Liver Cancer:雷莫芦单抗(Ramucirumab)治疗甲胎蛋白升高的中期肝细胞癌(HCC)患者的疗效:来自两项3期研究(REACH和REACH-2)的汇总结果

2021-07-13 yd2015 MedSci原创

REACH和REACH-2研究是随机、安慰剂对照、双盲、多中心、3期临床研究,评估研究了既往接受索拉非尼治疗进展或不耐受的肝细胞癌(HCC)患者使用雷莫芦单抗(Ramucirumab)的疗效。 患者每

REACH和REACH-2研究是随机、安慰剂对照、双盲、多中心、3期临床研究,评估既往接受索拉非尼治疗进展或不耐受的肝细胞癌(HCC)患者使用雷莫芦单抗(Ramucirumab)的疗效。 患者每2周接受静脉注射ramucirumab (8mg /kg)或安慰剂(REACH随机1:1;REACH-2随机2:1),联合最好的支持治疗,直到疾病进展,不可接受的毒性或死亡。其中REACH-2研究只纳入甲胎蛋白(AFP)≥400 ng/mL的患者。初期分析结果表明REACH-2研究的患者以及REACH研究中AFP≥400 ng/mL的患者使用ramucirumab可获得生存获益。近期,Liver Cancer杂志发表了两研究的汇总分析结果。

该研究是对REACH 研究(AFP≥400 ng/mL)和REACH-2研究的患者数据进行汇总荟萃分析。所有患者均为Child-Pugh A,ECOG评分为0-1,既往接受索拉非尼治疗,BCLC B期或C期。采用Kaplan-Meier法估计中位总生存期(OS)和无进展生存期(PFS)。采用Cox比例风险评估BCLC B期和C期的治疗效果。

纳入52例BCLC-B期 (ramucirumab, N = 30,安慰剂,N = 22)患者和490例BCLC-C期 (ramucirumab, N = 286;安慰剂,N=204)患者进行分析。BCLC-C期患者中位AFP水平(ramucirumab组:4472 ng/mL,安慰剂组:4375 ng/mL)高于BCLC-B期患者(ramu- cirumab组:1817 ng/mL,安慰剂组:2958 ng/mL)。单因素分析提示BCLC分期是其OS的预后因素(stage B vs. stage C; HR 0.68, 95% CI 0.49–0.94; p value= 0.02),但是多因素分析,没有统计学差异(stage B vs. stage C; HR 0.76, 95% CI 0.55–1.05; p value=0.0917)。

                  研究概况

不管BCLC-B或C期,患者接受ramucirumab治疗较安慰剂获得OS和PFS获益。总人群中,Ramucirumab组和安慰剂组的中位OS分别为8.1和5.0个月(HR (95% CI),0.69 (0.57–0.84));BCLC-B期患者,Ramucirumab组和安慰剂组的中位OS分别为13.7和8.2个月(HR (95% CI),0.43 (0.23–0.82));BCLC-C期患者,Ramucirumab组和安慰剂组的中位OS分别为7.7和4.8个月(HR (95% CI),0.72 (0.59–0.89))。

           OS分析

总人群中,Ramucirumab组和安慰剂组的中位PFS分别为2.8和1.5个月(HR (95% CI),0.57 (0.47–0.69));BCLC-B期患者,Ramucirumab组和安慰剂组的中位PFS分别为4.2和2.8个月(HR (95% CI),0.33 (0.17–0.64));BCLC-C期患者,Ramucirumab组和安慰剂组的中位PFS分别为2.8和1.5个月(HR (95% CI),0.60 (0.49–0.74))。

           PFS分析

BCLC-B期患者中,Ramucirumab组的客观缓解率(ORR)和疾病控制率(DCR)分别为17%和80%,安慰剂组分别为5%,59%;BCLC-C期患者中,Ramucirumab组的ORR和DCR分别为4%和54%,安慰剂组分别为1%,35%。

           疗效分析

不良事件(AEs)与两项研究的观察结果一致;高血压是最常见的3级AE。在整个研究过程中,肝功能保持不变,并且在不同 BCLC分期中两组治疗组患者的肝功能相似。

综上:无论BCLC分期如何,Ramucirumab治疗可取得生存利益,且在治疗期间耐受性良好,并不导致肝功能的损坏。

原始出处:

Masatoshi Kudo, Richard S. Finn,Manabu Morimoto, et al. Ramucirumab for Patients with Intermediate Stage Hepatocellular Carcinoma and Elevated Alpha-Fetoprotein: Pooled Results from Two Phase 3 Studies (REACH and REACH-2). DOI: 10.1159/000516605. Published online: July 12, 2021.

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    2021-10-25 snf701207
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    2021-09-27 xjy02
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    2021-07-15 jiyangfei
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    2021-07-13 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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