Chen 2011.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: open‐label Withdrawals: stated Jadad score: 2 |
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| Participants | Setting: single‐centre study, hospital outpatient department Number eligible: 115 Number enrolled: 115 Number in treatment group: 58 Number in control group: 57 Number of withdrawals (treatment/control): 0/0 Number completing trial (treatment/control): 58/57 Age range (treatment/control): 37 to 87 years/30 to 85 years Sex: 69 M, 45 F Ethnicity: Taiwanese NSCLC diagnosis: histological and cytological diagnosis of adenocarcinoma of the lung Inclusion criteria: stage IIIB or IV adenocarcinoma of the lung, age 18 years or older, failed previous chemotherapy, WHO PS of 0 to 3, clinically measurable disease, no previous radiotherapy directed at the measurable lesion(s), adequate bone marrow reserve with a white blood count > 4000/mm3 Exclusion criteria: previous treatment with 5FU‐related chemotherapeutic agent, interstitial lung disease, with inadequate liver function (total bilirubin > 1.5 times and alanine aminotransferase/aspartate transaminase > 3 times the upper limit normal) or inadequate renal function with creatinine > 2.0 mg/dl Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Gefitinib 250 mg/day Gefitinib (250 mg/day) + UFT (tegafur 100 mg + uracil 224 mg) |
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| Outcomes | Progression‐free survival Overall survival Tumour response – RECIST ASEs – NCI‐CTC Haematology and biochemical parameters Quality of life (LCS) |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised but no details provided Comment: there was insufficient detail reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups |
| Allocation concealment (selection bias) | Unclear risk | No information provided Comment: there was insufficient information to permit a clear judgement |
| 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 | 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 | Low risk | Grants from National Science Council of the Republic of China and Taipei Veterans General Hospital |