Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
Invest New Drugs. 2011 Oct;29(5):1050-6. doi: 10.1007/s10637-010-9409-3. Epub 2010 Mar 19.
To determine the efficacy and tolerance of irinotecan in combination with S-1 (IRIS) for patients whose disease progressed after treatment with an oxaliplatin-based therapy for colorectal cancer (CRC). Each patient's disease had progressed after the administration of a regimen containing oxaliplatin and 5-FU. S-1 was administered orally at a fixed dose of 40 mg/m(2) twice daily on days 1-14 and 21-35. Irinotecan (150 mg/m(2)) was administered via intravenous infusion on days 1, 15, and 29. Courses were repeated every 6 weeks. 20 patients were enrolled in this study between April 2006 and March 2008. The median age was 63 years (range: 34-74), and the dominant metastasis sites were the liver, lung, and lymph nodes. The objective response rate was 20%; 1 patient registered complete response and 3 patients registered partial responses; 7 patients were stabilized (35%); and 9 evidenced progression of disease (45%). Median progression-free survival was 3.0 months (95% CI, 2.1-3.9 months) and median overall survival was 9.8 months (95% CI, 6.3-13.3 months). For the 41 cycles analyzed, the most commonly detected hematologic toxicity was grade I-II anemia (63.4%). Leukopenia occurred in 18 cycles (41.5%), including eight cycles (19.5%) of grade 3-4 leukopenia. Frequently observed non-hematologic toxicities included the following: grade I vomiting was reported in 4 patients (20%), grade 2 neuropathy occurred in 3 patients (15%), and grade 2 mucositis was noted in 2 patients (10%). Two patients died from sepsis and hematemesis during treatment. Although the response rate in stage I reached the target (≥ 3/18, p0 = 10%) established for movement to stage II, this study had to be discontinued because two patients died during treatment. Additionally, the follow-up loss rate was higher (16.6%) than we had anticipated (<10%). Even though a regime consisting of irinotecan combined with S-1 (IRIS) has proven effective in oxaliplatin-pretreated patients with advanced CRC, treatment-related mortalities and the high follow-up loss rate suggested that this IRIS protocol should result in early closure and modification.
为了确定伊立替康联合 S-1（IRIS）在奥沙利铂为基础的治疗后疾病进展的结直肠癌（CRC）患者中的疗效和耐受性。每位患者在接受包含奥沙利铂和 5-FU 的方案治疗后疾病均有进展。S-1 每天口服 40mg/m²，每天两次，第 1-14 天和第 21-35 天。伊立替康（150mg/m²）于第 1、15 和 29 天静脉输注。每 6 周重复一个疗程。2006 年 4 月至 2008 年 3 月期间共纳入 20 例患者。中位年龄为 63 岁（范围：34-74 岁），主要转移部位为肝脏、肺部和淋巴结。客观缓解率为 20%；1 例患者完全缓解，3 例部分缓解；7 例患者病情稳定（35%）；9 例患者疾病进展（45%）。中位无进展生存期为 3.0 个月（95%CI，2.1-3.9 个月），中位总生存期为 9.8 个月（95%CI，6.3-13.3 个月）。对于分析的 41 个周期，最常见的血液学毒性为 I-II 级贫血（63.4%）。白细胞减少发生在 18 个周期（41.5%），其中 8 个周期（19.5%）为 3-4 级白细胞减少。常观察到的非血液学毒性包括以下内容：4 例患者（20%）报告有 I 级呕吐，3 例患者（15%）出现 2 级神经病变，2 例患者（10%）出现 2 级黏膜炎。2 例患者在治疗过程中因败血症和呕血死亡。虽然 I 期的缓解率达到了为进入 II 期设定的目标（≥3/18，p0=10%），但由于 2 例患者在治疗过程中死亡，本研究不得不停止。此外，随访失访率（16.6%）高于预期（<10%）。尽管伊立替康联合 S-1（IRIS）方案在奥沙利铂预处理的晚期 CRC 患者中已被证明有效，但与治疗相关的死亡率和较高的随访失访率表明，该 IRIS 方案应尽早关闭并修改。
