Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.
Acta Oncol. 2012 Sep;51(7):867-72. doi: 10.3109/0284186X.2012.682629. Epub 2012 May 4.
In Japan, a study comparing the effectiveness and safety of irinotecan plus S-1 (IRIS) with those of a combination of 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) as second-line treatment in patients with advanced or recurrent colorectal cancer demonstrated that IRIS was non-inferior to FOLFIRI. We previously reported that IRIS is also effective as first-line treatment.
Eligibility criteria included inoperable recurrent colorectal cancer with a confirmed diagnosis of adenocarcinoma, age ≥20 years, and no history of prior chemotherapy. S-1 (40-60 mg twice daily) was given orally on Days 1 to 14, and irinotecan (100 mg/m(2)) and bevacizumab (5 mg/kg) were given intravenously on Days 1 and 15 of a 28-day cycle. The primary endpoint was safety. The secondary endpoints included overall response (OR), progression-free survival (PFS), and overall survival (OS).
A total of 52 eligible patients were enrolled from October 2007 through March 2009. In safety analysis, the incidences of grade 3 or 4 adverse reactions were as follows: neutropenia, 27%; hypertension, 21%; and diarrhea, 17%. The overall response rate was 57.7%. Median progression-free survival was 16.7 months.
IRIS plus bevacizumab is a well-tolerated, highly effective chemotherapeutic regimen that is easy to administer.
在日本，一项比较伊立替康联合 S-1（IRIS）与氟尿嘧啶、亚叶酸钙和伊立替康联合（FOLFIRI）二线治疗晚期或复发性结直肠癌患者疗效和安全性的研究表明，IRIS 并不劣于 FOLFIRI。我们之前曾报道 IRIS 作为一线治疗也具有疗效。
入选标准包括经组织学证实的不可切除的复发性结直肠癌，年龄≥20 岁，且无先前化疗史。S-1（40-60mg 每日 2 次）口服，第 1-14 天；伊立替康（100mg/m2）和贝伐珠单抗（5mg/kg）静脉输注，第 1 和 15 天，每 28 天为一个周期。主要终点为安全性。次要终点包括总缓解率（OR）、无进展生存期（PFS）和总生存期（OS）。
2007 年 10 月至 2009 年 3 月共入选 52 例符合条件的患者。安全性分析中，3 或 4 级不良反应发生率如下：中性粒细胞减少症，27%；高血压，21%；腹泻，17%。总缓解率为 57.7%。中位无进展生存期为 16.7 个月。
IRIS 联合贝伐珠单抗是一种耐受性良好、疗效高、易于管理的化疗方案。
