Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection?
Clinical trial
Inclusion criterion
Pancreatic cancer
Prognosis
Journal
Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico
ISSN: 1699-3055
Titre abrégé: Clin Transl Oncol
Pays: Italy
ID NLM: 101247119
Informations de publication
Date de publication:
May 2024
May 2024
Historique:
received:
05
07
2023
accepted:
05
09
2023
pubmed:
5
10
2023
medline:
5
10
2023
entrez:
4
10
2023
Statut:
ppublish
Résumé
To analyze the 3-month life expectancy rate in pancreatic cancer (PC) patients treated within prospective trials from the German AIO study group. 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. 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). 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. NCT00440167 (AIO-PK0104), NCT01729481 (RASH), NCT01728818 (ACCEPT).
Identifiants
pubmed: 37794220
doi: 10.1007/s12094-023-03323-1
pii: 10.1007/s12094-023-03323-1
doi:
Banques de données
ClinicalTrials.gov
['NCT01729481', 'NCT00440167', 'NCT01728818']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1268-1272Informations de copyright
© 2023. The Author(s).
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