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CAIRO3

Maintenance Treatment With Capecitabine and Bevacizumab Versus Observation After Induction Treatment With Chemotherapy and Bevacizumab as First-line Treatment in Patients With Advanced Colorectal Carcinoma

Phase 3N = 558NCT00442637

Population
Previously untreated metastatic colorectal cancer with stable disease or better after six cycles of CAPOX-B
Design
Open-label randomised phase 3 trial in 64 hospitals in the Netherlands: patients with previously untreated metastatic colorectal cancer, stable disease or better after six 3-weekly cycles of capecitabine, oxaliplatin and bevacizumab (CAPOX-B), and WHO performance status 0 or 1 were randomly assigned (1:1) to maintenance capecitabine plus bevacizumab or observation. On first progression (PFS1) both groups were to receive CAPOX-B until second progression (PFS2), the primary endpoint. All endpoints were calculated from randomisation and analyses were by intention to treat. 558 patients were randomly assigned.
Primary endpoint
PFS2
Arms
  • Observation (control, n = 279): Observation after induction treatment
  • Maintenance capecitabine plus bevacizumab (experimental, n = 279): Maintenance capecitabine plus bevacizumab
People
Simkens LH
PFS2HR 0.67 (95% CI 0.56–0.81)Δ median PFS2+3.2 months
Show the numbers
Results reported for CAIRO3
EndpointAnalysisMaintenance capecitabine plus bevacizumabObservationEffect
PFS2primarymedian follow-up 48 monthsSimkens 2015median 11.7 monthsmedian 8.5 monthsHR 0.67 (95% CI 0.56–0.81)P<0.0001Primary endpoint: PFS2, from randomisation to second progression after reintroduction of CAPOX-B. The abstract states that quality of life did not deteriorate during maintenance and that hand-foot skin reaction occurred in 64 (23%) patients during maintenance.
Results reported for CAIRO3
EndpointAnalysisMaintenance capecitabine plus bevacizumabObservationEffect
PFS2primarymedian follow-up 48 monthsSimkens 2015median 11.7 monthsmedian 8.5 monthsHR 0.67 (95% CI 0.56–0.81)P<0.0001Primary endpoint: PFS2, from randomisation to second progression after reintroduction of CAPOX-B. The abstract states that quality of life did not deteriorate during maintenance and that hand-foot skin reaction occurred in 64 (23%) patients during maintenance.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS20.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS20.670.56–0.81
Illustrative — modelled from reported values, not trial data. PFS2, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Maintenance capecitabine plus bevacizumab (experimental)
  • Observation (control)

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

Data table (modelled values)
MonthsMaintenance capecitabine plus bevacizumabObservation
0100.0%100.0%
766.1%56.5%
1541.1%29.4%
2227.2%16.6%
2917.9%9.4%
Primary publication: Simkens LH, van Tinteren H, May A, ten Tije AJ, Creemers GJ, Loosveld OJ, et al. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet. 2015;385(9980):1843-52. PubMedDOI

Appears in

Sources

  1. Simkens LH, van Tinteren H, May A, ten Tije AJ, Creemers GJ, Loosveld OJ, et al. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet. 2015;385(9980):1843-52.

    PubMedDOI