Aigner Karl Reinhard, Selak Emir, Gailhofer Sabine
Department of Surgical Oncology, Medias Klinikum, Burghausen, Germany.
Onco Targets Ther. 2017 Jun 19;10:3049-3057. doi: 10.2147/OTT.S134126. eCollection 2017.
Therapy of malignant pleural mesothelioma and especially the adequate role of surgery in this context remain the subject of controversial discussions. Radical surgery in particular, which is associated with substantial morbidity, failed to translate into a definite survival advantage. We report on interim results of an ongoing Phase II study of regional chemotherapy in terms of isolated thoracic perfusion with chemofiltration (ITP-F).
Twenty-eight patients (25 male, 3 female, mean age 63.4 years) with advanced pleural mesothelioma were included in this study. Isolation of the chest was achieved by insertion of a venous and arterial stop-flow balloon catheter via a femoral access. The aorta and inferior vena cava were blocked at the level of the diaphragm and the upper arms were blocked by pneumatic cuffs. Chemotherapy, consisting of 60 mg/m cisplatin and 15 mg/m mitoxantrone, was administered directly into the aorta. The isolated circuit was maintained for 15 minutes followed bŷ45 minutes of chemofiltration with a hemoprocessor until 5 L of filtrate were reached. The endpoints of the study were overall survival and quality of life (QoL).
Out of 28 patients enrolled in the study, 5 had prior surgeries, 10 patients had systemic chemotherapy, and 5 patients additional irradiation. In all patients in restaging, clinical progress was noted. In all, 162 cycles were administered. Due to chemofiltration, toxicity was within tolerable limits, revealing World Health Organization grade I leucopenia and thrombocytopenia in 9 patients and mucositis grade I in 6 patients. The major surgical complication was inguinal lymphatic fistula in 40% of the cases. Gastrointestinal toxicity and/or neurotoxicity were never observed. One-year survival was 49%, 2-year and 3-year survival was 31%, and 5-year survival was 18%. Median overall survival was 12 months and progression-free survival 9 months.
ITP-F for patients with advanced pleural mesothelioma, progressive after standard therapies, is an effective and well-tolerated treatment modality, offering comparably long survival data at a good QoL.
恶性胸膜间皮瘤的治疗，尤其是手术在其中的适当作用，仍是备受争议的讨论话题。特别是根治性手术，虽伴有较高的发病率，但未能转化为明确的生存优势。我们报告了一项正在进行的关于区域化疗（即隔离胸廓灌注联合化学过滤，ITP-F）的II期研究的中期结果。
本研究纳入了28例晚期胸膜间皮瘤患者（25例男性，3例女性，平均年龄63.4岁）。通过经股动脉穿刺插入静脉和动脉停流球囊导管实现胸部隔离。在膈肌水平阻断主动脉和下腔静脉，通过气动袖带阻断上臂。将由60mg/m顺铂和15mg/m米托蒽醌组成的化疗药物直接注入主动脉。隔离循环维持15分钟，随后用血液处理器进行45分钟的化学过滤，直至滤出5L滤液。研究的终点是总生存期和生活质量（QoL）。
在纳入研究的28例患者中，5例曾接受过手术，10例接受过全身化疗，5例还接受过放疗。在所有进行再分期的患者中，均观察到临床进展。共进行了162个周期的治疗。由于进行了化学过滤，毒性在可耐受范围内，9例患者出现世界卫生组织I级白细胞减少和血小板减少，6例患者出现I级粘膜炎。主要手术并发症是40%的病例出现腹股沟淋巴瘘。未观察到胃肠道毒性和/或神经毒性。1年生存率为49%，2年和3年生存率为31%，5年生存率为18%。中位总生存期为12个月，无进展生存期为9个月。
对于标准治疗后进展的晚期胸膜间皮瘤患者，ITP-F是一种有效且耐受性良好的治疗方式，能在良好的生活质量下提供相对较长的生存数据。
