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. 2018 Jan 16;2018(1):CD006847. doi: 10.1002/14651858.CD006847.pub2

Maruyama 2008 V‐15‐32.

Methods Design: parallel‐group
Randomisation: yes, method stated
Blinding: open‐label
Withdrawals: stated
Participants Setting: multicentre study, hospital outpatient department
Number eligible: 511
Number enrolled: 489
Number in treatment group: 245
Number in control group: 244
Number of withdrawals (treatment/control): 233/241
Number completing trial (treatment/control): 12/3
Age range: < 64 years = 275, > 65 years = 216
Sex: M 302, F 187
Ethnicity: Japanese
NSCLC diagnosis: histologically or cytologically confirmed NSCLC (stage IIIB/IV)
Inclusion criteria: age 20 years or older, pretreated locally advanced/metastatic (stage IIIB/IV) NSCLC, or recurrent NSCLC, NSCLC not amenable to curative surgery or radiotherapy or postoperative recurrent NSCLC, failure of prior treatment with 1 or 2 chemotherapy regimens (> 1 platinum based regimen), life expectancy of 3 months or greater, WHO PS score 0 to 2, measurable disease by RECIST, WBC count of 4.0 to 12.0 x 109 cells/L, neutrophil count < 2.0 x 109 cells/L, platelet count > 100 x 109 cells/L, serum bilirubin < 1.5 x 109 cells/L, ALT or AST < 2.5 x upper limit of reference range, serum creatinine < 1.5 mg/dL, arterial oxygen tension > 70 torr.
Exclusion criteria: received last chemotherapy within 4 weeks before enrolment, received prior treatment with a docetaxel‐containing regimen or any anti‐EGFR therapy, an allergy or suspected allergy to gefitinib or docetaxel, other coexisting malignancies diagnosed within the last 5 years, with exceptions, any unresolved chronic toxicity greater than NCI‐CTC grade 2 from previous anticancer therapy, any evidence of severe or uncontrolled systemic disease, as judged by investigator, current status of pregnancy or breastfeeding, treatment with a non‐approved or investigational drug within 30 drugs before enrolment, intracerebral metastases, significant malabsorption syndrome, past history of or concurrent interstitial lung disease, idiopathic pulmonary fibrosis or pneumoconiosis, or radiation pneumonia or drug‐induced pneumonia, that required corticosteroids, fever with suspected infection or treatment with systemic corticosteroids for > 4 weeks
Baseline characteristics of treatment/control groups: comparable
Interventions Gefitinib 250 mg/day
Docetaxel every 3 weeks as a 1‐hour intravenous infusion of 60 mg/m2
Outcomes Overall survival
Progression‐free survival (PFS)
Tumour response ‐ RECIST
ASEs ‐ NCI‐CTC
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned by using stratification..."
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 Attrition and exclusions presented in Figure 1. Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups. 483/489 patients analysed for safety, 387/489 (79%) analysed for response (balanced between treatment arms)
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 Co‐authors have received honoraria from industry
Comment: this was judged as a low risk of bias