Abstract 1163P
Background
Patients (pts) with aggressive metastatic or locally advanced, non-resectable, grade 1-2 well-differentiated duodeno-pancreatic (WDDP) NETs should receive a combination of systemic chemotherapy until progression. Aggressive disease is defined as progressive and/or symptomatic metastases and/or with significant hepatic invasion (>30-50%), and/or bone metastases.
Methods
The aim of this academic randomized, double-blind, placebo-controlled study was to evaluate lanreotide autogel (LAN) as maintenance treatment after 1st line treatment (L1) in aggressive G1-G2 WDDP NET. Pts were randomly assigned in a 1:1 ratio to receive LAN or placebo (PBO) every 28 days until progression or toxicity. The main endpoint was the rate of pts alive without progression at 6 months 1 .
Results
Among the 53 included pts, 81% had a G2 tumour, 90.6% had metastatic disease including 29.2% with extrahepatic metastases. Percenatge of pts previously treated using somatostatin analogues was 14.8% in the LAN group and 19.2% in the PBO group, with a mean duration of 10.7 months (SD 8.7) and 11.4 months (SD 14.1), respectively. L1 therapy consisted of temozolomide-based (52.9%), dacarbazine-based (18.7%), streptozotocin-based (13.3%), oxaliplatin-based (11.3%) or sunitinib (3.8%). Median duration for L1 was 4.6 months (range: 2–7.7). At randomization, partial response occurred in 18.9% of patients and stable disease in 81.1%. Median follow-up duration was 27.0 months (95%CI 19.5;31.2). The 6 month progression-free survival (PFS) rate was 73.1% (90%CI 55.3; 86.6) in LAN vs. 54.2% % (90%CI 35.8;71.8) in PBO. Median PFS was 19.4 months (95%CI 7.6;32.6) and 7.6 months, (95%CI 3.0; 9.0), respectively. The median overall survival was not reached in LAN and was 41.9 months in PBO. The toxicity profile was mild with mainly grade 1-2 adverse events (AEs). Grade 3/4 AEs were seen in 9 pts (33%) in LAN vs. 6 pts (22%) in PBO. The most common AEs were abdominal pain (2 vs.1), diarrhea (2 vs. 0) hepato-biliary AE (0 vs. 2) metabolic AE (4 vs. 1), and sepsis (0 vs. 1).
Conclusions
The encouraging results of lanreotide LP 120 mg as maintenance treatment after L1 in aggressive G1/2 WDDP NETs should be further evaluated. 1. Lepage C Dig Liver Dis. 2017;49(5):568–571.
Clinical trial identification
NCT02288377.
Editorial acknowledgement
Legal entity responsible for the study
FFCD (Fédération Francophone de Cancérologie Digestive).
Funding
Ipsen.
Disclosure
C. Lepage: Advisory/Consultancy: AAA; Honoraria (self): Amgen; Advisory/Consultancy: Novartis; Honoraria (self): Bayer. J.M. Phelip: Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis. A. Lièvre: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AAA; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bayer; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: Haliodx; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly. D. Tougeron: Honoraria (self): Sanofi; Honoraria (self): Roche; Honoraria (self), Honoraria (institution): Servier; Honoraria (self): Merck; Honoraria (self), Honoraria (institution): Bayer; Honoraria (self), Honoraria (institution): AstraZeneca; Honoraria (institution): Novartis; Honoraria (institution): BMS; Honoraria (institution): MSD. L. Dahan: Travel/Accommodation/Expenses: Roche; Honoraria (self): BMS; Honoraria (self): Amgen; Honoraria (self): Sanofi; Honoraria (self): Servier. F. Di Fiore: Honoraria (self): Novartis; Honoraria (self): Ipsen; Honoraria (self): Pfizer. C. Lombard Bohas: Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen; Advisory/Consultancy: AAA. I. Borbath: Research grant/Funding (self): Novartis; Research grant/Funding (self): Ipsen; Research grant/Funding (self): Bayer; Research grant/Funding (self): Celgene; Research grant/Funding (self): Pfizer. R. Coriat: Advisory/Consultancy: AAA; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Keocyt. R. Guimbaud: Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Amgen. J.L. Legoux: Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Servier; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Keocyt; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Serono; Research grant/Funding (institution): Sanofi; Travel/Accommodation/Expenses: Ipsen. P. Michel: Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. G. Cadiot: Advisory/Consultancy: AAA; Advisory/Consultancy: Keocyt; Advisory/Consultancy, Research grant/Funding (self): Ipsen; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: Pfizer. D. Smith: Speaker Bureau/Expert testimony: Novartis. T. Walter: Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Advisory/Consultancy: AAA; Advisory/Consultancy, Speaker Bureau/Expert testimony: Keocyt. All other authors have declared no conflicts of interest.