Takeda 2010 WJTOG0203.
| Methods | Design: parallel‐group Randomisation: yes, method stated Blinding: double‐blind Withdrawals: stated |
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| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 604 Number enrolled: 603 Number in treatment group: 302 Number in control group: 301 Number of withdrawals (treatment/control): 4/4 Number completing trial (treatment/control): 298/297 Age range: treatment 25 to 74 years; control 35 to 74 years Sex: M 383, F 215 Ethnicity: Japanese NSCLC diagnosis: histologically or cytologically confirmed stage IIIB (with malignant pleural effusion or contralateral hilar lymph node metastases) or stage IV NSCLC Inclusion criteria: NSCLC who had not previously received any chemotherapy, patients who had recurrence after complete surgical resection were permitted, ECOG performance status 0 to 1, adequate organ function as indicated as WBC count > 4000/µL, absolute neutrophil count > 2000/µL, haemoglobin > 9.5 g/dL, AST/ALT < 2.5 times the upper limit of normal, total bilirubin < 1.5 mg/dL, serum creatinine < 1.2 mg/dL, PaO2 in arterial blood > 70 mmHg. Asymptomatic brain metastases were allowed provided they had been irradiated and were clinically and radiologically stable. Exclusion criteria: patients treated with either adjuvant or neoadjuvant chemotherapy. Radiologically or clinically apparent interstitial pneumonitis or pulmonary fibrosis. Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Arm A: platinum doublet chemotherapy ‐ up to 6 cycles Arm B: 3 cycles of chemotherapy followed by gefitinib 250g/day orally until disease progression |
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| Outcomes | Overall survival Progression‐free survival (PFS) Tumour response ‐ RECIST Quality of life ‐ FACT‐L |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomised" 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; withdrawals were stated in text. Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups. 595/604 included in 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 | Low risk | Co‐authors have received honoraria from industry Comment: this was judged as a low risk of bias |