Induction oxaliplatin capecitabine followed by switch to carboplatin-paclitaxel based RT versus continuing oxaliplatin capecitabine RT in operable esophageal adenocarcinoma: Survival analysis of the randomized phase II neoscope trial.

Authors

null

Somnath Mukherjee

University of Oxford, Oxford, United Kingdom

Somnath Mukherjee , Chris Hurt , Catrin Cox , Ganesh Radhakrishna , Sarah Gwynne , Andrew Rea Bateman , Simon Gollins , Maria A. Hawkins , Jo Canham , Heike I. Grabsch , Stephen Falk , Ricky A. Sharma , Ruby Ray , Rajarshi Roy , Wendy Wade , Rhydian Maggs , David joseph sebag-Montefiore , Tim Maughan , Gareth Owen Griffiths , Tom David Lewis Crosby

Organizations

University of Oxford, Oxford, United Kingdom, Centre for Trials Research, Cardiff University, Cardiff, United Kingdom, The Christie NHS Foundation Trust, Manchester, United Kingdom, South West Wales Cancer Centre, Swansea, United Kingdom, University of Southampton School of Medicine, Southampton, United Kingdom, North Wales Cancer Treatment Centre, Rhyl, United Kingdom, CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, United Kingdom, Cardiff University, Cardiff, United Kingdom, Maastricht University Medical Center, Maastricht, Netherlands, Bristol Haematology and Oncology Centre, Bristol, United Kingdom, University College London, London, United Kingdom, Castle Hill Hospital, Hull, United Kingdom, NISCHR CRC South East Wales Research Network, Cardiff, United Kingdom, Cardiff NCRI RTTQA Group, Cardiff, United Kingdom, St James's Institute of Oncology, Leeds, United Kingdom, Southampton Clinical Trials Unit, University of Southampton, Southampton, United Kingdom, Velindre Cancer Centre, Cardiff, United Kingdom

Research Funding

Other
NEOSCOPE

Background: Initial results of the NEOSCOPE trial comparing pre-operative CarPac vs OxCap based chemoradiotherapy (CRT) in patients with adenocarcinoma of the oesophagus or oesophagogastric junction showed comparable toxicity and improvement in pathological complete response (pCR) in favour of the CarPacRT. Here we report survival after a median follow-up of 40.7 months (95% CI: 45.1-53.6). Methods: NEOSCOPE was an open, randomised, ‘pick a winner’ phase II trial. Patients with resectable oesophageal adenocarcinoma ≥ cT3 and/or ≥ cN1 were randomised to OxCapRT (oxaliplatin 85 mg/m2 day 1, 15, 29; capecitabine 625 mg/m2 bd on days of RT) or CarPacRT (carboplatin AUC2; paclitaxel 50 mg/m2 day 1, 8, 15, 22, 29). RT dose was 45 Gy/25 fractions/5 weeks. Induction OxCap (2 cycles) was given prior to CRT. Surgery was performed 6–8 weeks after CRT.The primary endpoint was pCR, secondary endpoints were toxicity, PFS and OS. Results: Between Oct 2013 and Feb 2015, 85 patients were recruited from 17 UK centres. Median OS was not reached in the CarPacRT group and was 41.72 months (95% CI 19.58-.)in the OxCap group (HR 0.56[95% CI 0.29-1.07]; p=0.079). 3-year and 5-year OS rates were 74% (95% CI 58%-85%) and 54% (95% CI 34%-71%) (CarPacRT), and 52% (95% CI 35%-67%) and 39% (95% CI 21%-56%) (OxCapRT). Median PFS (not reached vs 35.3 months, HR=0.61 [95% CI 0.33-1.12]; p=0.111) and metastatic PFS (not reached vs 39.0 months, HR=0.61 [95% CI 0.32-1.14], p=0.118) both favoured the CarPacRT arm. Local recurrence rate was low (OxCapRT= 10%; CarPacRT= 7%). The OS benefit for CarPacRT was consistent across subgroups but not statistically significant. Conclusions: In this longer term analysis there was some evidence that induction OxCap followed by switch to CarPacRT was superior to continuing OxCapRT, with efficacy similar to that seen in other published studies such as ‘CROSS’ and ‘FLOT’. Taken together with the previously published pCR results CarPacRT rather than OxCapRT warrants inclusion in future trials. Funding: Cancer Research UK (C44694/A14614). Clinical trial information: NCT01843829

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Walks

Session Title

Poster Walks: Esophageal and Gastric Cancer

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT01843829

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 373)

Abstract #

373

Poster Bd #

E6

Abstract Disclosures