Kouroussis C, Souglakos J, Kakolyris S, Mavroudis D, Malamos N, Kalbakis K, Androulakis N, Agelaki A, Vardakis N, Samonis G, Georgoulias V
Department of Medical Oncology, School of Medicine, University General Hospital of Heraklion, Greece.
Oncology. 2001;61(1):36-41. doi: 10.1159/000055350.
To evaluate the efficacy and safety of oxaliplatin (L-OHP) in combination with leucovorin (LV)-modulated bolus plus infusional 5-fluorouracil (5-FU; de Gramont schedule) every 2 weeks in chemotherapy-naive patients with advanced colorectal cancer (CRC).
Thirty-two patients (median age: 69 years) with histologically confirmed and two-dimensionally measurable metastatic CRC were enrolled. The patients' performance status (WHO) was 0 in 14 (44%), 1 in 15 (47%), and 2 in 3 (9%) patients. Twenty (62.5%) patients had at least two metastatic sites. LV was administered at a dose of 200 mg/m2/day as a 2-hour intravenous infusion, followed by 5-FU as an intravenous bolus at the dose of 400 mg/m2 and then, as a 22-hour continuous infusion at the dose of 600 mg/m2/day for 2 consecutive days. L-OHP was administered on day 1 at the dose of 85 mg/m2 as a 2-hour infusion in parallel with LV but using different infusion lines. Treatment was administered every 2 weeks.
In an intention-to-treat analysis, 2 (6.2%) complete and 9 (28%) partial responses (28%; odds ratio 34.2%; 95% confidence interval 17.92-50.83%) were achieved while 8 (25%) patients had stable disease and 13 (41%) progressive disease. The median duration of response was 5 months, but the median time to progression has not yet been reached. After a median follow-up period of 11 months, the median survival has not yet been attained, but the projected probability for 1-year survival was 72%. Grade 3/4 neutropenia occurred in 16 (50%) patients while 1 (3%) of them developed febrile neutropenia. There was no treatment-related death. Peripheral neuropathy grade 2 and > or =3 occurred in 5 (16%) and 7 (21%) patients, respectively.
The bimonthly administration of L-OHP in association with LV-modulated bolus plus infusional 5-FU ('de Gramont' regimen) is a well-tolerated and effective front-line treatment for metastatic CRC.
评估奥沙利铂（L-OHP）联合亚叶酸钙（LV）调节的推注加持续输注5-氟尿嘧啶（5-FU；de Gramont方案），每2周给药一次，用于初治晚期结直肠癌（CRC）患者的疗效和安全性。
入组32例经组织学确诊且可二维测量的转移性CRC患者（中位年龄：69岁）。患者的体能状态（WHO）评分为0分的有14例（44%），1分的有15例（47%），2分的有3例（9%）。20例（62.5%）患者至少有两个转移部位。LV以200mg/m²/天的剂量静脉输注2小时，随后5-FU以400mg/m²的剂量静脉推注，然后以600mg/m²/天的剂量持续静脉输注22小时，连续2天。L-OHP于第1天以85mg/m²的剂量静脉输注2小时，与LV同时进行，但使用不同的输液管路。每2周进行一次治疗。
在意向性分析中，获得2例（6.2%）完全缓解和9例（28%）部分缓解（28%；优势比34.2%；95%置信区间17.92 - 50.83%），8例（25%）患者疾病稳定，13例（41%）疾病进展。中位缓解持续时间为5个月，但中位疾病进展时间尚未达到。中位随访11个月后，中位生存期尚未达到，但预计1年生存率为72%。16例（50%）患者发生3/4级中性粒细胞减少，其中1例（3%）发生发热性中性粒细胞减少。无治疗相关死亡。2级和≥3级周围神经病变分别发生在5例（16%）和7例（21%）患者中。
每两个月给予L-OHP联合LV调节的推注加持续输注5-FU（“de Gramont”方案）是转移性CRC一种耐受性良好且有效的一线治疗方案。
