Du 2013.
Methods | Single centre RCT of intrapleural cisplatin +/‐ bevacizumab in MPE due to non‐small cell lung cancer (NSCLC) (China) | |
Participants | Inclusion: Advanced NSCLC; large uni‐ or bilateral pleural effusion; positive pleural fluid cytology; no intrapleural therapy in previous month; Karnofsky performance score > 60%; age > 18; predicted survival > 3 months; no major organ disfunction; no previous chemotherapy in previous six weeks Exclusion: squamous cell carcinoma; allergy to biological agents; no detectable lesions; uncontrolled central nervous system metastasis; pregnancy or breastfeeding; infected wound; refractory psychiatric illness 72 participants randomised |
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Interventions | Participants underwent pleural fluid drainage by thoracentesis. Treatment given intrapleurally. Rest for two hours. Then rotate every 15 mins. Given every two weeks for 3 cycles Cisplatin: 30 mg cisplatin intrapleurally Cisplatin and bevacizumab: 30 mg cisplatin and 300 mg bevacizumab intrapleurally |
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Outcomes | Treatment response ('Complete remission (CR)' = accumulated fluid disappeared and stable for at least four weeks; 'Partial remission (PR)' = > 50% of the accumulated fluid had disappeared, symptoms had improved and the remaining fluid had not increased for at least four weeks; 'Remission not obvious (NC)' = < 50% of the accumulated fluid had disappeared; 'Progression (PD)' = accumulated fluid had increased). Treatment success defined as CR + PR Progression‐free survival Overall survival Adverse reactions Quality of life (QOL) Pleural fluid VEGF levels |
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Notes | People with trapped lung eligible for trial involvement Pleurodesis defined clinically and using radiology 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 | Methods not stated and no response from study authors to clarify |
Allocation concealment (selection bias) | Unclear risk | Methods not stated and no response from study authors to clarify |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated if blinded and no response from study authors to clarify |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if anyone was blinded. If not blinded, QOL, performance status, side effects and symptom recurrence could be biased by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data accounted for. ITT analysis |
Selective reporting (reporting bias) | Low risk | All outcomes reported on |
Other bias | Low risk | No other biases identified |