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西妥昔单抗作为口腔鳞状细胞癌高危患者预防性术后治疗的有效性:一项单中心回顾性队列研究。

Effectiveness of cetuximab as preemptive postsurgical therapy for oral squamous cell carcinoma patients with major risk: a single-center retrospective cohort study.

机构信息

Department of Oral and Maxillofacial Surgery, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Tochigi, Shimo-Tsuga, 321-0293, Japan.

Department of Dentistry, Oral and Maxillofacial Surgery, Sano Kosei General Hospital, 1728 Horigome, Sano, Tochigi, 327-8511, Japan.

出版信息

Invest New Drugs. 2021 Jun;39(3):846-852. doi: 10.1007/s10637-021-01062-0. Epub 2021 Jan 15.

Abstract

A retrospective cohort study was performed to investigate the effectiveness of preemptive postsurgical therapy with cetuximab for patients with a major risk of recurrence or metastasis after clinical complete resection of primary oral squamous cell carcinoma (OSCC). The study period was from 2007 to 2019 for patients treated at the Department of Oral and Maxillofacial Surgery, Dokkyo Medical University School of Medicine. OSCC patients with major risk (n = 88) in the follow-up period were divided into groups with no postsurgical treatment (NP group), with standard postsurgical treatment (SP group), and with postsurgical treatment including cetuximab (CP group), and prognosis were compared among those groups. The 5-year overall survival rate was significantly higher in patients who received postsurgical treatment with cetuximab (CP) compared to that in the other two groups ((CP vs. NP, p = 0.028; CP vs. SP, p = 0.042). Furthermore, we performed multivariate analysis to evaluate the effects of the main components of the treatment. Among CDDP, radiotherapy, and cetuximab, only cetuximab significantly contributed to improved survival by univariate analysis (crude HR:0.228, 95%CI:0.05-0.968, p = 0.045). cetuximab also showed the same tendency in multivariate analysis, although p value did not reach significant level (Adjusted HR: 0.233, 95%CI: 0.053-1.028, p = 0.054). The results suggest that the postsurgical treatment with cetuximab as a preemptive postsurgical therapy after complete surgical resection of a visible tumor is considerably effective for OSCC patients with major risk, in other words, invisible dormant metastasis.

摘要

一项回顾性队列研究旨在探讨在原发性口腔鳞状细胞癌(OSCC)患者临床完全切除后,对复发或转移高风险患者进行预防性术后西妥昔单抗治疗的效果。该研究的时间范围为 2007 年至 2019 年,患者均来自日本独协医科大学口腔颌面外科。在随访期间,将具有高复发风险的 OSCC 患者(n=88)分为未接受术后治疗(NP 组)、接受标准术后治疗(SP 组)和接受包括西妥昔单抗的术后治疗(CP 组),并比较这些组之间的预后。接受西妥昔单抗术后治疗(CP)的患者 5 年总生存率明显高于其他两组(CP 与 NP 相比,p=0.028;CP 与 SP 相比,p=0.042)。此外,我们进行了多变量分析,以评估治疗主要成分的影响。在顺铂、放疗和西妥昔单抗中,只有西妥昔单抗通过单因素分析显著提高了生存率(粗 HR:0.228,95%CI:0.05-0.968,p=0.045)。西妥昔单抗在多变量分析中也显示出相同的趋势,尽管 p 值未达到显著水平(调整后的 HR:0.233,95%CI:0.053-1.028,p=0.054)。结果表明,对于高风险的 OSCC 患者,在完全切除可见肿瘤后进行西妥昔单抗预防性术后治疗作为一种辅助治疗方法,对于看不见的休眠转移是相当有效的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8762/8068704/a7d1eaa47980/10637_2021_1062_Fig1_HTML.jpg

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