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. 2016 May 8;2016(5):CD010529. doi: 10.1002/14651858.CD010529.pub2

Luh 1992.

Methods Single centre RCT of OK‐432 and mitomycin C pleurodesis in lung cancer patients with MPE (Taiwan)
Participants Inclusion criteria: histo/cyto proven MPE due to lung cancer; effusion requiring repeated thoracentesis; ECOG performance score 0‐3
Exclusion criteria: previous anticancer chemotherapy within four weeks; previous radiation therapy to the ipsilateral chest within four weeks; concomitant systemic chemo or radio‐therapy; history or evidence of penicillin allergy
55 participants randomised
Interventions All participants hospitalised and a chest drain or pigtail catheter inserted into effusion. Drainage until < 200 ml/day. Tube clamped for one hour after drug administration. Drug administration repeated weekly for four weeks or until effusion resolved
ok‐432 group: 1 KE intrapleurally
Mitomycin C: 8 mg in 30 ml water intrapleurally
Outcomes Pleurodesis success at four weeks (defined as 'complete response' (CR) (no fluid accumulation and participants free of symptoms), 'partial response' (PR) (recurrence of effusion < 50% of original effusion volume, not symptomatic and no need for thoracentesis for symptom relief) or 'failure' (recurrence of effusion > 50% of the original volume, symptomatic and need for thoracentesis to relieve symptoms))
Survival
Effusion‐free period
Notes People with trapped lung included in the study
For this review, PR & CR counted as pleurodesis successes
Not included in network meta‐analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sealed envelopes
Allocation concealment (selection bias) Low risk Sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No mention of whether the study was blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Two participants excluded due to early death, both in OK‐432 arm
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Low risk No other biases identified