Lanreotide autogel every 6 weeks compared with Lanreotide microparticles every 3 weeks in patients with well differentiated neuroendocrine tumors: a Phase III Study.

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.

• Authors: Emilio Bajetta, Giuseppe Procopio, Laura Catena, Antonia Martinetti, Sara De Dosso, Sergio Ricci, Alberto S Lecchi, Paolo F Boscani, Stefano Iacobelli, Giacomo Carteni, Filippo De Braud, Paola Loli, Andreas Tartaglia, Roberto Bajetta, Leonardo Ferrari
• Journal: Cancer (Cancer) Vol. 107 Issue 10 Pg. 2474-81 (Nov 15 2006) ISSN: 0008-543X [Print] United States
• PMID: 17054107 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Peptides, Cyclic
• lanreotide
• Somatostatin

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects)
• Brain Neoplasms (drug therapy, pathology)
• Disease-Free Survival
• Drug Administration Routes
• Drug Administration Schedule
• Drug Compounding
• Female
• Humans
• Injections, Intramuscular
• Injections, Subcutaneous
• Male
• Middle Aged
• Neoplasm Staging
• Neuroendocrine Tumors (drug therapy, pathology)
• Peptides, Cyclic (administration & dosage, adverse effects)
• Somatostatin (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome