Resumen de Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection?
Lena Weiss, V. Heinemann, Laura E. Fischer, Frank Gieseler, Thomas Hoehler, Julia Mayerle, Detlef Quietzsch, Anke Reinacher-Schick, Michael Schenk, Gernot Seipelt, J. T. Siveke, Michael Stahl, Ursula Vehling-Kaiser, Dirk T. Waldschmidt, Klara Dorman, Danmei Zhang, C. B. Westphalen, Michael S. von Bergwelt Baildon, S. Boeck, M. Haas
Purpose To analyze the 3-month life expectancy rate in pancreatic cancer (PC) patients treated within prospective trials from the German AIO study group.
Patients and methods A pooled analysis was conducted for patients with advanced PC that were treated within five phase II/III studies conducted between 1997 and 2017 (Gem/Cis, Ro96, RC57, ACCEPT, RASH). The primary goal for the current report was to identify the actual 3-month survival rate, a standard inclusion criterion in oncology trials.
Results Overall, 912 patients were included, 83% had metastatic and 17% locally advanced PC; the estimated median overall survival (OS) was 7.1 months. Twenty-one percent of the participants survived < 3 months, with a range from 26% in RC57 to 15% in RASH. Significant predictors for not reaching 3-month OS were > 1 previous treatment line (p < 0.001) and performance status (p < 0.001).
Conclusions Despite the definition of a life expectancy of > 3 months as a standard inclusion criterion in clinical trials for advanced PC, a significant proportion of study patients does not survive > 3 months.
