Merkel cell carcinoma in Latin America: a contribution from an expanded access program for avelumab to address issues fr
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ORIGINAL ARTICLE
Merkel cell carcinoma in Latin America: a contribution from an expanded access program for avelumab to address issues from experts’ recommendations Rodrigo Ramella Munhoz1 · Federico Cayol2 · Luis Corrales3 · Raquel Gerson4 · Malena Tilli5 · Elluz Oliver Barreto6 · Jesús Oswaldo Sánchez Castillo7 · Rafael Aron Schmerling8 · Gabriela Cinat9 Received: 15 July 2020 / Accepted: 14 October 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Background Merkel cell carcinoma (MCC) is an aggressive malignancy, associated with poor outcomes in patients with metastatic disease (mMCC). Management has been dramatically altered as a result of incorporating immune checkpoint blockade agents. MCC data from Latin America (LATAM) come from case-series or individual records. Regional registries are lacking. A need for better registries to improve current knowledge about MCC is highlighted. Our objectives were to describe a real-world experience with avelumab as a second-line (or first-line in unfit patients) treatment in a subset of LATAM participants enrolled in a global Expanded Access Program (EAP) for patients with mMCC, and to evaluate its contribution to the resolution of the concerns described in a recent regional experts review. Materials and methods We reviewed data of LATAM participants in an avelumab EAP for mMCC treatment (NCT03089658). EAP patient had unresectable or mMCC with progressive disease after one line of chemotherapy, and were ineligible for clinical trials or unfit for chemotherapy. Results 46 patients (median age: 71.6 years; 60.9% males; median treatment duration: 7.9 months) were included in the LATAM EAP. Physician-assessed objective responses were available for 19 patients. Complete response rate was 15.8% and partial response rate reached 42.1%, summarizing an objective response rate of 57.9%. Stable disease rate was 10.5%, with a disease control response of 68.4%. Conclusion Avelumab showed robust efficacy and a safety profile consistent with global EAP data. Results are aimed to improve current knowledge about mMCC treatment and access to immunooncologic strategies for treating LATAM patients. Keywords Avelumab · Merkel cell carcinoma · Latin America · Skin cancer
Introduction Merkel cell carcinoma (MCC) is an aggressive skin cancer associated with poor survival outcomes in patients with metastatic disease [1, 2]. As with other skin neoplasms, MCC * Malena Tilli [email protected] 1
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Sarcoma and Melanoma Group, Oncology Center and Coordinator of the Medical Oncology Fellowship Program, Instituto do Cancer do Estado de São Paulo, Hospital Sirio Libanes, São Paulo, Brazil Hospital Italiano de Buenos Aires, Buenos Aires, Argentina Hospital Clínica Bíblica, CIMCA (Centro de Investigación y Manejo del Cáncer), San José, Costa Rica
development is associated with ultraviolet (UV) radiation exposure [3]. It is also hypothesized that chronic exposure to UV radiation may contribute to the increased incidence of MCC in people of advanced
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