Alice Baggi1, Pietro Quaglino2, Marco Rubatto2, Roberta Depenni3, Michele Guida4, Paolo Antonio Ascierto5, Claudia Trojaniello5, Paola Queirolo6, Maristella Saponara6, Ketty Peris7, Francesco Spagnolo8, Luca Bianchi9, Federica De Galitiis10, Maria Concetta Potenza11, Ilaria Proietti11, Riccardo Marconcini12, Andrea Botticelli13, Vito Barbieri14, Lisa Licitra15, Salvatore Alfieri16, Corrado Ficorella17, Alessio Cortellini18, Maria Concetta Fargnoli17, Teresa Troiani19, Luca Tondulli20, Paolo Bossi21. 1. University of Brescia, Department of Medical-Surgical Specialties, Radiological Sciences and Public Health, Medical Oncology, ASST-Spedali Civili, Brescia, Lombardia, Italy. 2. University of Turin, Dermatologic Clinic, Department of Medical Sciences Torino, Piemonte, Italy. 3. Università degli Studi di Modena e Reggio Emilia, Department of Oncology, Hematology, Modena, Emilia-Romagna, Italy. 4. IRCCS Istituto Oncologico di Bari Giovanni Paolo II, Oncology Department, Bari, Puglia, Italy. 5. Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy. 6. IEO, Division of Medical Oncology for Melanoma, Sarcoma and Rare Tumors, Milano, Lombardia, Italy. 7. Università Cattolica del Sacro Cuore Campus di Roma, Istitute of Dermatology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy. 8. IRCCS Ospedale Policlinico San Martino, Skin Cancer Unit, Genova, Liguria, Italy. 9. University of Rome Tor Vergata, Dermatologic Unit, Department of Systems Medicine, Roma, Lazio, Italy. 10. Istituto Dermopatico dell'Immacolata IRCCS, Roma, Lazio, Italy. 11. Sapienza University of Rome, Dermatology Unit "Daniele Innocenzi", Department of Medical-Surgical Sciences and Biotechnologies Polo Pontino, Terracina, Italy. 12. Azienda Ospedaliero Universitaria Pisana, Medical Oncology Unit, Pisa, Italy. 13. Sapienza University of Rome, Clinical and Molecular Department, Umberto I Policlinico di Roma, Roma, Lazio, Italy. 14. Azienda Ospedaliera di Catanzaro Pugliese Ciaccio, U.O. Oncologia, Catanzaro, Calabria, Italy. 15. Fondazione IRCCS Istituto Nazionale dei Tumori, Head and Neck Cancer Medical Oncology 3 Department, University of Milan, Department of Hematology and Oncology, Milano, Lombardia, Italy. 16. Fondazione IRCCS Istituto Nazionale dei Tumori, Head and Neck Cancer Medical Oncology 3 Department, Milano, Lombardia, Italy. 17. University of L'Aquila Department of Clinical Sciences and Applied Biotechnology, L'Aquila, Abruzzo, Italy; San Salvatore Hospital, Medical Oncology, L'Aquila, Abruzzo, Italy. 18. University of L'Aquila Department of Clinical Sciences and Applied Biotechnology, L'Aquila, Abruzzo, Italy; Imperial College London, Department of Surgery and Cancer, London, UK. 19. University of Campania Luigi Vanvitelli, Medical Oncology, Department of Precision Medicine, Napoli, Campania, Italy. 20. Integrated University Hospital of Verona, Oncology Department, University Hospital of Verona, Verona, Veneto, Italy. 21. University of Brescia, Department of Medical-Surgical Specialties, Radiological Sciences and Public Health, Medical Oncology, ASST-Spedali Civili, Brescia, Lombardia, Italy. Electronic address: paolo.bossi@unibs.it.
Abstract
BACKGROUND: Cutaneous squamous cell carcinoma (cSCC) has an overall favourable outcome, except for patients with an advanced stage disease. The programmed death protein-1 (PD-1) inhibitor cemiplimab has been approved for use in advanced cSCC. We report clinical outcomes from the named patient programme-compassionate use of cemiplimab for patients with advanced cSCC in Italy. METHODS: This is a retrospective, observational, multicentre study. We analysed medical records of patients with advanced cSCC treated with cemiplimab between May 2019 and February 2020 in 17 referral Italian centres. We assessed the safety profile according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v 5.0), the clinical activity in terms of response rate, clinical benefit and duration of response and baseline clinical-pathologic characteristics associated with response. RESULTS: 131 patients were included, with a median age of 79 years. Of them, 9.2% had a concurrent chronic lymphoproliferative disease and 8.5% a concomitant autoimmune disease. Some 42.7% of the total patients had at least one treatment-related adverse events (AEs); out of above, 9.2% had grade 3-4 adverse events, and there were two fatal adverse events. The overall response rate (ORR) was 58%, and the disease control rate (DCR) was 71.7%. Cutaneous squamous cell carcinomas (cSCCs) arising on the head and neck area (p = 0.007) and haemoglobin values in normal range (p = 0.034) were significantly associated with a better response, while cSCCs on the genitalia (p = 0.041), treatment with any systemic antibiotic within 1 month of cemiplimab initiation (p = 0.012), performance status ≥1 (p = 0.012), chronic corticosteroids therapy (p = 0.038), previous radiation therapy to lymph nodes (p = 0.052) and previous chemotherapy (p = 0.0020) were significantly associated with a worse response. CONCLUSIONS: Our real-world study showed safety and effectiveness results comparable to those obtained in clinical trials. We identified some clinical and biochemical factors potentially associated with response to cemiplimab.
BACKGROUND: Cutaneous squamous cell carcinoma (cSCC) has an overall favourable outcome, except for patients with an advanced stage disease. The programmed death protein-1 (PD-1) inhibitor cemiplimab has been approved for use in advanced cSCC. We report clinical outcomes from the named patient programme-compassionate use of cemiplimab for patients with advanced cSCC in Italy. METHODS: This is a retrospective, observational, multicentre study. We analysed medical records of patients with advanced cSCC treated with cemiplimab between May 2019 and February 2020 in 17 referral Italian centres. We assessed the safety profile according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v 5.0), the clinical activity in terms of response rate, clinical benefit and duration of response and baseline clinical-pathologic characteristics associated with response. RESULTS: 131 patients were included, with a median age of 79 years. Of them, 9.2% had a concurrent chronic lymphoproliferative disease and 8.5% a concomitant autoimmune disease. Some 42.7% of the total patients had at least one treatment-related adverse events (AEs); out of above, 9.2% had grade 3-4 adverse events, and there were two fatal adverse events. The overall response rate (ORR) was 58%, and the disease control rate (DCR) was 71.7%. Cutaneous squamous cell carcinomas (cSCCs) arising on the head and neck area (p = 0.007) and haemoglobin values in normal range (p = 0.034) were significantly associated with a better response, while cSCCs on the genitalia (p = 0.041), treatment with any systemic antibiotic within 1 month of cemiplimab initiation (p = 0.012), performance status ≥1 (p = 0.012), chronic corticosteroids therapy (p = 0.038), previous radiation therapy to lymph nodes (p = 0.052) and previous chemotherapy (p = 0.0020) were significantly associated with a worse response. CONCLUSIONS: Our real-world study showed safety and effectiveness results comparable to those obtained in clinical trials. We identified some clinical and biochemical factors potentially associated with response to cemiplimab.
Authors: Giulia Bertino; Ales Groselj; Luca G Campana; Christian Kunte; Hadrian Schepler; Julie Gehl; Tobian Muir; James A P Clover; Pietro Quaglino; Erika Kis; Matteo Mascherini; Brian Bisase; Giancarlo Pecorari; Falk Bechara; Paolo Matteucci; Joy Odili; Francesco Russano; Antonio Orlando; Rowan Pritchard-Jones; Graeme Moir; David Mowatt; Barbara Silvestri; Veronica Seccia; Werner Saxinger; Francesca de Terlizzi; Gregor Sersa Journal: Front Oncol Date: 2022-09-20 Impact factor: 5.738
Authors: Ignazio Stanganelli; Francesco Spagnolo; Giuseppe Argenziano; Paolo A Ascierto; Franco Bassetto; Paolo Bossi; Vittorio Donato; Daniela Massi; Cesare Massone; Roberto Patuzzo; Giovanni Pellacani; Pietro Quaglino; Paola Queirolo; Iris Zalaudek; Giuseppe Palmieri Journal: Cancers (Basel) Date: 2022-01-13 Impact factor: 6.639
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