Zusammenfassung
GRUNDLAGEN: Die neoadjuvante Therapie bringt bei Patienten mit Ösophaguskarzinom keine eindeutige Verbesserung des Gesamtüberlebens. Einen deutlichen Überlebensvorteil zeigen allerdings Patienten mit kompletter pathologischer Remission. METHODIK: Dieses Review fasst mehrere retrospektive klinische Studien zusammen, die p53 als potentiellen prädiktiven Marker für das Ansprechen auf Chemotherapie ausweisen. Um den Zusammenhang zwischen p53 und Chemotherapieansprechen auf hohem Evidenzniveau (Level I) zu untersuchen, wurde die • Pancho Studie initiiert. ERGEBNISSE: In der • Pancho Studie wird erstmals – prospektiv randomisiert – untersucht, ob eine Interaktion zwischen p53 und dem Ansprechen auf Chemotherapie besteht. In der vorliegenden Arbeit berichten wir über das • Pancho Studiendesign (Wechselwirkungsdesign), die Fallzahlberechnung, die Studienendpunkte und den Rekrutierungsstatus dieser Multizenter-Studie nach einem Jahr Laufzeit. SCHLUSSFOLGERUNGEN: Die • Pancho Studie testet erstmals in einem geeigneten Design, ob der p53 Genotyp ein valider Marker ist, um wirksame Chemotherapien zu selektieren und damit eine individuelle Krebstherapie zu ermöglichen.
Summary
BACKGROUND: In esophageal cancer patients neoadjuvant therapy failed to demonstrate a clear benefit in overall survival. A significant advantage can be seen in patients with complete pathological response. METHODS: This review summarizes the results of retrospective clinical studies suggesting p53 as a predictive marker for chemotherapy response. To advance these findings to level of evidence I the • Pancho trial was initiated. RESULTS: The • Pancho trial represents the first prospective randomized trial testing the interaction between p53 and response to chemotherapy. The special design of the • Pancho trial (interaction design), the sample size considerations, the study endpoints and the 12 months accrual of this nationwide study are reported. CONCLUSIONS: The • Pancho trial evaluates for the first time whether the p53 genotype is qualified to select patients who will respond to certain chemotherapy and to guide cancer therapy.
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Kappel, S., Bichler, C., Wolf, B. et al. Turning the tables on surgical oncology: the • Pancho trial unplugged. Eur Surg 40, 277–283 (2008). https://doi.org/10.1007/s10353-008-0438-5
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DOI: https://doi.org/10.1007/s10353-008-0438-5
Schlüsselwörter
- Individuelle Krebstherapie
- Ösophagus Karzinom
- p53
- Neoadjuvante Therapie
- Prädiktiver Marker
- Vorhersage des Ansprechens
- Pancho