PMID- 10050982
OWN - NLM
STAT- MEDLINE
DCOM- 19990311
LR  - 20190905
IS  - 0284-186X (Print)
IS  - 0284-186X (Linking)
VI  - 37
IP  - 7-8
DP  - 1998
TI  - Evaluation of clinical benefit of chemotherapy in patients with upper 
      gastrointestinal cancer.
PG  - 651-9
AB  - A new endpoint, the Clinical Benefit Response (CBR), was recently suggested as a 
      means of measuring the effectiveness of palliative chemotherapy in patients with 
      pancreatic cancer. We took advantage of extensive recordings of measurements of 
      treatment effects in two trials in patients with gastrointestinal cancer in order 
      to assess the relevance of CBR criteria. In 151 patients, 53 with pancreatic 
      cancer, 37 with biliary cancer and 61 with gastric cancer, who were randomized 
      between chemotherapy with best supportive care and best supportive care alone, 
      CBR criteria were applied retrospectively to the evaluations of the effects on 
      the patients' well-being made by the treating physician and by the patient in 
      quality-of-life questionnaires, chiefly EORTC QLQ C-30. When compared with 
      subjective response evaluations made by both the physician and the patients' 
      questionnaire data, it was found that CBR overestimated the beneficial effects in 
      certain patients and underestimated them in others. The reason for this 
      overestimation was mainly that the adverse effects of the chemotherapy were not 
      considered appropriately. The underestimation was mainly due to the fact that CBR 
      in practice is dominated by pain assessment, and alterations in other symptoms 
      are also clinically relevant. CBR did, however, show the same differences between 
      the two randomized groups as the subjective response evaluations and the 
      quality-of-life estimations. It is concluded that CBR can be used as a method of 
      measuring the beneficial clinical impact of a treatment strategy in clinical 
      trials, but its limitations in reflecting several important aspects influencing 
      the overall well-being of patients do, however, restrict its use. The criteria 
      designed for use in patients with pancreatic cancer cannot be immediately applied 
      to patients with other cancer types.
FAU - Hoffman, K
AU  - Hoffman K
AD  - Department of Oncology, University of Uppsala, Sweden. Katarina.Hoffman@ccs.uu.se
FAU - Glimelius, B
AU  - Glimelius B
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Sweden
TA  - Acta Oncol
JT  - Acta oncologica (Stockholm, Sweden)
JID - 8709065
SB  - IM
MH  - Adult
MH  - Aged
MH  - Algorithms
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Biliary Tract Neoplasms/*drug therapy
MH  - Body Weight
MH  - Female
MH  - Humans
MH  - Karnofsky Performance Status/statistics & numerical data
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - *Palliative Care
MH  - Pancreatic Neoplasms/*drug therapy
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - *Severity of Illness Index
MH  - Stomach Neoplasms/*drug therapy
MH  - Surveys and Questionnaires
EDAT- 1999/03/02 00:00
MHDA- 1999/03/02 00:01
CRDT- 1999/03/02 00:00
PHST- 1999/03/02 00:00 [pubmed]
PHST- 1999/03/02 00:01 [medline]
PHST- 1999/03/02 00:00 [entrez]
AID - 10.1080/028418698429991 [doi]
PST - ppublish
SO  - Acta Oncol. 1998;37(7-8):651-9. doi: 10.1080/028418698429991.