An 2016.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: double‐blind Withdrawals: not stated |
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| Participants | Setting: single‐centre study, hospital outpatient department Number eligible: 90 Number enrolled: 90 Number in treatment group: 45 Number in control group: 45 Number of withdrawals (treatment/control): not stated Number completing trial (treatment/control): not stated Age range: 57 to 83 years Sex: 50 M, 40 F Ethnicity: East Asian NSCLC diagnosis: histologic/cytologic diagnosis of non‐squamous NSCLC, stage IIIB to IV disease. Presence of EGFR sensitive mutation Inclusion criteria: at least one measurable lesion, an estimated life expectancy of at least 12 weeks, adequate major organ function Exclusion criteria: any of the following: myocardial infarction within the previous 3 months, uncontrolled angina pectoris or arrhythmia, brain metastasis, uncontrolled hypertension or diabetes, active infection, pulmonary fibrosis, pleural effusion or ascites requiring drainage, or cerebrovascular disease Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Pemetrexed 500 mg/m2 on day 1 PLUS gefitinib 250 mg on day 2 to 16 Cycles repeated every 3 weeks until disease progression Gefitinib 250 mg on day 2 to 16 PLUS placebo on day 1 Cycles repeated every 3 weeks until disease progression |
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| Outcomes | Tumour response – RECIST ASEs – NCI‐CTC Progression‐free survival Overall survival |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly divided.." but no further information provided Comment: there was insufficient information to permit a clear judgement of risk of bias |
| Allocation concealment (selection bias) | Unclear risk | No information provided Comment: there was insufficient information to permit a clear judgement of risk of bias |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "All investigators and patients were masked to treatment allocation" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided Comment: there was insufficient information to permit a clear judgement of risk of bias |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported Comment: this was judged as a low risk of bias |
| Other bias | Unclear risk | There were no declarations of potential conflicts of interest or indication of funding or support Comment: there was insufficient information to permit a clear judgement of the risk of bias |