Intrapleural Chemo- and Hyperthermotherapies for Malignant Pleural Effusion: A Randomized Prospective Study.

Objective: 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). Methods: 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. Result: Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%%) compared to those in Group B (79.8%%, χ2 == 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). Conclusion: 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. [ABSTRACT FROM AUTHOR]