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Bending the Curve Trial by Trial
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HORG

A Multicenter Trial Investigating the Duration of Adjuvant Therapy (3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer

Phase 3N = 1,115NCT01308086

Population
1,115 patients randomised: 413 with high-risk stage II and 702 with stage III colon cancer.
Design
Randomised comparison of 3 versus 6 months of FOLFOX4 or CAPOX within the IDEA project. The abstract reports disease-free survival at 3 years.
Arms
  • 3 months (experimental): 3 months of adjuvant oxaliplatin-containing chemotherapy
  • 6 months (control): 6 months of adjuvant oxaliplatin-containing chemotherapy
People
Souglakos J
DFSHR 1.05 (95% CI 0.61–1.55)Δ 36-month DFS−0.7 pointsDFSHR 1.06 (95% CI 0.81–1.42)Δ 36-month DFS−1.2 pointsDFSHR 1.18 (95% CI 0.74–1.86)Δ 36-month DFS−5.8 points
Show the numbers
Results reported for HORG
EndpointAnalysis3 months6 monthsEffect
DFSAll randomised patients (1,115); analysis population not labelled in the abstractprimarymedian follow-up 67 monthsSouglakos 201977.2% at 3 y (72.1–82.3%)77.9% at 3 y (72.6–82.5%)HR 1.05 (95% CI 0.61–1.55)P=0.647394 DFS events: 202 in the 3-month arm and 192 in the 6-month arm. The abstract prints the confidence interval for the hazard ratio as 0.61 to 1.55.
DFSStage III subgroup (702 randomised)exploratorySouglakos 201972.9% at 3 y74.1% at 3 yHR 1.06 (95% CI 0.81–1.42)P=0.622
DFSStage III patients receiving FOLFOX4 (regimen not randomised)exploratorySouglakos 201971.5% at 3 y77.3% at 3 yHR 1.18 (95% CI 0.74–1.86)
DFSStage III patients receiving CAPOX (regimen not randomised)exploratorySouglakos 201974.5% at 3 y74.7% at 3 yHR 0.99 (95% CI 0.70–1.44)
Results reported for HORG
EndpointAnalysis3 months6 monthsEffect
DFSAll randomised patients (1,115); analysis population not labelled in the abstractprimarymedian follow-up 67 monthsSouglakos 201977.2% at 3 y (72.1–82.3%)77.9% at 3 y (72.6–82.5%)HR 1.05 (95% CI 0.61–1.55)P=0.647394 DFS events: 202 in the 3-month arm and 192 in the 6-month arm. The abstract prints the confidence interval for the hazard ratio as 0.61 to 1.55.
DFSStage III subgroup (702 randomised)exploratorySouglakos 201972.9% at 3 y74.1% at 3 yHR 1.06 (95% CI 0.81–1.42)P=0.622
DFSStage III patients receiving FOLFOX4 (regimen not randomised)exploratorySouglakos 201971.5% at 3 y77.3% at 3 yHR 1.18 (95% CI 0.74–1.86)
DFSStage III patients receiving CAPOX (regimen not randomised)exploratorySouglakos 201974.5% at 3 y74.7% at 3 yHR 0.99 (95% CI 0.70–1.44)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFSDFSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS1.050.61–1.55
DFS1.060.81–1.42
DFS1.180.74–1.86
DFS0.990.7–1.44
Primary publication: Souglakos J, Boukovinas I, Kakolyris S, Xynogalos S, Ziras N, Athanasiadis A, et al. Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project. Ann Oncol. 2019;30(8):1304-1310. PubMedDOI

Appears in

Sources

  1. Souglakos J, Boukovinas I, Kakolyris S, Xynogalos S, Ziras N, Athanasiadis A, et al. Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project. Ann Oncol. 2019;30(8):1304-1310.

    PubMedDOI