S-1 and oxaliplatin (SOX) plus bevacizumab versus mFOLFOX6 plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer: updated overall survival analyses of the open-label, non-inferiority, randomised phase III: SOFT study.
S-1 and oxaliplatin (SOX) plus bevacizumab versus mFOLFOX6 plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer: updated overall survival analyses of the open-label, non-inferiority, randomised phase III: SOFT study.
复制标题
DOI：
10.1136/esmoopen-2016-000135
复制
发表时间：
2017
期刊：
影响因子：
7.3
通讯作者：
Sugihara K
中科院分区：
文献类型：
--
作者：
Baba H;Yamada Y;Takahari D;Matsumoto H;Yoshida K;Nakamura M;Yoshida M;Iwamoto S;Shimada K;Komatsu Y;Sasaki Y;Satoh T;Takahashi K;Mishima H;Muro K;Watanabe M;Sakata Y;Morita S;Shimada Y;Sugihara K
之前的SOFT研究证明，在作为转移性结直肠癌（mCRC）一线化疗的无进展生存期（PFS）主要终点方面，S-1和奥沙利铂（SOX）+贝伐珠单抗非劣效于左旋亚叶酸、氟尿嘧啶和奥沙利铂（mFOLFOX 6）+贝伐珠单抗。在主要分析时，总生存期（OS）数据尚不成熟。共入组512例患者，随机分配接受mFOLFOX 6+贝伐珠单抗治疗（5 mg/kg贝伐单抗，随后200 mg/m2的l-甲酰四氢叶酸与85 mg/m2的奥沙利铂同时给药，随后在第1天推注400 mg/m2的5-FU，然后在46小时内静脉输注2400 mg/m2的5-FU，每2周一次）或SOX加贝伐单抗（7.5 mg/kg贝伐单抗，第1天130 mg/m2奥沙利铂和40-60 mg S-1，每天两次，持续2周，随后休息1周）。主要终点是PFS。在主要分析后，随访调查于2013年9月30日截止，并分析了最终OS数据。中位随访时间为37.7个月，mFOLFOX 6+贝伐珠单抗组的中位生存时间（MST）为29.7个月，SOX+贝伐珠单抗组为29.6个月（HR，1.018; 95% CI 0.823 - 1.258）。mFOLFOX 6+贝伐珠单抗组的中位PFS为11.7个月，SOX+贝伐珠单抗组为12.2个月（HR，1.051; 95% CI 0.876 - 1.262; p非劣效性=0.0115）。我们的结果再次证实SOX联合贝伐珠单抗在PFS方面不劣于mFOLFOX 6联合贝伐珠单抗。两组之间的MST没有差异。SOX加贝伐珠单抗被认为是mCRC患者一线化疗的有效方案，可替代mFOLFOX 6加贝伐珠单抗。JapicCTI-090699。
The SOFT study previously demonstrated that S-1 and oxaliplatin (SOX) plus bevacizumab was non-inferior to l-leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) plus bevacizumab in terms of the primary end point of progression-free survival (PFS) as first-line chemotherapy for metastatic colorectal cancer (mCRC). The overall survival (OS) data were immature at the time of the primary analysis. A total of 512 patients were enrolled and randomly assigned to receive either mFOLFOX6 plus bevacizumab (5 mg/kg of bevacizumab, followed by 200 mg/m2 of l-leucovorin given simultaneously with 85 mg/m2 of oxaliplatin, followed by a 400 mg/m2 bolus of 5-FU on day 1 and then 2400 mg/m2 of 5-FU as an intravenous infusion over the course of 46 hours, every 2 weeks) or SOX plus bevacizumab (7.5 mg/kg of bevacizumab, 130 mg/m2 of oxaliplatin on day 1 and 40–60 mg of S-1 two times per day for 2 weeks, followed by a 1-week rest). The primary end point was PFS. After the primary analysis, the follow-up survey was cut-off on 30 September 2013, and the final OS data were analysed. With a median follow-up of 37.7 months, the median survival time (MST) was 29.7 months with mFOLFOX6 plus bevacizumab and 29.6 months with SOX plus bevacizumab (HR, 1.018; 95% CI 0.823 to 1.258). Median PFS was 11.7 months in the mFOLFOX6 plus bevacizumab group and 12.2 months in the SOX plus bevacizumab group (HR, 1.051; 95% CI 0.876 to 1.262; pnon-inferiority=0.0115). Our results reconfirmed that SOX plus bevacizumab is non-inferior to mFOLFOX6 plus bevacizumab in terms of PFS. MST did not differ between the groups. SOX plus bevacizumab is considered an effective regimen for first-line chemotherapy in patients with mCRC and can be used instead of mFOLFOX6 plus bevacizumab. JapicCTI-090699.
登录
查看更多内容
影响因子：
45.3
作者：
Tournigand, C;André, T;de Gramont, A
通讯作者：
de Gramont, A
影响因子：
45.3
作者：
Cassidy, Jim;Clarke, Stephen;Saltz, Leonard
通讯作者：
Saltz, Leonard
影响因子：
51.1
作者：
Hong, Yong Sang;Park, Young Suk;Lee, Jae Won
通讯作者：
Lee, Jae Won
影响因子：
50.5
作者：
Cremolini, C.;Loupakis, F.;Falcone, A.
通讯作者：
Falcone, A.
影响因子：
45.3
作者：
Piessevaux, Hubert;Buyse, Marc;Tejpar, Sabine
通讯作者：
Tejpar, Sabine