Hospital Clínic Barcelona, Department of Otorhinolaryngology, Universitat de Barcelona, Barcelona, Spain.
Hospital Clínic Barcelona, Department of Otorhinolaryngology, Universitat de Barcelona, Barcelona, Spain.
Braz J Otorhinolaryngol. 2024 Jan-Feb;90(1):101365. doi: 10.1016/j.bjorl.2023.101365. Epub 2023 Nov 22.
To evaluate the efficacy and tolerance after the electrochemotherapy treatment for local therapy of cutaneous and subcutaneous metastases of head-and-neck tumors and malignant melanoma refractory to standard therapies, mainly in neck metastasis of squamous cell carcinoma. And, to evaluate the relation of this response according to the skin reaction (healing with ulcer or dry crust).
prospective pase II, observational clinical study of 56 patients with metastases of head-and-neck squamous cell carcinoma (n=13), papillary thyroid carcinoma (n=4), adenoid cystic carcinoma of parotid gland (n=1) or malignant melanoma (n=37, 5 in head). Patients were treated by electrochemotherapy (application of electrical pulses into the tumor) after the administration of a single intravenous dose of bleomycin. Kaplan-Meier curves were performed. The statistical significance was evaluated using log-rank test; p-value of less than 0.05 was considered as significant.
Overall clinical response was observed in 47 patients (84%). Local side effects were mild in all the patients. Ten patients (76.9%) with neck metastasis of squamous cell carcinoma had some degree of response, but only in one was complete. Patients even with only partial response had a higher overall survival than patients without response (p= 0.02). Most of the patients with squamous cell carcinoma had diminution of pain and anxiety. Response rate and overall survival was higher in MM patients (86.5%) than in squamous cell cancer patients (76.9%) (p= 0.043). The healing process (dry crust/ulcer) was not associated with the overall survival (p= 0.86).
Electrochemotherapy is associated a higher overall survival and diminution of pain and anxiety. Therefore, it is an option as palliative treatment for patients with neck metastasis of squamous cell carcinoma refractory to other therapies or even as a concomitant treatment with newer immunotherapies. The type of healing of the surgical wound could not be associated with a higher rate of response or survival.
III.
评估电化学疗法治疗头颈部肿瘤和恶性黑色素瘤皮肤和皮下转移的局部治疗的疗效和耐受性,主要是针对鳞状细胞癌的颈部转移。并且,根据皮肤反应(愈合伴有溃疡或干燥结痂)来评估这种反应的相关性。
这是一项前瞻性的 II 期、观察性临床研究,共纳入了 56 例头颈部鳞状细胞癌(n=13)、甲状腺乳头状癌(n=4)、腮腺腺样囊性癌(n=1)或恶性黑色素瘤(n=37,5 例位于头部)转移患者。在给予单次静脉注射博来霉素后,对患者进行电化学疗法(将电脉冲应用于肿瘤)。采用 Kaplan-Meier 曲线进行分析。使用对数秩检验评估统计学意义;p 值小于 0.05 被认为具有统计学意义。
47 例患者(84%)观察到总体临床反应。所有患者的局部副作用均较轻。10 例(76.9%)颈部鳞状细胞癌转移患者有一定程度的反应,但只有 1 例完全缓解。即使只有部分缓解的患者总生存时间也高于无反应的患者(p=0.02)。大多数患有鳞状细胞癌的患者疼痛和焦虑程度减轻。恶性黑色素瘤患者的反应率和总生存率(86.5%)高于鳞状细胞癌患者(76.9%)(p=0.043)。愈合过程(干燥结痂/溃疡)与总生存时间无关(p=0.86)。
电化学疗法与更高的总生存率以及减轻疼痛和焦虑相关。因此,它是一种选择,适用于对其他治疗方法耐药的颈部鳞状细胞癌转移患者的姑息治疗,甚至可以与新型免疫疗法联合使用。手术伤口的愈合类型不能与更高的反应率或生存率相关联。
III。