Neuroendocrine - VL

Question 1

NETTER-1

Answer 1

P: Well-differentiated (Ki-67 20% or less), metastatic/unresectable locally advanced midgut neuroendocrine tumours in patients who progressed during first-line somatostatin analogue therapy; phase III; lesions had to have somatostatin receptors

I: 177Lu-Dotatate (7.4GBq q8weeks x4 infusions) + best supportive care + octreotide LAR 30mg q4weeks

C: Octreotide LAR 60mg q4weeks

O: Primary: PFS; 20-month PFS 65.2% vs 10.8%
Secondary: ORR 18% vs 3%, OS 14 deaths in experimental arm (vs 26 deaths in control arm HR=0.40), safety: Grade 3-4 neutropenia 1%, thrombocytopenia 2%, and lymphopenia 9% in experimental arm (vs none in control arm)

Question 2

PROMID

Answer 2

P: Well-differentiated metastatic midgut NET
I: Octreotide LAR 30mg IM q4weeks
C: Placebo
O: Primary: time to tumour progression: 14.3 vs 6 mo (HR=0.34)
Secondary: tumour response SD 66.7% vs 37.2%, mOS 84.7 vs 83.7 months (CI crosses 1, crossover was allowed)

Question 3

CLARINET

Answer 3

P: Metastatic/unresectable locally advanced well-differentiated or moderately differentiated, non-functioning, somatostatin receptor-positive NET (grade 1-2, KI-67 <10%) from pancreas, midgut or hindgut.

I: Lanreotide 120mg q28d x96 weeks

C: Placebo

O: Primary: mPFS not reached vs 18 mo (HR=0.47)
Secondary: OS no diff, QOL no diff, safety: diarrhea 26% in experimental arm (vs 9% in placebo)