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11.06.2018 | short communication | Ausgabe 4/2018 Open Access

European Surgery 4/2018

• Pancho trial (p53-adapted neoadjuvant chemotherapy for resectable esophageal cancer) completed—mutation rate of the marker higher than expected

Zeitschrift:
European Surgery > Ausgabe 4/2018
Autoren:
Sonja Kappel-Latif, Johannes Zacherl, Michael Hejna, Maria Westerhoff, Dietmar Tamandl, Ahmed Ba-Ssalamah, Martina Mittlböck, Brigitte Wolf, Friedrich Wrba, Irene Kührer, Ursula Pluschnig, Sebastian F. Schoppmann, Reinhold Függer, Ronald Zwrtek, Karl Glaser, Josef Karner, Friedrich Längle, Etienne Wenzl, Rudolf Roka, Dietmar Öfner, Jörg Tschmelitsch, Michael Hold, Felix Keil, Michael Gnant, MD, MBA Daniela Kandioler, the Pancho trialists and for the Medical University of Vienna p53research group
Wichtige Hinweise
Members of the Pancho trialists are listed in the appendix.

Summary

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.
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