Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris.
Ann Oncol. 2013 Dec;24(12):2963-7. doi: 10.1093/annonc/mdt423. Epub 2013 Nov 4.
Collecting duct carcinoma (CDC) is a rare and aggressive subtype of kidney cancer that responds to platinum-based chemotherapy. Recent phase II trials have established enhanced antitumor activity on combining bevacizumab with chemotherapy in patients with metastatic urothelial carcinoma, a tumor that shares many features with CDC. Our aim was to investigate whether combining bevacizumab with platinum-based chemotherapy might not also show promise in metastatic CDC (mCDC) patients.
Five previously untreated patients diagnosed with mCDC received bevacizumab (15 mg/kg) in combination with gemcitabine (1250 mg/m(2), D1-D8) and platinum salt (cisplatin 80 mg/m(2) or carboplatin AUC 5 mg/ml/min) every 3 weeks for up to six cycles. This was followed by bevacizumab maintenance therapy (15 mg/kg).
All five patients (median age, 62 years; range 45-66 years) had an Eastern Cooperative Oncology Group PS of 0-1. They received the triple-drug combination for a median of four cycles (range, 2-6) and bevacizumab maintenance therapy for a median of three cycles (range, 0-17). There were three cases of partial response, one case of stable disease (20 months) and one case of complete remission after surgery of the only metastatic site. Median progression-free survival (PFS) was 15.1 months [95% confidence interval (CI) 5.6-20.4]. Median overall survival (OS) was 27.8 months (95% CI 12.4-unreached). Grades 3 or 4 adverse events were pulmonary embolism (n = 2), neutropenia (n = 2), thrombopenia (n = 1), asthenia (n = 1) and hypertension (n = 1).
The addition of bevacizumab to platinum-based chemotherapy resulted in a longer PFS and longer OS than recorded in an earlier clinical trial of platinum-based chemotherapy alone. The triple combination was manageable. The French Collaborative Group (Groupe d'Etudes des Tumeurs Uro-Génitales) is planning a prospective multicenter phase II clinical trial of the triple combination in mCDC patients.
BEVABEL/MO28644 (EudraCT: 2013-001179-19).
集合管癌（CDC）是一种罕见且侵袭性的肾癌亚型，对铂类化疗有反应。最近的 II 期临床试验已经证实，在转移性尿路上皮癌患者中，贝伐珠单抗联合化疗具有增强的抗肿瘤活性，而转移性 CDC（mCDC）患者与 CDC 具有许多共同特征。我们的目的是研究贝伐珠单抗联合铂类化疗是否也有可能对 mCDC 患者有疗效。
5 名未经治疗的 mCDC 患者接受了贝伐珠单抗（15mg/kg）联合吉西他滨（1250mg/m2，D1-D8）和铂盐（顺铂 80mg/m2 或卡铂 AUC 5mg/ml/min）治疗，每 3 周为一个周期，最多 6 个周期。随后进行贝伐珠单抗维持治疗（15mg/kg）。
所有 5 名患者（中位年龄 62 岁；范围 45-66 岁）的东部肿瘤协作组 PS 评分为 0-1。他们接受了三联药物治疗，中位周期数为 4 个（范围 2-6），贝伐珠单抗维持治疗中位周期数为 3 个（范围 0-17）。3 例部分缓解，1 例稳定疾病（20 个月），1 例仅转移性部位手术完全缓解。中位无进展生存期（PFS）为 15.1 个月[95%置信区间（CI）5.6-20.4]。中位总生存期（OS）为 27.8 个月[95%CI 12.4-未达到]。3 级或 4 级不良事件包括肺栓塞（n=2）、中性粒细胞减少症（n=2）、血小板减少症（n=1）、乏力（n=1）和高血压（n=1）。
与单独使用铂类化疗的早期临床试验相比，贝伐珠单抗联合铂类化疗可延长 PFS 和 OS。三联疗法是可控的。法国协作组（Groupe d'Etudes des Tumeurs Uro-Génitales）正在计划一项前瞻性多中心 II 期临床试验，评估三联疗法在 mCDC 患者中的疗效。
BEVABEL/MO28644（EudraCT：2013-001179-19）。
Zotero 插件