Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial

Mukherjee, Somnath, Hurt, Christopher ORCID: https://orcid.org/0000-0003-1206-8355, Radhakrishna, Ganesh, Gwynne, Sarah, Bateman, Andrew, Gollins, Simon, Hawkins, Maria A., Canham, Joanna ORCID: https://orcid.org/0000-0003-3482-0990, Grabsch, Heike I., Falk, Stephen, Sharma, Ricky A., Ray, Ruby, Roy, Rajarshi, Cox, Catrin, Maynard, Nick, Nixon, Lisette ORCID: https://orcid.org/0000-0002-1270-6970, Sebag-Montefiore, David J., Maughan, Timothy, Griffiths, Gareth O. and Crosby, Tom D.L. 2021. Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial. European Journal of Cancer 153 , pp. 153-161. 10.1016/j.ejca.2021.05.020

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Abstract

Aim This is the first randomised study to evaluate toxicity and survival outcomes of two neoadjuvant chemoradiotherapy (CRT) regimens for patients with localised oesophageal adenocarcinoma (OAC) or gastro-oesophageal junction (GOJ) adenocarcinoma. The initial results showed comparable toxicity between regimens and pathological complete response (pCR) rate favouring CarPacRT. Herein, we report survival, progression patterns, and long-term toxicity after a median follow-up of 40.7 months. Methods NeoSCOPE was an open-label, UK multicentre, randomised, phase II trial. Eighty-five patients with resectable OAC or GOJ adenocarcinoma, ≥cT3 and/or ≥cN1 (TNM v7), suitable for neoadjuvant CRT, were recruited between October 2013 and February 2015. Patients were randomised to OxCapRT (oxaliplatin 85 mg/m2 on Days 1, 15, and 29; capecitabine 625 mg/m2 orally twice daily on days of radiotherapy [RT]) or CarPacRT (carboplatin AUC2; paclitaxel 50 mg/m2 on Days 1, 8, 15, 22, and 29). RT dose was 45 Gy/25 fractions/5 weeks. Both arms received induction chemotherapy (two cycles oxaliplatin 130 mg/m2 on Day 1, capecitabine 625 mg/m2 orally twice daily on Days 1–21) before CRT. Surgery was performed 6–8 weeks after CRT. The primary end-point was pCR. Secondary end-points were toxicity, progression-free survival (PFS), overall survival (OS), and patterns of progression. Results Eighty-five patients were recruited from 17 UK centres. The median OS was 41.7 months (95% confidence interval [CI] 19.6 to not reached) in the OxCapRT arm and was not reached in the CarPacRT arm (multivariable hazard ratio [HR] = 0.48, 95% CIs: 0.24–0.95, P = 0.035). The median PFS was 32.6 months (95% CIs: 17.1 to not reached) in the OxCapRT arm and was not reached in the CarPacRT arm (multivariable HR = 0.54, 95% CIs: 0.29–1.01, P = 0.053). In both arms, the distant progression was twice as common as locoregional progression. Conclusions OS and PFS favoured neoadjuvant CarPacRT over OxCapRT. Distant was more common than locoregional progression; therefore, priority should be given to optimising the systemic treatment component.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Additional Information:	This is an open access article under the CC BY license (http://creativecommons.org/ licenses/by/4.0/).
Publisher:	European School of Oncology (ESO)
ISSN:	0959-8049
Funders:	CRUK
Date of First Compliant Deposit:	7 July 2021
Date of Acceptance:	8 May 2021
Last Modified:	21 Oct 2023 01:06
URI:	https://orca.cardiff.ac.uk/id/eprint/142368

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