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Gastrointestinal tumours, colorectal

2585 - Perioperative chemotherapy with or without cetuximab in patients (pts) with resectable colorectal liver metastasis (CRLM): mature analysis of overall survival (OS) in the New EPOC randomised controlled trial

Date

10 Sep 2017

Session

Gastrointestinal tumours, colorectal

Presenters

John Bridgewater

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

J. Bridgewater1, S. Pugh2, A. Whitehead3, L. Stanton3, Z. Eminton3, J. Mellor3, A. Allen3, M. Finch-Jones4, S. Falk5, T. Iveson6, M. Rees7, J.W. Valle8, J. Hornbuckle9, T. Hickish10, D. Cunningham11, T. Maughan12, J. Garden13, G. Griffiths3, J. Primrose2

Author affiliations

  • 1 Oncology, UCL Cancer Institute/Paul O'Gorman Building, WC1E 6DD - London/GB
  • 2 Surgery, University of Southampton, SO17 1BJ - Southampton/GB
  • 3 Clinical Trials Unit, University of Southampton, SO17 1BJ - Southampton/GB
  • 4 Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol/GB
  • 5 Oncology, University Hospitals Bristol NHS Trust Bristol Haematology and Oncology Centre, BS2 8ED - Bristol/GB
  • 6 Oncology, Southampton General Hospital Southampton University Hospitals NHS Trust, SO16 6YD - Southampton/GB
  • 7 Surgery, Hampshire Hospitals NHS Foundation Trust, Basingstoke/GB
  • 8 Medical Oncology, The University of Manchester / The Christie, Manchester/GB
  • 9 Oncology, Weston Park Hospital Cancer Research Centre, S10 2SJ - Sheffield/GB
  • 10 Oncology, Bournemouth University, Bournemouth/GB
  • 11 Gi And Lymphoma Research Unit, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 12 Oncology, Oxford Institute for Radiation Oncology, OX3 7DQ - Oxford/GB
  • 13 Surgery, University of Edinburgh, Edinburgh/GB
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Resources

Abstract 2585

Background

The primary analysis of the New EPOC trial in 2013 demonstrated a shorter progression-free survival (PFS) when cetuximab was added to chemotherapy as perioperative treatment for CRLM. This analysis reports the mature OS data and novel exploratory analyses.

Methods

Pts with KRAS exon 2 wild-type resectable or suboptimally resectable CRLM were randomised to chemotherapy (CT) or chemotherapy and cetuximab (CTX) before and after liver resection. Trial recruitment and use of cetuximab were halted in 2012 on the recommendation of the Data Monitoring Committee.

Results

128 pts received CT and 129 CTX between Feb 2007 and Nov 2012. At a median follow-up of 69 months (IQR 59-81), 130 events (death from any cause) had been observed. Median OS was shorter for CTX vs CT (p = 0.035) and in contrast to the primary analysis, mature analysis of PFS was not significantly different (p = 0.291). There were numerically more multi-site progressions in CTX (n = 17/83, 20.5%) than CT (n = 8/78, 10.3%) pts and survival post-progression (PPS) was particularly poor for CTX pts (p = 0.014). Predefined subgroup analyses demonstrated the adverse effect of CTX was in pts conventionally thought to have good prognostic features. Whilst OS was the same for responders and non-responders on CT, it was improved for responders vs non-responders on CTX.Table:

483PD

Median survival (months)HR95%CI
CTCTX
PFS23.915.51.170.87-1.57
PPS35.423.51.601.10-2.33
OS
All81.055.41.451.02-2.05
OS by pre-operative response
Yes81.160.71.400.89-2.20
No79.934.52.191.22-3.95
≥4 metastases/poor differentiation of primary/N2 disease
Yes59.258.30.950.61-1.51
Nonot reached45.82.371.39-4.06

Conclusions

In the context of perioperative therapy for resectable CRLM CTX confers a shorter OS and survival post progression compared to CT. This detriment is in those with conventionally favourable prognostic features suggesting that cetuximab induces adverse biology in some pts, the biomarker profile of whom is being investigated. Response to CT alone does not improve OS compared to non-responders, suggesting conferred benefit is adjuvant not neoadjuvant.

Clinical trial identification

ISRCTN22944367

Legal entity responsible for the study

University Hospital Southampton NHS Foundation Trust

Funding

Cancer Research UK

Disclosure

J. Bridgewater: Honoraria and speakers fees: Merck, Celgene, Servier, Amgen; travel assistance Amgen, Merck Sharpe Dohme, Servier. T. Iveson: Consulting and/or advisory roles: Servier, Roche and Celgene; honoraria for services in the past two years: Lilly; travel expenses: Bayer, Servier. J.W. Valle: Consultant/advisor: Ipsen, Novartis, AstraZeneca, Lilly, Merck, Baxalta, Delcath Systems, Agios, Pfizer, Midatech. Speakers’ bureau: Novartis, Pfizer, Celgene. Conducted research for his institution funded by Novartis. T. Hickish: Has conducted research projects on behalf of his institution which have been funded, in whole or in part, by: Biotec, Roche. D. Cunningham: Has conducted research projects on behalf of his institution which have been funded, in whole or in part, by: Amgen, AstraZeneca, Bayer, Celgene, Merrimack, Medimmune, Merck Serono, Sanofi. T. Maughan: Has provided and been paid for consulting and/or advisory roles for the following company in the past two years: Vertex. J. Garden: Speakers\' bureau: Johnson and Johnson (Ethicon) workshop (May 2016). G. Griffiths: Consulting and/or advisory roles in the past two years: Sirtex, Celgene, GSK. All other authors have declared no conflicts of interest.

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