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Bending the Curve Trial by Trial
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BOND

Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer

N = 329

Population
Metastatic colorectal cancer that had progressed during or within three months after an irinotecan-based regimen
Design
Randomised comparison of cetuximab plus irinotecan with cetuximab monotherapy in metastatic colorectal cancer that progressed during or within three months of an irinotecan-based regimen. The irinotecan dose and schedule matched the prestudy regimen; irinotecan could be added to cetuximab monotherapy at progression. Radiologic response, time to progression, survival and side effects were evaluated.
Arms
  • Cetuximab monotherapy (control, n = 111): Cetuximab monotherapy
  • Cetuximab plus irinotecan (experimental, n = 218): Cetuximab plus irinotecan at the same dose and schedule as the prestudy regimen
People
Cunningham D
Δ ORR+12.1 pointsΔ median TTP+2.6 monthsΔ median OS+1.7 months
Show the numbers
Results reported for BOND
EndpointAnalysisCetuximab plus irinotecanCetuximab monotherapyEffect
ORRAll randomised patients (329)primaryCunningham 200422.9% (17.5–29.1%)10.8% (5.7–18.1%)P=0.007
TTPAll randomised patients (329)primaryCunningham 2004median 4.1 monthsmedian 1.5 monthsP<0.001P value by log-rank test.
OSAll randomised patients (329)primaryCunningham 2004median 8.6 monthsmedian 6.9 monthsP=0.48Irinotecan could be added to cetuximab monotherapy after progression.
Results reported for BOND
EndpointAnalysisCetuximab plus irinotecanCetuximab monotherapyEffect
ORRAll randomised patients (329)primaryCunningham 200422.9% (17.5–29.1%)10.8% (5.7–18.1%)P=0.007
TTPAll randomised patients (329)primaryCunningham 2004median 4.1 monthsmedian 1.5 monthsP<0.001P value by log-rank test.
OSAll randomised patients (329)primaryCunningham 2004median 8.6 monthsmedian 6.9 monthsP=0.48Irinotecan could be added to cetuximab monotherapy after progression.
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%0246810Months (modelled)
  • Cetuximab monotherapy (control)
  • Cetuximab plus irinotecan (experimental)

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

Data table (modelled values)
MonthsCetuximab monotherapyCetuximab plus irinotecan
0100.0%100.0%
325.0%60.2%
59.9%42.9%
82.5%25.9%
101.0%18.4%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Cetuximab monotherapy (control)
  • Cetuximab plus irinotecan (experimental)

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

Data table (modelled values)
MonthsCetuximab monotherapyCetuximab plus irinotecan
0100.0%100.0%
560.5%66.8%
1133.1%41.2%
1620.0%27.5%
2211.0%17.0%
Primary publication: Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004;351(4):337-45. PubMedDOI

Appears in

Sources

  1. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004;351(4):337-45.

    PubMedDOI