UK phase IV, observational study to assess quality of life in patients (pts) with pancreatic neuroendocrine tumours (pNETS) receiving treatment with everolimus: The “real-world” OBLIQUE study

Date

08 Oct 2016

Session

Poster Display

Presenters

John Ramage

Citation

Annals of Oncology (2016) 27 (6): 136-148. 10.1093/annonc/mdw369

Authors

J. Ramage1, P. Punia2, O. Faluyi3, A. Frilling4, T. Meyer5, G. Kapur6, J. Cave7, J. Wadsley8, S. Cummins9, D. Farrugia10, N. Starling11, L. Wall12, R. Saharan13, J.W. Valle14

Author affiliations

  • 1 Institute Of Liver Studies, King's College Hospital, SE5 9RS - London/GB
  • 2 Dept Oncology, Queen Elizabeth-University Hospital Birmingham NHS Foundation Trust, B15 2GW - Birmingham/GB
  • 3 Medical Oncology, Clatterbridge Cancer Centre, CH63 4JY - Liverpool/GB
  • 4 Surgery & Cancer, Imperial College London - Hammersmith Hospital, W12 0NN - London/GB
  • 5 Medical Oncology, University College London Cancer Institute, WC1E 6DD - London/GB
  • 6 Clinical Oncology, Norfolk and Norwich University Hospital, NR4 7UY - Norwich/GB
  • 7 Oncology, Southampton General Hospital Southampton University Hospitals NHS Trust, SO16 6YD - Southampton/GB
  • 8 Dept Oncology, Weston Park Hospital Cancer Research Centre, S10 2SJ - Sheffield/GB
  • 9 Dept Oncology, Royal Surrey County Hospital St Luke's Cancer Centre, GU2 7XX - Guildford/GB
  • 10 Oncology Department, Cheltenham General Hospital Gloucestershire Oncology Centre, GL53 7AN - Cheltenham/GB
  • 11 Gi & Lymphoma Unit, The Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 12 Edinburgh Cancer Centre, Western General Hospital, EH4 2XU - Edinburgh/GB
  • 13 Department Of Oncology, Novartis Pharma Ltd, GU15 3YL - Frimley/GB
  • 14 Department Of Medical Oncology, Enets Centre Of Excellence; Manchester Academic Health Sciences Centre, Institute Of Cancer Sciences, University Of Manchester, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
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Background

Everolimus, a mammalian target of rapamycin inhibitor, is licensed for use in adult pts with advanced well-differentiated pNETs in the UK. Limited Health-Related Quality-of-Life (HrQOL) data are available for everolimus therapy in these pts.

Methods

This prospective study assessed changes in HrQoL (by monthly patient-reported EORTC QLQ-C30, -G.I.NET21 and EQ-5D questionnaires), in pts with pNETs during the first 6 months (mo) of treatment with oral everolimus 10mg o.d. in routine clinical practice. Endpoints included change in EORTC QLQ-C30 score at 6 mo of treatment (primary); and changes in QLQC30/G.I.NET21/EQ-5D scores, efficacy and safety data (secondary)

Results

Of 52 enrolled pts, 48 met eligibility criteria and 46 criteria for inclusion in the Full Analysis Set. No significant worsening of the Global QLQ-C30 score was seen from baseline (Mean Score (MS) = 56.9; 95%CI, 50.3-63.6) to 6 mo (MS = 55.0; 95%CI, 48.1-61.9; P = 0.660). An initial decline in -C30 physical functioning scale from baseline (MS = 74.2; 95%CI, 67.5-80.9) to 3 mo (MS = 65.2; 95%CI, 56.5-73.9; P = 0.007), returned to baseline by 6 mo (MS = 72.7; 95%CI, 64.8-80.5). Disease-related worries (G.I.NET21) increased from baseline (MS = 48.3; 95%CI, 39.5-57.1) to 1 mo (MS = 37.4; 95%CI, 31.0-43.8; P = 0.002), returning to baseline by 6 mo (MS = 43.7; 95%CI, 33.6-53.8). Treatment-related symptoms (G.I.NET21) increased from baseline (MS = 10.1; 95%CI, 2.6-17.7) to 3 mo (MS = 22.0; 95%CI, 16.8-27.3; P 

Conclusions

OBLIQUE has shown there is no significant decline in Global QLQ-C30 score from baseline to 6 mo following initiation of everolimus in pNET pts. An initial significant decline in some individual scales was observed during the first 3 mo, with recovery to baseline with continued treatment.

Clinical trial identification

CRAD001PGB12 Protocol Released: 31-01-2013 UK Ethics (MREC) reference: 13/SC/0121

Legal entity responsible for the study

Medicines & Healthcare Products Regulatory Agency, London UK

Funding

Novartis Pharma Ltd, (UK Affiliate)

Disclosure

J. Ramage, P. Punia, O. Faluyi, A. Frilling, T. Meyer, G. Kapur, J. Cave, J. Wadsley, S. Cummins, D. Farrugia, N. Starling, L. Wall, R. Saharan, J.W. Valle: Engaged in corporate sponsored research. R. Saharan: Novartis Pharma Employee.

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