Lanreotide autogel every 6 weeks compared with Lanreotide microparticles every 3 weeks in patients with well differentiated neuroendocrine tumors

Abstract

BACKGROUND.The noninferiority of a 6‐week dosing schedule of lanreotide Autogel (Lan ATG) at a dose of 120 mg compared with a 3‐week dosing schedule of lanreotide microparticles (Lan MP) at a dose of 60 mg was investigated in patients with neuroendocrine tumors (NET).METHODS.Patients who had sporadic, well differentiated NET with a low grade of malignancy were recruited for this open‐label, Phase III, multicenter trial. Patients were randomized to receive either 3 deep subcutaneous injections of Lan ATG (120 mg, every 6 weeks) or 6 intramuscular injections of Lan MP (60 mg, every 3 weeks). Tumor markers, tumor size, and symptoms were assessed between baseline and Week 18. Success was classified as a response that ranged from disappearance to an increase <25% in tumor marker, tumor size, or symptom frequency.RESULTS.Sixty patients were randomized, and 46 patients completed the study. Both for tumor markers and for tumor size, Lan ATG was not inferior to Lan MP (55% and 59% of patients responded on tumor markers, respectively; 68% and 66% of patients responded on tumor size, respectively). There were too few symptomatic patients to compare carcinoid symptoms. Both treatments were tolerated well, and no safety concerns were identified.CONCLUSIONS.Lan ATG at a dose of 120 mg every 6 weeks was as effective for controlling NET as Lan MP at a dose of 60 mg every 3 weeks. Cancer 2006. © 2006 American Cancer Society.

GEP–NETs UPDATE: Biotherapy for neuroendocrine tumours

“…Treatment with high-dose octreotide 500 mg three times a day did not seem to offer additional benefit in tumour growth control. Those results were consistent with a contemporary phase II study that included 58 patients receiving 500-1000 mg three times a day (19), but slightly lower than those from Saltz et al, which investigated the activity of immediate-release octreotide in 34 patients with gastroenteropancreatic (GEP)-NETs (20). No objective response was identified, but 50% (17/34) of patients showed SD for at least 8 weeks and 71% of patients with symptomatic disease had symptom relief and hormone level reduction with a median survival of 22 months.…”

Inhibition of proliferation of small intestinal and bronchopulmonary neuroendocrine cell lines by using peptide analogs targeting receptors

“…5 Because the majority of these tumors express somatostatin receptor subtype 2 (SSTR2), to date the best available approach has been the use of long-acting somatostatin analogs such as Somatuline, which are effective in the amelioration of symptomatology. 8 Whereas this class of pharmacotherapeutic agents inhibits the secretion of bioactive agents and hence symptoms, it is ineffective in the inhibition of neuroendocrine cell proliferation. 2,5 An approach based on targeted antineoplastic therapy focusing on specific molecular pathways or receptors expressed by malignant cells, while leaving normal cells unaffected, has promise.…”

“…38 Whereas somatostatin effectively regulates carcinoid symptomatology (through inhibition of secretory products), 5,8 a role in inhibiting tumor growth in vivo remains to be proven. Doxorubicin itself is of modest and unpredictable efficacy (16%-20% objective therapeutic response) in the treatment of NETs.…”

Chromogranin A in Diagnosing and Monitoring Patients with Gastroenteropancreatic Neuroendocrine Neoplasms: A Large Series from a Single Institution

“…The objective response was evaluated according to the criteria released by the Italian Trials in Medical Oncology group (ITMO) [22] and classified as complete or partial response with a decrease >50%. The disease was considered stable with a decrease <50% or an increase <25% and progressive if the increase was >25%.…”