Yoshida 2007.
| Methods | Multicentre RCT of bleomycin,OK‐432 and cisplatin plus etoposide (PE) pleurodesis in MPE (Japan) | |
| Participants | Inclusion: cyto or histo proven MPE associated with newly diagnosed NSCLC; age ≤ 75; ECOG performance score 0 ‐ 2; full lung re‐expansion after chest drainage; adequate bone marrow reserve, liver and renal functions Exclusion: prior chemotherapy, thoracic RT or thoracic surgery; bilateral pleural effusion or pericardial effusion; symptomatic brain metastases; active synchronous cancer; interstitial pneumonitis; pulmonary fibrosis; uncontrolled angina/MI in preceding three months; uncontrolled diabetes or hypertension; pregnancy or breastfeeding; penicillin allergy 102 participants randomised |
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| Interventions | Large‐ or small‐bore chest tube inserted. After instillation of the study agent, participant rotated position for three hours Bleomycin group: 1 dose, 1 mg/kg (max 60 mg) of intrapleural bleomycin in 100 ml saline ok‐432 group: 1 dose of 0.2 KE units/kg (max 10 KE) of intrapleuralOK‐432 in 100 ml saline PE group: 1 dose cisplatin 80 mg/m2 and etoposide 80 mg/m2 intrapleurally in 100 ml saline |
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| Outcomes | Pleural progression‐free survival at 4, 8, 12 and 24 weeks (defined on CXR and need for local treatment) Overall survival Toxicity |
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| Notes | People with trapped lung not eligible for inclusion Study authors emailed for more information, but no response Not included in network meta‐analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated if anyone was blinded. Same volume of instillate in both arms |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if anyone was blinded. If unblinded, reporting of symptom recurrence and toxicity could have been biased. Not stated if radiology was reported blindly but the definition of pleurodesis also incorporated symptom recurrence |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow up |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | Radiology may be difficult to assess as population has underlying lung cancer |