吉西他滨治疗晚期子宫内膜癌：纪念斯隆-凯特琳癌症中心经验的回顾性研究。

Gemcitabine for advanced endometrial cancer: a retrospective study of the Memorial sloan-Kettering Cancer Center experience.

机构信息

Gynecologic Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.

出版信息

Int J Gynecol Cancer. 2012 Jun;22(5):807-11. doi: 10.1097/IGC.0b013e31824a33a2.

DOI:10.1097/IGC.0b013e31824a33a2

PMID:22635030

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3904291/

Abstract

BACKGROUND

Gemcitabine is active in several gynecologic malignancies including ovarian cancer, cervical cancer, and uterine leiomyosarcoma. It has been used in an off-label setting for the treatment of advanced endometrial cancer, despite lack of published data showing efficacy. We performed a retrospective study to determine the progression-free survival and response rate of endometrial cancer patients treated with gemcitabine at Memorial Sloan-Kettering Cancer Center.

METHODS

Eligible patients had histologically confirmed advanced (stage IV or recurrent) endometrial cancer that was treated with single-agent gemcitabine at Memorial Sloan-Kettering Cancer Center between 1999 and 2009. Response to therapy was determined by review of computed tomography imaging by Response Evaluation Criteria in Solid Tumors 1.1 criteria.

RESULTS

Forty-six patients were included in the analysis. Median age was 66 years (range, 52-87 years). All patients were previously treated with chemotherapy. The median number of prior lines of chemotherapy was 2 (range, 1-8). Median dose of gemcitabine administered was 800 mg/m infused on days 1 and 8 of a 21-day cycle. Predominant histology was endometrioid (48%, n = 22) followed by serous (35%, n = 16), clear cell (15%, n = 7), and undifferentiated (2%, n = 1). Overall response rate was 10.9% (95% confidence interval, 1.9%-19.9%); 5 patients (11%) achieved a partial response. Thirteen patients (28%) displayed stable disease lasting at least 3 months. Of note, 5 (71%) of the 7 patients with clear cell histology displayed stable disease or partial response (n = 5). The median progression-free survival was 3.0 months (95% confidence interval, 2.1-3.3 months). Nonhematologic grades 3 and 4 toxicities were rare. Ten patients (22%) were treated with granulocyte colony-stimulating factor during treatment. Grade 3 thrombocytopenia was seen in 4 patients (9%). There were no cases of grade 4 thrombocytopenia.

CONCLUSIONS

In a mixed population of patients with previously treated advanced endometrial cancer, gemcitabine was well tolerated and showed modest activity. Patients with clear cell histology appeared to have greater likelihood of benefit.

摘要

背景

吉西他滨在多种妇科恶性肿瘤中具有活性，包括卵巢癌、宫颈癌和子宫平滑肌肉瘤。尽管缺乏显示疗效的已发表数据，但它已在非适应证情况下用于治疗晚期子宫内膜癌。我们进行了一项回顾性研究，以确定在纪念斯隆-凯特琳癌症中心接受吉西他滨治疗的子宫内膜癌患者的无进展生存期和反应率。

方法

符合条件的患者具有组织学证实的晚期（IV 期或复发性）子宫内膜癌，这些患者在 1999 年至 2009 年间在纪念斯隆-凯特琳癌症中心接受单药吉西他滨治疗。通过实体瘤反应评估标准 1.1 标准对计算机断层扫描成像进行复查来确定治疗反应。

结果

46 例患者纳入分析。中位年龄为 66 岁（范围，52-87 岁）。所有患者均接受过化疗。中位化疗线数为 2 线（范围，1-8 线）。中位吉西他滨剂量为 800mg/m2，在 21 天周期的第 1 天和第 8 天输注。主要组织学类型为子宫内膜样（48%，n=22），其次为浆液性（35%，n=16）、透明细胞（15%，n=7）和未分化（2%，n=1）。总体反应率为 10.9%（95%置信区间，1.9%-19.9%）；5 名患者（11%）达到部分缓解。13 名患者（28%）显示至少 3 个月的稳定疾病。值得注意的是，7 名透明细胞组织学患者中有 5 名（71%）显示稳定疾病或部分缓解（n=5）。中位无进展生存期为 3.0 个月（95%置信区间，2.1-3.3 个月）。非血液学 3 级和 4 级毒性罕见。10 名患者（22%）在治疗期间接受了粒细胞集落刺激因子治疗。4 名患者（9%）出现 3 级血小板减少症。没有 4 级血小板减少症的病例。