In Patients With Well-Differentiated Neuroendocrine Tumours, There Is No Apparent Benefit of Somatostatin Analogues After Disease Control By Peptide Receptor Radionuclide Therapy

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Abstract Purpose Peptide receptor radionuclide therapy (PRRT) and somatostatin analogues (SSAs) are commonly combined as primary treatment for neuroendocrine neoplasm (NEN), and SSAs given as maintenance treatment. We sought to evaluate whether sequential therapy with PRRT followed by SSAs has progression or survival benefits in patients with NEN.Methods This prospective, randomised, single-centre study had as principal eligibility criteria: unresectable, locally-advanced, or metastatic, histologically-confirmed well-differentiated NEN; no symptoms of carcinoid syndrome; no SSAs or ≤3 months of SSAs before PRRT; and stable disease or partial/complete response after PRRT. Altogether 115 patients were randomised 2:1 to an SSA group (n=74) given octreotide acetate LAR every 4 weeks, or to a control group (n=41) receiving best supportive care. Octreotide treatment was to stop upon intolerable toxicity or patient refusal, or, at physician/patient discretion, upon progression. Primary study endpoint was progression-free survival (PFS).Results Overall, median (25th-75th percentile) follow-up from the first PRRT activity to death or latest observation was 6.6 (3.18-10.22) years. During that time, 71/115 patients (62%) progressed, 52/74 (70%) in the SSA group, 19/41 (46%) in the control group (p = 0.01). Eighty-eight /115 (76%) patients died, 58/74 (78%) in the SSA group, 30/41 (73%) in the control group (p = 0.52). Median (95% CI) PFS was respectively, 4.7 (2.8-7.7) in the SSA group, and 6.4 (4.1-not reached) years in controls. Median OS was 6,6 years in whole group of patients. Neither PFS nor OS differed between groups (p = 0.129, p = 0.985, respectively).Conclusions In patients with disease control after PRRT, subsequent SSA treatment appeared not to be associated with better PFS or OS. Whether to continue or stop SSA administration upon progression after PRRT requires evaluation in a prospective, randomised, controlled multicenter study with a relatively homogeneous sample.

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