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Impact of short-course preoperative radiotherapy for rectal cancer on patients' quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial

Impact of short-course preoperative radiotherapy for rectal cancer on patients' quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial
Impact of short-course preoperative radiotherapy for rectal cancer on patients' quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial

PURPOSE: The Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 (MRC CR07/NCIC CTG C016) trial showed that, in patients with operable rectal cancer, short-course preoperative radiotherapy (PRE) reduced the rate of local recurrence compared with surgery followed by selective postoperative chemoradiotherapy for patients with a positive circumferential resection margin. However, the advantages of giving PRE to all patients needs to be balanced against any negative impact on patients' quality of life.

PATIENTS AND METHODS: All 1,350 patients were asked to complete the Medical Outcomes Study Short-Form 36-item (MOS SF-36) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal 38-item (EORTC QLQ-CR38) questionnaires. A priori hypotheses related to the impact of treatment on sexual, bowel, and physical function and general health.

RESULTS: Male sexual dysfunction was significantly increased following surgery (P < .001), although there was no difference between treatment arms. However, a treatment difference had emerged at 6 months (PRE patients reporting significantly greater dysfunction; P = .004), which persisted out to at least 2 years (an insufficient number of female patients completed the sexual dysfunction questions to draw firm conclusions). Both treatment groups reported similar levels of decreased physical function at 3 months, but thereafter it returned to baseline levels. There was no evidence of any major changes between treatments or time points in terms of general health or bowel function, but exploratory analysis indicated a significant (P = .006 at 2 years) increase in the level of fecal incontinence with PRE.

CONCLUSION: These results from a large randomized trial using validated patient-completed questionnaires show that, for males, the main adverse effect was sexual dysfunction, and the main cause of this was surgery, but that PRE also affected sexual and some aspects of bowel functioning.

Academies and Institutes, Adenocarcinoma, Aged, Canada, Chemotherapy, Adjuvant, Chi-Square Distribution, Defecation, Dose Fractionation, Female, Humans, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Recurrence, Local, Quality of Life, Radiation Injuries, Radiotherapy, Adjuvant, Recovery of Function, Rectal Neoplasms, Sexual Dysfunction, Physiological, Surveys and Questionnaires, Time Factors, Treatment Outcome, United Kingdom, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
1527-7755
4233-9
Stephens, Richard J.
f792b135-01d0-4ca3-82f5-bd6da92fe82e
Thompson, Lindsay C.
3f579478-3014-41a7-89ed-a5437e5cdfba
Quirke, Phil
78b3a2aa-c089-458e-800b-b6fefae41d80
Steele, Robert
fb00d88c-b651-4285-8198-b8e57590343f
Grieve, Robert
391decfc-cd79-403e-9aa2-f262f1869414
Couture, Jean
aeddffe2-92a0-4841-a562-6aa14eb79b4a
Griffiths, Gareth O.
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Sebag-Montefiore, David
7cd6f558-4265-4adb-b8dd-771f47ab8343
Stephens, Richard J.
f792b135-01d0-4ca3-82f5-bd6da92fe82e
Thompson, Lindsay C.
3f579478-3014-41a7-89ed-a5437e5cdfba
Quirke, Phil
78b3a2aa-c089-458e-800b-b6fefae41d80
Steele, Robert
fb00d88c-b651-4285-8198-b8e57590343f
Grieve, Robert
391decfc-cd79-403e-9aa2-f262f1869414
Couture, Jean
aeddffe2-92a0-4841-a562-6aa14eb79b4a
Griffiths, Gareth O.
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Sebag-Montefiore, David
7cd6f558-4265-4adb-b8dd-771f47ab8343

Stephens, Richard J., Thompson, Lindsay C., Quirke, Phil, Steele, Robert, Grieve, Robert, Couture, Jean, Griffiths, Gareth O. and Sebag-Montefiore, David (2010) Impact of short-course preoperative radiotherapy for rectal cancer on patients' quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial. Journal of Clinical Oncology, 28 (27), 4233-9. (doi:10.1200/JCO.2009.26.5264).

Record type: Article

Abstract

PURPOSE: The Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 (MRC CR07/NCIC CTG C016) trial showed that, in patients with operable rectal cancer, short-course preoperative radiotherapy (PRE) reduced the rate of local recurrence compared with surgery followed by selective postoperative chemoradiotherapy for patients with a positive circumferential resection margin. However, the advantages of giving PRE to all patients needs to be balanced against any negative impact on patients' quality of life.

PATIENTS AND METHODS: All 1,350 patients were asked to complete the Medical Outcomes Study Short-Form 36-item (MOS SF-36) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal 38-item (EORTC QLQ-CR38) questionnaires. A priori hypotheses related to the impact of treatment on sexual, bowel, and physical function and general health.

RESULTS: Male sexual dysfunction was significantly increased following surgery (P < .001), although there was no difference between treatment arms. However, a treatment difference had emerged at 6 months (PRE patients reporting significantly greater dysfunction; P = .004), which persisted out to at least 2 years (an insufficient number of female patients completed the sexual dysfunction questions to draw firm conclusions). Both treatment groups reported similar levels of decreased physical function at 3 months, but thereafter it returned to baseline levels. There was no evidence of any major changes between treatments or time points in terms of general health or bowel function, but exploratory analysis indicated a significant (P = .006 at 2 years) increase in the level of fecal incontinence with PRE.

CONCLUSION: These results from a large randomized trial using validated patient-completed questionnaires show that, for males, the main adverse effect was sexual dysfunction, and the main cause of this was surgery, but that PRE also affected sexual and some aspects of bowel functioning.

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More information

Published date: 20 September 2010
Keywords: Academies and Institutes, Adenocarcinoma, Aged, Canada, Chemotherapy, Adjuvant, Chi-Square Distribution, Defecation, Dose Fractionation, Female, Humans, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Recurrence, Local, Quality of Life, Radiation Injuries, Radiotherapy, Adjuvant, Recovery of Function, Rectal Neoplasms, Sexual Dysfunction, Physiological, Surveys and Questionnaires, Time Factors, Treatment Outcome, United Kingdom, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
Organisations: Clinical Trials Unit

Identifiers

Local EPrints ID: 406322
URI: http://eprints.soton.ac.uk/id/eprint/406322
ISSN: 1527-7755
PURE UUID: c121fe63-14b3-437e-9749-2ac250df65f1
ORCID for Gareth O. Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 10 Mar 2017 10:44
Last modified: 16 Mar 2024 04:19

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Contributors

Author: Richard J. Stephens
Author: Lindsay C. Thompson
Author: Phil Quirke
Author: Robert Steele
Author: Robert Grieve
Author: Jean Couture
Author: David Sebag-Montefiore

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