title: Gemcitabine and vinorelbine combination in patients with metastatic breast cancer.
abstract: Both gemcitabine and vinorelbine as single agents have significant activity against metastatic breast cancer, with an overall response rate ranging from 14% to 40%. Because each drug has different mechanisms of action and toxicity profile, we have evaluated the activity and tolerability as a combined regimen in metastatic breast cancer patients. Thirty-two breast cancer patients with prior chemotherapy for metastatic disease received a combination of gemcitabine and vinorelbine at 1,200 and 30 mg/m2, respectively. The drugs were administered on days 1 and 8 of every 21-day cycle. The study was designed to evaluate the response rate, the duration of response, the time to progression, and overall survival. Toxicity and tolerability of this combination were also evaluated. Out of 32 patients analyzed, a complete response was achieved in 2 patients (6.3%) and a partial response in 12 patients (37.5%), with an overall response rate of 43.8%. After a median follow-up of 7 months, the median duration of response was 5.3 months, and the time to progression was 5.0 months. Overall survival was not reached because the majority of the patients were alive at the time of analysis. The gemcitabine and vinorelbine combination was tolerable, with hematologic toxicity being the most common side-effect. Three patients suffered from grade 4 neutropenia, and none suffered from grade 4 thrombocytopenia. Nonhematologic toxicity was minimal and transient, with nausea and phlebitis being the most common. The gemcitabine and vinorelbine combination at the previously specified doses shows significant activity in metastatic breast cancer patients. The treatment is well tolerated and has an acceptable toxicity profile. In patients previously treated with anthracyclines and taxanes, this combination regimen offers an alternative treatment with preservation of a good quality of life.
authors.affiliation: University of Florida Health Science Center, Jacksonville, Florida 32209, USA.
authors.forename: Salahattin M
authors.initials: SM
authors.lastname: Sanal
authors.forename: Erhan
authors.initials: E
authors.lastname: Gokmen
authors.forename: Bulent
authors.initials: B
authors.lastname: Karabulut
authors.forename: Canfeza
authors.initials: C
authors.lastname: Sezgin
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D010166:Palliative Care; D011788:Quality of Life; D012074:Remission Induction; D015996:Survival Rate; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine