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

Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized / administration & dosage Carcinoma, Squamous Cell / drug therapy Drug-Related Side Effects and Adverse Reactions / epidemiology Female Humans Immune Checkpoint Inhibitors / administration & dosage Italy Male Middle Aged Programmed Cell Death 1 Receptor / antagonists & inhibitors Response Evaluation Criteria in Solid Tumors Retrospective Studies Skin Neoplasms / drug therapy Young Adult

Cemiplimab Cutaneous squamous cell carcinoma Immunotherapy Real world

Journal

European journal of cancer (Oxford, England : 1990)

ISSN: 1879-0852

Titre abrégé: Eur J Cancer

Pays: England

ID NLM: 9005373

Informations de publication

Date de publication:
11 2021

Historique:

received: 30 05 2021

revised: 03 08 2021

accepted: 13 08 2021

pubmed: 19 9 2021

medline: 15 12 2021

entrez: 18 9 2021

Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND

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.

Identifiants

DOI: 10.1016/j.ejca.2021.08.018 PMID: 34536948

pubmed: 34536948

pii: S0959-8049(21)00536-0

doi: 10.1016/j.ejca.2021.08.018

pii:

doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0

Immune Checkpoint Inhibitors 0

PDCD1 protein, human 0

Programmed Cell Death 1 Receptor 0

cemiplimab 6QVL057INT

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

Pagination

250-258

Commentaires et corrections

Type : ErratumIn