Maemondo 2010 NEJ002.
| Methods | Design: parallel‐group Randomisation: yes, method not stated Blinding: not blinded Withdrawals: stated |
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| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 230 Number enrolled: 230 Number in treatment group: 115 Number in control group: 115 Number of withdrawals (treatment/control): 1/5 Number completing trial (treatment/control): 114/110 Age range: treatment: 43 to 75 years, control: 35 to 75 years Sex: 48 M, 145 F Ethnicity: not stated ‐ Japanese NSCLC diagnosis: advanced NSCLC Inclusion criteria: harbouring sensitive EGFR mutations, absence of resistant EGFR mutation T790M, no history of chemotherapy, age 75 or younger Exclusion criteria: presence of resistant EGFR mutation Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Treatment 1: gefitinib 250 mg/day Treatment 2: Paclitaxel (at least dose of 200 mg/m2 of body‐surface area, given intravenously over 3‐hour period) and carboplatin (at a dose equivalent to an area under the concentration‐time curve of 6, given intravenously over a 1‐hour period), both administered on the first day of every 3‐week cycle |
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| Outcomes | Overall survival ‐ date of randomisation to date of death Progression‐free survival (PFS) 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" 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 | Low risk | Exclusions presented in Figure 1, attrition stated in text. Reasons for missing data unlikely to be related to true outcome. 224/230 patients included in PFS population, 227/230 patients included in safety population. Intention‐to‐treat analysis performed 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 | Low risk | Quote: "In the planned interim analysis of data, PFS was significantly longer in the gefitinib group than in standard‐chemotherapy group resulting in early termination of the study" Funded by Japan Society for Promotion and Science and Japanese Foundation for Multidisciplinary Treatment of Cancer and Tokyo Cooperative Oncology Group Comment: this was judged as an unclear risk of bias |