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

Autor: Weiss L; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany., Heinemann V; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.; German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany., Fischer LE; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany., Gieseler F; Department of Hematology and Oncology, University Hospital Schleswig-Holstein-Campus Lübeck, Lübeck, Germany., Hoehler T; Department of Medicine I, Prosper Hospital, Recklinghausen, Germany., Mayerle J; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.; Department of Medicine II, University Hospital, LMU Munich, Munich, Germany., Quietzsch D; Department of Medical Oncology, Klinikum Chemnitz, Chemnitz, Germany., Reinacher-Schick A; Department of Hematology and Oncology, St. Josef Hospital, Ruhr University, Bochum, Germany., Schenk M; Department of Hematology and Oncology, Klinikum Barmherzige Brüder, Regensburg, Germany., Seipelt G; Onkologie Main-Taunus, Bad Soden, Germany., Siveke JT; West German Cancer Center, Bridge Institute of Experimental Tumor Therapy, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.; Division of Solid Tumor Translational Oncology, German Cancer Consortium (DKTK Partner Site Essen) and German Cancer Research Center, DKFZ, Heidelberg, Germany., Stahl M; Department of Medical Oncology, Evang. Kliniken Essen-Mitte, Essen, Germany., Vehling-Kaiser U; MVZ Dr. Vehling-Kaiser GmbH, Landshut, Germany., Waldschmidt DT; Department of Gastroenterology and Hepatology, University of Cologne, Cologne, Germany., Dorman K; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.; German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany., Zhang D; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.; German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany., Westphalen CB; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany., von Bergwelt-Baildon M; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.; German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany., Boeck S; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany.; German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany., Haas M; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany. michael.haas@med.uni-muenchen.de.; Comprehensive Cancer Center, University Hospital, LMU Munich, Munich, Germany. michael.haas@med.uni-muenchen.de.
Jazyk: angličtina
Zdroj: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico [Clin Transl Oncol] 2024 May; Vol. 26 (5), pp. 1268-1272. Date of Electronic Publication: 2023 Oct 04.
DOI: 10.1007/s12094-023-03323-1
Abstrakt: 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).
(© 2023. The Author(s).)
Databáze: MEDLINE
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