Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study.
OBJECTIVE
Combining anthracyclines and taxanes are to date the most active cytotoxic treatment option in the neoadjuvant and palliative therapy of breast cancer patients. Adding trastuzumab to these cytotoxic agents can improve outcome for women with human epidermal growth factor receptor 2 (HER2)-overexpressing advanced breast cancer. We conducted a pilot study of preoperative epidoxorubicin and docetaxel plus trastuzumab in outpatient patients suffering from breast cancer.


METHODS
Fourteen consecutive patients were enrolled in this prospective clinical pilot trial. Preoperative treatment consisted of weekly trastuzumab (4 mg/kg body-weight loading dose, 2 mg/kg/week maintenance dose), in combination with weekly epidoxorubicin (30 mg/m2 body surface area [BSA]) and docetaxel (35 mg/m2 BSA) once a week for 6 weeks followed by 1 week off therapy.


RESULTS
Patients received a total of 30 cycles (median: 2 cycles, range: 2-3 cycles) of this therapeutic regimen. Outpatient epidoxorubicin and docetaxel plus trastuzumab were well tolerated. A major response to this preoperative therapy regimen could be demonstrated in 12 of 14 patients (86%) leading to breast-conserving surgery in 11 of 14 patients (79%).


CONCLUSIONS
We conclude that outpatient epidoxorubicin and docetaxel plus trastuzumab are safe in the neoadjuvant treatment of patients suffering from breast cancer, based on a favorable side-effect and activity profile. Thus, this regimen can be considered for further clinical trials.
Wenzel
Catharina
C
Department of Internal Medicine I, Division of Oncology, University Hospital of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.
Hussian
Dagmar
D
Bartsch
Rupert
R
Pluschnig
Ursula
U
Locker
Gottfried J
GJ
Rudas
Margarethe
M
Gnant
Michael F
MF
Jakesz
Raimund
R
Zielinkski
Christoph C
CC
Steger
Guenther G
GG
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D004317:Doxorubicin; D015251:Epirubicin; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab