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Long-term results and recurrence patterns from SCOPE-1: A phase II/III randomised trial of definitive chemoradiotherapy +/- cetuximab in oesophageal cancer

Long-term results and recurrence patterns from SCOPE-1: A phase II/III randomised trial of definitive chemoradiotherapy +/- cetuximab in oesophageal cancer
Long-term results and recurrence patterns from SCOPE-1: A phase II/III randomised trial of definitive chemoradiotherapy +/- cetuximab in oesophageal cancer

BACKGROUND: The SCOPE-1 study tested the role of adding cetuximab to conventional definitive chemoradiotherapy (dCRT), and demonstrated greater toxicity and worse survival outcomes. We present the long-term outcomes and patterns of recurrence.

METHODS: SCOPE-1 was a phase II/III trial in which patients were randomised to cisplatin 60 mg m(-2) (day 1) and capecitabine 625 mg m(-2) bd (days 1-21) for four cycles +/- cetuximab 400 mg m(-2) day 1 then by 250 mg m(-2) weekly. Radiotherapy consisted of 50 Gy/25# given concurrently with cycles 3 and 4. Recruitment was between February 2008 and February 2012, when the IDMC recommended closure on the basis of futility.

RESULTS: About 258 patients (dCRT=129; dCRT+cetuximab (dCRT+C)=129) were recruited from 36 centres. About 72.9% (n=188) had squamous cell histology. The median follow-up (IQR) was 46.2 (35.9-48.3) months for surviving patients. The median overall survival (OS; months; 95% CI) was 34.5 (24.7-42.3) in dCRT and 24.7 (18.6-31.3) in dCRT+C (hazard ratio (HR)=1.25, 95% CIs: 0.93-1.69, P=0.137). Median progression-free survival (PFS; months; 95% CI) was 24.1 (15.3-29.9) and 15.9 (10.7-20.8) months, respectively (HR=1.28, 95% CIs: 0.94-1.75; P=0.114). On multivariable analysis only earlier stage, full-dose RT, and higher cisplatin dose intensity were associated with improved OS.

CONCLUSIONS: The mature analysis demonstrates that the dCRT regimen used in the study provided useful survival outcomes despite its use in patients who were largely unfit for surgery or who had inoperable disease. Given the competing risk of systemic and local failure, future studies should continue to focus on enhancing local control as well as optimising systemic therapy.

Journal Article
0007-0920
709-716
Crosby, T
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Hurt, C N
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Falk, S.
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Gollins, S
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Staffurth, J
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Ray, R
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Bridgewater, J A
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Geh, J I
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Cunningham, D
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Blazeby, J.
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Roy, R.
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Maughan, T
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Griffiths, G.
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Mukherjee, S.
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Crosby, T
82fd6364-ad6d-4e24-bb81-e1868258c4e6
Hurt, C N
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Falk, S.
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Gollins, S
bb471398-594e-43d3-81c6-3cf1cdcd3023
Staffurth, J
db58e06d-eb84-485a-8656-ea5d48ba548e
Ray, R
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Bridgewater, J A
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Geh, J I
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Cunningham, D
02b4fd3a-f452-4419-96a7-f98f609f098d
Blazeby, J.
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Roy, R.
b73b6155-b144-48c3-8eb6-cffe00e385ef
Maughan, T
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Griffiths, G.
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Mukherjee, S.
d9278fe6-ec80-45e0-b3ab-137e668787e8

Crosby, T, Hurt, C N, Falk, S., Gollins, S, Staffurth, J, Ray, R, Bridgewater, J A, Geh, J I, Cunningham, D, Blazeby, J., Roy, R., Maughan, T, Griffiths, G. and Mukherjee, S. (2017) Long-term results and recurrence patterns from SCOPE-1: A phase II/III randomised trial of definitive chemoradiotherapy +/- cetuximab in oesophageal cancer British Journal of Cancer, 116, (6), pp. 709-716. (doi:10.1038/bjc.2017.21).

Record type: Article

Abstract

BACKGROUND: The SCOPE-1 study tested the role of adding cetuximab to conventional definitive chemoradiotherapy (dCRT), and demonstrated greater toxicity and worse survival outcomes. We present the long-term outcomes and patterns of recurrence.

METHODS: SCOPE-1 was a phase II/III trial in which patients were randomised to cisplatin 60 mg m(-2) (day 1) and capecitabine 625 mg m(-2) bd (days 1-21) for four cycles +/- cetuximab 400 mg m(-2) day 1 then by 250 mg m(-2) weekly. Radiotherapy consisted of 50 Gy/25# given concurrently with cycles 3 and 4. Recruitment was between February 2008 and February 2012, when the IDMC recommended closure on the basis of futility.

RESULTS: About 258 patients (dCRT=129; dCRT+cetuximab (dCRT+C)=129) were recruited from 36 centres. About 72.9% (n=188) had squamous cell histology. The median follow-up (IQR) was 46.2 (35.9-48.3) months for surviving patients. The median overall survival (OS; months; 95% CI) was 34.5 (24.7-42.3) in dCRT and 24.7 (18.6-31.3) in dCRT+C (hazard ratio (HR)=1.25, 95% CIs: 0.93-1.69, P=0.137). Median progression-free survival (PFS; months; 95% CI) was 24.1 (15.3-29.9) and 15.9 (10.7-20.8) months, respectively (HR=1.28, 95% CIs: 0.94-1.75; P=0.114). On multivariable analysis only earlier stage, full-dose RT, and higher cisplatin dose intensity were associated with improved OS.

CONCLUSIONS: The mature analysis demonstrates that the dCRT regimen used in the study provided useful survival outcomes despite its use in patients who were largely unfit for surgery or who had inoperable disease. Given the competing risk of systemic and local failure, future studies should continue to focus on enhancing local control as well as optimising systemic therapy.

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e-pub ahead of print date: 14 February 2017
Published date: 14 March 2017
Keywords: Journal Article

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Local EPrints ID: 414067
URI: http://eprints.soton.ac.uk/id/eprint/414067
ISSN: 0007-0920
PURE UUID: b8bb0f91-ce09-4604-8c8f-2418dd0cb9a2
ORCID for G. Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 13 Sep 2017 16:31
Last modified: 01 Nov 2017 17:34

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Contributors

Author: T Crosby
Author: C N Hurt
Author: S. Falk
Author: S Gollins
Author: J Staffurth
Author: R Ray
Author: J A Bridgewater
Author: J I Geh
Author: D Cunningham
Author: J. Blazeby
Author: R. Roy
Author: T Maughan
Author: G. Griffiths ORCID iD
Author: S. Mukherjee

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