Phase II study of gemcitabine plus cisplatin in patients with anthracycline- and taxane- pretreated metastatic breast cancer.
OBJECTIVE
Metastatic breast cancer patients are usually exposed to taxane and anthracycline as neoadjuvant, adjuvant and palliative chemotherapeutic agents. This study was designed to determine the efficacy and safety of the use of a gemcitabine and cisplatin (GP) combination treatment in patients with metastatic breast cancer that were pretreated with anthracycline and taxane.


METHODS
We evaluated the use of a GP regimen (1,000 mg/m(2) gemcitabine administered on days 1 and 8 plus 60 mg/m(2) cisplatin administered on day 1 every 3 weeks) in 38 breast cancer patients who had received prior chemotherapy with anthracycline and taxane as an adjuvant or neoadjuvant therapy, or as a palliative therapy.


RESULTS
The median patient age was 49 years (age range, 35 approximately 69 years). The overall response rate was 28.9% in 11 patients (95% confidence interval [CI], 14 approximately 44%). The median time to progression was 5.2 months (95% CI, 3.6 approximately 6.8 months). Median survival was 19.5 months (95% CI, 11.2 approximately 27.8 months). Major grade 3/4 hematological toxicity was due to leukopenia (36 of 157 cycles, 23.1%). Non-hematological toxicity was rarely severe; grade 1/2 nausea and vomiting were observed in 37.8% of the patients. There were no treatment related deaths.


CONCLUSIONS
Our results suggest that the use of gemcitabine plus cisplatin appears to be effective and has an acceptable toxicity profile in patients with advanced breast cancer that have been pretreated with anthracycline and taxane.
Kim
Jung Hwan
JH
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
Oh
Sung Yong
SY
Kwon
Hyuk-Chan
HC
Lee
Suee
S
Kim
Sung-Hyun
SH
Kim
Dae-Cheol
DC
Lee
Jin-Hwa
JH
Lee
Hyung-Sik
HS
Cho
Se-Heun
SH
Kim
Hyo-Jin
HJ
Cancer Chemother Pharmacol. 2006 May;57(5):640-6
16163537
Semin Oncol. 1997 Apr;24(2 Suppl 7):S7-17-S7-23
9194475
Breast. 2000 Dec;9(6):338-42
14965758
Oncology (Williston Park). 2003 Dec;17(12 Suppl 14):26-32
14768402
N Engl J Med. 1998 Oct 1;339(14):974-84
9753714
Ann Oncol. 2001 Sep;12(9):1259-64
11697837
Oncology. 2003;64(3):191-206
12697958
Clin Breast Cancer. 2001 Oct;2(3):190-208; discussion 209
11899413
Oncology. 2001;60(4):303-7
11408796
Cancer Res. 2001 Dec 15;61(24):8723-9
11751391
Semin Oncol. 2006 Jun;33(3 Suppl 9):S19-23
16797378
Semin Oncol. 2003 Apr;30(2 Suppl 3):6-10
12722018
Cancer. 1981 Jan 1;47(1):207-14
7459811
Cancer Invest. 2004;22(5):655-62
15581045
J Clin Oncol. 2002 Jan 1;20(1):37-41
11773151
J Clin Oncol. 2000 Jun;18(11):2245-9
10829044
Oncology. 2002;62(1):2-8
11810037
Anticancer Drugs. 1999 Feb;10(2):155-62
10211545
Cancer Invest. 2000;18(6):503-9
10923097
Ann Oncol. 2000 Apr;11(4):495-6
10847474
Semin Oncol. 2006 Feb;33(1 Suppl 2):S6-14
16472712
Ann Oncol. 2004 Jan;15(1):95-9
14679126
Cancer Res Treat. 2004 Apr;36(2):103-14
20396549
Oncology. 2004;66(1):18-23
15031594
Ann Oncol. 2000 Jul;11(7):873-5
10997817