Bouzid K, Khalfallah S, Tujakowski J, Piko B, Purkalne G, Plate S, Padrik P, Serafy M, Pshevloutsky E M, Boussard B
EHS Centre Pierre et Marie Curie, Algiers, Algeria.
Ann Oncol. 2003 Jul;14(7):1106-14. doi: 10.1093/annonc/mdg288.
Three different therapeutic regimens of irinotecan (CPT-11) in combination with 5-fluorouracil (5-FU) and folinic acid (FA) were evaluated for efficacy and safety in the first-line therapy of advanced colorectal cancer.
Patients were randomly assigned to receive intravenously either: CPT-11 125 mg/m(2), FA 20 mg/m(2) followed by 5-FU 500 mg/m(2) bolus, weekly for 4 weeks (arm A, Saltz regimen); or CPT-11 180 mg/m(2) day 1 then FA 200 mg/m(2) over 2 h and 5-FU 400 mg/m(2) bolus and 5-FU 600 mg/m(2) 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or CPT-11 350 mg/m(2) (days 1 and 43) alternating with FA 20 mg/m(2)/day followed by 5-FU bolus 425 mg/m(2)/day during 5 days (days 22-26) (arm C, Mayo Clinic regimen).
A total of 154 patients were included in the study (arm A, 51 patients; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable patient populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. Neutropenia was the main serious adverse event in arms A (30% of patients) and C (22% of patients) but occurred in only 8% of patients in arm B. Delayed diarrhea was the main severe adverse event for the three regimens, from 15% to 22%.
All three regimens were highly active. The biweekly combination of CPT-11 and 5-FU/FA (arm B) was notable for its low incidence of grade 3/4 neutropenia. The incidence of grade 3/4 delayed diarrhea was equivalent for the three treatment arms.
评估了伊立替康（CPT - 11）联合5 - 氟尿嘧啶（5 - FU）和亚叶酸（FA）的三种不同治疗方案用于晚期结直肠癌一线治疗的疗效和安全性。
患者被随机分配接受以下静脉治疗：CPT - 11 125mg/m²、FA 20mg/m²，随后5 - FU 500mg/m²推注，每周一次，共4周（A组，萨尔茨方案）；或CPT - 11 180mg/m²第1天，然后FA 200mg/m²静脉滴注2小时，5 - FU 400mg/m²推注及5 - FU 600mg/m²持续22小时静脉滴注，第1天和第2天给药，每2周一次（B组，杜亚尔方案）；或CPT - 11 350mg/m²（第1天和第43天）与FA 20mg/m²/天交替，随后5 - FU推注425mg/m²/天，持续5天（第22 - 26天）（C组，梅奥诊所方案）。
共154例患者纳入研究（A组51例；B组53例；C组50例）。意向性治疗人群的总体缓解率在A组、B组和C组分别为33%[95%置信区间（CI）21%至48%]、42%（95%CI 28%至56%）和30%（95%CI 18%至45%）。A组、B组和C组的中位进展时间分别为6个月、8个月和7个月。A组、B组和C组的中位生存时间分别为15个月、12个月和17个月。可评估患者人群的总体缓解率在A组为40%（95%CI 24%至58%），B组为44%（95%CI 29%至60%），C组为31%（95%CI 17%至47%）。中性粒细胞减少是A组（30%的患者）和C组（22%的患者）的主要严重不良事件，但仅在B组8%的患者中发生。延迟性腹泻是三种方案的主要严重不良事件，发生率为15%至22%。
所有三种方案均具有高活性。CPT - 11与5 - FU/FA每2周一次的联合方案（B组）以3/4级中性粒细胞减少发生率低为显著特点。三个治疗组3/4级延迟性腹泻的发生率相当。
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