Phase II study of a gemcitabine and cisplatin combination regimen in taxane resistant metastatic breast cancer.
OBJECTIVE
To determine the safety and efficacy of gemcitabine and cisplatin in patients with taxane resistant metastatic breast cancer.


METHODS
Thirty-three taxane resistant metastatic breast cancer patients were treated with gemcitabine 1,250 mg/m2 IV infusion over 30 min on days 1 and 8, and with cisplatin 75 mg/m2 by IV infusion over 1 h on day 1 in 21 day cycles.


RESULTS
Of the 30 evaluable patients, there were 9 (30%) partial responses and no complete response, an overall objective response rate of 30%. Median time to progression and median survival duration for all study subjects were 7 (95% CI 5.1-8.9 months) and 15 months (95% CI 10.5-19.5 months), respectively. Toxicities included grade 3 and 4 leucopenia in 10 (30%), thrombocytopenia in 6 (18%), anemia in 2 (6%) and oral mucositis in 2 (6%). No grade 3 or 4 peripheral neuropathy, renal dysfunction, hepatic dysfunction, or nausea/vomiting was observed, and no treatment-related deaths occurred.


CONCLUSIONS
The described gemcitabine plus cisplatin combination was found to be an active and tolerable salvage regimen in patients with taxane resistant metastatic breast cancer.
Seo
Jae Hong
JH
Department of Internal Medicine, Division of Hematology/Oncology, College of Medicine, Korea University Guro Hospital, 97 Gurodong-gil, Guro-ku, Seoul, Korea, 152-703.
Oh
Sang Cheul
SC
Choi
Cheul Won
CW
Kim
Byung Soo
BS
Shin
Sang Won
SW
Kim
Yeul Hong
YH
Kim
Jun Suk
JS
Kim
Ae-Ree
AR
Lee
Jae-Bok
JB
Koo
Bum Hwan
BH
D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000740:Anemia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012008:Recurrence; D012720:Severity of Illness Index; D013280:Stomatitis / Q000139:chemically induced; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D001952:Bridged-Ring Compounds; D043823:Taxoids; D003841:Deoxycytidine; C080625:taxane; D002945:Cisplatin; D000093542:Gemcitabine