Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise.

2.50
Hdl Handle:
http://hdl.handle.net/10541/87866
Title:
Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise.
Authors:
Stephens, Richard J; Hopwood, Penelope; Girling, David J
Abstract:
The assessment of symptom palliation is an essential component of many treatment comparisons in clinical trials, yet an extensive literature search revealed no consensus as to its precise definition, which could embrace relief of symptoms, time to their onset, duration, degree, as well as symptom control and prevention. In an attempt to assess the importance of these aspects and to compare different methods of analysis, we used one symptom (cough) from a patient self-assessment questionnaire (the Rotterdam Symptom Checklist) in a large (>300 patient) multicentre randomized clinical trial (conducted by the Medical Research Council Lung Cancer Working Party) of palliative chemotherapy in small-cell lung cancer. The regimens compared were a two-drug regimen (2D) and a four-drug regimen (4D). No differences were seen between the regimens in time of onset of palliation or its duration. The degree of palliation was strongly related to the initial severity: 90% of the patients with moderate or severe cough at baseline reported improvement, compared with only 53% of those with mild cough. Analyses using different landmark time points gave conflicting results: the 4D regimen was superior at 1 month and at 3 months, whereas at 2 months the 2D regimen appeared superior. When improvement at any time up to 3 months was considered, the 4D regimen showed a significant benefit (4D 79%, 2D 60%, P = 0.02). These findings emphasize the need for caution in interpreting results, and the importance of working towards a standard definition of symptom palliation. The current lack of specified criteria makes analysis and interpretation of trial results difficult, and comparison across trials impossible. A standard definition of palliation for use in the analysis of clinical trials data is proposed, which takes into account aspects of onset, duration and degree of palliation, and symptom improvement, control and prevention.
Affiliation:
MRC Cancer Trials Office, Cambridge, UK.
Citation:
Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise. 1999, 79 (3-4):538-44 Br. J. Cancer
Journal:
British Journal of Cancer
Issue Date:
Feb-1999
URI:
http://hdl.handle.net/10541/87866
DOI:
10.1038/sj.bjc.6690085
PubMed ID:
10027327
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorStephens, Richard Jen
dc.contributor.authorHopwood, Penelopeen
dc.contributor.authorGirling, David Jen
dc.date.accessioned2009-12-14T15:29:31Z-
dc.date.available2009-12-14T15:29:31Z-
dc.date.issued1999-02-
dc.identifier.citationDefining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise. 1999, 79 (3-4):538-44 Br. J. Canceren
dc.identifier.issn0007-0920-
dc.identifier.pmid10027327-
dc.identifier.doi10.1038/sj.bjc.6690085-
dc.identifier.urihttp://hdl.handle.net/10541/87866-
dc.description.abstractThe assessment of symptom palliation is an essential component of many treatment comparisons in clinical trials, yet an extensive literature search revealed no consensus as to its precise definition, which could embrace relief of symptoms, time to their onset, duration, degree, as well as symptom control and prevention. In an attempt to assess the importance of these aspects and to compare different methods of analysis, we used one symptom (cough) from a patient self-assessment questionnaire (the Rotterdam Symptom Checklist) in a large (>300 patient) multicentre randomized clinical trial (conducted by the Medical Research Council Lung Cancer Working Party) of palliative chemotherapy in small-cell lung cancer. The regimens compared were a two-drug regimen (2D) and a four-drug regimen (4D). No differences were seen between the regimens in time of onset of palliation or its duration. The degree of palliation was strongly related to the initial severity: 90% of the patients with moderate or severe cough at baseline reported improvement, compared with only 53% of those with mild cough. Analyses using different landmark time points gave conflicting results: the 4D regimen was superior at 1 month and at 3 months, whereas at 2 months the 2D regimen appeared superior. When improvement at any time up to 3 months was considered, the 4D regimen showed a significant benefit (4D 79%, 2D 60%, P = 0.02). These findings emphasize the need for caution in interpreting results, and the importance of working towards a standard definition of symptom palliation. The current lack of specified criteria makes analysis and interpretation of trial results difficult, and comparison across trials impossible. A standard definition of palliation for use in the analysis of clinical trials data is proposed, which takes into account aspects of onset, duration and degree of palliation, and symptom improvement, control and prevention.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subject.meshCarcinoma, Small Cell-
dc.subject.meshClinical Trials as Topic-
dc.subject.meshCough-
dc.subject.meshFalse Positive Reactions-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshPalliative Care-
dc.subject.meshQuality of Life-
dc.subject.meshQuestionnaires-
dc.subject.meshReproducibility of Results-
dc.subject.meshResearch Design-
dc.subject.meshSensitivity and Specificity-
dc.titleDefining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise.en
dc.typeArticleen
dc.contributor.departmentMRC Cancer Trials Office, Cambridge, UK.en
dc.identifier.journalBritish Journal of Canceren

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