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19.05.2016 | Original Research Article | Ausgabe 5/2016

Targeted Oncology 5/2016

Safety and QOL in Patients with Advanced NET in a Phase 3b Expanded Access Study of Everolimus

Zeitschrift:
Targeted Oncology > Ausgabe 5/2016
Autoren:
Marianne Pavel, Nicole Unger, Ivan Borbath, Sergio Ricci, Tsann-Long Hwang, Thomas Brechenmacher, Jinhee Park, Fabian Herbst, Jennifer L. Beaumont, Oliver Bechter
Wichtige Hinweise

Earlier Presentations

Presented in part at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO), May 31 to June 4, 2013, Chicago, IL, USA; the European Cancer Congress/European Society for Medical Oncology, September 27 to October 1, 2013, Amsterdam, Netherlands; and the 2014 European Neuroendocrine Tumor Society conference, March 5 to 7, 2014, Barcelona, Spain.

Abstract

Background/Aims

An open-label, multi-center, expanded access study was conducted in patients with advanced neuroendocrine tumors (NET) treated with everolimus (10 mg/day) to assess safety and health-related quality of life (HRQOL).

Methods

Of the 246 patients enrolled, 126 have pancreatic NET (pNET) and 120 have non-pNET. Patients continued treatment until disease progression, unacceptable toxicity, death, until commercial availability of everolimus, or May 2012, whichever came first. Adverse events (AEs) were analyzed according to Common Terminology Criteria version 4.0. HRQOL was assessed at baseline, for three 28-day cycles, and then at every three cycles until end of treatment (EOT) with EQ-5D, EORTC QLQ-C30, and EORTC QLQ-GINET21 instruments.

Results

The most common grade 3 or 4 AEs included hyperglycemia, infections, stomatitis, fatigue, and abdominal pain. In patients with pNET, mean (± SD) EQ VAS score remained stable at EOT (baseline, 68.8 ± 19.9 vs. EOT, 66.5 ± 20.6) without clinically significant change in QLQ-C30 global health status (change from baseline, - 3.9; n = 86). For patients with non-pNET, a reduction in EQ VAS score (63.9 ± 19.0 vs. 55.3 ± 23.0) with clinically significant changes in QLQ-C30 global health status (-13.0; n = 69) was seen by EOT. EQ-5D utility scores remained stable in patients with pNET and a moderate decrease was reported by patients with non-pNET.

Conclusions

The safety profile of everolimus was consistent with the previous studies without adversely affecting HRQOL in pNET. Lower baseline HRQOL scores and more frequent comorbidities might have contributed to the worse outcomes in non-pNET.

Trial Registration

EudraCT no. 2010-023032-17

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