Photodynamic therapy in primary breast cancer: the first human study (Conference Presentation)

S. Banerjee, S. E. Sheikh, A. Malhotra, S. Mosse, S. Parker, N. Williams, S. Macrobert, R. Hamoudi, S. Bown, M. Keshtgar
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Abstract

Primary breast cancer while increasing in incidence has been successfully treated with a combination of surgery and adjuvant therapies in the majority of patients. Novel treatments for primary breast cancer need to show additional benefits to existing treatments with equivalent or improved efficacy for niche groups. Photodynamic therapy (PDT) is a potential novel treatment and a Phase I/IIA, open label, non-randomised, single site trial of photodynamic therapy for the treatment of primary breast cancer was conducted. The primary aim was to identify the light dose required for 12 mm of tumour necrosis (or a plateau of necrosis) assessed by histopathology. Post-dose MRI correlation with histopathology findings in treated tumours and in normal breast tissue was sought. In addition adverse events were recorded and comparison of outcome made with matched controls. Results of the first human clinical trial with 12 patients with median follow-up of 39 months showed PDT was well tolerated, with no adverse effects and comparable outcome to control populations. Tumour necrosis increased with incremental increases in light dose, however some patients showed a poor response even at the highest light dose. Analysis suggests that there may be predictive factors for good and poor response. PDT in primary breast cancer requires further investigation to identify which patients would most benefit from this therapy.
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原发性乳腺癌的光动力疗法:首次人体研究(会议报告)
原发性乳腺癌虽然发病率越来越高,但大多数患者通过手术和辅助治疗的结合成功地治疗了乳腺癌。原发性乳腺癌的新治疗方法需要显示出对现有治疗方法的额外益处,并对小众群体具有同等或更好的疗效。光动力疗法(PDT)是一种潜在的新型治疗方法,一项I/IIA期、开放标签、非随机、单点试验进行了光动力疗法治疗原发性乳腺癌。主要目的是确定通过组织病理学评估的12mm肿瘤坏死(或坏死平台)所需的光剂量。在治疗肿瘤和正常乳腺组织中,寻求剂量后MRI与组织病理学结果的相关性。此外,记录不良事件,并将结果与匹配对照进行比较。第一次人体临床试验的结果显示,12名患者的中位随访时间为39个月,PDT耐受性良好,无不良反应,结果与对照人群相当。肿瘤坏死随着光剂量的增加而增加,但一些患者即使在最高光剂量下也表现出较差的反应。分析表明,可能存在反应好坏的预测因素。原发性乳腺癌的PDT治疗需要进一步调查,以确定哪些患者将从这种治疗中获益最多。
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