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Health-related quality of Life in SCALOP, a randomized phase 2 trial comparing chemoradiation therapy regimens in locally advanced pancreatic cancer

Health-related quality of Life in SCALOP, a randomized phase 2 trial comparing chemoradiation therapy regimens in locally advanced pancreatic cancer
Health-related quality of Life in SCALOP, a randomized phase 2 trial comparing chemoradiation therapy regimens in locally advanced pancreatic cancer
Purpose: chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.

Methods and materials: patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).

Results: a total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.

Conclusions: although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.
Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Chemoradiotherapy, Deoxycytidine, Drug Administration Schedule, Fatigue, Feeding and Eating Disorders, Female, Follow-Up Studies, Gastrointestinal Diseases, Health Status, Humans, Induction Chemotherapy, Male, Pancreatic Neoplasms, Quality of Life, Statistics, Nonparametric, Surveys and Questionnaires, United Kingdom, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Validation Studies
0360-3016
810-818
Hurt, Christopher N.
bf8b37a0-8f08-4b47-b3f3-6fc65f7ab87f
Mukherjee, Somnath
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Bridgewater, John
a7c51f93-a80e-4b89-828f-34f477259d5c
Falk, Stephen
6bda4f5d-d5b0-4558-89d3-9e32cacf202a
Crosby, Tom
d641cb6d-efc6-45ae-b083-a21c599a032c
McDonald, Alec
3c068f31-c845-455f-9cb9-5573bb0fbe10
Joseph, George
dca177d4-1711-4477-ab78-c852685fd32a
Staffurth, John
51734078-ea1f-4188-8d32-75f786921586
Abrams, Ross A.
e54ad202-abde-4079-b960-82403827f119
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
Bridges, Sarah
4864c2ba-e794-4fb5-bb1b-dd868e1d20b4
Dutton, Peter
b984314b-813d-41f5-9040-c713c07ebb33
Griffiths, Gareth
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Maughan, Tim
9f5b1ca4-9ed7-4100-bf04-c4026e4b5395
Johnson, Colin
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
et al.
Hurt, Christopher N.
bf8b37a0-8f08-4b47-b3f3-6fc65f7ab87f
Mukherjee, Somnath
b2ff936d-d068-48d5-9bb5-9f3431013b5b
Bridgewater, John
a7c51f93-a80e-4b89-828f-34f477259d5c
Falk, Stephen
6bda4f5d-d5b0-4558-89d3-9e32cacf202a
Crosby, Tom
d641cb6d-efc6-45ae-b083-a21c599a032c
McDonald, Alec
3c068f31-c845-455f-9cb9-5573bb0fbe10
Joseph, George
dca177d4-1711-4477-ab78-c852685fd32a
Staffurth, John
51734078-ea1f-4188-8d32-75f786921586
Abrams, Ross A.
e54ad202-abde-4079-b960-82403827f119
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
Bridges, Sarah
4864c2ba-e794-4fb5-bb1b-dd868e1d20b4
Dutton, Peter
b984314b-813d-41f5-9040-c713c07ebb33
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Maughan, Tim
9f5b1ca4-9ed7-4100-bf04-c4026e4b5395
Johnson, Colin
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a

Hurt, Christopher N., Mukherjee, Somnath and Bridgewater, John , et al. (2015) Health-related quality of Life in SCALOP, a randomized phase 2 trial comparing chemoradiation therapy regimens in locally advanced pancreatic cancer. International Journal of Radiation Oncology*Biology*Physics, 93 (4), 810-818. (doi:10.1016/j.ijrobp.2015.08.026).

Record type: Article

Abstract

Purpose: chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.

Methods and materials: patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).

Results: a total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.

Conclusions: although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.

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Accepted/In Press date: 13 August 2015
e-pub ahead of print date: 24 August 2015
Published date: 19 October 2015
Keywords: Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Chemoradiotherapy, Deoxycytidine, Drug Administration Schedule, Fatigue, Feeding and Eating Disorders, Female, Follow-Up Studies, Gastrointestinal Diseases, Health Status, Humans, Induction Chemotherapy, Male, Pancreatic Neoplasms, Quality of Life, Statistics, Nonparametric, Surveys and Questionnaires, United Kingdom, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Validation Studies
Organisations: Cancer Sciences, Clinical Trials Unit

Identifiers

Local EPrints ID: 383080
URI: http://eprints.soton.ac.uk/id/eprint/383080
ISSN: 0360-3016
PURE UUID: 1776d14a-e874-44c8-b47f-4f5e11e4f482
ORCID for Christopher N. Hurt: ORCID iD orcid.org/0000-0003-1206-8355
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

Catalogue record

Date deposited: 21 Oct 2015 13:45
Last modified: 23 Mar 2024 03:13

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Contributors

Author: Christopher N. Hurt ORCID iD
Author: Somnath Mukherjee
Author: John Bridgewater
Author: Stephen Falk
Author: Tom Crosby
Author: Alec McDonald
Author: George Joseph
Author: John Staffurth
Author: Ross A. Abrams
Author: Jane M. Blazeby
Author: Sarah Bridges
Author: Peter Dutton
Author: Tim Maughan
Author: Colin Johnson
Corporate Author: et al.

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