Sun 2012 KCSG‐LU08‐01.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: open‐label Withdrawals: stated |
|
| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 147 Number enrolled: 141 Number in treatment group: 71 Number in control group: 70 Number of withdrawals (treatment/control): 3/3 Number completing trial (treatment/control): 68/67 Age range: (treatment/control): 40 to 77 years/30 to 78 years Sex: 20 M, 115 F Ethnicity: Asian NSCLC diagnosis: histologically or cytologically confirmed pulmonary adenocarcinoma Inclusion criteria: histologically or cytologically confirmed pulmonary adenocarcinoma that progressed after just 1 previous platinum‐based chemotherapy regimen for advanced disease, never‐smoker, 18 years or older, ECOG PS 0 to 2, measurable or evaluable disease, adequate bone marrow, renal and hepatic function Exclusion criteria: prior EGFR TKI or pemetrexed treatment and symptomatic or uncontrolled brain metastases Baseline characteristics of treatment/control groups: comparable |
|
| Interventions | Gefitinib 250 mg/day Pemetrexed 500 mg/m2 on day 1 of a 21‐day cycle Cycles repeated until disease progression, unacceptable toxicity, or until patient or investigator requested therapy discontinuation |
|
| Outcomes | Tumour response – RECIST Overall survival Progression‐free survival ASEs – NCI‐CTC Haematology and biochemical parameters Quality of life – EORTC Quality of Life Questionnaire C30 (EORTC QLQ‐C30) |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "consecutively assigned to either arm according to a predefined computer‐generated randomisation scheme developed by statisticians" Comment: this was judged as a low risk of bias |
| Allocation concealment (selection bias) | Low risk | Quote: "consecutively assigned to either arm according to a predefined computer‐generated randomisation scheme developed by statisticians" Comment: this was judged as a low 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 | Exclusions and attrition presented in Figure 1. Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups. 135/141 patients analysed for efficacy. 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 specific funding was disclosed and authors made no disclosure of conflicts of interest Comment: this was judged as an unclear risk of bias |