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新辅助西米普利单抗治疗II - IV期皮肤鳞癌患者可有效改善预后
作者:小柯机器人 发布时间:2022/9/16 14:49:15

美国德州大学安德森癌症中心Neil D. Gross团队研究了新辅助西米普利单抗治疗II - IV期皮肤鳞癌的疗效与安全性。该项研究成果发表在2022年9月12日出版的《新英格兰医学杂志》上。

在一项涉及皮肤鳞状细胞癌患者的试点研究中,术前使用两剂新辅助西米普利单抗的患者中有较高比例在术后病理学完全缓解。仍需2期临床研究的数据来证实这些发现。

研究组进行了一项临床2期、证实性、多中心、非随机研究,以评估西米普利单抗作为可切除II、III或IV期(M0)皮肤鳞状细胞癌患者新辅助治疗的效果。患者在接受治疗性手术前接受西米普利单抗,每3周350 mg,最多4次。主要终点是在中心实验室进行独立审查时的病理学完全缓解(手术标本中没有活肿瘤细胞),并假设25%的患者会观察到病理学完全缓解。关键次要终点包括独立审查的病理学主要缓解(活性肿瘤细胞的存在少于手术标本的10%)、当地实验室研究者评估的病理学完全缓解和病理学主要缓解、成像的客观缓解和不良事件。

共有79名患者入选并接受新辅助西米普利单抗。在独立审查中,40名患者观察到病理学完全缓解(51%),10名患者观察到病理学主要缓解(13%)。这些结果与研究者评估确定的病理缓解一致。在54例患者中观察到成像的客观缓解(68%)。在69名患者(87%)中观察到研究期间发生的任何级别的不良事件,无论其是否归因于研究治疗。14名患者(18%)中观察到研究期间发生的3级及以上不良事件。

研究结果表明,西米普利单抗的新辅助治疗与高比例可切除皮肤鳞状细胞癌患者的病理完全缓解相关。

附:英文原文

Title: Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma | NEJM

Author: Neil D. Gross, M.D.,, David M. Miller, M.D., Ph.D.,, Nikhil I. Khushalani, M.D.,, Vasu Divi, M.D.,, Emily S. Ruiz, M.D., M.P.H.,, Evan J. Lipson, M.D.,, Friedegund Meier, M.D.,, Yungpo B. Su, M.D.,, Paul L. Swiecicki, M.D.,, Jennifer Atlas, M.D.,, Jessica L. Geiger, M.D.,, Axel Hauschild, M.D.,, Jennifer H. Choe, M.D., Ph.D.,, Brett G.M. Hughes, M.D.,, Dirk Schadendorf, M.D.,, Vishal A. Patel, M.D.,, Jade Homsi, M.D.,, Janis M. Taube, M.D.,, Annette M. Lim, M.D., Ph.D.,, Renata Ferrarotto, M.D.,, Howard L. Kaufman, M.D.,, Frank Seebach, M.D.,, Israel Lowy, M.D., Ph.D.,, Suk-Young Yoo, Ph.D.,, Melissa Mathias, M.D.,, Keilah Fenech, B.Sc.,, Hyunsil Han, Ph.D.,, Matthew G. Fury, M.D., Ph.D.,, and Danny Rischin, M.D.

Issue&Volume: 2022-09-12

Abstract:

Background

In a pilot study involving patients with cutaneous squamous-cell carcinoma, a high percentage of patients had a pathological complete response with the use of two doses of neoadjuvant cemiplimab before surgery. Data from a phase 2 study are needed to confirm these findings.

Methods

We conducted a phase 2, confirmatory, multicenter, nonrandomized study to evaluate cemiplimab as neoadjuvant therapy in patients with resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma. Patients received cemiplimab, administered at a dose of 350 mg every 3 weeks for up to four doses, before undergoing surgery with curative intent. The primary end point was a pathological complete response (the absence of viable tumor cells in the surgical specimen) on independent review at a central laboratory, with a null hypothesis that a pathological complete response would be observed in 25% of patients. Key secondary end points included a pathological major response (the presence of viable tumor cells that constitute ≤10% of the surgical specimen) on independent review, a pathological complete response and a pathological major response on investigator assessment at a local laboratory, an objective response on imaging, and adverse events.

Results

A total of 79 patients were enrolled and received neoadjuvant cemiplimab. On independent review, a pathological complete response was observed in 40 patients (51%; 95% confidence interval [CI], 39 to 62) and a pathological major response in 10 patients (13%; 95% CI, 6 to 22). These results were consistent with the pathological responses determined on investigator assessment. An objective response on imaging was observed in 54 patients (68%; 95% CI, 57 to 78). Adverse events of any grade that occurred during the study period, regardless of whether they were attributed to the study treatment, were observed in 69 patients (87%). Grade 3 or higher adverse events that occurred during the study period were observed in 14 patients (18%).

Conclusions

Neoadjuvant therapy with cemiplimab was associated with a pathological complete response in a high percentage of patients with resectable cutaneous squamous-cell carcinoma.

DOI: 10.1056/NEJMoa2209813

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2209813

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home