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PROFILE 1007

Crizotinib versus chemotherapy in advanced ALK-positive lung cancer after one prior platinum-based regimen (PROFILE 1007)

Phase 3N = 347NCT00932893

Population
Locally advanced or metastatic ALK-positive lung cancer previously treated with one platinum-based regimen
Design
Open-label phase 3 trial; crossover to crizotinib permitted after progression on chemotherapy (separate study); primary endpoint progression-free survival
Primary endpoint
PFS
Arms
  • Crizotinib (experimental): Crizotinib 250 mg twice daily
  • Pemetrexed or docetaxel (control): Pemetrexed 500 mg per square metre or docetaxel 75 mg per square metre every 3 weeks
People
Shaw AT
PFSHR 0.49 (95% CI 0.37–0.64)Δ median PFS+4.7 monthsΔ ORR+45 pointsOSHR 1.02 (95% CI 0.68–1.54)
Show the numbers
Results reported for PROFILE 1007
EndpointAnalysisCrizotinibPemetrexed or docetaxelEffect
PFSAll randomised patients (n=347)primaryShaw 2013median 7.7 monthsmedian 3 monthsHR 0.49 (95% CI 0.37–0.64)P<0.001
ORRAll randomised patients (n=347)primaryShaw 201365% (58–72%)20% (14–26%)P<0.001
OSAll randomised patients (n=347)interimShaw 2013——HR 1.02 (95% CI 0.68–1.54)P=0.54Interim analysis; crossover to crizotinib after chemotherapy progression was permitted.
Results reported for PROFILE 1007
EndpointAnalysisCrizotinibPemetrexed or docetaxelEffect
PFSAll randomised patients (n=347)primaryShaw 2013median 7.7 monthsmedian 3 monthsHR 0.49 (95% CI 0.37–0.64)P<0.001
ORRAll randomised patients (n=347)primaryShaw 201365% (58–72%)20% (14–26%)P<0.001
OSAll randomised patients (n=347)interimShaw 2013——HR 1.02 (95% CI 0.68–1.54)P=0.54Interim analysis; crossover to crizotinib after chemotherapy progression was permitted.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.490.37–0.64
OS1.020.68–1.54
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Crizotinib (experimental)
  • Pemetrexed or docetaxel (control)

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

Data table (modelled values)
MonthsCrizotinibPemetrexed or docetaxel
0100.0%100.0%
563.8%31.5%
1040.6%9.9%
1428.4%3.9%
1918.1%1.2%
Primary publication: Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368(25):2385-94. PubMedDOI

Appears in

Sources

  1. Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368(25):2385-94.

    PubMedDOI