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Long-term results and recurrence patterns from SCALOP: a phase II randomised trial of gemcitabine- or capecitabine-based chemoradiation for locally advanced pancreatic cancer

Long-term results and recurrence patterns from SCALOP: a phase II randomised trial of gemcitabine- or capecitabine-based chemoradiation for locally advanced pancreatic cancer
Long-term results and recurrence patterns from SCALOP: a phase II randomised trial of gemcitabine- or capecitabine-based chemoradiation for locally advanced pancreatic cancer

Background: SCALOP, a randomised, phase II trial, tested the activity and safety of gemcitabine (GEM)-based and capecitabine (CAP)-based chemoradiation (CRT) for locally advanced pancreatic cancer (LAPC). Here we present the long-term outcomes.

Methods: eligibility: histologically proven LAPC ⩽7 cm. Following 12 weeks of induction GEMCAP chemotherapy (three cycles: GEM 1000 mg m(-2) days 1, 8, 15; CAP 830 mg m(-2) days 1-21 q28 days) patients with stable/responding disease, tumour ⩽6 cm, and WHO Performance Status 0-1 were randomised to receive one cycle GEMCAP followed by CAP (830 mg m(-2) b.d. on weekdays only) or GEM (300 mg m(-2) weekly) with radiation (50.4 Gy per 28 fractions).

Results: one-hundred fourteen patients (28 UK centres) were registered between 24 December 2009 and 25 October 2011, and 74 were randomised (CAP-RT=36; GEM-RT=38). At the time of this analysis, 105 of the 114 patients had died and the surviving 9 patients had been followed up for a median of 10.9 months (IQR: 2.9-18.7). Updated median OS was 17.6 months (95% CI: 14.6-22.7) in the CAP-CRT arm and 14.6 months (95% CI: 11.1-16.0) in the GEM-CRT arm (intention-to-treat adjusted hazard ratio (HR): 0.68 (95% CI: 0.38-1.21, P=0.185)); median progression-free survival (PFS) was 12.0 months (95% CI: 10.0-15.2) in the CAP-CRT arm and 10.4 months (95% CI: 8.8-12.7) in the GEM-CRT arm (intention-to-treat adjusted HR: 0.60 (95% CI: 0.32-1.14, P=0.120)). In baseline multivariable model, age ⩾65 years, better performance status, CA19.9<613 IU l(-1), and shorter tumour diameter predicted improved OS. CAP-CRT, age ⩾65 years, better performance status, CA19.9 <46 IU ml(-1) predicted improved OS and PFS in the pre-radiotherapy model. Nine-month PFS was highly predictive of OS.

Conclusions: CAP-CRT remains the superior regimen. SCALOP showed that patients with CA19.9 <46 IU ml(-1) after induction chemotherapy are more likely to benefit from CRT..

Journal Article
0007-0920
1264-1270
Hurt, C.N.
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Falk, S.
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Crosby, T.
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McDonald, A.
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Ray, R.
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Joseph, G.
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Staffurth, J.
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Abrams, R.A.
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Griffiths, G.
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Maughan, T.
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Mukherjee, S.
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et al.
Hurt, C.N.
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Falk, S.
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Crosby, T.
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McDonald, A.
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Ray, R.
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Joseph, G.
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Staffurth, J.
db58e06d-eb84-485a-8656-ea5d48ba548e
Abrams, R.A.
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Griffiths, G.
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Maughan, T.
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Mukherjee, S.
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Hurt, C.N., Falk, S. and Crosby, T. , et al. (2017) Long-term results and recurrence patterns from SCALOP: a phase II randomised trial of gemcitabine- or capecitabine-based chemoradiation for locally advanced pancreatic cancer. British Journal of Cancer, 116, 1264-1270. (doi:10.1038/bjc.2017.95).

Record type: Article

Abstract

Background: SCALOP, a randomised, phase II trial, tested the activity and safety of gemcitabine (GEM)-based and capecitabine (CAP)-based chemoradiation (CRT) for locally advanced pancreatic cancer (LAPC). Here we present the long-term outcomes.

Methods: eligibility: histologically proven LAPC ⩽7 cm. Following 12 weeks of induction GEMCAP chemotherapy (three cycles: GEM 1000 mg m(-2) days 1, 8, 15; CAP 830 mg m(-2) days 1-21 q28 days) patients with stable/responding disease, tumour ⩽6 cm, and WHO Performance Status 0-1 were randomised to receive one cycle GEMCAP followed by CAP (830 mg m(-2) b.d. on weekdays only) or GEM (300 mg m(-2) weekly) with radiation (50.4 Gy per 28 fractions).

Results: one-hundred fourteen patients (28 UK centres) were registered between 24 December 2009 and 25 October 2011, and 74 were randomised (CAP-RT=36; GEM-RT=38). At the time of this analysis, 105 of the 114 patients had died and the surviving 9 patients had been followed up for a median of 10.9 months (IQR: 2.9-18.7). Updated median OS was 17.6 months (95% CI: 14.6-22.7) in the CAP-CRT arm and 14.6 months (95% CI: 11.1-16.0) in the GEM-CRT arm (intention-to-treat adjusted hazard ratio (HR): 0.68 (95% CI: 0.38-1.21, P=0.185)); median progression-free survival (PFS) was 12.0 months (95% CI: 10.0-15.2) in the CAP-CRT arm and 10.4 months (95% CI: 8.8-12.7) in the GEM-CRT arm (intention-to-treat adjusted HR: 0.60 (95% CI: 0.32-1.14, P=0.120)). In baseline multivariable model, age ⩾65 years, better performance status, CA19.9<613 IU l(-1), and shorter tumour diameter predicted improved OS. CAP-CRT, age ⩾65 years, better performance status, CA19.9 <46 IU ml(-1) predicted improved OS and PFS in the pre-radiotherapy model. Nine-month PFS was highly predictive of OS.

Conclusions: CAP-CRT remains the superior regimen. SCALOP showed that patients with CA19.9 <46 IU ml(-1) after induction chemotherapy are more likely to benefit from CRT..

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Accepted/In Press date: 17 March 2017
e-pub ahead of print date: 4 April 2017
Published date: 9 May 2017
Keywords: Journal Article
Organisations: Clinical Trials Unit

Identifiers

Local EPrints ID: 407984
URI: http://eprints.soton.ac.uk/id/eprint/407984
ISSN: 0007-0920
PURE UUID: 452070e2-3bdb-46e6-967f-92344d9e7582
ORCID for C.N. Hurt: ORCID iD orcid.org/0000-0003-1206-8355
ORCID for G. Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 06 May 2017 01:03
Last modified: 21 Mar 2024 03:14

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Contributors

Author: C.N. Hurt ORCID iD
Author: S. Falk
Author: T. Crosby
Author: A. McDonald
Author: R. Ray
Author: G. Joseph
Author: J. Staffurth
Author: R.A. Abrams
Author: G. Griffiths ORCID iD
Author: T. Maughan
Author: S. Mukherjee
Corporate Author: et al.

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