title: Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.
abstract: 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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cancer Center, The Third Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, China. cwj2233@126.com
authors.forename: Wen-Jun
authors.initials: WJ
authors.lastname: Chen
authors.forename: Shao-Fei
authors.initials: SF
authors.lastname: Yuan
authors.forename: Qing-Yuan
authors.initials: QY
authors.lastname: Yan
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Xiong
authors.forename: Sen-Ming
authors.initials: SM
authors.lastname: Wang
authors.forename: Wei-E
authors.initials: WE
authors.lastname: Zheng
authors.forename: Wu
authors.initials: W
authors.lastname: Zhang
authors.forename: Hong-Yu
authors.initials: HY
authors.lastname: Sun
authors.forename: Hua
authors.initials: H
authors.lastname: Chen
authors.forename: Li-Li
authors.initials: LL
authors.lastname: Wu
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010844:Picibanil / Q000008:administration & dosage / Q000009:adverse effects; D016066:Pleural Effusion, Malignant / Q000188:drug therapy / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis
chemical_list: D010844:Picibanil; D002945:Cisplatin