Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma

被引:76
作者
Baggi, Alice [1 ]
Quaglino, Pietro [2 ]
Rubatto, Marco [2 ]
Depenni, Roberta [3 ]
Guida, Michele [4 ]
Ascierto, Paolo Antonio [5 ]
Trojaniello, Claudia [5 ]
Queirolo, Paola [6 ]
Saponara, Maristella [6 ]
Peris, Ketty [7 ]
Spagnolo, Francesco [8 ]
Bianchi, Luca [9 ]
De Galitiis, Federica [10 ]
Potenza, Maria Concetta [11 ]
Proietti, Ilaria [11 ]
Marconcini, Riccardo [12 ]
Botticelli, Andrea [13 ]
Barbieri, Vito [14 ]
Licitra, Lisa [15 ]
Alfieri, Salvatore [16 ]
Ficorella, Corrado [17 ,18 ]
Cortellini, Alessio [17 ,19 ]
Fargnoli, Maria Concetta [17 ,18 ]
Troiani, Teresa [20 ]
Tondulli, Luca [21 ]
Bossi, Paolo [1 ]
机构
[1] Univ Brescia, ASST Spedali Civili, Dept Med Surg Specialties Radiol Sci & Publ Hlth, Piazzale Spedali Civili 1, I-25123 Brescia, Lombardia, Italy
[2] Univ Turin, Dermatol Clin, Dept Med Sci Torino, Piemonte, Italy
[3] Univ Modena & Reggio Emilia, Dept Oncol Hematol, Modena, Emilia Romagna, Italy
[4] IRCCS Ist Oncol Bari Giovanni Paolo II, Oncol Dept, Bari, Puglia, Italy
[5] Ist Nazl Tumori IRCCS Fdn Pascale, Unit Melanoma Canc Immunotherapy & Dev Therapeut, Naples, Campania, Italy
[6] IEO, Div Med Oncol Melanoma Sarcoma & Rare Tumors, Milan, Lombardia, Italy
[7] Univ Cattolica Sacro Cuore, Fdn Policlin Univ Agostino Gemelli IRCCS, Ist Dermatol, Campus Roma, Rome, Lazio, Italy
[8] IRCCS Osped Policlin San Martino, Skin Canc Unit, Genoa, Liguria, Italy
[9] Univ Roma Tor Vergata, Dermatol Unit, Dept Syst Med, Rome, Lazio, Italy
[10] Ist Dermopat Immacolata IRCCS, Rome, Lazio, Italy
[11] Sapienza Univ Rome, Dermatol Unit Daniele Innocenzi, Dept Med Surg Sci & Biotechnol Polo Pontino, Terracina, Italy
[12] Azienda Osped Univ Pisana, Med Oncol Unit, Pisa, Italy
[13] Sapienza Univ Rome, Clin & Mol Dept, Umberto I Policlin Roma, Rome, Lazio, Italy
[14] Azienda Osped Catanzaro Pugliese Ciaccio, UO Oncol, Calabria, Italy
[15] Univ Milan, Fdn IRCCS Ist Nazl Tumori, Head & Neck Canc Med Oncol Dept 3, Dept Hematol & Oncol, Milan, Lombardia, Italy
[16] Fdn IRCCS Ist Nazl Tumori, Head & Neck Canc Med Oncol Dept 3, Milan, Lombardia, Italy
[17] Univ Aquila, Dept Clin Sci & Appl Biotechnol, Laquila, Abruzzo, Italy
[18] San Salvatore Hosp, Med Oncol, Laquila, Abruzzo, Italy
[19] Imperial Coll London, Dept Surg & Canc, London, England
[20] Univ Campania Luigi Vanvitelli, Med Oncol, Dept Precis Med, Naples, Campania, Italy
[21] Univ Hosp Verona, Integrated Univ Hosp Verona, Oncol Dept, Verona, Veneto, Italy
关键词
Cutaneous squamous cell carcinoma; Immunotherapy; Cemiplimab; Real world;
D O I
10.1016/j.ejca.2021.08.018
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. (c) 2021 Elsevier Ltd. All rights reserved.
引用
收藏
页码:250 / 258
页数:9
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