Chemotherapy (CT) and hormonotherapy (HT) as neoadjuvant treatment in luminal breast cancer patients: results from the GEICAM/2006-03, a multicenter, randomized, phase-II study.
BACKGROUND
Luminal breast cancer is a highly endocrine responsive disease. However, the therapeutic benefit of chemotherapy (CT) in this population is not fully characterized. This study investigates the value of CT and hormone therapy (HT) in luminal breast cancer patients in the neoadjuvant setting.


METHODS
Patients with operable breast cancer and immunophenotypically defined luminal disease (ER+/PR+/HER2-/cytokeratin 8/18+) were recruited. Patients were randomized to CT (epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) 4 cycles followed by docetaxel 100 mg/m(2 )4 cycles [EC-T]) or HT (exemestane 25 mg daily 24 weeks [combined with goserelin in premenopausal patients]). The primary end point was the clinical response measured by magnetic resonance imaging.


RESULTS
Ninety-five patients were randomized (47 CT, 48 HT). The clinical response rate was 66% for CT and 48% for HT (P = 0.075). We performed an unplanned analysis based on Ki67 levels (cut-off of 10%). Similar clinical response was seen between arms in patients with low Ki67 (CT: 63%, HT: 58%; P = 0.74); patients with high Ki67 had a better response with CT (67 versus 42%; P = 0.075). Grade 3/4 toxicity was more frequent with CT.


CONCLUSIONS
Luminal immunophenotype is not enough to identify patients who do not benefit from neoadjuvant CT. Luminal patients with low proliferation index could potentially avoid CT.
Department of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga. Electronic address: ealbac@uma.es.
E
E
Alba
Department of Medical Oncology, C H U Juan Canalejo, A Coruna.
L
L
Calvo
Department of Medical Oncology, H del Mar, Barcelona.
J
J
Albanell
Department of Medical Oncology, Hospital Reina Sofia, Cordoba.
J R
JR
De la Haba
Department of Medical Oncology, Consorci Sanitari de Terrassa, Barcelona.
A
A
Arcusa Lanza
Department of Medical Oncology, H Virgen de la Salud, Toledo.
J I
JI
Chacon
Department of Medical Oncology, C H de Jaen, Jaen.
P
P
Sanchez-Rovira
Department of Medical Oncology, Onkologikoa, Donostia.
A
A
Plazaola
Department of Medical Oncology, H C U San Carlos, Madrid.
J A
JA
Lopez Garcia-Asenjo
Department of Medical Oncology, Hospital Clinico Universitario, Valencia.
B
B
Bermejo
GEICAM, Madrid, Spain.
E
E
Carrasco
Department of Medical Oncology, Hospital Clinico Universitario, Valencia.
A
A
Lluch
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use; D066246:ErbB Receptors / Q000378:metabolism; D005260:Female; D006801:Humans; D053538:Keratin-18 / Q000378:metabolism; D053533:Keratin-8 / Q000378:metabolism; D019394:Ki-67 Antigen / Q000378:metabolism; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects*; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D018931:Antineoplastic Agents, Hormonal; D053538:Keratin-18; D053533:Keratin-8; D019394:Ki-67 Antigen; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D066246:ErbB Receptors