ADVANCED BREAST-CANCER - A PHASE-II TRIAL WITH GEMCITABINE
ADVANCED BREAST-CANCER - A PHASE-II TRIAL WITH GEMCITABINE
复制标题
DOI：
10.1200/jco.1995.13.11.2731
复制
发表时间：
1995-11-01
影响因子：
45.3
通讯作者：
HARRIS, AL
中科院分区：
文献类型：
--
作者：
CARMICHAEL, J;POSSINGER, K;HARRIS, AL
目的：在这个第二阶段的研究中，吉西他滨的疗效和耐受性进行了研究，在44例局部晚期或转移性乳腺cancer.Patients和方法：40例患者评估的反应，14化疗初治，7人接受辅助化疗，19人接受了一个先前的化疗方案转移性疾病。吉西他滨每周一次静脉输注30分钟，持续3周，随后每4周休息1周。平均完成给药周期数为2.7，平均给药剂量为725 mg/m2/注射。结果：有3例完全缓解和7例部分缓解，总缓解率为25.0%（95%置信区间[CI]，12.7%至41.2%）。4例患者的疗效无法评估（1例治疗不足，2例无二维可测量疾病，1例两者均无）。所有缓解均由外部肿瘤学审查委员会独立验证。在治疗早期观察到缓解，中位缓解时间为1.9个月。所有40例可评估患者的中位生存期为11.5个月。血液学毒性通常为轻度，分别有6.8%和2.3%的患者发生世界卫生组织（WHO）3级和4级白细胞减少症，23.3%和7.0%的患者发生中性粒细胞减少症。仅有的其他4级毒性为感染、恶心和呕吐，各1例患者。1例患者因呼吸短促退出研究，可能与药物相关。在6.8%的患者中报告了轻度、短暂且可通过对乙酰氨基酚治疗的流感样症状。结论：吉西他滨单药治疗晚期乳腺癌疗效好，毒性反应小，作用机制新颖，值得临床进一步研究，是一种理想的联合治疗方案。(C)1995年，美国临床肿瘤学会。
Purpose: In this phase II study, the efficacy and tolerability of gemcitabine were studied in 44 patients with locally advanced or metastatic breast cancer.Patients and Methods: Of 40 patients assessable for response, 14 were chemotherapy-naive, seven had received adjuvant chemotherapy, and 19 had received one prior chemotherapy regimen for metastatic disease. Gemcitabine was administered as a 30-minute intravenous infusion once a week for 3 weeks followed by a 1-week rest every 4 weeks. The mean number of completed cycles administered was 2.7 and the mean dosage delivered was 725 mg/m(2) per injection. Eighty-one percent of doses were delivered as scheduled.Results: There were three complete responses and seven partial responses, for an overall response rate of 25.0% (95% confidence interval [CI], 12.7% to 41.2%). Four patients were not assessable for efficacy (one had insufficient therapy, two had no bidimensionally measurable disease, and one had neither). All responses were independently validated by an external oncology review board. Responses were observed early in treatment, with a median time to response of 1.9 months. The median survival duration for all 40 assessable patients was 11.5 months. Hematologic toxicity was generally mild, with World Health Organization (WHO) grade 3 and 4 leukopenia occurring in 6.8% and 2.3% of patients and neutropenia in 23.3% and 7.0%, of patients, respectively. The only other grade 4 toxicities were infection and nausea and vomiting in one patient each. One patient was withdrawn due to shortness of breath, possibly drug-related. Flu-like symptoms, which were mild, transient, and treatable with acetominophen, were reported in 6.8% of patients. Only one patient developed alopecia of severity greater than WHO grade 2.Conclusion: In view of the single-agent activity seen in advanced breast cancer, modest toxicity profile, and novel mechanism of action, gemcitabine deserves evaluation in breast cancer and is an ideal candidate for combination therapy.(C) 1995 by American Society of Clinical Oncology.