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

Hurt, Chris Nicholas ORCID: https://orcid.org/0000-0003-1206-8355, Falk, S., Crosby, T., McDonald, A., Ray, R., Joseph, G., Staffurth, John Nicholas ORCID: https://orcid.org/0000-0002-7834-3172, Abrams, R. A., Griffiths, G., Maughan, T. and Mukherjee, S. 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 (10) , pp. 1264-1270. 10.1038/bjc.2017.95

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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 less than or equal to7 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 less than or equal to6 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 greater than or equal to65 years, better performance status, CA19.9<613 IU l−1, and shorter tumour diameter predicted improved OS. CAP-CRT, age greater than or equal to65 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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Uncontrolled Keywords:	pancreatic; chemoradiotherapy; phase II; randomised; trial; gemcitabine; capecitabine
Publisher:	Nature Publishing Group
ISSN:	0007-0920
Funders:	CRUK
Date of First Compliant Deposit:	5 April 2017
Date of Acceptance:	17 March 2017
Last Modified:	21 Oct 2023 01:10
URI:	https://orca.cardiff.ac.uk/id/eprint/99636

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