JAMA Oncol:VALENTINO研究:帕尼单抗一线维持治疗RAS野生型结直肠癌劣于帕尼单抗联合氟尿嘧啶

2019-07-14 Linda 肿瘤资讯

2019年7月3日,JAMA Oncology 在线发表VALENTINO研究结果,证明帕尼单抗单药一线维持治疗RAS野生型转移性结直肠癌劣于帕尼单抗联合氟尿嘧啶。

2019年7月3日,JAMA Oncology 在线发表VALENTINO研究结果,证明帕尼单抗单药一线维持治疗RAS野生型转移性直肠癌劣于帕尼单抗联合氟尿嘧啶。

1562837103217930.pngVALENTINO是一项开放标签的随机Ⅱ期研究,在意大利的多个中心进行。从2015年7月7日—2017年10月27日,共入组229例RAS野生型不可切除的转移性直肠癌腺癌患者,先前未接受过针对转移性疾病的治疗。

入组后随机分为2组,给予8个周期的诱导治疗,序贯不同的维持治疗。诱导治疗方案为帕尼单抗(6 mg/kg,d1)+FOLFOX-4(奥沙利铂85 mg/m2,d1;亚叶酸钙200 mg/m2,氟尿嘧啶400 mg/m2静脉推注,然后600 mg/m2持续静滴24小时,d1~2;每2周为1周期)。维持治疗方案为帕尼单抗+氟尿嘧啶-亚叶酸钙(A组,117例),或帕尼单抗单药(B组,112例)。维持治疗至疾病进展、出现不可接受的毒性反应或撤回知情同意。

主要研究终点为意向性治疗人群的10个月无进展生存(PFS)率,B组相比于A组HR的单侧90% CI的非劣效性上限值设为1.515。

数据截止至2018年7月30日,中位随访18.0个月,PFS结果显示B组劣效于A组,HR单侧90% CI的上限为1.857,超过了预设的1.515的界值。10个月PFS率A组显著高于B组,分别为59.9%和49.0%(P=0.01)。中位PFS分别为12.0个月和9.9个月。见图1。



图1. 两组的PFS结果

18个月的OS率分别为66.4%和62.4%(P=0.60),无显著性差异(图2)。



图2. 两组的OS结果

总缓解率(66.7% vs 67.0%)和疾病控制率(82.9% vs 83.9%)亦无组间差异。

维持治疗期间,A组的≥3级治疗相关不良事件发生率高于B组,分别为42.4%和20.3%。帕尼单抗相关的不良事件发生率亦以A组更高,分别为31.8%和16.4%。

该项Ⅱ期研究表明,对于RAS野生型转移性结直肠癌患者,一线FOLFOX联合帕尼单抗后,序贯帕尼单抗单药维持治疗,PFS劣于帕尼单抗联合氟尿嘧啶-亚叶酸钙,但联合维持治疗的毒性也略有增加。

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    2020-02-02 minlingfeng
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    2019-07-14 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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