Division of Oncology, Department of Medicine, University Hospital of Patras, Rion, Patras, Greece.
Anticancer Res. 2010 Oct;30(10):4325-33.
This study reports the long-term follow-up of patients with metastatic colorectal cancer (CRC) participating in a randomised phase II study that compared the efficacy and toxicity of the combination of irinotecan (IRI), fluorouracil (FU) with leucovorin (LV) (arm A) versus sequential chemotherapy with IRI plus FU/LV followed by oxaliplatin (OXA) plus FU/LV (arm B) as first line therapy.
Intent-to-treat analysis was performed on 417 patients (211 in arm A and 206 in arm B). Treatment schedules of weekly IRI 80 mg/m(2) or OXA 45 mg/m(2) plus LV 200 mg/m(2) immediately followed by intravenous bolus FU 450 mg/m(2) for 6 weeks were followed by a 2-week rest period. Treatment continued for 4 cycles. Patients in arm A were treated with IRI/FU/LV for 4 cycles, while patients in arm B were initially treated with IRI/FU/LV for 2 cycles followed by sequential administration of 2 cycles of OXA/FU/LV.
No significant difference emerged in overall response rate or overall survival. There was a difference in progression-free survival (median, 7.3 versus 8.2 months, p=0.040) in favour of arm B. Toxicity profiles were similar in both arms.
IRI/FU/LV and IRI/FU/LV followed by OXA/FU/LV showed comparable activity with a manageable toxicity profile.
本研究报告了转移性结直肠癌（CRC）患者的长期随访结果，这些患者参加了一项随机 II 期研究，该研究比较了伊立替康（IRI）、氟尿嘧啶（FU）联合亚叶酸（LV）（A 组）与 IRI 联合 FU/LV 序贯化疗后奥沙利铂（OXA）联合 FU/LV（B 组）作为一线治疗的疗效和毒性。
对 417 例患者（A 组 211 例，B 组 206 例）进行意向治疗分析。每周给予 IRI 80 mg/m2 或 OXA 45 mg/m2 联合 LV 200 mg/m2，随后立即静脉推注 FU 450 mg/m2，持续 6 周，随后休息 2 周。治疗持续 4 个周期。A 组患者接受 IRI/FU/LV 治疗 4 个周期，而 B 组患者最初接受 IRI/FU/LV 治疗 2 个周期，随后序贯给予 2 个周期的 OXA/FU/LV。
总缓解率和总生存期无显著差异。无进展生存期（中位时间，7.3 个月与 8.2 个月，p=0.040）有差异，B 组更优。两组的毒性谱相似。
IRI/FU/LV 和 IRI/FU/LV 序贯 OXA/FU/LV 治疗的疗效相似，毒性可管理。
