Souglakos J, Pallis A, Kakolyris S, Mavroudis D, Androulakis N, Kouroussis C, Agelaki S, Xenidis N, Milaki G, Georgoulias V
Department of Medical Oncology, School of Medicine, University General Hospital of Heraklion, Crete, Greece.
Oncology. 2005;69(5):384-90. doi: 10.1159/000089992. Epub 2005 Nov 24.
To evaluate the efficacy and tolerance of irinotecan (CPT-11) in combination with bolus and continuous infusion of 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFIRI regimen) as first-line treatment of elderly patients with metastatic colorectal cancer (MCC).
Thirty consecutive, previously untreated patients with metastatic colorectal cancer, aged (median 76 years; range 70-84) were enrolled. The performance status (WHO) was 0 in 8, 1 in 16 and 2 in 6 patients; 19 (63%) patients had prior surgery and 8 (27%) adjuvant chemotherapy. CPT-11 (180 mg/m(2) as a 90 min i.v. infusion) was administered on day 1, LV (200 mg/m(2) as a 2-hour i.v. infusion), 5-FU (400 mg/m(2)/d i.v. bolus followed by 600 mg/m(2)/d as a 22-hour i.v. continuous infusion) were given on days 1 and 2 every 2 weeks.
Complete response was achieved in one (3.3%) patient and partial response in 10 (33.3%) (overall response rate: 36.6%; 95% C.I.: 26.6-48.4%); 11 (36.6%) patients had stable disease and, 8 (26.6%) disease progression. The median duration of response was 7.5 months and the median time to disease progression 7.0 months. After a median follow-up period of 17 months, the median overall survival was 14.5 months. Main toxicities were: grade 3-4 neutropenia (n = 6; 20%), grade 3 thrombocytopenia (n = 1; 3.3%), grade 2 anemia (n = 9; 30%), grade 3-4 diarrhea (n = 5; 17%) and grade 3 asthenia (n = 3; 10%). There was one treatment-related death due to neutropenic sepsis.
The FOLFIRI combination is an active regimen with manageable toxicity as front-line treatment in patients above 70 years of age.
评估伊立替康（CPT-11）联合推注及持续输注5-氟尿嘧啶（5-FU）和亚叶酸钙（LV）（FOLFIRI方案）作为老年转移性结直肠癌（MCC）患者一线治疗的疗效和耐受性。
连续纳入30例既往未接受过治疗的转移性结直肠癌患者，年龄中位数为76岁（范围70 - 84岁）。其中8例患者的体能状态（WHO）为0，16例为1，6例为2；19例（63%）患者曾接受过手术，8例（27%）接受过辅助化疗。第1天给予伊立替康（180 mg/m²，静脉输注90分钟），第1天和第2天每2周给予亚叶酸钙（200 mg/m²，静脉输注2小时）、5-氟尿嘧啶（400 mg/m²/d静脉推注，随后600 mg/m²/d持续静脉输注22小时）。
1例（3.3%）患者达到完全缓解，10例（33.3%）患者达到部分缓解（总缓解率：36.6%；95%置信区间：26.6 - 48.4%）；11例（36.6%）患者病情稳定，8例（26.6%）患者疾病进展。缓解持续时间中位数为7.5个月，疾病进展时间中位数为7.0个月。中位随访17个月后，总生存中位数为14.5个月。主要毒性反应为：3 - 4级中性粒细胞减少（n = 6；20%），3级血小板减少（n = 1；3.3%），2级贫血（n = 9；30%），3 - 4级腹泻（n = 5；17%）和3级乏力（n = 3；10%）。有1例因中性粒细胞减少性败血症导致的治疗相关死亡。
FOLFIRI方案作为70岁以上患者的一线治疗是一种活性方案，毒性可控。
