Kasahara 2006.
| Methods | Multicentre phase 2 trial ofOK‐432, evaluating two different doses of intrapleural (IP) OK‐432 (Japan) | |
| Participants | Inclusion criteria: histological or cytological proof of MPE with non‐small cell lung cancer (NSCLC); no previous therapy for MPE; age > 20; ECOG performance score 0‐3; life expectancy > 12weeks; adequate organ and bone marrow function; daily chest tube drainage < 200 ml Exclusion criteria: previous TB pleuritis; unstable heart disease or diabetes; active double cancer; pregnancy; lactation; allergy to OK‐432 or benzylpenicillin 38 participants randomised |
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| Interventions | All participants underwent chest tube drainage. Two doses ofOK‐432 given (on days 1 and 3) Arm A: IPOK‐432 at a dose of 10 KE in 100 ml saline Arm B: IPOK‐432 at a dose of 1 KE in 100 ml saline |
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| Outcomes | MPE control on day 28 (defined as a complete response (the effusion disappeared completely and no further treatment required), partial response (the effusion persisted but local treatment was not needed) or no change (further local treatment was needed or the residual effusion volume was > 100 ml) MPE control rate Duration of drainage Fluid volume drained Time to progression Drug adverse events Overall survival |
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| Notes | People with trapped lung included in the study For purposes of this review, complete and partial responses were counted as pleurodesis successes 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 whether blinded. Drugs diluted in same volume in both study arms |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Need for repeat intervention and side effects could be biased if patients and personnel unblinded, but not stated if this was the case |
| 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 | High risk | In arm B, if low dose ineffective, patients given a high dose of OK‐432 anyway (prior to measurement of primary outcome) Paper does not state whether patients were symptomatic from MPE at enrolment |