Ahn 2012.
| Methods | Design: parallel‐group Randomisation: yes, method stated Blinding: open‐label Withdrawals: stated |
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| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 86 Number enrolled: 73 Number in treatment group: 39 Number in control group: 31 Number of withdrawals (treatment/control): TP1 14/31; TPII 25/24 Number completing trial (treatment/control): 0/0 Age range: (treatment/control) 35 to 73 years/29 to 76 years Sex: 15 M, 55 F Ethnicity: East Asian NSCLC diagnosis: histologic/cytologic diagnosis of NSCLC, stage IIIB to IV disease Inclusion criteria: stage IIIB to IV NSCLC with at least one measurable lesion, ECOG PS 0 or 1, EGFR mutation status unknown Exclusion criteria: received treatment for NSCLC other than palliative radiotherapy, smoker of more than 100 cigarettes in lifetime, life expectancy of < 12 weeks Baseline characteristics of treatment/control groups: comparable |
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| Interventions |
TP1 All patients received first‐line chemotherapy: Pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Intravenously on day 1 of 3‐week cycle for 4 cycles TPII Received either: Gefitinib 250 mg/day OR Pemetrexed 500 mg/m2 with optional cisplatin 75 mg/m2 in first 2 cycles intravenously |
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| Outcomes | Progression‐free survival Overall survival Tumour response – RECIST Duration of response ASEs – NCI‐CTC Haematology and biochemical parameters |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Stratified random assignment method, random allocation sequence generated by central computerised voice response unit" Comment: this was judged as a low risk of bias |
| Allocation concealment (selection bias) | Low risk | Quote: "random allocation sequence generated by central computerised voice response unit" Comment: this was judged as adequate |
| 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 reasons for withdrawals presented in Figure 1. Missing outcome data balanced in numbers across interventional groups with similar reasons for missing data across groups. Data analysed using intention‐to‐treat analysis 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 | Funded by Eli Lilly and Company. Authors have received honoraria from Eli Lilly and some authors are current employees or previous employees of Eli Lilly. Comment: this was judged as an unclear risk of bias |