Department of Urology, Cancer Institute Hospital, Japanese Foundation of Cancer Research, Tokyo, Japan.
Department of Urology, Cancer Institute Hospital, Japanese Foundation of Cancer Research, Tokyo, Japan.
Urol Oncol. 2014 Jan;32(1):35.e1-7. doi: 10.1016/j.urolonc.2013.01.007. Epub 2013 Apr 4.
This study sought to examine the combination chemotherapy of gemcitabine, etoposide, and cisplatin (GEP) as a first-line treatment for advanced urothelial carcinoma (UC) to assess its antitumor activity and toxicity.
Eligible patients with advanced UC had undergone no previous chemotherapy. Advanced UC was defined as unresectable or metastatic disease. Subsequent recurrent disease, either locally or distantly following primary radical surgery, was not excluded. GEP was recycled every 4 weeks. Etoposide and cisplatin were given on days 1 through 3 at doses of 60 mg/m(2) and 20mg/m(2), respectively, and gemcitabine was given on days 1, 8, and 15 at a dose of 800 mg/m(2). The primary end point was objective response rate, and the secondary end points included progression-free survival, overall survival (OS), and toxicity.
Forty-two patients were enrolled and subsequently treated with GEP. Nineteen had visceral/bone metastases, 16 had disease restricted to the lymph nodes, and the remaining 7 had unresectable disease at the primary site. The median number of GEP courses was 4. Thirty of the 42 assessable patients (71.4%, 95% confidence interval [CI]: 56.4%-82.8%) demonstrated objective responses. At a median follow-up of 14.6 months, median progression-free survival and OS periods were 8.7 months (95% CI: 6.9-14.6 mo) and 16.2 months (95% CI: 13.1-25.4 mo), respectively. In the multivariate analysis, anemia and visceral/bone metastasis were significant pretreatment prognostic factors for OS. Grade 4 hematologic events were neutropenia (83.3%), thrombocytopenia (23.8%), and anemia (7.1%). There were no toxic deaths and no instances of severe nonhematologic toxicity.
GEP as a first-line chemotherapy treatment was very active and moderately tolerable for advanced UC. Anemia and visceral/bone metastasis were important negative predictive factors of GEP for OS.
本研究旨在探讨吉西他滨、依托泊苷和顺铂（GEP）联合化疗作为晚期尿路上皮癌（UC）一线治疗的方法，评估其抗肿瘤活性和毒性。
符合条件的晚期 UC 患者既往未接受过化疗。晚期 UC 定义为不可切除或转移性疾病。排除了原发性根治性手术后局部或远处复发的疾病。GEP 每 4 周循环使用。依托泊苷和顺铂分别于第 1-3 天给予 60mg/m²和 20mg/m²，吉西他滨于第 1、8 和 15 天给予 800mg/m²。主要终点为客观缓解率，次要终点包括无进展生存期、总生存期（OS）和毒性。
42 例患者入组并接受 GEP 治疗。19 例有内脏/骨转移，16 例有淋巴结疾病，其余 7 例原发部位有不可切除的疾病。GEP 疗程中位数为 4 个。42 例可评估患者中，30 例（71.4%，95%可信区间[CI]：56.4%-82.8%）有客观反应。中位随访 14.6 个月时，中位无进展生存期和 OS 分别为 8.7 个月（95% CI：6.9-14.6 mo）和 16.2 个月（95% CI：13.1-25.4 mo）。多变量分析显示，贫血和内脏/骨转移是 OS 的重要预处理预后因素。4 级血液学事件为中性粒细胞减少症（83.3%）、血小板减少症（23.8%）和贫血（7.1%）。无治疗相关死亡，无严重非血液学毒性。
GEP 作为一线化疗治疗晚期 UC 非常有效且耐受性适中。贫血和内脏/骨转移是 GEP 治疗 OS 的重要负预测因素。
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