1. Phase II study of neoadjuvant gemcitabine, pegylated liposomal doxorubicin, and docetaxel in locally advanced breast cancer.
- Author
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Artioli G, Mocellin S, Borgato L, Cappetta A, Bozza F, Zavagno G, Zovato S, Marchet A, and Pastorelli D
- Subjects
- Adult, Aged, Breast Neoplasms pathology, Breast Neoplasms surgery, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Docetaxel, Doxorubicin administration & dosage, Doxorubicin adverse effects, Doxorubicin analogs & derivatives, Female, Humans, Mastectomy, Middle Aged, Neoplasm Staging, Polyethylene Glycols administration & dosage, Polyethylene Glycols adverse effects, Taxoids administration & dosage, Taxoids adverse effects, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Neoadjuvant Therapy methods
- Abstract
Aim: This was a phase II study to assess the activity of a novel neoadjuvant regimen in locally-advanced breast cancer., Patients and Methods: Fifty patients with histological confirmation of locally advanced breast cancer received treatment with gemcitabine 1000 mg/m(2) (day 1) followed by gemcitabine 800 mg/m(2) plus docetaxel 75 mg/m(2) plus pegylated liposomal doxorubicin (PLD) 30 mg/m(2) (day 8) every 3 weeks for at least 4 cycles, plus a final 2 additional cycles. Tumour size was T1 (n=2), T2 (n=32), T3 (n=14), T4 (n=2). All 50 patients underwent surgery., Results: Clinical complete, partial and no response were observed in 13 (26%), 24 (48%) and 11 (22%) patients, respectively (overall response rate: 74%). The number of chemotherapy cycles was found to be an independent predictor of a pathologic complete response., Conclusion: The combination of gemcitabine-docetaxel-PLD can yield high tumour response rates in patients with locally-advanced breast cancer who undergo a full treatment of 6 cycles.
- Published
- 2010