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Bending the Curve Trial by Trial
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AFFIRM

Increased survival with enzalutamide in prostate cancer after chemotherapy

Phase 3N = 1,199NCT00974311

Population
Men with castration-resistant prostate cancer after chemotherapy
Design
Randomized (2:1), double-blind, placebo-controlled phase 3 trial of enzalutamide 160 mg daily versus placebo, stratified by ECOG performance status and pain intensity; stopped after a planned interim analysis at 520 deaths.
Primary endpoint
OS
Arms
  • Placebo (control, n = 399): Placebo
  • Enzalutamide (experimental, n = 800): Enzalutamide 160 mg per day orally
People
Scher HI, AFFIRM Investigators
OSHR 0.63 (95% CI 0.53–0.75)Δ median OS+4.8 monthsrPFSHR 0.4Δ median rPFS+5.4 months
Show the numbers
Results reported for AFFIRM
EndpointAnalysisEnzalutamidePlaceboEffect
OSRandomized men (analysis population not stated in the abstract)interimScher 2012median 18.4 monthsmedian 13.6 months (11.3–15.8)HR 0.63 (95% CI 0.53–0.75)P<0.001Planned interim analysis at 520 deaths. The 95% CI for the enzalutamide median is 17.3 to not yet reached.
rPFSRandomized men (analysis population not stated in the abstract)interimScher 2012median 8.3 monthsmedian 2.9 monthsHR 0.4P<0.001Radiographic progression-free survival, a secondary end point; the abstract gives no confidence interval.
Results reported for AFFIRM
EndpointAnalysisEnzalutamidePlaceboEffect
OSRandomized men (analysis population not stated in the abstract)interimScher 2012median 18.4 monthsmedian 13.6 months (11.3–15.8)HR 0.63 (95% CI 0.53–0.75)P<0.001Planned interim analysis at 520 deaths. The 95% CI for the enzalutamide median is 17.3 to not yet reached.
rPFSRandomized men (analysis population not stated in the abstract)interimScher 2012median 8.3 monthsmedian 2.9 monthsHR 0.4P<0.001Radiographic progression-free survival, a secondary end point; the abstract gives no confidence interval.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.630.53–0.75
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%010203040Months (modelled)
  • Placebo (control)
  • Enzalutamide (experimental)

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

Data table (modelled values)
MonthsPlaceboEnzalutamide
0100.0%100.0%
1254.2%63.6%
2331.0%42.0%
3516.8%26.8%
469.6%17.7%
Illustrative — modelled from reported values, not trial data. rPFS, interim.
0%25%50%75%100%05101520Months (modelled)
  • Placebo (control)
  • Enzalutamide (experimental)

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

Data table (modelled values)
MonthsPlaceboEnzalutamide
0100.0%100.0%
530.3%65.9%
109.2%43.4%
162.2%26.3%
210.7%17.3%
Primary publication: Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187-97. PubMedDOI

Appears in

Sources

  1. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187-97.

    PubMedDOI