Soria 2015 IMPRESS.
| Methods | Design: parallel‐group Randomisation: yes, method stated Blinding: placebo‐controlled Withdrawals: stated |
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| Participants | Setting: multicentre study, hospital outpatient department Number eligible: 287 Number enrolled: 265 Number in treatment group: 133 Number in control group: 132 Number of withdrawals (treatment/control): 1/0 Number completing trial (treatment/control): 23/18 Age range: (treatment/control) 33 to 79 years/35 to 79 years Sex: 94 M, 171 F Ethnicity: East Asian 78%; Spanish/French/German/Italian/Russia 22% NSCLC diagnosis: histologic/cytologic diagnosis of NSCLC, stage IIIB to IV disease, chemotherapy‐naive Inclusion criteria: age ≥ 18 years; chemotherapy‐naive advanced NSCLC and an activating EGFR mutation as confirmed by local testing, who had achieved a complete or partial response for longer than 4 months, or durable stable disease for at least 6 months on first‐line gefitinib and had subsequently developed radiological disease progression. Life expectancy of > 12 months, and a WHO PS of 0 or 1. Exclusion criteria: NSCLC of predominately squamous cell histology, a history of interstitial lung disease, any other coexisting malignancies diagnosed within the past 5 years (excluding basal cell carcinoma, cervical cancer in situ, or completely resected intramucosal gastric cancer) or treatment with another investigational drug 4 weeks of less before random allocation Baseline characteristics of treatment/control groups: comparable |
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| Interventions | Gefitinib 250 mg daily PLUS cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on day 1 of cycle Placebo PLUS cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on day 1 of cycle |
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| Outcomes | Progression‐free survival Tumour response – RECIST Overall survival ASEs – NCI‐CTC Health‐related quality of life – FACT‐L, LCS, TOI |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Use of "central block randomisation to allocate patients (1:1)..." Comment: this was judged as a low risk of bias |
| Allocation concealment (selection bias) | Low risk | Patients were assigned a unique enrolment number using an interactive web response system Comment: this was judged as a low risk of bias |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo‐controlled with identical packaging Comment: this was judged as a low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals stated in Figure 1 Missing outcome data balanced in numbers across intervention groups with similar reasons for missing data across groups 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 | Authors have received honoraria, consultant and advisor fees from industry Study funded by Astra Zeneca, who co‐ordinated the trial, managed the database and undertook analyses Comment: this was judged as an unclear risk of bias |