A phase II study of ifosfamide, 5-fluorouracil and leucovorin in patients with recurrent nasopharyngeal carcinoma previously treated with platinum chemotherapy
A phase II study of ifosfamide, 5-fluorouracil and leucovorin in patients with recurrent nasopharyngeal carcinoma previously treated with platinum chemotherapy
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DOI：
10.1016/s0959-8049(00)00008-3
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发表时间：
2000-04-01
影响因子：
8.4
通讯作者：
Choy, D
中科院分区：
文献类型：
--
作者：
Chua, DTT;Kwong, DLW;Choy, D
本研究的目的是评估异环磷酰胺、5-氟尿嘧啶（5-FU）和亚叶酸蛋白（IFL）作为二线化疗方案对复发性未分化鼻咽癌（NPC）患者的疗效和毒性，这些鼻咽癌患者之前接受过铂/5-FU治疗。在1997年6月至1999年2月期间，18名患者被纳入研究。局部-区域复发3例。远处转移13例，局部复发和远处转移3例。所有患者之前都接受过铂/5-FU作为辅助或姑息性治疗。IFL方案由异环磷酰胺1.2 g/m(2)（与mesna）， 5- fu 375 mg/m(2)和亚叶酸素20 mg/m(2)组成，持续5天，每21天重复一次。异环磷酰胺剂量根据骨髓毒性在后续周期中递增至1.4和1.6 g/m(2)， 5-FU剂量根据粘膜炎的严重程度分别递增至450和525 mg/m(2)。患者接受IFL治疗的中位数为3个周期（范围：2-6），异环磷酰胺总剂量中位数为21 g/m(2)（范围：13-46），5-FU总剂量中位数为6.75 g/m(2)（范围：4.1-14.7）。中位随访时间为10个月（4-25个月）。9例患者（50%）达到部分缓解，1例患者（6%）达到完全缓解，总缓解率为56%（95%置信区间（CI）： 32-80%）。对于那些对IFL有反应的患者，8例在随访中出现疾病进展，中位反应持续时间为7.1个月（95% CI: 5.3-8.9）。所有患者的中位进展时间为6.5个月（95% Ci: 4.7-8.7）。12例患者仍然存活，估计1年生存率为51%。治疗耐受性良好，仅有1例出现3级呕吐。所有患者均无3/4级贫血、白细胞减少或血小板减少，尽管有1例患者因持续的血小板减少而停用了IFL。IFL是复发性鼻咽癌患者的有效二线治疗方案，耐受性好，毒性轻。化疗患者联合使用铂和IFL可能会进一步提高总体缓解率和持续时间，值得在未来的试验中进行研究。(C) 2000 Elsevier Science Ltd.版权所有。
The aim of this study was to evaluate the efficacy and toxicity of ifosfamide, 5-fluorouracil (5-FU) and leucovorin (IFL) as a second-line chemotherapy regimen in patients with recurrent undifferentiated nasopharyngeal carcinoma (NPC) previously treated with platinum/5-FU. Between June 1997 and February 1999, 18 patients were entered into the study. 3 patients had loco-regional recurrence. 13 had distant metastases and 3 had both loco-regional recurrence and distant metastases. All patients had previously received platinum/5-FU as adjuvant or palliative treatments. The IFL regimen consisting of ifosfamide 1.2 g/m(2) (with mesna), 5-FU 375 mg/m(2) and leucovorin 20 mg/m(2) for 5 days and was repeated every 21 days. The dose of ifosfamide was escalated to 1.4 and 1.6 g/m(2) in subsequent cycles according to the bone marrow toxicity, and the dose of 5-FU to 450 and 525 mg/m(2) according to the severity of mucositis. Patients received a median of 3 cycles of IFL (range: 2-6), with a median total ifosfamide dose of 21 g/m(2) (range: 13-46) and a median total 5-FU dose of 6.75 g/m(2) (range: 4.1-14.7). The median follow-up was 10 months (range: 4-25). 9 patients (50%) achieved a partial response and 1 patient (6%) achieved a complete response, with an overall response rate of 56% (95% confidence interval(CI): 32-80%). For those patients who responded to IFL, 8 had subsequent disease progression on followup, with a median response duration of 7.1 months (95% CI: 5.3-8.9). The median time to progression for all patients was 6.5 months (95% Ci: 4.7-8.7). 12 patients are still alive with an estimated 1-year survival probability rate of 51%. Treatments were well tolerated, only 1 patient had grade 3 emesis. None of the patients had grade 3/4 anaemia, leucopenia or thrombocytopenia, although IFL was discontinued in 1 patient because of persisting thrombocytopenia. IFL is an effective second-line regimen in patients with recurrent NPC and is well tolerated with mild toxicity. Combining platinum and IFL in chemonaive patients may further improve the overall response rate and duration and is worth investigating in future trials. (C) 2000 Elsevier Science Ltd. All rights reserved.