Possinger K, Kaufmann M, Coleman R, Stuart N S, Helsing M, Ohnmacht U, Arning M
Medizinische Klinik II der Charité, Berlin, Germany.
Anticancer Drugs. 1999 Feb;10(2):155-62. doi: 10.1097/00001813-199902000-00003.
In this phase II study, the efficacy and tolerability of gemcitabine were studied in 42 patients with locally advanced or metastatic breast cancer who had received up to one prior chemotherapy regimen in an adjuvant setting. Ten patients had received adjuvant chemotherapy. Twenty-eight patients (67%) had visceral disease spread at entry. Gemcitabine (1000 mg/m2) was administered weekly on days 1, 8 and 15 of a 28-day cycle. The mean number of completed cycles was 3.9 and the mean dose delivered was 942.2 mg/m2. Ninety-seven percent of injections were administered as assigned. No complete responses were observed, but there were six partial responses and 24 patients with stable disease lasting 2-9 months. The overall response rate was 14.3% (95% CI 5.4-28.5%). The median survival for all patients was 15.2 months. Maximum WHO grade 3 and 4 toxicities were observed in five patients for nausea and vomiting, one patient for diarrhea, one patient for pain, seven patients for alanine transaminase, and eight patients for segmented neutrophils. There were no grade 3 and 4 toxicities for alopecia. These data confirm modest single-agent gemcitabine activity in advanced or metastatic breast cancer. Gemcitabine's favorable toxicity profile makes it an ideal candidate for combination chemotherapy.
在这项II期研究中，对42例局部晚期或转移性乳腺癌患者的吉西他滨疗效和耐受性进行了研究，这些患者在辅助治疗中最多接受过一种先前的化疗方案。10例患者接受过辅助化疗。28例患者（67%）在入组时出现内脏转移。吉西他滨（1000mg/m²）在28天周期的第1、8和15天每周给药一次。完成周期的平均次数为3.9次，平均给药剂量为942.2mg/m²。97%的注射按计划进行。未观察到完全缓解，但有6例部分缓解，24例患者病情稳定持续2 - 9个月。总缓解率为14.3%（95%CI 5.4 - 28.5%）。所有患者的中位生存期为15.2个月。5例患者出现3级和4级恶心呕吐、1例患者出现腹泻、1例患者出现疼痛、7例患者出现谷丙转氨酶升高、8例患者出现分叶核中性粒细胞减少的最高毒性反应。未出现3级和4级脱发毒性反应。这些数据证实了吉西他滨单药治疗晚期或转移性乳腺癌的活性有限。吉西他滨良好的毒性特征使其成为联合化疗的理想候选药物。
