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Bending the Curve Trial by Trial
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ARCC

Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

Phase 3N = 626NCT00065468

Population
Previously untreated, poor-prognosis metastatic renal cell carcinoma
Design
Multicentre randomised phase 3 trial of intravenous temsirolimus 25 mg weekly, interferon alfa 3 MU (increased to 18 MU) subcutaneously three times weekly, or temsirolimus 15 mg weekly plus interferon alfa 6 MU three times weekly. Primary end point overall survival in the comparisons of the temsirolimus group and of the combination group with the interferon group.
Primary endpoint
OS
Arms
  • Interferon alfa (control): Interferon alfa 3 MU subcutaneously three times weekly, increased to 18 MU
  • Temsirolimus (experimental): Temsirolimus 25 mg intravenously weekly
  • Temsirolimus plus interferon alfa (experimental): Temsirolimus 15 mg weekly plus interferon alfa 6 MU three times weekly
People
Hudes G, Global ARCC Trial
OSHR 0.73 (95% CI 0.58–0.92)Δ median OS+3.6 monthsOSHR 0.96 (95% CI 0.76–1.20)Δ median OS+1.1 months
Show the numbers
Results reported for ARCC
EndpointAnalysisTemsirolimus / Temsirolimus plus interferon alfaInterferon alfaEffect
OSRandomised patients as described in the abstract (analysis population not stated there)primaryHudes 2007median 10.9 monthsmedian 7.3 monthsHR 0.73 (95% CI 0.58–0.92)P=0.008The abstract also reports longer progression-free survival with temsirolimus than with interferon alone (P<0.001) without giving values.
OSRandomised patients as described in the abstract (analysis population not stated there)primaryHudes 2007median 8.4 monthsmedian 7.3 monthsHR 0.96 (95% CI 0.76–1.20)P=0.70
Results reported for ARCC
EndpointAnalysisTemsirolimus / Temsirolimus plus interferon alfaInterferon alfaEffect
OSRandomised patients as described in the abstract (analysis population not stated there)primaryHudes 2007median 10.9 monthsmedian 7.3 monthsHR 0.73 (95% CI 0.58–0.92)P=0.008The abstract also reports longer progression-free survival with temsirolimus than with interferon alone (P<0.001) without giving values.
OSRandomised patients as described in the abstract (analysis population not stated there)primaryHudes 2007median 8.4 monthsmedian 7.3 monthsHR 0.96 (95% CI 0.76–1.20)P=0.70
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.730.58–0.92
OS0.960.76–1.2
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Temsirolimus (experimental)
  • Interferon alfa (control)

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

Data table (modelled values)
MonthsTemsirolimusInterferon alfa
0100.0%100.0%
764.1%51.4%
1441.1%26.5%
2028.0%15.0%
2718.0%7.7%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Temsirolimus plus interferon alfa (experimental)
  • Interferon alfa (control)

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

Data table (modelled values)
MonthsTemsirolimus plus interferon alfaInterferon alfa
0100.0%100.0%
566.2%62.2%
1140.3%35.2%
1626.7%21.9%
2117.7%13.6%
Primary publication: Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271-81. PubMedDOI

Appears in

Sources

  1. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271-81.

    PubMedDOI