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Weiss, Lena; Heinemann, Volker; Fischer, Laura E.; Gieseler, Frank; Hoehler, Thomas; Mayerle, Julia; Quietzsch, Detlef; Reinacher-Schick, Anke; Schenk, Michael; Seipelt, Gernot; Siveke, Jens T.; Stahl, Michael; Vehling-Kaiser, Ursula; Waldschmidt, Dirk T.; Dorman, Klara; Zhang, Danmei; Westphalen, C. Benedikt; von Bergwelt-Baildon, Michael; Boeck, Stefan; Haas, Michael

Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection?

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  • Media type: E-Article
  • Title: Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection?
  • Contributor: Weiss, Lena; Heinemann, Volker; Fischer, Laura E.; Gieseler, Frank; Hoehler, Thomas; Mayerle, Julia; Quietzsch, Detlef; Reinacher-Schick, Anke; Schenk, Michael; Seipelt, Gernot; Siveke, Jens T.; Stahl, Michael; Vehling-Kaiser, Ursula; Waldschmidt, Dirk T.; Dorman, Klara; Zhang, Danmei; Westphalen, C. Benedikt; von Bergwelt-Baildon, Michael; Boeck, Stefan; Haas, Michael
  • Published: Springer Science and Business Media LLC, 2023
  • Published in: Clinical and Translational Oncology, 26 (2023) 5, Seite 1268-1272
  • Language: English
  • DOI: 10.1007/s12094-023-03323-1
  • ISSN: 1699-3055
  • Origination:
  • Footnote:
  • Description: Abstract 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. Trial registration numbers NCT00440167 (AIO-PK0104), NCT01729481 (RASH), NCT01728818 (ACCEPT).