Lanreotide, a Somatostatin Analogue, in Advanced Merkel Cell Carcinoma: A Prospective Single‐Arm Phase II Study
Abstract
Background: Merkel 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). Methods: Patients 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. Results: Between 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. Conclusion: Although 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 Registration Identifier: NCT02351128
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BibTeX
@article{charles2026lanreotide,
title = {{Lanreotide, a Somatostatin Analogue, in Advanced Merkel Cell Carcinoma: A Prospective Single‐Arm Phase II Study}},
author = {Julie Charles and Aude Belbezier and Stéphane Mouret and Brigitte Dreno and Stéphane Dalle and Céleste Lebbe and Ewa Hainaut‐wierzbicka and Andreea Stefan and Julie de Quatrebarbes and Olivier Dereure and Ouidad Zehou and Sandrine Mansard and Alain Dupuy and Caroline Dutriaux and Florent Grange and Caroline Gaudy‐marqueste and Henri Montaudié and Jean‐philippe Arnault and Yannick Le Corre and Thibault Kervarrec and Jean‐louis Quesada and Mahtab Samimi and Marie‐thérèse Leccia and . Group of Cutaneous Oncology of The French Society of Dermatology - Groupe de Cancérologie Cutanée de la Société Française de Dermatologie},
journal = {Cancer Medicine},
year = {2026},
month = sep,
doi = {10.1002/cam4.72295},
url = {https://hal.inrae.fr/hal-05841860v1},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Lanreotide, a Somatostatin Analogue, in Advanced Merkel Cell Carcinoma: A Prospective Single‐Arm Phase II Study
AU - Julie Charles
AU - Aude Belbezier
AU - Stéphane Mouret
AU - Brigitte Dreno
AU - Stéphane Dalle
AU - Céleste Lebbe
AU - Ewa Hainaut‐wierzbicka
AU - Andreea Stefan
AU - Julie de Quatrebarbes
AU - Olivier Dereure
AU - Ouidad Zehou
AU - Sandrine Mansard
AU - Alain Dupuy
AU - Caroline Dutriaux
AU - Florent Grange
AU - Caroline Gaudy‐marqueste
AU - Henri Montaudié
AU - Jean‐philippe Arnault
AU - Yannick Le Corre
AU - Thibault Kervarrec
AU - Jean‐louis Quesada
AU - Mahtab Samimi
AU - Marie‐thérèse Leccia
AU - . Group of Cutaneous Oncology of The French Society of Dermatology - Groupe de Cancérologie Cutanée de la Société Française de Dermatologie
PY - 2026
DA - 2026/09/25
JO - Cancer Medicine
DO - 10.1002/cam4.72295
UR - https://hal.inrae.fr/hal-05841860v1
AB - Background: Merkel 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). Methods: Patients 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. Results: Between 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. Conclusion: Although 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 Registration Identifier: NCT02351128
SN - 2045-7634
SN - 2045-7634
ER -