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不可切除胆管癌的区域联合全身化疗:一项II期研究。

Regional combined with systemic chemotherapy in unresectable biliary tract cancers: a phase II study.

作者信息

Cantore M, Fiorentini G, Mambrini A, Rabbi C, Zamagni D, Carlone N, Manni A, Caudana R, Torri T

机构信息

Oncological Department, USL 1 Massa e Carrara, Empoli.

出版信息

J Exp Clin Cancer Res. 2003 Dec;22(4 Suppl):59-64.

PMID:16767908
Abstract

Unresectable biliary tract cancers have a very poor prognosis. No good systemic chemotherapeutic regimen is available. This study aimed to evaluated the activity and toxicity of a novel approach of combined loco-regional and systemic chemotherapy. Twenty four patients with advanced or metastatic biliary tumors were treated with epiadriamycin 50 mg/m2 and cisplatin 60 mg/m2 administered bolus in proper hepatic artery on day 1, combined with systemic continuous infusion of 5-fluorouracil 200 mg/m2/day, from day 1 to day 14, every 3 weeks. The overall response rate was 8/24 (33%), including one complete response and 7 partial responses (stable disease 46%, progression 21%). The treatment was well tolerated with a minimal hematological toxicity; the major clinical problem was the deep venous thrombosis related to central venous catheter, that occurred in 5 patients (21%). Median overall survival was 14,6 months and 1-year and 2-year survival were 54% and 38% respectively. Performance status improved in 33% of patients and weight gain more than 7% was observed in 17%. This novel combined loco-regional and systemic chemotherapeutic regimen is active and safe for advanced biliary tract cancer patients.

摘要

无法切除的胆管癌预后很差。目前尚无有效的全身化疗方案。本研究旨在评估一种新的局部区域联合全身化疗方法的活性和毒性。24例晚期或转移性胆管肿瘤患者,于第1天在肝固有动脉推注表柔比星50mg/m²和顺铂60mg/m²,同时从第1天至第14天,每3周持续静脉输注5-氟尿嘧啶200mg/m²/天。总缓解率为8/24(33%),包括1例完全缓解和7例部分缓解(疾病稳定46%,进展21%)。该治疗耐受性良好,血液学毒性极小;主要临床问题是与中心静脉导管相关的深静脉血栓形成,5例患者(21%)出现该情况。中位总生存期为14.6个月,1年和2年生存率分别为54%和38%。33%的患者体能状态改善,17%的患者体重增加超过7%。这种新的局部区域联合全身化疗方案对晚期胆管癌患者有效且安全。

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