A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane.
OBJECTIVE
This study was designed to evaluate the efficacy and safety of single-agent gemcitabine for the treatment of patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC). Eligible patients were required to have bidimensionally measurable MBC that had been treated with 2-4 prior chemotherapy regimens that included an anthracycline and a taxane. Gemcitabine was delivered at a dose of 800 mg/m2 on days 1, 8, and 15 of a 28-day cycle until evidence of disease progression.


METHODS
Twenty-two patients were enrolled and included in the safety analysis; 18 patients were evaluable for response. The median age of patients was 54 years (range, 36-70 years). The mean number of prior chemotherapy regimens for metastatic disease was 2.3, and the mean dose of gemcitabine delivered was 911 mg/m2 (range, 600-1600 mg/m2).


RESULTS
Overall, gemcitabine was well tolerated with minimal grade 3 toxicities; the only grade 4 toxicity was 1 case of pulmonary embolus. Three patients had evidence of partial tumor regression (17%; 95% CI, 4%-41%), and 1 patient had a 41% decrease in tumor volume, including liver metastasis.


CONCLUSIONS
Gemcitabine is active and well tolerated as monotherapy given in heavily pretreated patients with MBC after anthracyclines and taxanes. The activity and safety reported in this trial are consistent with previous reports in similar patients.
Modi
Shanu
S
Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Currie
Violante E
VE
Seidman
Andrew D
AD
Bach
Ariadne M
AM
Panageas
Katherine S
KS
Theodoulou
Maria
M
Moasser
Mark M
MM
D'Andrea
Gabriella M
GM
Lake
Diana E
DE
Choi
Jennifer
J
Norton
Larry
L
Hudis
Clifford A
CA
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000556:secondary*; D008175:Lung Neoplasms / Q000556:secondary*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011379:Prognosis; D016879:Salvage Therapy; D012878:Skin Neoplasms / Q000556:secondary; D012983:Soft Tissue Neoplasms / Q000556:secondary; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D000093542:Gemcitabine
D018943:Anthracyclines; D001952:Bridged-Ring Compounds; D043823:Taxoids; D003841:Deoxycytidine; C080625:taxane; D004317:Doxorubicin; D000093542:Gemcitabine