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Clinical benefit response was the measure invented for the 1997 trial that got gemcitabine approved for pancreatic cancer: a patient counted as benefiting if pain, painkiller use, day-to-day function or weight improved for at least four weeks without any of the others getting worse. It is a symptom endpoint, and it is why gemcitabine was accepted on a survival gain of about five weeks.
In the pivotal trial, 126 patients with advanced symptomatic pancreas cancer completed a lead-in period to characterise and stabilise their pain and were randomised to weekly gemcitabine or weekly fluorouracil. The primary efficacy measure was clinical benefit response, a composite of pain (analgesic consumption and pain intensity), Karnofsky performance status and weight; clinical benefit required a sustained improvement of at least four weeks in one parameter without worsening in any other. It was experienced by 23.8 percent of gemcitabine patients against 4.8 percent on fluorouracil, and median survival was 5.65 against 4.41 months (Burris 1997). The composite was designed for a disease in which tumours rarely shrink measurably and in which pain, weight loss and function are what patients notice, and the US approval of gemcitabine in 1996 rested on it alongside the survival difference. It is specific to that era: later pancreatic trials used overall survival (PRODIGE 4, MPACT, NAPOLI 3), disease-free survival in the adjuvant setting (PRODIGE 24: median 21.6 against 12.8 months for modified FOLFIRINOX against gemcitabine, Conroy 2018) or progression-free survival, and patient-reported outcomes are now collected with validated questionnaires rather than a bespoke composite. The phrase clinical benefit rate used in other cancers (complete plus partial response plus stable disease for a set time) is a different, tumour-measurement endpoint and should not be confused with it. The general endpoint terms on this site (overall survival, progression-free survival, event-free and disease-free survival) cover the modern measures.
Showing the molecule this term concerns: Gemcitabine.
Shares Metastatic pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares PRODIGE 24 / CCTG PA6, Gemcitabine, Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares Metastatic pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares Metastatic pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.
Shares Pancreatic ductal adenocarcinoma and the tags gi, pancreatic.