Gemcitabine and capecitabine in previously anthracycline-treated metastatic breast cancer: a multicenter phase II study (SOLTI 0301 trial).
BACKGROUND
On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile.


METHODS
Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days.


RESULTS
Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred.


CONCLUSIONS
Combination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancer patients.
Ciruelos
E M
EM
Medical Oncology Department, University Hospital 12 de Octubre, Madrid. Electronic address: eciruelos@hotmail.com.
Cortés
J
J
Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.
Cortés-Funes
H
H
Medical Oncology Department, University Hospital 12 de Octubre, Madrid.
Mayordomo
J I
JI
Medical Oncology Division, Hospital Clínico de Zaragoza, Zaragoza.
Bermejo
B
B
Medical Oncology Division, Hospital Clínico de Valencia, Valencia.
Ojeda
B
B
Medical Oncology Division, Hospital de Sant Pau, Barcelona.
García
E
E
Medical Oncology Division, Hospital Morales Meseguer, Murcia.
Rodríguez
C A
CA
Medical Oncology Division, Hospital Clínico de Salamanca, Salamanca.
Muñoz
M
M
Medical Oncology Division, Hospital Clínico de Barcelona, Barcelona, Spain.
Gómez
P
P
Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.
Manso
L
L
Medical Oncology Department, University Hospital 12 de Octubre, Madrid.
Andrés
R
R
Medical Oncology Division, Hospital Clínico de Zaragoza, Zaragoza.
Lluch
A
A
Medical Oncology Division, Hospital Clínico de Valencia, Valencia.
Saura
C
C
Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.
Mendiola
C
C
Medical Oncology Department, University Hospital 12 de Octubre, Madrid.
Baselga
J
J
Medical Oncology Division, Hospital Vall d'Hebron, Barcelona.
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016879:Salvage Therapy; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
D018943:Anthracyclines; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine