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. 2024 May;26(5):1268-1272.
doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4.

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  1   2 , Volker Heinemann  1   2   3 , Laura E Fischer  1   2 , Frank Gieseler  4 , Thomas Hoehler  5 , Julia Mayerle  2   6 , Detlef Quietzsch  7 , Anke Reinacher-Schick  8 , Michael Schenk  9 , Gernot Seipelt  10 , Jens T Siveke  11   12 , Michael Stahl  13 , Ursula Vehling-Kaiser  14 , Dirk T Waldschmidt  15 , Klara Dorman  1   2   3 , Danmei Zhang  1   2   3 , C Benedikt Westphalen  1   2 , Michael von Bergwelt-Baildon  1   2   3 , Stefan Boeck  1   2   3 , Michael Haas  16   17
Affiliations

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 et al. Clin Transl Oncol. 2024 May.

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).

Keywords: Clinical trial; Inclusion criterion; Pancreatic cancer; Prognosis.

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Conflict of interest statement

Lena Weiss has received honoraria for scientific presentations from Roche and Servier and travel accommodation expenses from Amgen. Volker Heinemann received honoraria for talks and advisory board role for Merck, Amgen, Roche, Sanofi, Servier, Pfizer, Pierre-Fabre, AstraZeneca, BMS; MSD, Novartis, Terumo, Oncosil, NORDIC, Seagen, GSK. Research funding from Merck, Amgen, Roche, Sanofi, Boehringer-Ingelheim, SIRTEX, Servier. Anke Reinacher-Schick received honoraria from Amgen, Roche, Merck Serono, BMS, MSD, MCI Group, Astra Zeneca, for advisory and consultancy Amgen, Roche, Merck Serono, BMS, MSD, Astra Zeneca, Pierre Fabre, Research grant/Funding Roche, Celgene, Ipsen, Amgen, Alexion Pharmaceuticals, Atra Zeneca, Lilly, Servier, AIO Studien gGmbH, Rafael Pharmaceutics, Erytech Pharma, BioNTech, Travel expenses Roche, Amgen, Pierre Fabre. Jens T. Siveke receives honoraria as consultant or for continuing medical education presentations from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Immunocore, MSD Sharp Dohme, Novartis, Roche/Genentech, and Servier. His institution receives research funding from Abalos Therapeutics, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eisbach Bio, and Roche/Genentech; he holds ownership and serves on the Board of Directors of Pharma15, all outside the submitted work. Michael Stahl received honoraria from Lilly. Klara Dorman has received travel support from Servier, GSK, and BMS, as well as honoraria from AstraZeneca. Danmei Zhang received honoraria from Astra Zeneca. Stefan Boeck had a consulting and advisory role for Celgene, Servier, Incyte, Fresenius, Janssen-Cilag, AstraZeneca, MSD, and BMS, and received honoraria for scientific presentations from Roche, Celgene, Servier, and MSD. Michael Haas has received travel support from servier and honoraria for scientific presentations from Falk Foundation. All other authors declare no conflict of interest.

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