Phase II clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neoadjuvant treatment in stages II and IIIA HER2-overexpressing breast cancer patients. GEICAM 2003-03 study.
BACKGROUND
we previously reported a phase I trial of liposome-encapsulated doxorubicin citrate (LD), docetaxel and trastuzumab as neoadjuvant in stages II and IIIA human epidermal growth factor receptor 2-overexpressing breast cancer patients. This study evaluates the efficacy of this regimen in a phase II trial.


METHODS
patients were treated with LD 50 mg/m(2) and docetaxel 60 mg/m(2) every 21days associated with standard trastuzumab dose and pegfilgrastim support.


RESULTS
fifty-nine patients were enrolled; median age: 48 years (range 24-71 years); premenopausal patients: 36 (61%); 19 patients (32%) presented stage IIIA disease and 40 patients (67%) stage II; histological grades 2-3 tumors: 50 patients (84%) and estrogen receptor-progesterone receptor negative: 28 patients (47%). In all, 27% achieved a pathological complete response in breast and axilla (grade 5-Miller and Payne classification); 15% of patients achieved grade 4. Clinical and radiological response rates were 86% and 81%, respectively. Forty-two patients (71%) underwent breast-conserving surgery. The main grades 3-4 toxic effects were non-febrile neutropenia (29%) and fatigue (8%). Grade 2 left ventricular ejection fraction decline was observed in nine patients. No congestive heart failure was observed.


CONCLUSIONS
LD plus docetaxel combination associated with trastuzumab as neoadjuvant is active in breast cancer and entails a favorable cardiotoxicity profile. This regimen is a new treatment option in these patients.
Antón
A
A
Oncology Department, Hospital Universitario Miguel Servet, Zaragoza. Electronic address: aantont@gmail.com.
Ruiz
A
A
Oncology Department, Instituto Valenciano de Oncología, Valencia.
Plazaola
A
A
Oncology Department, Onkologikoa, San Sebastián.
Calvo
L
L
Oncology Department, Complejo Hospitalario Universitario de A Coruña, A Coruña.
Seguí
M A
MA
Oncology Department, Consorci Sanitari Parc Taulí, Sabadell.
Santaballa
A
A
Oncology Department, Hospital Universitario La Fe, Valencia.
Muñoz
M
M
Oncology Department, Hospital Clínic i Provincial, Barcelona.
Sánchez
P
P
Oncology Department, Complejo Hospitalario de Jaén, Jaén.
Miguel
A
A
Oncology Department, Althaia-Xarxa Assistencial de Manresa, Manresa.
Carrasco
E
E
Staff members of GEICAM, Madrid, Spain.
Lao
J
J
Oncology Department, Hospital Universitario Miguel Servet, Zaragoza.
Camps
J
J
Oncology Department, Instituto Valenciano de Oncología, Valencia.
Alfaro
J
J
Oncology Department, Onkologikoa, San Sebastián.
Antolín
S
S
Oncology Department, Complejo Hospitalario Universitario de A Coruña, A Coruña.
Cámara
M C
MC
Staff members of GEICAM, Madrid, Spain.
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011092:Polyethylene Glycols; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors / Q000096:biosynthesis*; D011994:Recombinant Proteins; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000068878:Trastuzumab; D055815:Young Adult
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D004317:Doxorubicin; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor; D011092:Polyethylene Glycols; D018719:Erb-b2 Receptor Tyrosine Kinases; D011994:Recombinant Proteins; D043823:Taxoids; D000068878:Trastuzumab; C455861:pegfilgrastim