Abstract 1451
Background
Cytotoxic chemotherapy for advanced, unresectable pancreatic and gastrointestinal foregut neuroendocrine tumours (GEPNETs) commonly comprises 5-fluorouracil (FU) plus streptozocin (S). The NET01 trial, conducted in the pre-kinase inhibitor era, recruited a broad spectrum of patients (pts) to investigate whether capecitabine (Cap) was an acceptable alternative to FU, with or without adding cisplatin (Cis). At median follow up 3.4 years, objective responses (primary endpoint) were reported as similar in the 2 arms, but CapSCis was more toxic. Final progression-free survival (PFS) and overall survival (OS) (secondary endpoints) as well as outcome predictors are now reported with longer follow up.
Methods
Pts with previously untreated advanced, unresectable NETs of pancreatic, gastrointestinal foregut or unknown primary site were randomised to receive three-weekly Cap 625mg/m2 twice daily orally, S 1·0g/m2 IV on day 1, ± Cis 70mg/m2 IV on day 1. Pts could receive the same treatment beyond 6 cycles if there was evidence of benefit. All pts were followed 12 weekly for a minimum of 5 years.
Results
Of 86 (44 CapS, 42 CapSCis) pts randomised, 16% had poorly differentiated histology. With long-term median follow-up of 8 years, 83 (97%) pts have progressed/died and 69 (80%) pts have died. The estimated median PFS was 11.1 months for CapS and 9·6 months for CapSCis (HR = 0.82, 95%CI: 0.53, 1.27). Median OS was 27 months for CapS and 26 months for CapSCis (HR = 0.97, 95%CI: 0.60, 1.56). Three and 5-year OS rates were 40% and 29%, with no difference between arms. Statistically significant factors predicting for OS were tumour Ki67 level, WHO grade and pt age. Addition of Cis to CapS did not appear to influence OS for high grade, poorly differentiated tumours, although numbers are small.
N | Overall CapS | CapSCis | Median OS (yrs) | Overall CapS | CapSCis | ||
---|---|---|---|---|---|---|---|
Age (yrs) | ConclusionsPFS and OS were similar for the CapS ± Cis regimens. High patient age, tumour Ki67 and grade all predicted for poorer outcomes. Clinical trial identificationLegal entity responsible for the studyCambridge University Hospitals NHS Foundation Trust FundingUK NETwork and Cancer Research UK DisclosureJ.W. Valle: Keocyt (honoraria for Advisory Board in 2010 and 2012) – this relates to streptozocin. D. Cunningham: Research funding only to RMH from Amgen, AstraZeneca, Bayer, Celgene, Medimmune, Merrimack, Merck Serono, Sanofi. All other authors have declared no conflicts of interest. Resources from the same session2354 - The clinicopathologic features and treatment of 607 hindgut neuroendocrine tumor (NET) patients at a single institutionPresenter: Seung Tae Kim Session: Poster Display Resources: Abstract 2594 - Neuroendocrine carcinomas of the colorectal origin - Polish experiencePresenter: Agnieszka Kolasińska-Ćwikła Session: Poster Display Resources: Abstract 2539 - Neuroendocrine neoplasms of the appendix including goblet cell carcinoidsPresenter: Agnieszka Kolasinska-Cwikla Session: Poster Display Resources: Abstract 1245 - Prognostic validity of AJCC staging system in neuroendocrine tumors of the appendixPresenter: Amir Mehrvarz Sarshekeh Session: Poster Display Resources: Abstract 3902 - Enhancer of zest homolog 2 (EZH2) expression in well and moderately differentiated pancreatic neuroendocrine tumor (pNET)Presenter: Riccardo Marconcini Session: Poster Display Resources: Abstract 3882 - Differential clinical and pathological characteristics of hereditary neuroendocrine pancreatic tumours (NEPT)Presenter: Gema Marín Zafra Session: Poster Display Resources: Abstract 2296 - Natural course of thyroid cancer nodules compared with benign thyroid nodulesPresenter: Kyung-Jin Yun Session: Poster Display Resources: Abstract 4083 - Reassessment of proliferative activity at disease progression in neuroendocrine neoplasmsPresenter: Noemi Cicchese Session: Poster Display Resources: Abstract 3866 - 18F-FDG-PET to predict disease progression in advanced digestive neuroendocrine neoplasmsPresenter: Maria Rinzivillo Session: Poster Display Resources: Abstract 3651 - 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 studyPresenter: John Ramage Session: Poster Display Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
|