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Bending the Curve Trial by Trial
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CRYSTAL

Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

Phase 3NCT00154102

Population
EGFR-positive metastatic colorectal cancer with unresectable metastases, previously untreated
Design
Randomised trial of FOLFIRI with or without cetuximab as first-line treatment of EGFR-positive colorectal cancer with unresectable metastases. The primary endpoint was progression-free survival. Tumour KRAS mutation status was examined in relation to clinical response to cetuximab.
Primary endpoint
PFS
Arms
  • FOLFIRI (control, n = 599): FOLFIRI (irinotecan, fluorouracil, leucovorin) alone
  • Cetuximab plus FOLFIRI (experimental, n = 599): Cetuximab plus FOLFIRI
People
Van Cutsem E
PFSHR 0.85 (95% CI 0.72–0.99)OSHR 0.93 (95% CI 0.81–1.07)PFSHR 0.68 (95% CI 0.50–0.94)
Show the numbers
Results reported for CRYSTAL
EndpointAnalysisCetuximab plus FOLFIRIFOLFIRIEffect
PFSAll randomised patients (analysis population not stated in the abstract)primaryVan 2009——HR 0.85 (95% CI 0.72–0.99)P=0.048Hazard ratio for progression-free survival, cetuximab plus FOLFIRI versus FOLFIRI; medians not given in the abstract. Patients assigned to each arm: 599 received cetuximab plus FOLFIRI and 599 received FOLFIRI.
OSAll randomised patients (analysis population not stated in the abstract)primaryVan 2009——HR 0.93 (95% CI 0.81–1.07)P=0.31
PFSPatients with wild-type KRAS tumoursexploratoryVan 2009——HR 0.68 (95% CI 0.50–0.94)The interaction between treatment group and KRAS mutation status was P=0.03 for tumour response, P=0.07 for progression-free survival and P=0.44 for overall survival.
Results reported for CRYSTAL
EndpointAnalysisCetuximab plus FOLFIRIFOLFIRIEffect
PFSAll randomised patients (analysis population not stated in the abstract)primaryVan 2009——HR 0.85 (95% CI 0.72–0.99)P=0.048Hazard ratio for progression-free survival, cetuximab plus FOLFIRI versus FOLFIRI; medians not given in the abstract. Patients assigned to each arm: 599 received cetuximab plus FOLFIRI and 599 received FOLFIRI.
OSAll randomised patients (analysis population not stated in the abstract)primaryVan 2009——HR 0.93 (95% CI 0.81–1.07)P=0.31
PFSPatients with wild-type KRAS tumoursexploratoryVan 2009——HR 0.68 (95% CI 0.50–0.94)The interaction between treatment group and KRAS mutation status was P=0.03 for tumour response, P=0.07 for progression-free survival and P=0.44 for overall survival.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.850.72–0.99
OS0.930.81–1.07
PFS0.680.5–0.94
Primary publication: Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360(14):1408-17. PubMedDOI

Appears in

Sources

  1. Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360(14):1408-17.

    PubMedDOI