Real world safety outcomes using cemiplimab for cutaneous squamous cell carcinoma

Valentin, Julie; Gérard, E.; Ferté, Thomas; Prey, S.; Dousset, L.; Dutriaux, Caroline; Beylot‐Barry, M.; Pham‐Ledard, Anne

doi:10.1016/j.jgo.2021.02.026

Cited by 26 publications

(22 citation statements)

References 9 publications

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“…The main reason for this comment was that 77% of patients in their cohort reported variable adverse effects with severity ranging from grade 3 to grade 5. However, it is prudent to note that all patients who presented with adverse effects were aged >65 years, and 36% of the patients in this study group were significantly immunocompromised 35 …”

Section: Discussionmentioning

confidence: 87%

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Cemiplimab in advanced cutaneous squamous cell carcinoma

Naik

2021

Dermatologic Therapy

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Cemiplimab, a high-affinity, highly potent human monoclonal antibody that binds to the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) receptor, is the only drug to attain Food and Drug Administration (FDA) approval and marketing authorization from the European Commission for use in patients with metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation therapy as a first-or later-line treatment. In

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Section: Discussionmentioning

confidence: 87%

“…of the patients in this study group were significantly immunocompromised. 35 A generally non-explored but crucial dimension of any skin cancer treatment is cost-effectiveness. Fortunately, an analysis showed that cemiplimab provides has great value for the money spent and is costeffective.…”

Section: Discussionmentioning

confidence: 99%

Cemiplimab in advanced cutaneous squamous cell carcinoma

Naik

2021

Dermatologic Therapy

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“…However, despite remarkable advance has been made with the introduction of cemiplimab, the quality of evidence is limited as cemiplimab has not been investigated in randomized controlled trials, and its approval is based on two early‐phase clinical trials 18,19 . A real‐life experience of cemiplimab use in cSCC exhibited a worse safety profile than in clinical trials, with more treatment discontinuation, especially in older patients (> 65 years old) 20 . Therefore, a mixed treatment including weekly hypofractionated and cemiplimab should be conscientiously evaluated.…”

Section: Discussionmentioning

confidence: 99%

Definitive weekly hypofractionated radiotherapy in cutaneous squamous cell carcinoma: response rates and outcomes in elderly patients unfit for surgery

et al. 2021

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Introduction The optimal definitive radiotherapy (RT) scheme in cutaneous squamous cell carcinoma (cSCC) remains controversial, especially in elderly patients.Methods Data of elderly patients with cSCC lesion(s) treated with weekly hypofractionated RT (8 Gy per week per 7-8 weeks) were analyzed.Results Eighteen patients (median age 89 years) with 23 cSCC lesions have been identified including nine males (50%) and nine females (50%). The most common tumor localization was the head and neck region (n = 21; 91.3%), and the majority of lesions (n = 15; 65.2%) was stage ≥ III. At diagnosis, pain and bleeding were ascribed in 13 (56.5%) and eight (34.8%) cSCC, respectively. Compliance with weekly hypofractionated RT was excellent. The overall response rate at 12 weeks after treatment was 95.7%.Bleeding and pain relief were achieved in all cases. Severe toxicity was not recorded. The 1-year overall survival was 66.0%. The 1-year progression-free survival was 58.7%. ConclusionsWeekly hypofractionated RT provides a safe, efficient, and cost-effective treatment in elderly cSCC patients with minimal side effects. 8 weekly fractions of 8 Gy (T3-4) was prescribed. This solution-56-64 Gy in 7-8 Gy/fraction given once a week-[Correction added on May 15, 2022, after first online publication: CRUI funding statement has been added.]

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“…All patients with rheumatologic disease experienced lower-grade immune exacerbation. A French case series on patients receiving ICIs for advanced cSCC [47] showed 3 serious adverse events out of 8 immune-compromised patients (due to hematological disease and HIV infection). The CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.)…”

Section: Immunotherapy In Cscc and Special Patient Populationsmentioning

confidence: 99%

Treatment of Cutaneous Squamous Cell Carcinoma with Immune Checkpoint Inhibitors in Special Populations

Bossi

Lorini

2021

Dermatol Pract Concept

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Cutaneous squamous cell carcinoma (cSCC) may develop in patients with dysregulated immune activation (pre-existing autoimmune diseases or immunosuppression due to hematopoietic/solid organ transplant recipients), patients with a compromised immune function (long-term immunosuppression), and patients carrying chronic viral infections, or those affected by lymphoproliferative diseases. It should be also considered that patients presenting with immunosuppression have a high incidence of cSCC (65–250-times higher than general population), highlighting the central role played by the immune system in the development of cSCC. All these cases must be considered as “special populations” for treatment with immune checkpoint inhibitors (ICIs), as the safety and activity of these drugs have not been studied on these specific cases, since these patients were excluded from clinical trials leading to approval of ICIs. It is therefore important to gain as much information as possible from the analysis of real-life data, to derive an indication to be adopted in everyday clinical setting. Moreover, therapeutic alternatives other than ICIs are scarce, mainly consisting in chemotherapy and anti-EGFR agents, whose activity is lower than immunotherapy and whose toxicity (particularly with chemotherapy) are not sustainable by this frail population. Here, we describe the current evidence of treatment with ICIs in special populations and conclude that it is necessary to find a balance between treatment risks (toxicities) and benefits (efficacy), as well as engaging a multidisciplinary team of experts to thoroughly manage and treat these patients.

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Real world safety outcomes using cemiplimab for cutaneous squamous cell carcinoma

Cited by 26 publications

References 9 publications

Cemiplimab in advanced cutaneous squamous cell carcinoma

Cemiplimab in advanced cutaneous squamous cell carcinoma

Definitive weekly hypofractionated radiotherapy in cutaneous squamous cell carcinoma: response rates and outcomes in elderly patients unfit for surgery

Treatment of Cutaneous Squamous Cell Carcinoma with Immune Checkpoint Inhibitors in Special Populations

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