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 session3713 - ZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract 3305 - ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract 3222 - ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract 1560 - Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract 2335 - Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract 3291 - Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract 3607 - What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract 1963 - What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract 3503 - Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract 1997 - Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe 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.
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