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首页> 美国卫生研究院文献>Frontiers in Oncology >Preliminary Clinical and Pharmacologic Investigation of Photodynamic Therapy with the Silicon Phthalocyanine Photosensitizer Pc 4 for Primary or Metastatic Cutaneous Cancers
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Preliminary Clinical and Pharmacologic Investigation of Photodynamic Therapy with the Silicon Phthalocyanine Photosensitizer Pc 4 for Primary or Metastatic Cutaneous Cancers

机译：硅酞菁光敏剂Pc 4对原发性或转移性皮肤癌进行光动力疗法的初步临床和药理研究

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Photodynamic therapy (PDT) for cutaneous malignancies has been found to be an effective treatment with a range of photosensitizers. The phthalocyanine Pc 4 was developed initially for PDT of primary or metastatic cancers in the skin. A Phase I trial was initiated to evaluate the safety and pharmacokinetic profiles of systemically administered Pc 4 followed by red light (Pc 4-PDT) in cutaneous malignancies. A dose-escalation study of Pc 4 (starting dose 0.135 mg/m2) at a fixed light fluence (135 J/cm2 of 675-nm light) was initiated in patients with primary or metastatic cutaneous malignancies with the aim of establishing the maximum tolerated dose (MTD). Blood samples were taken at intervals over the first 60 h post-PDT for pharmacokinetic analysis, and patients were evaluated for toxicity and tumor response. A total of three patients (two females with breast cancer and one male with cutaneous T-cell lymphoma) were enrolled and treated over the dose range of 0.135 mg/m2 (first dose level) to 0.54 mg/m2 (third dose level). Grade 3 erythema within the photoirradiated area was induced in patient 2, and transient tumor regression in patient 3, in spite of the low photosensitizer doses. Pharmacokinetic observations fit a three-compartment exponential elimination model with an initial rapid distribution phase (∼0.2 h) and relatively long terminal elimination phase (∼28 h), Because of restrictive exclusion criteria and resultant poor accrual, the trial was closed before MTD could be reached. While the limited accrual to this initial Phase I study did not establish the MTD nor establish a complete pharmacokinetic and safety profile of intravenous Pc 4-PDT, these preliminary data support further Phase I testing of this new photosensitizer.
机译：已经发现用于皮肤恶性肿瘤的光动力疗法（PDT）是使用一系列光敏剂的有效疗法。酞菁Pc 4最初是针对皮肤中原发性或转移性癌症的PDT开发的。开始了一项I期试验，以评估全身施用的Pc 4继之以红光（Pc 4-PDT）在皮肤恶性肿瘤中的安全性和药代动力学特征。开始进行剂量递增研究，以固定的光通量（675 nm的光通量为135 J / cm 2 ）的Pc 4（起始剂量为0.135 mg / m 2 ）目的是确定原发性或转移性皮肤恶性肿瘤患者的最大耐受剂量（MTD）。在PDT后的最初60小时内，每隔一段时间采集一次血液样本进行药代动力学分析，并评估患者的毒性和肿瘤反应。总共招募了三名患者（两名女性乳腺癌和一名男性皮肤T细胞淋巴瘤），并在0.135 mg / m 2 （第一剂水平）至0.54 mg的剂量范围内接受治疗/ m 2 （第三剂量水平）。尽管光敏剂剂量低，但在患者2中诱导了光照射区域内的3级红斑，在患者3中诱导了短暂的肿瘤消退。药代动力学观察结果符合三室指数消除模型，具有初始快速分布期（〜0.2 h）和相对长的终末消除期（〜28 h），由于限制性排除标准和应计结果较差，该试验在MTD能够应用之前已经关闭达到。虽然最初的第一阶段研究的结果有限，但并未建立MTD，也没有建立静脉Pc 4-PDT的完整药代动力学和安全性概况，但这些初步数据支持对该新型光敏剂进行进一步的第一阶段测试。

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