Cancer Center, The Third Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, China.
Cancer Invest. 2012 Feb;30(2):126-30. doi: 10.3109/07357907.2011.633292. Epub 2011 Dec 7.
The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE).
A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups.
Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p < .05). The median survival time for patients in Group A and Group B were 8.9 and 6.2 months, respectively (p > .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05).
In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.
本前瞻性随机研究旨在评估顺铂联合 OK-432（派斯欣）与热疗治疗恶性胸腔积液（MPE）的安全性和有效性。
共纳入 358 例因晚期恶性肿瘤导致 MPE 的患者，并随机分为两组，A 组（n = 179）为顺铂联合 OK-432 加热疗，B 组（n = 179）为顺铂联合 OK-432 不加热疗。两组患者均有恶心、呕吐、厌食、骨髓抑制、发热等轻度毒性反应。
A 组（热疗组）的总有效率（93.4%）明显高于 B 组（79.8%，χ²=43.11，p<.05）。A 组和 B 组患者的中位生存时间分别为 8.9 个月和 6.2 个月（p>.05）。治疗后，两组患者的生活质量评分均较治疗前显著提高（p<.05）。
综上所述，本研究表明，顺铂联合 OK-432 加热疗治疗 MPE 更有效，可改善患者的生活质量。
