Chen 2007.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: nil Withdrawals: stated | |
| Participants | Setting: single‐centre study, hospital outpatient department Number eligible: 48 Number enrolled: 48 Number in treatment group: 21 Number in control group: 27 Number of withdrawals (treatment/control): 6/0 Number completing trial (treatment/control): 15/27 Age range: treatment 39 to 80; control 35 to 85 Sex: 25 M, 23 F Ethnicity: Ethnic Chinese NSCLC diagnosis: histologic or cytologic diagnosis of stage IV adenocarcinoma Inclusion criteria: failed previous chemotherapy with ?2 regimens (including taxanes and platinum‐based chemotherapy); clinically measurable disease; no previous radiotherapy directed at lesions; adequate bone marrow reserve with WBC count < 4000/mm3; platelets < 100,000/mm3; haemoglobin < 10 g/dL; life expectancy of > 2 months Exclusion criteria: inadequate liver function (total bilirubin > 1.5 times upper limit of normal and alanine and aspartate aminotransferase levels > 3 times upper limit of normal) or inadequate renal function with creatinine levels > 2 mg/dL Baseline characteristics of treatment/control groups: no difference between groups |
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| Interventions | 250 mg gefitinib daily Vinorelbine (15 mg/m2) on day 1, 250 mg gefitinib daily on days 2 to 14 every 2 weeks | |
| Outcomes | Overall survival Time to progression, 1‐year progression‐free survival Tumour response ‐ RECIST ASEs ‐ NCI‐CTC EGFR FISH examination LCS of FACT‐L | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Eligible patients were 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 | High risk | No information provided Comment: this was judged as a high 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 |