1. Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial
- Author
-
Simon Gollins, Rajarshi Roy, Maria A. Hawkins, Gareth Griffiths, Tim Maughan, Lisette Sheena Nixon, Chris Nicholas Hurt, Ruby Ray, Stephen Falk, Andrew Bateman, Tom Crosby, Sarah Gwynne, Ricky A. Sharma, Somnath Mukherjee, Catrin Cox, Ganesh Radhakrishna, David Sebag-Montefiore, Joanne Canham, Heike I. Grabsch, Nick Maynard, RS: GROW - R2 - Basic and Translational Cancer Biology, and Pathologie
- Subjects
0301 basic medicine ,Male ,Cancer Research ,medicine.medical_specialty ,Survival ,Esophageal Neoplasms ,Paclitaxel ,Adenocarcinoma ,Gastroenterology ,law.invention ,Carboplatin ,Capecitabine ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Original Research ,Aged ,Randomised controlled trial ,business.industry ,PERIOPERATIVE CHEMOTHERAPY ,Oesophageal cancer ,Hazard ratio ,Induction chemotherapy ,Chemoradiotherapy, Adjuvant ,medicine.disease ,CANCER ,Oxaliplatin ,Clinical trial ,Neoadjuvant chemoradiotherapy ,030104 developmental biology ,Oncology ,chemistry ,030220 oncology & carcinogenesis ,Surgery ,Female ,business ,medicine.drug - 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. Clinical trial information EudraCT Number: 2012-000640-10; ClinicalTrials.gov: NCT01843829., Highlights • Randomised study of neoadjuvant chemoradiotherapy for oesophageal adenocarcinoma. • The median overall survival was significantly better with CarPacRT. • Across both arms, the distant was more common than locoregional progression.
- Published
- 2021