title: Carboplatin and gemcitabine combination in metastatic triple-negative anthracycline- and taxane-pretreated breast cancer patients: a phase II study.
abstract: Triple-negative breast cancer (TNBC) is characterized by lack of hormone receptors and HER-2 and shares many features with BRCA1-associated cancer. Preclinical data indicate cisplatin sensitivity, suggesting that these tumors may have defects in the BRCA1 pathway. The carboplatin and gemcitabine (CG) combination is active in unselected anthracycline/taxane pretreated metastatic breast cancer patients, so we carried out a phase II study to evaluate the activity of the CG combination in pretreated metastatic TNBC patients. From 10/2004 to 3/2009 we enrolled 31 patients. Median age was 57 years and 29 patients out of 31 had visceral involvement. The overall response rate (ORR) was 32% (1 complete response /9 partial responses), in addition 5 patients obtained stable disease for >12 weeks. After a median follow-up of 34 months, all patients progressed with a median time to progression of 5.5 months and median overall survival of 11 months. Dose reductions, delays and omissions occurred in 75 (60%), 36 (29%) and 22 (18%) cycles. Grade 3/4 neutropenia occurred in 17 and febrile neutropenia in 4 patients. Ten patients had Grade 3/4 thrombocytopenia. Non hematological toxicities were manageable. The CG combination is a reasonable option for the treatment of metastatic pretreated TNBC patients.
authors.affiliation: Unità Operativa di Oncologia Medica, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy. maisano@supereva.it
authors.forename: R
authors.initials: R
authors.lastname: Maisano
authors.forename: M
authors.initials: M
authors.lastname: Zavettieri
authors.forename: D
authors.initials: D
authors.lastname: Azzarello
authors.forename: M
authors.initials: M
authors.lastname: Raffaele
authors.forename: M
authors.initials: M
authors.lastname: Maisano
authors.forename: M
authors.initials: M
authors.lastname: Bottari
authors.forename: M
authors.initials: M
authors.lastname: Nardi
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D019313:BRCA1 Protein / Q000378:metabolism; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D057832:Watchful Waiting; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D019313:BRCA1 Protein; D001952:Bridged-Ring Compounds; D016190:Carboplatin; D003841:Deoxycytidine; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D043823:Taxoids; D000093542:Gemcitabine; C080625:taxane