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S-1与奥沙利铂(SOX)联合贝伐单抗作为不可切除结直肠癌患者一线治疗的研究

[Study of S-1 and oxaliplatin(SOX) plus bevacizumab as first-line therapy in patients with unresectable colorectal cancer].

作者信息

Maruo Hirotoshi, Suzuki Katsunori, Ishikawa Shintaro, Murakami Tomohiro, Higashi Yukihiro, Shoji Tsuyoshi, Yamazaki Masanori, Taniguchi Masami, Nishiyama Raisuke

机构信息

Dept. of Surgery, Shizuoka City Shimizu Hospital.

出版信息

Gan To Kagaku Ryoho. 2014 Dec;41(13):2583-6.

PMID:25596052
Abstract

We examined the safety and efficacy of S-1 and oxaliplatin plus bevacizumab (SOX+BV)as first-line therapy for advanced/recurrent unresectable colorectal cancer. The subjects were 14 patients with colorectal cancer who received ≥3 courses of SOX+BV therapy in our department.The dosing regimen for 1 course was as follows: BV (7.5 mg/kg) and oxaliplatin (130 mg/m(2)) were administered via intravenous drip infusion on the first day of the course, and S-1 was orally administered twice a day for 2 weeks, repeated every 3 weeks. All patients completed the study treatment, and the median number of courses completed was 9 courses (range: 3-17 courses). In terms of anti-tumor efficacy, complete remission (CR) was observed in 1 patient (7.1%); partial remission (PR), in 9 patients (64.3%); stable disease (SD), in 3 patients (21.4%); and progressive disease (PD), in 1 patient (7.1%), with a response rate of 71.4% and a disease control rate of 92.9%. The median relapse-free survival based on baseline PD was 12 months, and the median relapse-free survival based on PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) was 10 months.The most common adverse events observed included peripheral sensory neuropathy (100%), fatigue (68.3%), anorexia (57.1%), and leukopenia/neutropenia (35.7%); however, almost all adverse events were Grade≤2 and could be managed.The SOX+BV therapy demonstrated an antitumor efficacy similar to that observed with oxaliplatin, fluorouracil, and folinic acid (FOLFOX)+BV therapy without the use of a central venous port.Therefore, the SOX+BV therapy may be among the effective option as first-line therapy for advanced/recurrent colorectal cancer.

摘要

我们研究了S-1联合奥沙利铂及贝伐单抗(SOX+BV)作为晚期/复发性不可切除结直肠癌一线治疗方案的安全性和疗效。研究对象为14例在我科接受≥3个疗程SOX+BV治疗的结直肠癌患者。1个疗程的给药方案如下:疗程第1天,通过静脉滴注给予贝伐单抗(7.5mg/kg)和奥沙利铂(130mg/m²),S-1每日口服2次,共2周,每3周重复。所有患者均完成了研究治疗,完成疗程的中位数为9个疗程(范围:3-17个疗程)。在抗肿瘤疗效方面,1例患者(7.1%)达到完全缓解(CR);9例患者(64.3%)达到部分缓解(PR);3例患者(21.4%)病情稳定(SD);1例患者(7.1%)疾病进展(PD),有效率为71.4%,疾病控制率为92.9%。基于基线期PD的无复发生存期中位数为12个月,根据实体瘤疗效评价标准(RECIST)基于PD的无复发生存期中位数为10个月。观察到的最常见不良事件包括周围感觉神经病变(100%)、疲劳(68.3%)厌食(57.1%)和白细胞减少/中性粒细胞减少(35.7%);然而,几乎所有不良事件均为≤2级,且可进行处理。SOX+BV治疗显示出与奥沙利铂、氟尿嘧啶和亚叶酸(FOLFOX)+BV治疗相似的抗肿瘤疗效,且无需使用中心静脉导管。因此,SOX+BV治疗可能是晚期/复发性结直肠癌一线治疗的有效选择之一。

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