <2005->: Wien : Springer
Original Publication: Wien : Blackwell Verlag, [2002]-
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References:
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Contributed Indexing:
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Investigator: D Kandioler; J Zacherl; M Hejna; S Schoppmann; M Gnant; U Pluschnig; I Kührer; W Klepetko; G Prager; M Riegler; C Aigner; B Teleky; S Kappel-Latif; C Bichler; B Wolf; G Werba; C Sandurkov; D Tamandl; A Ba-Ssalamah; M Uffmann; F Wrba; M Mittlböck; B Niederle; R Jakesz; F Mühlbacher; J Friedl; R Kain; L Brammen; K Glaser; F Berger; S Brugger; S Sporn; K Strasser-Weipl; R Fortelny; M Essenther; A Chott; J Karner; S Thalhammer; M Klimpfinger; R Roka; M Schermann; M Kees-Belyus; V Sagaster; T Grünberger; E Bonner; M Hold; M Bernhart; S Roka; C Österreicher; V Riegler; A Nader; J Haller; R Zwrtek; P Götzinger; M Pober; T Schenk; W Guggenberger; R Sedivy; M Kitzwögerer; G Heinz; M Thür; F Längle; I Viragos-Toth; E Frcena; H Pourebrahim; E Kristandl; W Stiglbauer; R Függer; F Tomaselli; S Metz; F Moinfar; F Keil; U Kastner; H Rabl; C Tinchon; V Odelga; N Rapp; N Eberhard; H Kainz; M Maderdonner; G Leitner; J Tschmelitsch; T Eberl; HJ Neumann; H Weiß; J Mühlmann; K Weeber; G Danko; D Öfner; G Mühlmann; M Zitt; H Maier; B Heinke; W Eisterer; N Bergmann; E Dablander; G Mikuz; A Brunner; E Wenzl; A Haid; K Ammann; M Knauer; A Lang; B Hartmann; M Lercher-Lueger; F Offner; B Aberer; M Hudec; M Hohlagschwandtner; W Trabe; P Merz; V Kadlecek; U Smetana; D Veit; T Veit; D Kerjaschki; O Braun; R Kuzmits; D Kosak; W Adolf; T Kessler; C Wüstinger; N Neuhold; F Beer; C Freibauer; S Naude; OM Braun; M Mostegel; F Pantucek; J Feichtinger; W Sega; H Gogl; W Höbling; R Silye; E Beck; H Denk; G Höfler; K Lichtenegger; H Rogatsch; S Galowitsch; O Dietze
Keywords: Mark53; Predictive marker; Randomized biomarker trial; Response prediction
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Entry Date(s):
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Date Created: 20181219 Latest Revision: 20220330
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Update Code:
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20240105
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PubMed Central ID:
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PMC6290852
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DOI:
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10.1007/s10353-018-0527-z
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PMID:
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30559831
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Background: In operable esophageal cancer patients, neoadjuvant therapy benefits only those who respond to the treatment. The • Pancho trial represents the first prospective randomized trial evaluating the relevance of the mark53 status for predicting the effect of two different neoadjuvant chemotherapies.
Method: Biomarker analysis was conducted using the mark53 analysis. Calculation of patient number needed was based on a 60% rate of marker positivity, deduced from the results of a phase II pilot study.
Results: From 2007-2012, the • Pancho trial recruited 235 patients with operable esophageal cancer in Austria. A total of 181 patients were eligible and could be subjected to mark53 analysis and randomization. After randomizing 74 patients, the overall TP53 mutation rate was 79%. However, due to the high prevalence of marker positivity, the number of projected patients was increased to 181 patients in order to ensure a sufficient number of marker-negative patients. After completion of the trial, the overall TP53 mutation rate was 77.9%.
Conclusion: Due to high medical need, the recruitment for the academic trial was excellent. Mark53 analysis clearly detected more mutations in the TP53 gene as compared to the cancer-specific p53 literature. Final analysis examining the interaction between the mark53 status and the effect of chemotherapies applied in the • Pancho trial is now awaited.
Competing Interests: S. Kappel-Latif was a part-time employee of MARK53 LTD Vienna. D. Kandioler is an uncompensated consultant and holds a leadership position at MARK53 LTD Vienna. J. Zacherl, M. Hejna, M. Westerhoff, D. Tamandl, A. Ba-Ssalamah, M. Mittlböck, B. Wolf, F. Wrba, I. Kührer, U. Pluschnig, S.F. Schoppmann, R. Függer, R. Zwrtek, K. Glaser, J. Karner, F. Längle, E. Wenzl, R. Roka, D. Öfner, J. Tschmelitsch, M. Hold, F. Keil and M. Gnant declare that they have no competing interests.Informed consent was obtained from all patients for being included in the study.
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