Abstract
AimThis 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. MethodsNeoSCOPE 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. ResultsEighty-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. ConclusionsOS 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 informationEudraCT Number: 2012-000640-10; ClinicalTrials.gov: NCT01843829.
Highlights
Except for early stage disease, treatment by surgery alone confers poor outcome in patients with resectable oesophageal cancer
The CROSS trial showed that neoadjuvant CarPacRT was associated with a doubling of median overall survival (OS) to 49.4 months compared with surgery alone and established a new standard of care [1]
Oxaliplatin has been shown to be comparable in efficacy to cisplatin in advanced gastrooesophageal cancer and can be conveniently delivered as a 2-h infusion, and oxaliplatin-capecitabine was considered as an international standard of care for advanced gastro-oesophageal adenocarcinoma [2]
Summary
Except for early stage disease, treatment by surgery alone confers poor outcome in patients with resectable oesophageal cancer. The CROSS trial showed that neoadjuvant CarPacRT was associated with a doubling of median overall survival (OS) to 49.4 months compared with surgery alone and established a new standard of care [1]. Oxaliplatin has been shown to be comparable in efficacy to cisplatin in advanced gastrooesophageal cancer and can be conveniently delivered as a 2-h infusion, and oxaliplatin-capecitabine was considered as an international standard of care for advanced gastro-oesophageal adenocarcinoma [2]. NeoSCOPE was a randomised phase II trial that evaluated the efficacy and toxicity of OxCapRT and CarPacRT in the neoadjuvant treatment of patients with locally advanced resectable oesophageal adenocarcinoma (OAC) and assessed the feasibility of safely introducing neoadjuvant chemoradiotherapy (nCRT) into clinical practice in the United Kingdom, where previously neoadjuvant chemotherapy was standard of care. The pCR rate was higher in the CarPacRT arm (12/41 [29.3%] versus 4/36 [11.1%])
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