Lou 2014.
| 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: 51 Number enrolled: 51 Number in treatment group: 25 Number in control group: 26 Number of withdrawals (treatment/control): 0/0 Number completing trial (treatment/control): 25/26 Age range: (treatment/control): 34 to 73years/36 to 76 years Sex: 9 M, 42 F Ethnicity: East Asian NSCLC diagnosis: histologic or pathologically proven diagnosis of NSCLC, stage IIIB to IV disease Inclusion criteria: age ≥ 18 years, non‐smoker (< 100 cigarettes consumed in lifetime) or former light smoker (< 10 pack‐year history), received no prior chemotherapy of biological/immunological anti‐cancer therapy Exclusion criteria: not stated Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Gefitinib 250 mg/day Paclitaxel 200 mg/m2 with carboplatin AUC5 intravenously for 6 cycles or until disease progression |
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| Outcomes | Progression‐free survival Overall survival Tumour response – RECIST |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomized" 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 | No blinding but review authors judge that outcome is not likely to be influenced by lack of blinding Comment: this was judged as a low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data Comment: this was judged as a low 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 | No information provided Comment: there was insufficient information to permit a clear judgement of risk of bias |