Motzer 2010.
| Study characteristics | ||
| Methods |
Study type: multicentre RCT Phase: 3 Accrual period: August 2004 to October 2005 Blinding: imaging Strata: LDH, PS, nephrectomy status IMC: used for data and safety Crossover: study amended when sunitinib approved in January 2006 to allow cross‐over of patients on IFN on documented disease progression as primary endpoint of PFS had been met ‒ agreed with IMC |
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| Participants |
Histology: clear cell Prior systemic therapy: treatment‐naïve Measurable disease: required Non metastatic %: metastatic disease required M/F %: 536/214 Eligible PS: ECOG 0 to 1 Age median (range): 61 (27 to 87) Prior nephrectomy: 675 Prognostic strata: system, good/intermediate/poor risk %: MSKCC, 37/56/7% |
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| Interventions | (1) SUNITINIB 50 mg oral daily for 4 weeks of 6‐week cycle; (2) Interferon‐alfa2a 9 MU sc tiw (with cross‐over to SUNITINIB at disease progression, after second interim analysis) | |
| Outcomes |
PFS: primary endpoint OS: secondary endpoint AE: toxicity table, secondary endpoint QoL: secondary endpoint (FACT‐G, FKSI) RR: secondary endpoint Other: cross‐over post study |
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| Funding Sources | Industry sponsored | |
| Declarations of interest | Reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “patients were randomly assigned”, presumed central randomisation |
| Allocation concealment (selection bias) | Unclear risk | Data not found |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Open label study design, participants and personnel were not blinded to treatment, no effect on OS expected |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Open label study design, participants and personnel were not blinded to treatment, 2 active treatments used with different administration forms |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Assessed by investigator, no effect on OS expected |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | "A blinded central review of radiologic images was used to assess the primary end point and the objective response rate" |
| Incomplete outcome data (attrition bias) PFS, OS | Low risk | 8% of patients withdrew consent on the control arm (vs 1%, P < 0.001) but primary end‐ point was analysed by allocation |
| Incomplete outcome data (attrition bias) Response rate | Low risk | All randomised participants analysed |
| Incomplete outcome data (attrition bias) Serious and minor adverse events | Low risk | All treated participants analysed |
| Incomplete outcome data (attrition bias) Quality of life | Unclear risk | No information on how many participants completed questionnaire found |
| Selective reporting (reporting bias) | Low risk | All planned outcomes reported |
| Other bias | High risk | Cross‐over permitted after second interim analysis but planned accrual had been completed, OS analysis secondary endpoint |