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 Anti-Cancer Agents & Biologic Therapy
Neuroendocrine Cancers
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.