Cufer 2006 SIGN.
| 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: 141 Number enrolled: 141 Number in treatment 1 group: 68 Number in treatment 2 group: 73 Number of withdrawals (treatment 1/treatment 2): 0/0 Number completing trial (treatment 1/treatment 2): 68/73 Age range: treatment 1 34 to 85 years; treatment 2 29 to 83 years Sex: 98 M, 43 F Ethnicity: 42.6% Caucasian; 44.0% Hispanic; 5.0% Oriental; 1.5% Black; 7.1% other NSCLC diagnosis: histologically or cytologically confirmed advanced (stage IIIb or IV) NSCLC that had progressed on or after 1 previous chemotherapy regimen. Also 1 or more measurable lesion according to RECIST Inclusion criteria: WHO PS 0 to 2; life expectancy > 12 weeks, age > 18 years, symptomatic (LCS score < 24), capable of understanding the FACT‐L questionnaire Exclusion criteria: previous taxane treatment, treatment with any chemotherapeutic within 30 days prior to study, radiotherapy within 3 weeks prior to study, known cerebral metastasis, any evidence of ongoing interstitial lung disease (ILD), coexisting malignancies, malignancies diagnosed within the last 5 years, with exception of basal cell carcinoma or cervical carcinoma in situ, any unresolved chronic toxicity above grade 2 NCI‐CTC from previous anti‐cancer therapy, laboratory values outside requested limits, psychiatric disorders that may affect completion of FACT‐L questionnaire Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Treatment 1: gefitinib 250 mg/day Treatment 2: docetaxel 75 mg/m2 IV every 3 weeks |
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| Outcomes | LCS component of FACT‐L Tumour response ‐ RECIST Overall survival, progression‐free survival ASEs ‐ NCI‐CTC |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "sealed randomisation envelopes which were allocated sequentially to patients" Comment: this was judged as low risk of bias |
| Allocation concealment (selection bias) | Low risk | Quote: "sealed randomisation envelopes which were allocated sequentially to patients" Comment: this was judged as low 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 low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcomes balanced in numbers across intervention groups with similar reasons for missing data across groups. 139/141 completed the trial. Comment: this was judged as low risk of bias |
| Selective reporting (reporting bias) | Unclear risk | All prespecified outcomes were reported. Progression‐free survival was not a prespecified outcome but included in results. Quote: "Progression‐free survival was not defined as a study variable in the protocol, but as tumour assessments were performed consistently for both treatment arms, it was also estimated." Comment: this was judged as an unclear risk of bias |
| Other bias | Unclear risk | There were no declarations of potential conflicts of interest or indication of funding or support Comment: there was insufficient information to permit a clear judgement of the risk of bias |