Xue 2015.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: open‐label Withdrawals: stated |
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| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 155 Number enrolled: 100 Number in treatment group: 48 Number in control group: 48 Number of withdrawals (treatment/control): 2/2 Number completing trial (treatment/control): 8/10 Age range: (treatment/control) 33 to 83 years/32 to 83 years Sex: 43 M, 53 F Ethnicity: East Asian NSCLC diagnosis: histologic/cytologic diagnosis of NSCLC, stage IIIB to IV disease Inclusion criteria: advanced, refractory or recurrent NSCLC after at least 1 previous regimen; achievement of stable disease after 1 month of gefitinib 250 mg daily therapy; measurable lesions by RECIST criteria; ECOG PS 0 to 2; satisfactory renal, haematological and cardiac function. Stable brain metastases were allowed. Exclusion criteria: previous EGFR TKI therapy, pregnancy, breastfeeding, or unable to take oral medications Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Gefitinib 500 mg/day Gefitinib 250 mg/day |
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| Outcomes | Tumour response – RECIST Progression‐free survival Overall survival ASEs – NCI‐CTC |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "...randomized " 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 | Open‐label 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 | Withdrawals stated with reasons such as "consent not given" provided 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 | Low risk | Study supported by Wu Jieping Medical Foundation Project grant and National funding programmes. One author has declared having received research support from industry. Comment: this was judged as a low risk of bias |