Kleontas Athanasios, Sioga Antonia, Pandria Niki, Barbetakis Nikolaos, Lazopoulos Achilleas, Katsikas Ioannis, Asteriou Christos, Paliouras Dimitrios, Kamperis Efstathios, Ikonomou Dimitrios, Papamitsou Theodora, Filippou Dimitrios, Destouni Chariklia, Ikonomou Louiza, Zarogoulidis Konstantinos, Papagiannopoulos Kostas
Department of Thoracic Surgery, European Interbalkan Medical Center of Thessaloniki, Thessaloniki, Greece.
Laboratory of Histology-Embryology, Medical School of Aristotle University of Thessaloniki, Thessaloniki, Greece.
J Thorac Dis. 2019 May;11(5):1788-1798. doi: 10.21037/jtd.2019.05.25.
There is a plethora of treatment algorithms for managing patients with malignant pleural effusions (MPEs), sharing many common points and principles. Our study aims to compare hyperthermic intrapleural chemotherapy (HITHOC) and talc pleurodesis (TALC), as treatment options for patients with non-small cell lung cancer (NSCLC) and metastatic MPE.
This prospective, randomized trial was conducted at a single thoracic surgery center, the "Theagenio" Cancer Institute, in Greece, under the identification code NCT01409551 and was completed. All 40 patients enrolled were adults with histologically proven metastatic, unilateral, MPE caused by NSCLC. Exclusion criteria included patients >80 years, trapped lung, and major comorbidities. Patients were randomly and equally assigned 1:1 to either HITHOC (group A) or TALC (group B) by video assisted thoracic surgery (VATS). The primary outcome was the median overall survival (OS) from trial intervention to death, while secondary outcome was the identification of clinical factors affecting the survival.
The patients were followed up for 45 months. The OS of the full group was 8 months (95% CI: 7.046-8.954). Participants who underwent HITHOC had an OS of 8 months (95% CI: 7.141-8.859), whereas the participants of TALC had an OS of 9 months (95% CI: 7.546-10.454), with no significant difference between groups. Among fifty-four factors that were tested for their effects on survival, only TNM stage and creatinine values both preoperatively and 7 days postoperatively could be regarded as risk-factors for survival. Other recorded parameters, which had significant variance between the two groups, were urea levels, C-reactive protein, white blood cells and total in hospital length of stay (LOS).
Both HITHOC and TALC are equally effective and safe therapeutic options in treating patients with MPE and NSCLC with acceptable survival. The study revealed independent clinical risk factors influencing survival, which could be utilized as starting points for larger clinical studies.
Pleurodesis; pleural effusion; malignant; carcinoma; non-small cell lung; hyperthermia.
治疗恶性胸腔积液（MPE）患者的治疗算法众多，有许多共同点和原则。我们的研究旨在比较热灌注胸腔内化疗（HITHOC）和滑石粉胸膜固定术（TALC），作为非小细胞肺癌（NSCLC）和转移性MPE患者的治疗选择。
这项前瞻性随机试验在希腊的“西阿格尼奥”癌症研究所这一单一胸外科中心进行，识别代码为NCT01409551，现已完成。所有纳入的40例患者均为经组织学证实由NSCLC引起的转移性、单侧MPE的成年人。排除标准包括年龄>80岁、肺陷闭和严重合并症。通过电视辅助胸腔镜手术（VATS）将患者按1:1随机且均等分配至HITHOC组（A组）或TALC组（B组）。主要结局是从试验干预到死亡的中位总生存期（OS），次要结局是确定影响生存的临床因素。
对患者进行了45个月的随访。全组的OS为8个月（95%CI：7.046 - 8.954）。接受HITHOC治疗的参与者的OS为8个月（95%CI：7.141 - 8.859），而接受TALC治疗的参与者的OS为9个月（95%CI：7.546 - 10.454），两组之间无显著差异。在测试的54个对生存有影响的因素中，只有术前和术后7天的TNM分期及肌酐值可被视为生存的危险因素。两组之间有显著差异的其他记录参数为尿素水平、C反应蛋白、白细胞和住院总时长（LOS）。
HITHOC和TALC在治疗MPE和NSCLC患者方面都是同样有效且安全的治疗选择，生存期可接受。该研究揭示了影响生存的独立临床危险因素，可作为更大规模临床研究的起点。
胸膜固定术；胸腔积液；恶性；癌；非小细胞肺癌；热疗
