9537 Background: Programmed death receptor-1 (PD-1)–blocking antibodies are approved as monotherapy treatment for patients (pts) with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation. Cosibelimab is a high-affinity, fully human programmed death ligand-1 (PD-L1)–blocking antibody with a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) against tumor cells. Study CK-301-101 (NCT03212404) is a global, multicenter, multicohort, pivotal trial that enrolled pts with select advanced cancers for treatment with cosibelimab. Here we present the primary analysis of the registration-enabling expansion cohort in pts with metastatic CSCC. Methods: Adult pts with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 who had metastatic (nodal and/or distant) CSCC not amenable to local therapy were eligible to participate. Cosibelimab was administered as a fixed dose of 800 mg every 2 weeks (Q2W) intravenously. The primary endpoint was confirmed objective response rate (ORR; complete response [CR] + partial response [PR]) assessed by independent central review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and the key secondary endpoint was duration of response. Results: Seventy-eight pts with metastatic CSCC were treated with cosibelimab and comprise the efficacy and safety populations (59M/19F; median age: 71 years). The confirmed ORR was 47.4% (95% CI: 36.0, 59.1; 6 CRs and 31 PRs) and the median duration of response was not reached at the time of data cutoff (median duration of follow-up: 15.2 months), with 76% of responses ongoing (range: 1.4-31.8+ months). The Kaplan–Meier estimated probability of maintaining a response at 6 and 24 months was 88.1% and 72.5%, respectively. Treatment-related adverse events (TRAEs) were reported in 54 pts (69.2%); 7 pts (9.0%) experienced at least 1 grade 3 TRAE (no grade 4 or grade 5 TRAEs were reported) with the most common being increased serum lipase in 2 pts. Conclusions: Treatment with cosibelimab monotherapy resulted in a robust ORR with durable responses and demonstrated a predictable and manageable safety profile in pts with metastatic CSCC, supporting its use in the treatment of this cancer. Clinical trial information: NCT03212404.
The role of pathological biomineralization (PBM) as a prognostic and diagnostic marker in thyroid cancer is continuously debated among investigators. Detection of pathological biomineralization in the lymph nodes of the neck is an alarming signal for clinicians. Typically, a lymph node with signs of calcification is a symptom of papillary thyroid cancer. The lymph node contains such a form of calcification as psammoma bodies in such cases. Psammoma bodies of relatively large size (more than 200 μm) can be detected by ultrasound. Our study aims to study the crystal-chemical and phase characteristics of calcifications of metastatic lymph nodes in thyroid cancer to develop promising methods of early diagnosis. Materials and methods. Several complex research methods have been conducted for a deeper understanding of the pathological biomineralization of metastatic lymph nodes in thyroid cancer, such as macroscopic examination, ultrasound diagnostics, detection of strict lymph node, histological, histochemical, and electron microscopic (scanning electron microscopy, X-ray diffraction, and transmission electron microscopy). Our study found that the main component of pathological biomineral deposits is calcium phosphate compounds. The Ca / P ratio corresponds to the characteristic features of hydroxyapatite. A significant proportion of β-tricalcium magnesium phosphate was also detected in some cases. The specific plate structure and the known phase and crystal-chemical composition of psammoma bodies can be the point of application of searches for their early detection using the latest diagnostic methods with high resolution. Conclusion. Our study demonstrated the significance of PBM in lymph nodes as a diagnostic symptom of papillary thyroid cancer patients. The presence and extent of PBM in the lymph nodes should be considered a metastasis of papillary thyroid cancer. The study of the structure, physicochemical, phase composition of lymph node calcifications, and visualization features is promising given the possible practical application for early diagnosis of metastases of papillary thyroid cancer.
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