Adjuvant chemotherapy in older women with early-stage breast cancer. HB Muss, DA Berry, CT Cirrincione, M Theodoulou, AM Mauer, AB Kornblith, AH Partridge, LG Dressler, HJ Cohen, HP Becker, PA Kartcheske, JD Wheeler, EA Perez, AC Wolff, JR Gralow, HJ Burstein, AA Mahmood, G Magrinat, BA Parker, RD Hart, D Grenier, L Norton, CA Hudis, EP Winer N Engl J Med 2009 5;360(20):2055-65
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May 22, 2009 |
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This adjuvant chemotherapy study by Dr Muss and the CALGB is critical on several accounts. Firstly, most of the adjuvant chemotherapy studies performed in the US have had an under-representation of older women, causing physicians and patients to be less certain of both the benefits and toxicities of adjuvant chemotherapy in this group of women. This study was restricted to women 65 years and older, and accrued over 600 subjects. Secondly, this study demonstrated that standard chemotherapy was significantly better than the investigational chemotherapy, single agent capecitabine. The concept that oral chemotherapy would be a “better, friendlier and gentler” approach for these women was proved incorrect. Not only was survival inferior for women receiving capecitabine as compared to standard chemotherapy, but toxicity was not significantly less for women receiving capecitabine. Two treatment related deaths occurred, both in women receiving capecitabine. Thirdly, this study demonstrated significant survival advantage for adjuvant chemotherapy in women 65 years and older, especially in women with estrogen receptor negative disease. Though there was no “no-treatment” control arm, the survival advantage of standard chemotherapy over capecitabine, demonstrates that there is at least this degree of benefit over no therapy at all, and possibly more. Lastly, and very importantly, this study utilized a creative biostatistical approach which minimized the number of patients necessary to successfully complete the study with meaningful results, also allowing the study to be completed in the minimum amount of time, making these important results available as soon as possible. Lawrence Shulman, MD
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