Mok 2009 IPASS.
| Methods | Design: parallel‐group Randomisation: yes, method stated Blinding: not blinded Withdrawals: stated |
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| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 1329 Number enrolled: 1217 Number in treatment group: 609 Number in control group: 608 Number of withdrawals (treatment/control): 12/28 Number completing trial (treatment/control): 597/580 Age range: treatment: 24 to 84 years, control: 25 to 84 years Sex: M 252, F 965 Ethnicity: Chinese 618, Japanese 233, other East Asian 363, other 3 NSCLC diagnosis: histologically or cytologically confirmed stage IIIB or IV NSCLC with histological features of adenocarcinoma Inclusion criteria: 18 years or older, non‐smoker or former light smokers (those who had stopped smoking at least 15 years previously and had a total of ?10 pack‐years of smoking), no previous chemotherapy or biologic or immunologic therapy, WHO PS 0 to 2, measurable disease according to RECIST criteria with at least 1 measurable lesion, not previously irradiated, adjuvant chemotherapy permitted if not platinum‐based and completed > 6 months previously, absolute neutrophil count > 2.0 x 109 and adequate hepatic function Exclusion criteria: not stated Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Treatment: gefitinib 250 mg/day Control: Paclitaxel (200 mg/m2 of body‐surface area, administered intravenously over a 3‐hour period on the first day of the cycle) followed immediately by carboplatin (at a dose calculated to produce an area under the curve of 5.0 to 6.0 per mL per min, administered intravenously over a period of 15 to 60 min) |
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| Outcomes | Overall survival Progression‐free survival (PFS) Tumour response ‐ RECIST ASEs ‐ NCI‐CTC Quality of life ‐ FACT‐L, TOI, LCS score of FACT‐L |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomisation was performed with the use of dynamic balancing..." Comment: this was judged as a low 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 and attrition presented in Figure 1. Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups. 1159/1217 (95%) included in analysis 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 | Unclear risk | Funding from the Chinese Lung Cancer Research Foundation. Co‐authors received consulting fees and grant support from industry. Comment: this was judged as an unclear risk of bias |