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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4864 - SCALOP-2: A multi-centre randomised trial of induction chemotherapy followed by capecitabine +/-nelfinavir with high or standard dose radiotherapy for locally advanced pancreatic cancer (LAPC): results of Stage 1 - the non-randomised dose-finding component

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Pancreatic Cancer

Presenters

Somnath Mukherjee

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

S. Mukherjee1, P. Virdee2, R. Shaw3, J. Bridgewater4, G. Radhakrishna5, S. Falk6, M. Scott-Brown7, V.Y. Strauss2, C. Brooks3, R. Gillmore8, N. Patel9, B. Tranter10, P. Parsons11, D. Sebag-Montefiore12, M. Hawkins1, P.G. Corrie13, T.S. Maughan1

Author affiliations

  • 1 Oncology, Oxford Institute for Radiation oncology, OX3 7DQ - Oxford/GB
  • 2 Centre For Statistics In Medicine, Oxford University, Oxford/GB
  • 3 Oncology, Oncology Clinical Trials Office, Oxford/GB
  • 4 Oncology, University College London Hospitals, London/GB
  • 5 Oncology, Christie NHS Foundation Trust, Manchester/GB
  • 6 Bristol Haematology And Cancer Centre, Bristol University Hospitals NHS Foundation Trust, Bristol/GB
  • 7 Arden Cancer Centre, University Hospitals Coventry and Warwickshire, Coventry/GB
  • 8 Oncology, Royal Free London NHS Foundation Trust, London/GB
  • 9 Radiology, Oxford University Hospitals NHS Foundation Trust, Oxford/GB
  • 10 Pharmacy, Velindre NHS University Trust, Cardiff/GB
  • 11 Velindre Cancer Centre, Velindre NHS University Trust, Cardiff/GB
  • 12 Gi Unit, University of Leeds, LS2 9LU - Leeds/GB
  • 13 Oncology Centre, Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, CB2 0QQ - Cambridge/GB
More

Resources

Abstract 4864

Background

The anti-retroviral agent, nelfinavir, demonstrates radiosensitising effects in pre-clinical models of pancreatic cancer. The primary objective of Stage 1 was to establish the maximum tolerated dose (MTD) of nelfinavir combined with capecitabine-chemoradiation (CRT) after gemcitabine+nab-paclitaxel (GEMABX) induction chemotherapy.

Methods

Patients with inoperable, histologically/cytologically proven LAPC and WHO performance status 0-1 were eligible for this rolling-six dose-escalation stage. After 3 cycles of induction GEMABX (28-day cycle of nab-paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on days 1, 8, and 15), patients with non-progressive disease had 1 further cycle followed by CRT (50.4Gy/28 fractions, capecitabine 830mg/m2 bd on radiotherapy days) and 1000mg or 1250mg nelfinavir bd continuously during CRT. Other outcomes included overall survival and progression-free survival.

Results

27 patients were recruited from 8 UK centres (March 2016-June 2017). Median age was 62 years, 30% were male, 78% had head tumours, and 30% had biliary stents. Baseline median tumour diameter was 36mm. 67% commenced CRT. 11 patients received 1000mg and there was one dose-limiting toxicity (DLT) in this group: grade 3 acute coronary syndrome. The nelfinavir dose was escalated as per the rolling-six design. 7 patients received 1250mg nelfinavir and no DLTs were observed. During GEMABX, common grade ≥3 toxicities among participants were neutropenia (30%), fatigue (22%), and diarrhoea (15%). During CRT, grade ≥3 toxicities included fatigue (6%) and anorexia (6%). No grade 5 adverse events were reported in Stage 1. Survival analysis will be presented.

Conclusions

1250mg nelfinavir was recommended for combining with capecitabine-CRT in the ongoing randomised component of the trial (Stage 2).

Clinical trial identification

ISRCTN50083238.

Legal entity responsible for the study

University of Oxford, UK.

Funding

Cancer Research UK, Celgene.

Editorial Acknowledgement

Disclosure

S. Mukherjee, P.G. Corrie: Research funding: Celgene. J. Bridgewater: Consultancy: Celgene. N. Patel: Part-time employee of GSK. All other authors have declared no conflicts of interest.

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