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Capecitabine 2000mg d1-14 Q3wks x 6 cycles (n = 299)

Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: Results of CALGB/CTSU 49907.

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Capecitabine 2000mg d1-14 Q3wks x 6 cycles (n = 299)

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  1. Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: Results of CALGB/CTSU 49907. Authors: H. B. Muss, D. L. Berry, C. Cirrincione, M. Theodoulou, A. Mauer, H. Cohen, A. H. Partridge, L. Norton, C. A. Hudis, E. P. Winer, North American Breast Cancer Intergroup Date posted: June 1, 2008

  2. Adaptive Sample Size detection (prospectively defined and evaluated) Primary Outcome: RFS Secondary Outcome: OS, QOL, Toxicity, adherence Non-inferiority study design using Bayesian Prediction model CMF x 6 (n = 132) OR AC x 4 (n = 184) R Capecitabine 2000mg d1-14 Q3wks x 6 cycles (n = 299) Population: >/= 65 yrs T1-4 N0-3 M0 Median Follow-up 2.4 yrs Stratified by age, PS, Her2

  3. RESULTS Unplanned subgroup analysis: Capecitabine in ER/PR negative tumours vs. all others HR = 4.39, P < 0.0001

  4. TOXICITY

  5. STUDY COMMENTARY • Study design used Bayesian method which takes into account what is known about use of polychemotherapy in elderly already, and incorporates what is learned by current data to come to final conclusion. • Likely an approach that will be utilized increasingly in oncology trials • Polychemotherapy with either CMF or AC had improved RFS and OS compared to single agent Capecitabine • Especially in ER/PR negative tumours • BUT, subgroup analysis not specified a priori • No drug related deaths on standard chemo arms, compared to 2 deaths on Capecitabine

  6. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Single agent capecitabine is inferior to polychemotherapy (AC or CMF) for adjuvant treatment of breast cancer in elderly population • Hormone receptor negative patients may benefit more from polychemotherapy than hormone receptor negative (but caution generalization of this unplanned subgroup analysis) • In the future, adjuvant chemotherapy trials need to be prospectively designed to specifically evaluate based on receptor status • Capecitabine may still be effective in ER/PR positive, Her 2 negative patients in the adjuvant setting, but we will need a prospective trial to address this • Future studies likely to employ Bayesian model to increase efficiency and applicability

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