title: A prematurely terminated phase III trial of intraoperative intrapleural hypotonic cisplatin treatment in patients with resected non-small cell lung cancer with positive pleural lavage cytology: the incidence of carcinomatous pleuritis after surgical intervention.
abstract: BACKGROUND
  The prognosis of patients with resected non-small cell lung cancer without carcinomatous pleuritis whose intrapleural cancer cells were detected by means of a cytologic examination of pleural lavage fluid obtained immediately after a thoracotomy has been reported to be poor.
  
  
  METHODS
  The Japan Clinical Oncology Group conducted a phase III trial for a 3-year period starting from October 1994 to determine whether intraoperative intrapleural hypotonic cisplatin treatment could effectively control pleural disease and thereby prolong the survival of these patients. The patients were randomized to receive either intraoperative intrapleural hypotonic cisplatin treatment or no treatment before closure of the open thorax. The intraoperative intrapleural hypotonic cisplatin treatment consisted of exposing the entire thorax to cisplatin (50 microg/mL) in distilled water for 15 minutes.
  
  
  RESULTS
  Because of the slow registration pace, the study was prematurely terminated in January 1998. During the 41-month period from the start of the registration, 49 patients were entered into the study, and all were eligible. Twenty-five and 24 patients were randomly assigned to the treatment and control groups, respectively. No statistically significant difference in the overall survival and disease-free survival between the 2 groups was observed. However, the appearance of carcinomatous pleuritis was suppressed by the hypotonic cisplatin treatment (42% of the control group vs 8% of the treatment group, P =.008).
  
  
  CONCLUSIONS
  Although the randomized trial was prematurely terminated, the intraoperative intrapleural hypotonic cisplatin treatment was found to effectively suppress the appearance of carcinomatous pleuritis in resected patients who demonstrated a positive pleural lavage cytology finding.
authors: National Kyushu Cancer Center, Fukuoka; National Cancer Center Hospital, Tokyo, Japan. yichinos@nk-cc.go.jp
authors: Yukito
authors: Y
authors: Ichinose
authors: Ryosuke
authors: R
authors: Tsuchiya
authors: Teruaki
authors: T
authors: Koike
authors: Tsutomu
authors: T
authors: Yasumitsu
authors: Kenji
authors: K
authors: Nakamura
authors: Hirohito
authors: H
authors: Tada
authors: Hirokuni
authors: H
authors: Yoshimura
authors: Tetsuya
authors: T
authors: Mitsudomi
authors: Ken
authors: K
authors: Nakagawa
authors: Kohei
authors: K
authors: Yokoi
authors: Harubumi
authors: H
authors: Kato
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001992:Bronchoalveolar Lavage Fluid / Q000166:cytology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007038:Hypotonic Solutions; D015994:Incidence; D007430:Intraoperative Care; D007564:Japan / Q000453:epidemiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010997:Pleural Neoplasms / Q000401:mortality / Q000556:secondary; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D012008:Recurrence; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007038:Hypotonic Solutions; D002945:Cisplatin