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在局部晚期头颈癌中,将尼妥珠单抗添加至标准TPF方案的单机构研究。

Addition of Nimotuzumab to Standard TPF Regimen in Locally Advanced Head and Neck Cancer: A Single Institutional Study.

作者信息

Koramati Samuel Luke, Sarathy Vinu, Varayathu Hrishi, Thomas Beulah Elsa, Naik Radheshyam

机构信息

Department of Clinical Pharmacology, Healthcare Global Enterprises Limited, Bengaluru, Karnataka, India.

Department of Medical Oncology, Healthcare Global Enterprises Limited, Bengaluru, Karnataka, India.

出版信息

J Oncol. 2021 Apr 16;2021:6641963. doi: 10.1155/2021/6641963. eCollection 2021.

Abstract

BACKGROUND

Induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by definitive concurrent chemoradiation remains the standard of care in locally advanced squamous cell carcinoma of head and neck cancers despite which the survival remains low. So, we analyzed the efficacy and adverse effect profile of the addition of nimotuzumab to standard TPF induction chemotherapy. Methods. We included 20 patients with locally advanced squamous cell carcinoma of the head and neck. Patients were administered with induction chemotherapy with nimotuzumab plus docetaxel, cisplatin, and 5-fluorouracil (TPF + N) followed by definitive concurrent chemoradiation with carboplatin. Treatment responses were assessed by PET-CT following induction chemotherapy and concurrent chemoradiation. Response rates, survival, and adverse effects data were tabulated and analyzed using the Kaplan Meier method.

RESULTS

At a minimum follow-up of two years, the median progression-free survival (PFS) and median overall survival (OS) were 16 months and 38 months, respectively. PFS and OS were not reached (NR) in patients who showed a complete radiological response (CR). Median PFS and OS in patients who had partial response were 17.6 and 34.5 months, respectively. All subsites of primary including oral cavity, hypopharynx, and oropharynx showed similar response rates and survival. Overall the treatment was well tolerated with predominantly grade 1/2 toxicities.

CONCLUSIONS

Patients with locally advanced head and neck cancer could possibly have a better response and survival with nimotuzumab added to the standard TPF regimen. A complete response may serve as a good surrogate for survival irrespective of the primary site of head and neck cancer.

摘要

背景

尽管诱导多西他赛、顺铂和5-氟尿嘧啶(TPF)化疗后进行确定性同步放化疗仍是局部晚期头颈部鳞状细胞癌的标准治疗方案,但生存率仍然较低。因此,我们分析了在标准TPF诱导化疗中添加尼妥珠单抗的疗效和不良反应情况。方法。我们纳入了20例局部晚期头颈部鳞状细胞癌患者。患者接受尼妥珠单抗联合多西他赛、顺铂和5-氟尿嘧啶(TPF+N)的诱导化疗,随后进行以卡铂为基础的确定性同步放化疗。在诱导化疗和同步放化疗后通过PET-CT评估治疗反应。使用Kaplan Meier方法将反应率、生存率和不良反应数据制成表格并进行分析。

结果

在至少两年的随访中,中位无进展生存期(PFS)和中位总生存期(OS)分别为16个月和38个月。影像学完全缓解(CR)的患者未达到PFS和OS(NR)。部分缓解患者的中位PFS和OS分别为17.6个月和34.5个月。原发灶的所有亚部位,包括口腔、下咽和口咽,显示出相似的反应率和生存率。总体而言,治疗耐受性良好,主要为1/2级毒性。

结论

对于局部晚期头颈部癌患者,在标准TPF方案中添加尼妥珠单抗可能会有更好的反应和生存率。无论头颈部癌的原发部位如何,完全缓解都可能是生存的良好替代指标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb53/8068547/7c90fa0c0d1d/JO2021-6641963.001.jpg

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