Phase II study of gemcitabine plus paclitaxel in metastatic breast cancer patients with prior anthracycline exposure

被引:12
作者
Demiray, M [1 ]
Kurt, E [1 ]
Evrensel, T [1 ]
Kanat, O [1 ]
Arslan, M [1 ]
Saraydaroglu, O [1 ]
Ercan, K [1 ]
Gonullu, G [1 ]
Gokgoz, S [1 ]
Topal, U [1 ]
Tolunay, S [1 ]
Tasdelen, I [1 ]
Manavoglu, O [1 ]
机构
[1] Uludag Univ, Sch Med, Dept Med Oncol, TR-16059 Gorukle, Turkey
关键词
gemcitabine; paclitaxel; metastatic breast cancer;
D O I
10.1081/CNV-200067133
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Chemotherapy provides palliation and modest prolongation of symptom-free survival in metastatic breast cancer. Taxane containing regimens are commonly considered to be among the initials in metastatic setting due to earlier use of anthracyclines in the course of breast cancer. Therefore, we conducted this Phase 11 study to assess efficacy and safety of gemcitabine plus paclitaxel (GT) combination therapy in anthracycline pretreated metastatic first-line setting. Patients and Methods: The study enrolled 26 women with pathologically confirmed and measurable metastatic breast cancer who were previously treated with anthracycline but no prior chemotherapy for metastatic disease. Twenty six and twenty four patients were eligible for toxicity and efficacy evaluations respectively. Mean age was 47.3 years and median ECOG performance status was 0. Twenty patients (76.9 percent) had visceral metastases, most commonly located in liver and lung. Treatment schedule was as follows: paclitaxel 175 mg/m(2) was administered intravenously in 3 hours on Day 1 and gemcitabine 1000 mg/m2 was administered intravenously in 30 minutes on Day 1 after paclitaxel application, and on Day 8 every 21 days. Results: Objective response rate was 41.7 percent (95 percent CI: 21.9-61.4) with 16.7 percent (95 percent CI: 1.7-31.6 percent) CR, and 25.0 percent (95 percent CI: 7.6-42.3 percent) PR. Median time to progression and overall survival were 9.6 and 14.5 months, respectively. Grade 3-4 toxicity was observed in 34.6 percent (9) patients. Treatment of two patients was discontinued due to toxicity, consisting of Grade 3 hypersensitivity reactions and Grade 4 infections in one patient each. Dose reductions due to myelotoxicity were performed in 4 (15.3 percent) patients. Hematologic toxicities were generally manageable with appropriate dose modifications and supportive care. Conclusion: Gemcitabine and paclitaxel combination regimen is effective and has manageable toxicity profile as first line metastatic setting.
引用
收藏
页码:386 / 391
页数:6
相关论文
共 28 条
[1]   PACLITAXEL ACTIVITY IN HEAVILY PRETREATED BREAST-CANCER - A NATIONAL-CANCER-INSTITUTE TREATMENT REFERRAL CENTER TRIAL [J].
ABRAMS, JS ;
VENA, DA ;
BALTZ, J ;
ADAMS, J ;
MONTELLO, M ;
CHRISTIAN, M ;
ONETTO, N ;
DESMONDHELLMANN, S ;
CANETTA, R ;
FRIEDMAN, MA ;
ARBUCK, SG .
JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (08) :2056-2065
[2]  
[Anonymous], 1989, Analysis of binary data
[3]   A systematic overview of chemotherapy effects in breast cancer [J].
Bergh, J ;
Jönsson, PE ;
Glimelius, B ;
Nygren, P .
ACTA ONCOLOGICA, 2001, 40 (2-3) :253-281
[4]   Gemcitabine as first-line therapy in patients with metastatic breast cancer: A phase II trial [J].
Blackstein, M ;
Vogel, CL ;
Ambinder, R ;
Cowan, J ;
Iglesias, J ;
Melemed, A .
ONCOLOGY, 2002, 62 (01) :2-8
[5]   Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure [J].
Bonneterre, J ;
Roché, H ;
Monnier, A ;
Guastalla, JP ;
Namer, M ;
Fargeot, P ;
Assadourian, S .
BRITISH JOURNAL OF CANCER, 2002, 87 (11) :1210-1215
[6]   Single-agent gemcitabine as second- and third-line treatment in metastatic breast cancer [J].
Brodowicz, T ;
Kostler, WJ ;
Möslinger, R ;
Tomek, S ;
Vaclavik, I ;
Herscovici, V ;
Wiltschke, C ;
Steger, GG ;
Wein, W ;
Seifert, M ;
Kubista, E ;
Zielinski, CC .
BREAST, 2000, 9 (06) :338-342
[7]   Biweekly paclitaxel plus gemcitabine in advanced breast cancer:: phase II trial and predictive value of HER2 extracellular domain [J].
Colomer, R ;
Llombart-Cussac, A ;
Lluch, A ;
Barnadas, A ;
Ojeda, B ;
Carañana, V ;
Fernández, Y ;
García-Conde, J ;
Alonso, S ;
Montero, S ;
Hornedo, J ;
Guillem, V .
ANNALS OF ONCOLOGY, 2004, 15 (02) :201-206
[8]   Chemotherapy for metastatic breast cancer -: report of a European expert panel [J].
Crown, J ;
Diéras, V ;
Kaufmann, M ;
von Minckwitz, G ;
Kaye, S ;
Leonard, R ;
Marty, M ;
Misset, JL ;
Osterwalder, B ;
Piccart, M .
LANCET ONCOLOGY, 2002, 3 (12) :719-727
[9]  
EINHORN L, 1998, PHASE I TRIAL GEMCIT, pA207
[10]  
GERSON R, 2000, P AM SOC CLIN ONC AN, pA145