A prospective study of XELOX plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer (KSCC 0902).
A prospective study of XELOX plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer (KSCC 0902).
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DOI：
10.1007/s10147-015-0895-3
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发表时间：
2016-04
影响因子：
3.3
通讯作者：
Kyushu Study Group of Clinical Cancer (KSCC)
中科院分区：
文献类型：
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作者：
Ogata Y;Shimokawa M;Tanaka T;Emi Y;Oki E;Saeki H;Sadanaga N;Kusumoto T;Touyama T;Kimura M;Baba H;Akagi Y;Shirouzu K;Maehara Y;Kyushu Study Group of Clinical Cancer (KSCC)
这项研究旨在评估XELOX联合贝伐单抗在包括老年患者在内的日本转移性结直肠癌人群中的有效性和安全性。这是一项多中心、单臂、开放标签的前瞻性研究。主要纳入标准是以前未治疗的转移性结直肠癌，存在可测量的病变，年龄20岁的≥；东部合作肿瘤组的表现状态为0-2，以及器官功能良好。患者接受贝伐单抗(第1天7.5 mg/kg)和XELOX(第1天130 mg/m2奥沙利铂加1,000 mg/m2卡培他滨，2次/d)。在第1-14天)每隔3周。主要终点为确定的客观有效率。该研究包括2010年5月至2011年3月期间入选的47名患者(男性/女性30/17；中位年龄69岁；年龄38-81岁，10名患者≥75岁；PS 0/1/2，40/5/2)。对46名符合条件的患者进行了反应评估。客观有效率为52.2%(95%可信区间为37.0~67.1)。中位无进展生存期和总生存期分别为10.0个月(95%可信区间7.8~12.3)和34.6个月(95%可信区间19.9-不可估量)。本研究中常见的3级和4级不良事件为天冬氨酸氨基转移酶升高(23.4%)、丙氨酸氨基转移酶升高(21.3%)、厌食(12.8%)、中性粒细胞减少(10.6%)、疲劳(8.5%)和贫血(6.4%)。未发现3级或4级周围神经病变。在包括老年患者在内的日本转移性结直肠癌患者的临床实践中，XELOX加贝伐单抗的一线治疗显示出有希望的应答率和可接受的耐受性。UMIN-CTR，ID号：UMIN000003915，URL:https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004706&language=E
This study was designed to evaluate the efficacy and safety of XELOX plus bevacizumab in a Japanese metastatic colorectal cancer population that included elderly patients. This was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated metastatic colorectal cancer, presence of measurable lesions, age ≥20 years; Eastern Cooperative Oncology Group performance status of 0–2, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELOX (130 mg/m2 oxaliplatin on day 1 plus 1,000 mg/m2 capecitabine b.i.d. on days 1–14) every 3 weeks. The primary endpoint was confirmed objective response rate. The study included 47 patients (male/female 30/17; median age 69 years; age range 38–81 years with 10 patients ≥75 years; PS 0/1/2, 40/5/2) enrolled between May 2010 and March 2011. Responses were assessed in 46 eligible patients. The objective response rate was 52.2 % (95 % confidence interval [CI] 37.0–67.1). The median progression-free survival and overall survival were 10.0 months (95 % CI 7.8–12.3) and 34.6 months (95 % CI 19.9–not estimable), respectively. Frequently encountered grade 3 and 4 adverse events in this study were aspartate aminotransferase elevation (23.4 %), alanine aminotransferase elevation (21.3 %), anorexia (12.8 %), neutropenia (10.6 %), fatigue (8.5 %) and anemia (6.4 %). Grade 3 or 4 peripheral neuropathy was not observed. First-line treatment with XELOX plus bevacizumab showed a promising response rate and an acceptable tolerability profile in the clinical practice of Japanese metastatic colorectal cancer patients that included elderly patients. UMIN-CTR, ID number: UMIN000003915, URL:https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004706&language=E