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Bending the Curve Trial by Trial
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Interferon-alpha versus medroxyprogesterone acetate in metastatic renal carcinoma (Medical Research Council Renal Cancer Collaborators)

Population
Patients with metastatic renal carcinoma
Design
Multicentre randomised trial of subcutaneous interferon-alpha (5 MU, 5 MU, 10 MU in the first week, then 10 MU three times per week for 11 further weeks) versus oral medroxyprogesterone acetate (MPA) 300 mg once daily for 12 weeks. Primary endpoint overall survival, analysis by intention to treat. A triangular sequential design allowed early termination; the trial was stopped in November 1997 when data were available for 335 patients (167 interferon-alpha, 168 MPA).
Primary endpoint
OS
Arms
  • Medroxyprogesterone acetate (control, n = 176): Oral medroxyprogesterone acetate 300 mg once daily for 12 weeks
  • Interferon-alpha (experimental, n = 174): Subcutaneous interferon-alpha, 10 MU three times per week after a first-week lead-in
People
Medical Research Council Renal Cancer Collaborators, Medical Research Council Renal Cancer Collaborators
OSHR 0.72 (95% CI 0.55–0.94)Δ median OS+2.5 monthsΔ 12-month OS+12 points
Show the numbers
Results reported for Interferon-alpha versus medroxyprogesterone acetate in metastatic renal carcinoma (Medical Research Council Renal Cancer Collaborators)
EndpointAnalysisInterferon-alphaMedroxyprogesterone acetateEffect
OSinterimMedical 1999median 8.5 months; 43% at 12 momedian 6 months; 31% at 12 moHR 0.72 (95% CI 0.55–0.94)P=0.017Early results: 111 deaths in the interferon-alpha group and 125 in the MPA group among 335 patients with data when the trial stopped. The PubMed record has no listed author, only the group name.
Results reported for Interferon-alpha versus medroxyprogesterone acetate in metastatic renal carcinoma (Medical Research Council Renal Cancer Collaborators)
EndpointAnalysisInterferon-alphaMedroxyprogesterone acetateEffect
OSinterimMedical 1999median 8.5 months; 43% at 12 momedian 6 months; 31% at 12 moHR 0.72 (95% CI 0.55–0.94)P=0.017Early results: 111 deaths in the interferon-alpha group and 125 in the MPA group among 335 patients with data when the trial stopped. The PubMed record has no listed author, only the group name.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.720.55–0.94
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%05101520Months (modelled)
  • Interferon-alpha (experimental)
  • Medroxyprogesterone acetate (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsInterferon-alphaMedroxyprogesterone acetate
0100.0%100.0%
566.5%56.1%
1140.8%28.1%
1627.1%15.7%
2118.0%8.8%
Primary publication: Medical Research Council Renal Cancer Collaborators. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet. 1999;353(9146):14-7. PubMedDOI

Appears in

Sources

  1. Medical Research Council Renal Cancer Collaborators. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet. 1999;353(9146):14-7.

    PubMedDOI