LFP疗法（5-氟尿嘧啶持续静脉输注及低剂量顺铂连续给药）用于晚期胆管癌的II期研究。
A phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) in advanced biliary tract carcinoma.
作者信息
Kobayashi Kazuma, Tsuji Akihito, Morita Sojiro, Horimi Tadashi, Shirasaka Tetsuhiko, Kanematsu Takashi
机构信息
Internal medicine, Clinical Oncology Group, Kochi Municipal Central Hospital, Kochi, Japan.
出版信息
BMC Cancer. 2006 May 6;6:121. doi: 10.1186/1471-2407-6-121.
BACKGROUND
Unresectable biliary tract carcinoma is known to demonstrate a poor prognosis. We conducted a single arm phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) for advanced biliary tract malignancies basically on an outpatient basis.
METHODS
Between February 1996 and September 2003, 42 patients were enrolled in this trial. LFP THERAPY: By using a total implanted CV-catheter system, 5-FU (160 mg/m2/day) was continuously infused over 24 hours for 7 consecutive days and CDDP (6 mg/m2/day) was infused for 30 minutes twice a week as one cycle. The administration schedule consisted of 4 cycles as one course. RESIST criteria (Response evaluation criteria for solid tumors) and NCI-CTC (National Cancer Institute-Common Toxicity Criteria) (ver.3.0) were used for evaluation of this therapy. The median survival time (MST) and median time to treatment failure (TTF) were calculated by the Kaplan-Meier method.
RESULTS
Patients characteristics were: mean age 66.5(47-79): male 24 (54%): BDca (bile duct carcinoma) 27 GBca (Gallbladder carcinoma) 15: locally advanced 26, postoperative recurrence 16. The most common toxicity was anemia (26.2%). Neither any treatment related death nor grade 4 toxicity occurred. The median number of courses of LFP Therapy which patients could receive was two (1-14). All the patients are evaluable for effects with an over all response rates of 42.9% (95% confidence interval C.I.: 27.7-59.0) (0 CR, 18 PR, 13 NC, 11 PD). There was no significant difference regarding the anti tumor effects against both malignant neoplasms. Figure 2 Shows the BDca a longer MST and TTF than did GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.The estimated MST and median TTF were 225 and 107 days, respectively. The BDca had a longer MST and TTF than GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.
CONCLUSION
LFP therapy appears to be useful modality for the clinical management of advanced biliary tract malignancy.
背景
不可切除的胆管癌预后较差。我们开展了一项单臂II期研究，主要在门诊对晚期胆道恶性肿瘤患者进行LFP疗法（5-氟尿嘧啶持续静脉输注（CVI）及低剂量顺铂连续给药（CDDP））。
方法
1996年2月至2003年9月期间，42例患者纳入本试验。LFP疗法：通过使用完全植入式CV导管系统，5-氟尿嘧啶（160mg/m²/天）持续24小时输注，连续7天，顺铂（6mg/m²/天）每周两次输注30分钟，作为一个周期。给药方案为4个周期作为一个疗程。采用实体瘤疗效评价标准（RESIST）和美国国立癌症研究所通用毒性标准（NCI-CTC）（第3.0版）评估该疗法。采用Kaplan-Meier法计算中位生存时间（MST）和中位治疗失败时间（TTF）。
结果
患者特征为：平均年龄66.5岁（47 - 79岁）；男性24例（54%）；胆管癌（BDca）27例，胆囊癌（GBca）15例；局部晚期26例，术后复发16例。最常见的毒性反应为贫血（26.2%）。未发生任何与治疗相关的死亡，也未出现4级毒性反应。患者能够接受的LFP疗法的中位疗程数为两个（1 - 14个）。所有患者均可评估疗效，总体缓解率为42.9%（95%置信区间C.I.：27.7 - 59.0）（0例完全缓解，18例部分缓解，13例疾病稳定，11例疾病进展）。两种恶性肿瘤的抗肿瘤效果无显著差异。图2显示，胆管癌的MST和TTF均长于胆囊癌（分别为234天对150天，117天对85天），但差异均无统计学意义。估计的MST和中位TTF分别为225天和107天。胆管癌的MST和TTF长于胆囊癌（分别为234天对150天，117天对他，85天），但差异均无统计学意义。
结论
LFP疗法似乎是晚期胆道恶性肿瘤临床治疗的一种有效方式。
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