Randomized Phase III Trial of Perioperative Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

开始日期2025-01-09

申办/合作机构

National Cancer Institute

NCT06662058 / Not yet recruitingN/AIIT

Ototoxicity Monitoring and Remote Audiometry

This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.

开始日期2025-01-01

申办/合作机构

Emory University

[+2]

NCT06580054 / Not yet recruiting临床2期IIT

Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma (cSCC)

This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and/or periorbital cSCC.

开始日期2024-12-01

申办/合作机构

Rogel Cancer Center: University of Michigan

100 项与复发性头颈部皮肤鳞状细胞癌相关的临床结果

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100 项与复发性头颈部皮肤鳞状细胞癌相关的转化医学

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0 项与复发性头颈部皮肤鳞状细胞癌相关的专利（医药）

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项与复发性头颈部皮肤鳞状细胞癌相关的文献（医药）

2023-12-01·Indian Journal of Otolaryngology and Head & Neck Surgery

Histopathological Pattern of Head and Neck Recurrent BCC After Previous Cryotherapy

Article

作者: Martins, Manoela Domingues ; Girardi, Fábio Muradás ; de Carvalho Neto, Antônio Augusto

Surgical resection is the gold standard treatment for basal cell carcinomas, although there is literature supporting cryotherapy for low-risk cases. Our aim was to compare the histopathological aspects of recurrent postcryotherapy head and neck cutaneous BCC with de novo tumors, using a case-control study. 51 Recurrent postcryotherapy cases were selected between January 2017 and December 2021 and compared to 132 controls filtered from a consecutive series of de novo head and neck cutaneous BCC operated between January and December 2021. Aggressive variants, multifocality, invasion beyond adipose tissue and higher Clark levels were associated with recurrent cases on multivariate analysis. Previous cryotherapy treatment may have contributed to an increased risk of more aggressive recurrent disease and caution using this treatment modality is advised.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12070-023-03919-7.

2020-07-01·ANZ Journal of Surgery4区 · 医学

Surgical management of recurrent cutaneous squamous cell carcinoma of the head and neck after definitive surgery and radiotherapy

4区 · 医学

Article

作者: Henderson, Michael A. ; Rischin, Danny ; Webb, Angela ; Magarey, Matthew J. R. ; Tham, Yik Seng ; Toppi, Jason

AbstractBackgroundSurgery is the primary treatment for patients with recurrent head and neck cutaneous squamous cell carcinoma (cSCC) who have previously been treated by definitive surgery and radiotherapy. There are limited published data to direct management and the role of immunotherapy is currently under evaluation.MethodsThis was a retrospective study of patients with at least stage III recurrent head and neck cSCC previously managed by definitive surgery and radiotherapy.ResultsA total of 30 patients met the inclusion criteria. Eighty‐seven percent were male and the median age at the time of surgery was 79 years. After salvage surgery, 7% developed local recurrence and 43% regional or distant failure. The 2‐year overall survival and disease‐free survival were 45% (95% confidence interval 24–64) and 11% (95% confidence interval 1–34), respectively. Advanced age was associated with a higher risk of overall mortality (P < 0.05).ConclusionPatients with recurrent head and neck cSCC in the setting of previous radiotherapy have high recurrence rates with poor survival justifying consideration for treatment with anti‐PD‐1 immunotherapy strategies.

2017-01-01·European Archives of Oto-Rhino-Laryngology3区 · 医学

Management of locoregional recurrence in cutaneous squamous cell carcinoma of the head and neck

3区 · 医学

Article

作者: Hofauer, Benedikt ; Knopf, Andreas ; Jacobi, Christian ; Strassen, Ulrich

Cutaneous squamous cell carcinomas often affect elderly patients. Follow-up monitoring is difficult in these patients due to their multi-morbidity and reduced compliance. Tumour recurrence is consequently diagnosed in advanced tumour stages. Surgical therapy with curative intention often requires extended resections. The study at hand should determine whether surgical concepts are warranted in this collective. Sixty-seven patients who underwent surgical procedure due to recurrent disease of cutaneous head and neck squamous cell carcinoma were included. The cohort was divided in patients with/without adjuvant therapeutic regimens. Data were assessed retrospectively. Complete tumour resection was achieved in 85 % of our patients. Patients with adjuvant treatment demonstrated a favorable 5-year-recurrence-free interval (78 vs 30 %) and overall survival (79 vs 46 %). Complete surgical resection of advanced recurrent head and neck cutaneous squamous cell carcinomas is possible and yields favorable results in terms of survival, especially if combined with adjuvant treatment.

项与复发性头颈部皮肤鳞状细胞癌相关的新闻（医药）

2023-11-06

·医药观澜

ORR达60%！君实生物公布“免疫+靶向”联合疗法最新临床结果

▎药明康德内容团队编辑近日，君实生物PD-1抑制剂特瑞普利单抗联合抗EGFR单抗西妥昔单抗治疗复发或转移性头颈部鳞状细胞癌（R/M-HNSCC）的1b/2期临床研究结果，在2023年第38届癌症免疫治疗学会（SITC）年会上壁报展示。该研究由同济大学附属东方医院郭晔教授牵头开展，结果显示，总体人群的客观缓解率（ORR）达60%，患者实现肿瘤长期缓解，中位缓解持续时间（DoR）达17.9个月。HNSCC是全球常见癌症，该病侵袭性强，遗传背景复杂并且难于治疗，HNSCC通常与高度心理压力和生活质量降低相关。R/M-HNSCC患者预后较差，在接受一线铂类标准治疗失败后，目前二线标准治疗的中位生存期仅为8个月左右，临床需求亟待满足。有研究显示，PD-1抑制剂和抗EGFR单抗对R/M-HNSCC均具有疗效，且两者联用可能存在潜在的协同作用。特瑞普利单抗注射液（拓益）正是一款以PD-1为靶点的单抗药物，已在中国获批6项适应症，覆盖黑色素瘤、鼻咽癌、尿路上皮癌、食管鳞癌等瘤种。目前，该产品已在全球开展了覆盖超过15个适应症的40多项由公司发起的临床研究。此次研究人员在SITC大会上详细报告了特瑞普利单抗联合西妥昔单抗治疗既往铂类治疗失败的R/M-HNSCC患者的1b/2期临床研究队列A数据。其中，研究队列A纳入接受一线含铂方案治疗后进展的R/M-HNSCC以及含铂新辅助/辅助或放化疗治疗6个月内进展为R/M-HNSCC的患者，所有患者接受特瑞普利单抗和西妥昔单抗联合治疗。主要研究终点为独立审查委员会（IRC）根据RECIST v1.1标准评估的ORR。次要终点包括研究者评估的ORR、疾病控制率（DCR）、DoR、无进展生存期（PFS）、总生存期（OS）和安全性等。截至2023年4月14日，队列A共纳入45例患者，中位年龄为59岁（范围：32~74），35例（77.8%）男性患者，18例（40.0%）患者伴有远处转移，31例（68.9%）患者PD-L1表达阳性（CPS≥1）。中位随访时间为10.0个月。结果显示，IRC评估的经确认的ORR为60%，包括1例完全缓解（CR）和26例部分缓解（PR）；DCR为80%，中位DOR为17.9个月。生存分析显示，中位PFS为9.9个月，1年PFS率为40.7%。中位OS达15.4个月，1年OS率为54.4%。亚组分析显示，PD-L1表达阳性（CPS≥1）患者较阴性患者（CPS<1）的临床获益更高（ORR：64.5% vs 40.0%，中位PFS：10.4个月 vs 4.0个月，中位OS：15.4个月 vs 11.7个月）。安全性方面，93.3%的患者发生了治疗相关不良事件（TRAE），其中10例（22.2%）患者发生了≥3级TRAE。11例（24.4%）患者报告了免疫相关不良事件（irAE），无≥3级irAE发生。未报告与研究治疗相关的致死性AE。综上，研究者认为，既往铂类治疗失败的R/M-HNSCC患者接受特瑞普利单抗联合西妥昔单抗耐受性良好，并展现出令人鼓舞的临床疗效。参考资料：[1]ORR达60%，中位OS 15.4个月！“免疫+靶向”联合方案二线治疗复发或转移性头颈鳞癌实现患者长生存. Retrieved Nov 6， 2023. From https://mp.weixin.qq.com/s/M1TJGdrX6xU4AlWrwFE36Q本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床结果免疫疗法