Bernhard, Jürg; Dietrich, Daniel; Glimelius, Bengt; Bodoky, György; Scheithauer, Werner; Herrmann, Richard (2014). Clinical benefit response in pancreatic cancer trials revisited. Oncology research and treatment, 37(1-2), pp. 42-48. Karger 10.1159/000357965
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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.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology |
UniBE Contributor: |
Bernhard, Jürg Theodor |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2296-5262 |
Publisher: |
Karger |
Language: |
English |
Submitter: |
Marianne Zahn |
Date Deposited: |
26 Jun 2015 12:39 |
Last Modified: |
21 Sep 2023 10:12 |
Publisher DOI: |
10.1159/000357965 |
PubMed ID: |
24613908 |
BORIS DOI: |
10.7892/boris.69811 |
URI: |
https://boris.unibe.ch/id/eprint/69811 |
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