1147P - Everolimus (EVE) treatment for advanced G1-G2 neuroendocrine tumours (NETs) in the community setting: Clinical benefit irrespective of grade or pri...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Neuroendocrine Cancers
Therapy
Biological therapy
Presenter Ana Custodio
Citation Annals of Oncology (2014) 25 (suppl_4): iv394-iv405. 10.1093/annonc/mdu345
Authors A. Custodio1, P. Jimenez Fonseca2, V. Alonso-Orduna3, C. López4, T. Alonso Gordoa5, G. Crespo6, A. Carmona-Bayonas7, C. Alvarez-Escola8, E. Polo3, M. Mangas4, R.G. Herrera Gómez6, M.D.P. Solís Hernández9, R. Jimeno4, P. Reguera10, S. Ayuela11, R. Madero12, E. Burgos13, E. Grande14, J. Feliu1, J. Barriuso1
  • 1Medical Oncology Department, La Paz University Hospital, 28046 - Madrid/ES
  • 2Servicio De Oncologia Medica, Hospital Universitario Central de Asturias, ES-33006 - Oviedo/ES
  • 3Medical Oncology Department, Miguel Servet University Hospital, 50009 - Zaragoza/ES
  • 4Medical Oncology Department, Marqués de Valdecilla University Hospital, 39008 - Santander/ES
  • 5Medical Oncology Department, Ramón y Cajal University Hospital, 28034 - Madrid/ES
  • 6Medical Oncology Department, Hospital Universitario de Burgos, 09006 - Burgos/ES
  • 7Medical Oncology - Haematology, Morales Meseguer University Hospital, 30008 - Murcia/ES
  • 8Endocrinology Department, La Paz University Hospital, 28046 - Madrid/ES
  • 9Medical Oncology, Hospital Universitario Central de Asturias, 33006 - Oviedo/ES
  • 10Medical Oncology, Ramón y Cajal University Hospital, 28031 - Madrid/ES
  • 11Surgical Oncology Department, La Paz University Hospital, 28046 - Madrid/ES
  • 12Biostatistics Unit, La Paz University Hospital, 28046 - Madrid/ES
  • 13Pathology Department, La Paz University Hospital, 28046 - Madrid/ES
  • 14Medical Oncology Department, Ramon y Cajal University Hospital, Madrid/ES

Abstract

Aim

Randomized studies have demonstrated that EVE has antitumour activity in advanced G1-G2 NETs. However, data in the “real-world” setting outside regulatory trials are limited. We aim to assess EVE efficacy and tolerability in patients (pts) with advanced NETs from daily clinical practice.

Methods

A retrospective analysis was carried out on pts with advanced G1-G2 NETs of gastroenteropancreatic and lung origin treated with EVE in six Spanish University hospitals between June-2009 and December-2013.

Results

71 pts (61.9% males) were evaluated with a median age of 56.7 years (20-84). Primary tumor locations were pancreas (pNETs) (50.7%), small intestine (22.5%), colon (7.1%), lung (15.5%) and unknown (1.4%). 32 (45.1%) and 39 (54.9%) pts had G1 and G2 tumours, respectively. Previous systemic therapies included somatostatin analogs (SSAs) (76.1%), chemotherapy (25.3%), sunitinib (23.9%), interferon (7.04%) and other agents (12.7%). Most pts (80.3%) received EVE in combination with SSAs. At the time of the data cut-off (April-2014), 24 (33.8%) pts were still on treatment. Partial response as the best outcome according to RECIST 1.1 criteria was recorded in 7 (9.9%) pts (13.9% pNET, 5.7% non-pNET), stable disease in 59 (83.1%) pts (75% pNET, 83.1% non-pNET) and progressive disease in 5 (7.05%) pts (11.1% pNET, 2.9% non-pNET). With a median follow-up of 18.6 months (ms) (range 6-51), the estimated median progression-free survival (PFS) was 14.4 ms (95% CI, 12.2-15.8) and the median overall survival was not reached. No significant differences in PFS were observed in terms of primary site (pNET: 13.7 ms; 95% CI, 11.3-16.7; non-pNET: 15.2 ms; 95% CI, 12.2-17.8; p = 0.31) or tumour grade (G1: 14.6 ms; 95 CI, 12.8-16.9; G2: 13.2 ms; 95% CI, 11.2-15.8; p = 0.39). EVE-related adverse events (AEs) were mostly grade 1-2 and 15 (21.2%) pts experienced grade 3-4 toxicity. The most common AEs of any grade included stomatitis (67.6%), asthenia (56.3%), diarrhea (54.9%), hyperglycemia (54.9%) and pneumonitis (21.1%).

Conclusions

EVE has shown to be an active and well tolerated therapeutic option for unselected patients with both pancreatic and non-pancreatic G1-G2 NETs in routine clinical practice.

Disclosure

All authors have declared no conflicts of interest.