Feliu J, López Alvarez M P, Jaraiz M A, Constenla M, Vicent J M, Belón J, López Gómez L, de Castro J, Dorta J, González Barón M
Services of Medical Oncology, La Paz, Madrid, Spain.
Cancer. 2000 Oct 15;89(8):1706-13. doi: 10.1002/1097-0142(20001015)89:8<1706::aid-cncr9>3.0.co;2-i.
Use of chemotherapy for advanced pancreatic carcinoma (APC) pursues a palliative objective. Gemcitabine is active against this tumor and shows in vitro synergism with 5-fluorouracil. UFT is a combination of tegafur (a prodrug of 5-flouorouracil) and uracil that can be given orally. The administration of UFT for several weeks may simulate the effects of a continuous infusion of 5-fluorouracil. The objective of the current study was to assess the efficacy and toxicity of the combination gemcitabine-UFT-leucovorin in the treatment of APC.
Forty-two patients with bidimensionally measurable APC were included. The study regimen consisted of gemcitabine 1000 mg/m(2) once weekly for 3 consecutive weeks, followed by a 1-week rest, intravenous 6S-steroisomer of leucovorin (6SLV) 250 mg/m(2) in 2 hours on Day 1, oral 6SLV 7.5 mg/12 hours on Days 2-14, and oral UFT 390 mg/m(2)/day (in 2 doses) on Days 1-14. Cycles were repeated every 4 weeks for a minimum of 3 per patient unless progressive disease was detected.
One hundred eighty-three courses were given, with a median of 4 per patient. World Health Organization Grade 3-4 toxicity was: diarrhea in 7 patients (17%), leucopenia in 2 (5%), nausea/vomiting in 2 (5%), and anemia in 1 (4%). Among 38 patients evaluable for response, 6 achieved a partial response (16%; 95% confidence interval (CI), 6-31. 4), 15 had stable disease (39%), and 17 had progression (45%). Improvement in performance status and symptoms (pain, analgesic consumption, and weight) was present in 11 (29%) and 17 (45%) patients, respectively. Eighteen patients (47%; 95% CI, 31.5-54.5) experienced a clinical benefit response.
The combination of gemcitabine-UFT-6SLV is convenient and moderately active and shows a low toxicity for the palliative treatment of patients with APC.
晚期胰腺癌（APC）的化疗旨在实现姑息治疗目标。吉西他滨对该肿瘤具有活性，并在体外显示出与5-氟尿嘧啶的协同作用。优福定是替加氟（5-氟尿嘧啶的前体药物）和尿嘧啶的组合，可口服给药。连续数周给予优福定可能模拟持续输注5-氟尿嘧啶的效果。本研究的目的是评估吉西他滨-优福定-亚叶酸联合用药治疗APC的疗效和毒性。
纳入42例二维可测量的APC患者。研究方案包括：吉西他滨1000mg/m²，每周1次，连续3周，随后休息1周；第1天静脉滴注亚叶酸（6S-异构体）250mg/m²，持续2小时，第2 - 14天口服亚叶酸6SLV 7.5mg/12小时，第1 - 14天口服优福定390mg/m²/天（分2次给药）。每4周重复1个周期，每位患者至少进行3个周期，除非检测到疾病进展。
共给予183个疗程，每位患者中位数为4个疗程。世界卫生组织3 - 4级毒性反应为：腹泻7例（17%），白细胞减少2例（5%），恶心/呕吐2例（5%），贫血1例（4%）。在38例可评估疗效的患者中，6例获得部分缓解（16%；95%置信区间（CI），6 - 31.4），15例病情稳定（39%），17例病情进展（45%）。分别有11例（29%）和17例（45%）患者的体能状态和症状（疼痛、镇痛药用量和体重）有所改善。18例患者（47%；95%CI，31.5 - 54.5）出现临床获益反应。
吉西他滨-优福定-6SLV联合用药方便且具有一定活性，对APC患者的姑息治疗毒性较低。
