title: Catheter drainage followed by the instillation of bleomycin to manage malignant pericardial effusion in non-small cell lung cancer: a multi-institutional phase II trial.
abstract: BACKGROUND
  Malignant pericardial effusion (MPE) causes cardiac tamponade and an extremely poor outcome unless it is well controlled. The effect of pericardial drainage and the intra-pericardial instillation of bleomycin on the control of MPE was examined in this prospective multi-institutional phase II trial.
  
  
  METHODS
  In eligible patients with cytologically defined MPE resulting from non-small cell lung cancer, the pericardial effusion of such cases was continuously drained. After complete drainage, 10 mg of bleomycin was then locally instilled via a catheter. The catheter was then removed if the total amount of drainage was less than 30 ml/day. If the catheter could not be removed within 5 days after treatment, bleomycin was administered one more time.
  
  
  RESULTS
  Among the 22 patients who entered this trial, the tube drainage catheter was successfully removed from 17 patients with one instillation, whereas four required such instillation twice and one required such instillation three times. No severe adverse events were observed, except for constrictive pericarditis, which resulted in the treatment-related death of one patient. The control rate of pericardial effusion was 95% +/- 0.09 (95% confidence interval). No restoration of pericardial effusion was observed during the follow-up period or until death from any cause. Median survival time from the beginning of the protocol was 17.9 weeks.
  
  
  CONCLUSIONS
  Pericardial drainage followed by the instillation of bleomycin was found to be a safe and effective method for the management of MPE associated with non-small cell lung cancer.
authors.affiliation: Kyushu Yamaguchi Thoracic Oncology Group, Kyushu Cancer Center, Minami-ku, Fukuoka, Japan. rmaruyama@nk-cc.go.jp
authors.forename: Riichiroh
authors.initials: R
authors.lastname: Maruyama
authors.forename: Hideki
authors.initials: H
authors.lastname: Yokoyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.forename: Seiji
authors.initials: S
authors.lastname: Nagashima
authors.forename: Kosuke
authors.initials: K
authors.lastname: Kashiwabara
authors.forename: Jun
authors.initials: J
authors.lastname: Araki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Semba
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D001761:Bleomycin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications*; D002408:Catheters, Indwelling; D003131:Combined Modality Therapy; D004322:Drainage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010490:Pericardial Effusion / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate
chemical_list: D000903:Antibiotics, Antineoplastic; D001761:Bleomycin