Trial reportCancer medicine2026
Lanreotide, a Somatostatin Analogue, in Advanced Merkel Cell Carcinoma: A Prospective Single-Arm Phase II Study.
Trial report in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02351128 (Traitement Des Carcinomes à Cellules de Merkel inopérables et/ou métastatiques Par Analogue de la Somatostatine - Etude Nationale Multicentrique Mono-bras de Phase II.), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Traitement Des Carcinomes à Cellules de Merkel inopérables et/ou métastatiques Par Analogue de la Somatostatine - Etude Nationale Multicentrique Mono-bras de Phase II.
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Authors and funding
24 authors.
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Abstract
backgroundMerkel Cell Carcinoma (MCC) is a rare, aggressive neuroendocrine and epithelial skin cancer. Somatostatin analogues, such as lanreotide, have shown efficacy in managing other neuroendocrine tumors. Retrospective studies suggest that lanreotide may induce partial response or disease stabilization in patients with advanced MCC. To test this hypothesis, we conducted a Phase II, non-randomized, open trial investigating lanreotide in MCC patients with advanced disease (ClinicalTrials.gov identifier: NCT02351128).
methodsPatients with Stage IIIB-IV MCC received lanreotide monotherapy (120 mg every 28 days) at any line of systemic therapy, until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR) (defined as the proportion of patients with complete response, partial response, and stable disease) at 3 months. Secondary endpoints included progression-free survival (PFS), overall survival (OS), somatostatin receptor (SSTR) tumor expression, and treatment safety.
resultsBetween April, 2015, and November, 2016, 35 patients received lanreotide, with 12 evaluable at 3 months. The DCR at 3 months was 33.3% (4) among evaluable patients (all with stable disease) and 11.4% for the full cohort. Statistical analyses showed no significant difference from the expected 20% response rate (p = 0.205 for intention-to-treat; p = 0.939 for per-protocol). Kaplan-Meier analysis revealed median OS and PFS of 3.1 months (95% CI, 2-5.5) and 3.5 months (95% CI, 2.3-5.5), respectively. SSTR tumor expression did not correlate with treatment response.
conclusionAlthough limited by its implementation before the era of immunotherapy, this non-randomized study shows the limited effectiveness of lanreotide as monotherapy in treating patients with advanced MCC.
trial registrationIdentifier: NCT02351128.
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