uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Clinical Benefit Response in Pancreatic Cancer Trials Revisited
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
Show others and affiliations
2014 (English)In: Oncology Research and Treatment, ISSN 2296-5270, Vol. 37, no 1-2, 42-48 p.Article in journal (Refereed) Published
Abstract [en]

Objectives: Clinical benefit response (CBR), based on changes in pain, Karnofsky performance status, and weight, is an established palliative endpoint in trials for advanced gastrointestinal cancer. We investigated whether CBR is associated with survival, and whether CBR reflects a wide-enough range of domains to adequately capture patients' perception. Methods: CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer (n = 311) in parallel with patient-reported outcomes (PROs). Results: The median time to treatment failure was 3.4 months (range: 0-6). The majority of the CBRs (n = 39) were noted in patients who received chemotherapy for at least 5 months. Patients with CBR (n = 62) had longer survival than non-responders (n = 182) (hazard ratio = 0.69; 95% confidence interval: 0.51-0.94; p = 0.013). CBR was predicted with a sensitivity and specificity of 77-80% by various combinations of 3 mainly physical PROs. A comparison between the duration of CBR (n = 62, median = 8 months, range = 4-31) and clinically meaningful improvements in the PROs (n = 100-116; medians = 9-11 months, range = 4-24) showed similar intervals. Conclusion: CBR is associated with survival and mainly reflects physical domains. Within phase III chemotherapy trials for advanced gastrointestinal cancer, CBR can be replaced by a PRO evaluation, without losing substantial information but gaining complementary information.

Place, publisher, year, edition, pages
2014. Vol. 37, no 1-2, 42-48 p.
Keyword [en]
Clinical benefit response, Patient-reported outcome, Quality of life, Palliation, Pancreatic carcinoma, advanced
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-221972DOI: 10.1159/000357965ISI: 000332308100007OAI: oai:DiVA.org:uu-221972DiVA: diva2:710935
Available from: 2014-04-08 Created: 2014-04-07 Last updated: 2014-04-08Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full text

Search in DiVA

By author/editor
Glimelius, Bengt
By organisation
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 206 hits
ReferencesLink to record
Permanent link

Direct link