PMID- 34536948
OWN - NLM
STAT- MEDLINE
DCOM- 20211206
LR  - 20220328
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 157
DP  - 2021 Nov
TI  - Real world data of cemiplimab in locally advanced and metastatic cutaneous 
      squamous cell carcinoma.
PG  - 250-258
LID - S0959-8049(21)00536-0 [pii]
LID - 10.1016/j.ejca.2021.08.018 [doi]
AB  - 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.
CI  - Copyright (c) 2021 Elsevier Ltd. All rights reserved.
FAU - Baggi, Alice
AU  - Baggi A
AD  - University of Brescia, Department of Medical-Surgical Specialties, Radiological 
      Sciences and Public Health, Medical Oncology, ASST-Spedali Civili, Brescia, 
      Lombardia, Italy.
FAU - Quaglino, Pietro
AU  - Quaglino P
AD  - University of Turin, Dermatologic Clinic, Department of Medical Sciences Torino, 
      Piemonte, Italy.
FAU - Rubatto, Marco
AU  - Rubatto M
AD  - University of Turin, Dermatologic Clinic, Department of Medical Sciences Torino, 
      Piemonte, Italy.
FAU - Depenni, Roberta
AU  - Depenni R
AD  - Universita degli Studi di Modena e Reggio Emilia, Department of Oncology, 
      Hematology, Modena, Emilia-Romagna, Italy.
FAU - Guida, Michele
AU  - Guida M
AD  - IRCCS Istituto Oncologico di Bari Giovanni Paolo II, Oncology Department, Bari, 
      Puglia, Italy.
FAU - Ascierto, Paolo Antonio
AU  - Ascierto PA
AD  - Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto 
      Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
FAU - Trojaniello, Claudia
AU  - Trojaniello C
AD  - Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto 
      Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
FAU - Queirolo, Paola
AU  - Queirolo P
AD  - IEO, Division of Medical Oncology for Melanoma, Sarcoma and Rare Tumors, Milano, 
      Lombardia, Italy.
FAU - Saponara, Maristella
AU  - Saponara M
AD  - IEO, Division of Medical Oncology for Melanoma, Sarcoma and Rare Tumors, Milano, 
      Lombardia, Italy.
FAU - Peris, Ketty
AU  - Peris K
AD  - Universita Cattolica del Sacro Cuore Campus di Roma, Istitute of Dermatology, 
      Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy.
FAU - Spagnolo, Francesco
AU  - Spagnolo F
AD  - IRCCS Ospedale Policlinico San Martino, Skin Cancer Unit, Genova, Liguria, Italy.
FAU - Bianchi, Luca
AU  - Bianchi L
AD  - University of Rome Tor Vergata, Dermatologic Unit, Department of Systems 
      Medicine, Roma, Lazio, Italy.
FAU - De Galitiis, Federica
AU  - De Galitiis F
AD  - Istituto Dermopatico dell'Immacolata IRCCS, Roma, Lazio, Italy.
FAU - Potenza, Maria Concetta
AU  - Potenza MC
AD  - Sapienza University of Rome, Dermatology Unit "Daniele Innocenzi", Department of 
      Medical-Surgical Sciences and Biotechnologies Polo Pontino, Terracina, Italy.
FAU - Proietti, Ilaria
AU  - Proietti I
AD  - Sapienza University of Rome, Dermatology Unit "Daniele Innocenzi", Department of 
      Medical-Surgical Sciences and Biotechnologies Polo Pontino, Terracina, Italy.
FAU - Marconcini, Riccardo
AU  - Marconcini R
AD  - Azienda Ospedaliero Universitaria Pisana, Medical Oncology Unit, Pisa, Italy.
FAU - Botticelli, Andrea
AU  - Botticelli A
AD  - Sapienza University of Rome, Clinical and Molecular Department, Umberto I 
      Policlinico di Roma, Roma, Lazio, Italy.
FAU - Barbieri, Vito
AU  - Barbieri V
AD  - Azienda Ospedaliera di Catanzaro Pugliese Ciaccio, U.O. Oncologia, Catanzaro, 
      Calabria, Italy.
FAU - Licitra, Lisa
AU  - Licitra L
AD  - 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.
FAU - Alfieri, Salvatore
AU  - Alfieri S
AD  - Fondazione IRCCS Istituto Nazionale dei Tumori, Head and Neck Cancer Medical 
      Oncology 3 Department, Milano, Lombardia, Italy.
FAU - Ficorella, Corrado
AU  - Ficorella C
AD  - University of L'Aquila Department of Clinical Sciences and Applied Biotechnology, 
      L'Aquila, Abruzzo, Italy; San Salvatore Hospital, Medical Oncology, L'Aquila, 
      Abruzzo, Italy.
FAU - Cortellini, Alessio
AU  - Cortellini A
AD  - 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.
FAU - Fargnoli, Maria Concetta
AU  - Fargnoli MC
AD  - University of L'Aquila Department of Clinical Sciences and Applied Biotechnology, 
      L'Aquila, Abruzzo, Italy; San Salvatore Hospital, Medical Oncology, L'Aquila, 
      Abruzzo, Italy.
FAU - Troiani, Teresa
AU  - Troiani T
AD  - University of Campania Luigi Vanvitelli, Medical Oncology, Department of 
      Precision Medicine, Napoli, Campania, Italy.
FAU - Tondulli, Luca
AU  - Tondulli L
AD  - Integrated University Hospital of Verona, Oncology Department, University 
      Hospital of Verona, Verona, Veneto, Italy.
FAU - Bossi, Paolo
AU  - Bossi P
AD  - 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.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20210915
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immune Checkpoint Inhibitors)
RN  - 0 (PDCD1 protein, human)
RN  - 0 (Programmed Cell Death 1 Receptor)
RN  - 6QVL057INT (cemiplimab)
SB  - IM
EIN - Eur J Cancer. 2022 May;166:309-310. PMID: 35341663
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Carcinoma, Squamous Cell/*drug therapy/immunology
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/immunology
MH  - Female
MH  - Humans
MH  - Immune Checkpoint Inhibitors/*administration & dosage/adverse effects
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Programmed Cell Death 1 Receptor/antagonists & inhibitors
MH  - Response Evaluation Criteria in Solid Tumors
MH  - Retrospective Studies
MH  - Skin Neoplasms/*drug therapy/immunology
MH  - Young Adult
OTO - NOTNLM
OT  - Cemiplimab
OT  - Cutaneous squamous cell carcinoma
OT  - Immunotherapy
OT  - Real world
EDAT- 2021/09/19 06:00
MHDA- 2021/12/15 06:00
CRDT- 2021/09/18 20:30
PHST- 2021/05/30 00:00 [received]
PHST- 2021/08/03 00:00 [revised]
PHST- 2021/08/13 00:00 [accepted]
PHST- 2021/09/19 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/09/18 20:30 [entrez]
AID - S0959-8049(21)00536-0 [pii]
AID - 10.1016/j.ejca.2021.08.018 [doi]
PST - ppublish
SO  - Eur J Cancer. 2021 Nov;157:250-258. doi: 10.1016/j.ejca.2021.08.018. Epub 2021 
      Sep 15.