Xu 2015.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: open‐label Withdrawals: not stated |
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| Participants | Setting: single‐centre study, hospital outpatient department Number eligible: 188 Number enrolled: 188 Number in treatment group: 94 Number in control group: 94 Number of withdrawals (treatment/control): not stated Number completing trial (treatment/control): not stated Age range: (treatment/control): 60 to 82 years Sex: 98 M, 90 F Ethnicity: East Asian NSCLC diagnosis: histologic/cytologic diagnosis of NSCLC, stage IIIB to IV disease Inclusion criteria: stage IIIB to IV NSCLC, inoperable due to medical reasons or rejecting surgery, or the patients accepting 4 to 8 cycles of first‐line chemotherapy and achieving complete remission, partial response or stability. KPS ≥ 60, no other disease interfering patients to complete the treatment; no brain metastases, with good compliance Exclusion criteria: not stated Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Pemetrexed 500 mg/m2 day 1 to 3 Gefitinib 250 mg/daily |
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| Outcomes | Tumour response – RECIST 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 | High risk | Withdrawals not stated Comment: this was judged as a high risk of bias |
| Selective reporting (reporting bias) | High risk | "survival time" was a prespecified outcome but not reported in methods; reason for this is unclear Comment: this was judged as a high risk of bias |
| Other bias | Low risk | Disclosed no conflicts of interest Comment: this was judged as a low risk of bias |