Dai 2013.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: open‐label Withdrawals: stated |
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| Participants | Setting: single‐centre study, hospital outpatient department Number eligible: 46 Number enrolled: 46 Number in treatment group: 23 Number in control group: 23 Number of withdrawals (treatment/control): 0/0 Number completing trial (treatment/control): 23/23 Age range: (treatment/control): 41 to 74years/47 to 72 years Sex: 29 M, 17 F Ethnicity: East Asian NSCLC diagnosis: histologic or pathologically proven diagnosis of nonsquamous NSCLC, stage IIIB to IV disease Inclusion criteria: age 18 to 75 years, Received prior platinum‐based chemotherapy of 4 to 6 cycles and has had progressive disease,at least 1 target lesion, ECOG 0 to 2, adequate bone marrow and organ function Exclusion criteria: not stated Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Gefitinib 250 mg/day Pemetrexed 500 mg/m2 intravenously, every 4 weeks until disease progression or unacceptable toxicity |
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| Outcomes | Tumour response – RECIST Progression‐free survival Overall survival Toxicity – CTCAE Quality of life – FACT‐L |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomized" but random sequence generation not discussed 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 | No blinding but review authors judge that outcome is not likely to be influenced by lack of blinding Comment: this was judged as low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data Comment: this was judged as low risk of bias |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported Comment: this was judged as low risk of bias |
| Other bias | Unclear risk | No information provided Comment: there was insufficient information to permit a clear judgement of risk of bias |