Endocrine Abstracts (2016) 46 P17 | DOI: 10.1530/endoabs.46.P17

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

John Ramage1, Pankaj Punia2, Faluyi Olusola3, Andrea Frilling4, Tim Meyer5, Gaurav Kapur6, Judith Cave7, Johnathan Wadsley8, Sebastian Cummins9, David Farrugia10, Naureen Starling11, Lucy Wall12, Ruby Saharan13 & Juan Valle14

1Kings College Hospital, London, UK; 2Queen Elizabeth Hospital, Birmingham, UK; 3Clatterbridge Cancer Centre, The Wirral, UK, 4Hammersmith Hospital, London, UK, 5Royal Free Hospital, London, UK; 6Norfolk & Norwich University Hospital, Norfolk, UK; 7Southampton University Hospital, Southampton, UK; 8Weston Park Hospital, Sheffield, UK; 9Royal Surrey County Hospital, Guildford, UK; 10Cheltenham General Hospital, Cheltenham, UK; 11Royal Marsden Hospitals, London, UK; 12Edinburgh Cancer Centre, Edinburgh, UK; 13Novartis Oncology UK, Surrey, UK; 14University of Manchester/The Christie Hospital NHS FoundationTrust, Manchester, UK.

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 10 mg 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<0.009), with recovery toward baseline by 6 mo (MS=14.1; 95%CI, 9.3–18.9). The EQ-5D utility score decreased from baseline (MS=0.72; 95%CI, 0.67–0.77) to 3 mo (MS=0.67; 95%CI, 0.61–0.73); with recovery by 6 mo (MS=0.73; 95%CI, 0.67–0.78). One patient stopped treatment due to adverse events in months 1–3, and 4 in months 3–6; with 32 pts still on treatment at week 24.

Conclusion: 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.