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, 50.363.6) to 6 mo (MS=55.0; 95%CI, 48.161.9; P=0.660). An initial decline in -C30 physical functioning scale from baseline (MS=74.2; 95%CI, 67.580.9) to 3 mo (MS=65.2; 95%CI, 56.573.9; P=0.007), returned to baseline by 6 mo (MS=72.7; 95%CI, 64.880.5). Disease-related worries (G.I.NET21) increased from baseline (MS=48.3; 95%CI, 39.557.1) to 1 mo (MS=37.4; 95%CI, 31.043.8; P=0.002), returning to baseline by 6 mo (MS=43.7; 95%CI, 33.653.8). Treatment-related symptoms (G.I.NET21) increased from baseline (MS=10.1; 95%CI, 2.617.7) to 3 mo (MS=22.0; 95%CI, 16.827.3; P<0.009), with recovery toward baseline by 6 mo (MS=14.1; 95%CI, 9.318.9). The EQ-5D utility score decreased from baseline (MS=0.72; 95%CI, 0.670.77) to 3 mo (MS=0.67; 95%CI, 0.610.73); with recovery by 6 mo (MS=0.73; 95%CI, 0.670.78). One patient stopped treatment due to adverse events in months 13, and 4 in months 36; 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.
05 Dec 2016
UK and Ireland Neuroendocrine Tumour Society