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Bending the Curve Trial by Trial
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IMPACT B2

Needs review

International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2): fluorouracil and folinic acid after resection of B2 colon cancer

Phase meta-analysisN = 1,016

Population
1016 patients with B2 colon cancer after potentially curative resection, entered onto five separate trials.
Design
Pooled analysis of five separate randomised trials in which patients with B2 colon cancer were randomised to fluorouracil plus leucovorin or observation; event-free survival and overall survival analysed with a stratified log-rank test and a Cox model.
Arms
  • Observation (control): Observation after resection
  • Fluorouracil plus leucovorin (experimental): Adjuvant fluorouracil plus leucovorin
People
International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2) Investigators, IMPACT B2 Investigators
EFSHR 0.83Δ 60-month EFS+3 pointsOSHR 0.86Δ 60-month OS+2 points
Show the numbers
Results reported for IMPACT B2
EndpointAnalysisFluorouracil plus leucovorinObservationEffect
EFSPatients with B2 colon cancer from five trials (1016)primarymedian follow-up 5.75 yearsInternational 199976% at 5 y73% at 5 yHR 0.83The abstract gives a 90% confidence interval for the hazard ratio, 0.72 to 1.07, which is not centred on the point estimate (0.83); it is reproduced as published and could not be checked against the full text. The authors report no significant increase in EFS. No P value is given in the abstract.
OSPatients with B2 colon cancer from five trials (1016)primarymedian follow-up 5.75 yearsInternational 199982% at 5 y80% at 5 yHR 0.8690% confidence interval for the hazard ratio, 0.68 to 1.07, as published. The authors report no significant increase in OS. No P value is given in the abstract.
Results reported for IMPACT B2
EndpointAnalysisFluorouracil plus leucovorinObservationEffect
EFSPatients with B2 colon cancer from five trials (1016)primarymedian follow-up 5.75 yearsInternational 199976% at 5 y73% at 5 yHR 0.83The abstract gives a 90% confidence interval for the hazard ratio, 0.72 to 1.07, which is not centred on the point estimate (0.83); it is reproduced as published and could not be checked against the full text. The authors report no significant increase in EFS. No P value is given in the abstract.
OSPatients with B2 colon cancer from five trials (1016)primarymedian follow-up 5.75 yearsInternational 199982% at 5 y80% at 5 yHR 0.8690% confidence interval for the hazard ratio, 0.68 to 1.07, as published. The authors report no significant increase in OS. No P value is given in the abstract.
Primary publication: International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2) Investigators. Efficacy of adjuvant fluorouracil and folinic acid in B2 colon cancer. J Clin Oncol. 1999;17(5):1356-63. PubMedDOI

Appears in

Sources

  1. International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2) Investigators. Efficacy of adjuvant fluorouracil and folinic acid in B2 colon cancer. J Clin Oncol. 1999;17(5):1356-63.

    PubMedDOI