TAILORx Trial

  • The Oncotype DX recurrence score:
    • Is based on a 21-gene panel:
      • Developed to predict:
        • The risk of distant recurrence and the potential benefit of adjuvant chemotherapy
    • Retrospective analyses of tissue samples from prospective, randomized trials:
      • Showed that the score estimates:
        • The risk of distant recurrence and predicts the benefit from adjuvant chemotherapy
    • The TAILORx trial was designed to determine:;
      • Whether Oncotype DX could be used prospectively:
        • To guide decision making regarding the use of adjuvant chemotherapy:
          • In node-negative, hormone receptor-positive breast cancers:
            • With an intermediate recurrence score:
              • A group where the benefit of chemotherapy is less clear:
                • The intermediate score for purposes of the trial was defined as 11 to 25
      • All patients were treated with hormonal therapy
      • Patients with scores of less than 11:
        • Were treated with hormonal therapy alone
      • Those with scores above 25:
        • Were treated with chemotherapy plus hormonal therapy
      • Patients with intermediate scores (11 to 25):
        • Were randomized to receive chemotherapy or not
      • Primary endpoints of the trial:
        • Are disease-free survival and overall survival
  • Methods:
    • Eligibility criteria included:
      • Women 18 to 75 years of age
      • HR-positive
      • HER2-negative
      • Axillary node (AN)-negative breast cancer
      • Tumors 1.1 to 5.0 cm in size:
        • Or 0.6 to 1.0 cm and intermediate grade to high grade
      • Agreed to have chemotherapy assigned or randomized based on the RS
      • Women with a mid-range RS (11 to 25):
        • Were randomized to receive:
          • Endocrine therapy (ET) or
          • Chemotherapy and endocrine therapy (CET)
      • The primary endpoint was:
        • Invasive disease-free survival (iDFS),
      • The trial was designed to show non-inferiority for ET alone by not rejecting equality:
        • Hazard ratio [HR] margin up to 1.322 for omission of chemotherapy, 1-sided type I error rate 10%, type II error rate 5%
      • The target sample size was adjusted to compensate for non-adherence to randomized treatment, and the protocol-specified final analysis was triggered after 835 iDFS events
  • Results:
    • Of the 10,253 eligible women enrolled between 4/7/06-10/6/10:
      • 6711 (65.5%) had a:
        • RS of 11 to 25 and adequate information
    • There were 836 iDFS events at final analysis:
      • With amedian followup of 90 months
    • ET was non-inferior to CET for iDFS:
      • HR 1.08, 95% confidence intervals [CI] 0.94, 1.24, p=0.26) in the intention-to-treat (ITT) population
    • ET was also non-inferior for distant recurrence-free interval:
      • DRFI:
        • HR 1.03, p=0.80
    • ET was also non-inferior for recurrence-free interval:
      • RFI:
        • HR 1.12, p=0.28
    • ET was also non-inferior for overall survival:
      • OS:
        • HR 0.97, p=0.80
    • Nine year rates were similar for:
      • iDFS:
        • 83.3% vs. 84.3%
      • DRFI:
        • 94.5% vs. 95.0%
      • RFI:
        • 92.2% vs. 92.9%
      • OS:
        • 93.9% vs. 93.8%
    • Recurrence:
      • Accounted for 338 (41.6%) the first iDFS event:
        • Of which 199 (23.8%) were distant recurrences
    • Treatment interaction tests were significant for age (iDFS p=0.03; RFI p= 0.02), but not menopause, tumor size, grade, or RS (continuous or RS 11-15, 16-20, 21-25).
  • Conclusions:
    • In women with HR-positive, HER2-negative, AN-negative breast cancer and a RS of 11 to 25:

REFERENCES

  1. Solin LJ. The Eastern Cooperative Oncology (ECOG) experience. In: Kuerer HM, ed. Kuerer’s Breast Surgical Oncology. New York, NY: McGraw-Hill Companies; 2010:578-581.
  2. National Cancer Institute at the National Institutes of Health Web site. Featured Clinical Trials. Phase III Randomized Study of Adjuvant Combination Chemotherapy and Hormonal Therapy Versus Adjuvant Hormonal Therapy in Women with Previously Resected Axillary Node-Negative Breast Cancer with Various Levels of Risk for Recurrence (TAILORxTrial) (ECOG-PACCT-1). Available at: clinicaltrials.gov/ct2/show?term=TAILORx&rank=1.

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