Abstract
Every-2-week (dose-dense) adjuvant doxorubicin (A) plus cyclophosphamide (C) followed by paclitaxel is a safe and effective adjuvant chemotherapy regimen. Every-3-week nab-paclitaxel is safe and more effective at 50% higher dose than every-3-week paclitaxel in metastatic breast cancer (BC). This study evaluated the safety of adjuvant dose-dense AC followed by dose-dense nab-paclitaxel for early-stage BC. Women with operable, histologically confirmed BC received four cycles of dose-dense A 60 mg/m2 plus C 600 mg/m2 with pegfilgrastim, followed by dose-dense 260 mg/m2 nab-paclitaxel (with pegfilgrastim given as needed). Endpoints were adverse events (AEs), including myelosuppression. Patients with neuropathy were followed until symptom improvement to grade ≤1. Thirty women received four cycles of dose-dense AC with no unanticipated AEs, one withdrew after AC therapy. Of 29 women who began nab-paclitaxel therapy, 27 received all the four doses (mean cumulative dose, 959 mg/m2); one discontinued nab-paclitaxel after two doses due to unacceptable AEs. Four patients had a grade 3 nab-paclitaxel-related neuropathy (no grade 4 event). Of 29 patients, 34% received pegfilgrastim during nab-paclitaxel therapy and 31% had a nab-paclitaxel treatment delay, mainly due to hematologic toxicity. Based on the Kaplan–Meier probability estimates, the percentage of patients having ≤1 grade neuropathy at the end of treatment, 2, and 8 months after treatment were 59, 79, and 97%. Administering adjuvant dose-dense AC followed by 260 mg/m2 dose-dense nab-paclitaxel was feasible in women with early-stage BC, with manageable AEs. Most patients had ≤1 grade neuropathy 2 months after treatment completion.
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Acknowledgments
This study was sponsored by Abraxis BioScience, Los Angeles, California. Medical writing assistance was provided by Anita Nagypál Schmid, PhD, Abraxis BioScience.
Conflict of interest
Alicia Clawson and Jose Iglesias, MD, are employees and stockholders of Abraxis BioScience. Joyce O’Shaughnessy, MD, is on Abraxis Speakers Bureau. The other authors have no conflict of interest to disclose.
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Robert, N., Krekow, L., Stokoe, C. et al. Adjuvant dose-dense doxorubicin plus cyclophosphamide followed by dose-dense nab-paclitaxel is safe in women with early-stage breast cancer: a pilot study. Breast Cancer Res Treat 125, 115–120 (2011). https://doi.org/10.1007/s10549-010-1187-2
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DOI: https://doi.org/10.1007/s10549-010-1187-2