亚叶酸/5-氟尿嘧啶/伊立替康(FOLFIRI 1)方案用于老年患者作为转移性结直肠癌一线治疗的II期研究。

Use of the folinic acid/5-fluorouracil/irinotecan (FOLFIRI 1) regimen in elderly patients as a first-line treatment for metastatic colorectal cancer: a Phase II study.

作者信息

François Eric, Berdah Jean-François, Chamorey Emmanuel, Lesbats Gérard, Teissier Eric, Codoul Jean-François, Badetti Jean-Luc, Hébert Christophe, Mari Véronique

机构信息

Centre Antoine-Lacassagne, 33 Ave de Valombrose, 06189, Nice Cedex 2, France.

出版信息

Cancer Chemother Pharmacol. 2008 Nov;62(6):931-6. doi: 10.1007/s00280-008-0681-2. Epub 2008 Feb 14.

Abstract

BACKGROUND

The aim of this study was to evaluate the effects of a combination of folinic acid, 5-fluorouracil (5FU) and irinotecan (FOLFIRI 1) administered every 2 weeks in a population of elderly subjects with advanced colorectal cancer.

PATIENTS AND METHODS

Patients with metastatic colorectal cancer included in this study were aged at least 70 years, with a performance status of 0/1, without geriatric syndrome and without previous palliative chemotherapy. They received irinotecan [180 mg/m(2) intravenous (iv) infusion over 90 min] followed by folinic acid (400 mg/m(2) iv over 2 h), then 5FU (400 mg/m(2) iv bolus) and 5FU (2,400 mg/m(2) continuous iv infusion for 46 h) every 2 weeks.

RESULTS

Forty eligible patients were included. The median age was 77.3 years (range 70-84.7). The objective response rate was 40% and the stabilisation rate was 45%. Median progression-free survival was 8 months, overall survival was 17.2 months and cancer-related specific survival was 20.2 months. In total, 300 cycles of chemotherapy were administered with a median number of eight cycles per patient (range 1-18). Tolerance was good; grade 3/4 toxicities included diarrhoea (15%), asthenia (15%), nausea/vomiting (7.5%) and neutropenia (7.5%). One toxic death was observed due to grade 4 diarrhoea.

CONCLUSION

The FOLFIRI 1 regimen is a valid therapeutic option for elderly patients in good clinical condition.

摘要

背景

本研究旨在评估每2周给予亚叶酸、5-氟尿嘧啶(5FU)和伊立替康联合方案(FOLFIRI 1)对老年晚期结直肠癌患者的疗效。

患者与方法

本研究纳入的转移性结直肠癌患者年龄至少70岁,体能状态为0/1,无老年综合征且既往未接受过姑息化疗。他们每2周接受伊立替康[180mg/m²静脉输注90分钟],随后是亚叶酸(400mg/m²静脉输注2小时),然后是5FU(400mg/m²静脉推注)和5FU(2400mg/m²持续静脉输注46小时)。

结果

纳入40例符合条件的患者。中位年龄为77.3岁(范围70 - 84.7岁)。客观缓解率为40%,疾病稳定率为45%。中位无进展生存期为8个月,总生存期为17.2个月,癌症相关特异性生存期为20.2个月。总共进行了300个化疗周期,每位患者的中位周期数为8个(范围1 - 18)。耐受性良好;3/4级毒性包括腹泻(15%)、乏力(15%)、恶心/呕吐(7.5%)和中性粒细胞减少(7.5%)。观察到1例因4级腹泻导致的毒性死亡。

结论

FOLFIRI 1方案对于临床状态良好的老年患者是一种有效的治疗选择。

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