Health-related quality of life (HRQL) in patients with advanced cutaneous squamous cell carcinoma (CSCC) treated with cemiplimab: Post hoc exploratory analyses of a phase II clinical trial.

Abstract

10033 Background: Cemiplimab-rwlc (cemiplimab), a PD-1 Inhibitor, showed a robust clinical response in patients (pts) with metastatic (mCSCC) or locally advanced (laCSCC) CSCC not eligible for curative surgery/radiation. This post hoc exploratory analysis examined data from the EORTC cancer specific 30-item HRQL questionnaire (QLQ-C30) for pts participating in a cemiplimab phase 2 clinical trial (clinicaltrials.gov NCT02760498). Methods: Adults (N = 193) with invasive CSCC, ≥1 lesion and ECOG performance status ≤1 received IV cemiplimab 3mg/kg q2w (mCSCC n = 59; laCSCC n = 78) or 350mg q3w (mCSCC n = 56). At baseline (BL) and day 1 of each treatment cycle, pts were administered the QLQ-C30. Mixed effects repeated measures (MMRM) models were used to estimate mean change from BL to cycle 5 (C5) for domains/items of the QLQ-C30. For pts with data from BL to C5, the proportion who reported clinically meaningful improvement or worsening (≥10 points) or maintenance (those who did not have ≥10 point change) on each domain was determined for combined and individual treatment groups. Results: BL scores indicated moderate to high levels of functioning and low symptom burden. From BL to C5, a clinically meaningful improvement in pain score was observed (least squares [LS] mean [standard error] change -12.1 [2.1]; P< .0001); other domains/items remained stable or showed a trend towards improvement (LS mean changes < 10 points). By C5, the majority of pts experienced clinically meaningful improvement or remained stable across key domains (Table). Similar findings were observed on individual symptoms (85%-94% for dyspnea, nausea/vomiting, diarrhea, constipation, appetite loss) and in each treatment group. Conclusions: Cemiplimab-treated patients achieved a clinically meaningful reduction in pain and most pts either improved or maintained their HRQL, function with low symptom burden. Clinical trial information: NCT02760498. [Table: see text]

Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629

“…Growing evidence from immunotherapy trials has shown that monotherapy with PD-1 inhibitors provides efficacy and safety benefits while maintaining or improving HRQoL in several tumour types [30]. The results of KEY-NOTE-629 and a phase 2 trial of cemiplimab further support the benefits of PD-1 inhibitors in cSCC, with both studies reporting durable responses with stable or improved HRQoL in patients with advanced cSCC receiving treatment with a PD-1 inhibitor [13,14,31]. In the exploratory analysis of HRQoL in the phase 2 trial of cemiplimab, patients with unresectable locally advanced or metastatic cSCC had a clinically meaningful reduction in pain at cycle 5 of cemiplimab (administered at 3 mg/kg every 2 weeks for 12 cycles or 350 mg every 3 weeks for 6 cycles), with most patients having stable or a trend toward improved HRQoL scores across the other EORTC QLQ-C30 domains [31].…”

A structured review of quality of life in advanced and high‐risk cutaneous squamous cell carcinoma shows the need for more studies and better measures

“…Migden and colleagues 30 report QoL data from a phase 2 clinical trial of cemiplimab in metastatic or locally advanced cSCC. This was measured using the EORTC QLQ‐C30 and EQ‐5D.…”

“…(Continues) STARKINGS ET AL. EORTC QLQ-C30 28,30 and FACT-G 34 or more specifically, such as the FACT-H&N. 31 The EQ-5D is a widely used measure of generic health related QoL, comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/ depression. 35 It provides a utility score for health economics with a cursory QoL assessment.…”

Immunotherapy for the Treatment of Cutaneous Squamous Cell Carcinoma

“…Cemiplimab was the first PD-1 inhibitor receiving an indication in CSCC after showing in a clinical trial rapid and durable responses in more than 40% of patients (in Figures 1, 2 we reported two clinical cases of rapid clinical response), with a favorable safety profile. In addition to that, cemiplimab led to an improvement in health-related quality of life with a reduction in cancer-related pain after a few cycles of therapy (18,43,44).…”

“…Only 5% of patients had to discontinue therapy due to an adverse event of grade 3 or higher (18). According to health-related quality of life data, cemiplimab led to a clinically relevant improvement in terms of both QLQ-C30 pain scale and QLQ-C30 global health status (44).…”