JCO:GOG-0218最终OS结果出炉:贝伐珠单抗一线维持治疗卵巢癌未能改善生存

2019-07-01 Lisa 肿瘤资讯

目前,在卵巢癌患者中进行了多项抗血管生成治疗的研究,但均未观察到总生存(OS)获益。GOG-0218研究在减瘤术后的Ⅲ期或Ⅳ期卵巢癌患者中对比了贝伐珠单抗同步化疗或同步化疗+维持治疗和单纯化疗,2011年《新英格兰医学杂志》公布的结果显示贝伐珠单抗联合化疗或联合并用于化疗后维持治疗对比单用化疗可以降低28%的疾病进展风险。近日,《临床肿瘤学杂志》(Journal of Clinical Oncol

目前,在卵巢癌患者中进行了多项抗血管生成治疗的研究,但均未观察到总生存(OS)获益。GOG-0218研究在减瘤术后的Ⅲ期或Ⅳ期卵巢癌患者中对比了贝伐珠单抗同步化疗或同步化疗+维持治疗和单纯化疗,2011年《新英格兰医学杂志》公布的结果显示贝伐珠单抗联合化疗或联合并用于化疗后维持治疗对比单用化疗可以降低28%的疾病进展风险。近日,《临床肿瘤学杂志》(Journal of Clinical Oncology)进一步公布了这一研究OS的结果。

背景

鉴于卵巢癌早期缺乏特异性临床表现,且迄今尚无有效的筛查手段,因此是目前预后最差的妇科肿瘤,10年无病生存(DFS)率<10%。目前关于卵巢癌的重要研究问题包括:减瘤手术和开始化疗的间期,新辅助化疗,减瘤手术的时机,剂量密集治疗,腹腔内化疗、腹腔内热灌注化疗以及整合靶向治疗。尽管通过广泛性的减瘤术和铂类、紫杉类为基础的化疗后,80%的患者取得完全临床缓解,但大多数会出现复发。因此,寻找有效且耐受性好的维持治疗方案成为临床未被满足的需求。

高级别浆液性癌可以通过活化促血管生成通路促进早期播散。因此,抗血管生成对于这类患者而言是一个有效的治疗靶点,在复发性患者中,贝伐珠单抗可以取得20%的缓解率。GOG-0218研究先前报道的结果显示,贝伐珠单抗联合化疗+化疗后维持治疗对比单用化疗可以降低28%的疾病进展风险。然而,大多数关于抗血管生成药物的研究均仅观察到无进展生存(PFS)的获益,而OS无显著差异。PFS和OS之间获益的不一致性可能是因为进展后交叉、新药的出现、潜在的预后或预测指标如合并腹水、BRCA1/2和CD31状态的影响。GOG-0218研究探索性分析了临床、病理和分子特征,并在近期的《临床肿瘤学杂志》上报道了该研究的最终OS结果。

方法

FIGO分期为Ⅲ或Ⅳ期的上皮性卵巢癌、原发性腹膜癌或输卵管癌患者在接受了最大程度的减瘤术后12周内入组研究。Ⅲ期患者要求术后存在肉眼残留灶(即理想残留灶≤1 cm,次理想残留灶>1 cm),GOG体力状态评分为0~2分。排除Ⅲ期完全性切除的患者以及既往合并出血事件或有小肠梗阻症状的患者。

GOG-0218是一项多中心、双盲、安慰剂对照的Ⅲ期研究,包括2个试验组和1个对照组,对照组患者接受每21天为1个周期共6个周期的紫杉醇(175 mg/m2)+卡铂(AUC 6)化疗后,给予每21天为1个周期共16周期的安慰剂维持治疗。为了减少出血并发症,贝伐珠单抗联合治疗从化疗第2个周期开始。贝伐珠单抗同步治疗组接受化疗联合贝伐珠单抗治疗(第2~6个周期);贝伐珠单抗同步-维持治疗组在同步治疗基础上给予单药维持(第7~22个周期)。患者按1∶1 ∶1分配至3个治疗组,分层因素包括:外科减瘤术后结局、分期和初始GOG评分(0分 vs 1或2分)。研究最初设定OS作为主要终点,但后续为了进展后揭盲,主要研究终点改为PFS。

结果

研究共入组1873例患者,3组患者的临床和病理特征均衡。患者的中位年龄为60岁,Ⅳ期患者占25%。中心病理评估显示,高级别浆液性肿瘤超过80%,低分化肿瘤超过70%。在中位随访17.4个月后进行PFS分析,结果显示,贝伐珠单抗同步-维持治疗组对比对照组,进展风险降低28%,中位PFS分别为14.1个月和10.3个月(HR 0.717;95% CI:0.625~0.824,P<0.001)。

OS分析的截止日期为2018年1月17日,在中位随访102.9个月后,对照组共493例患者死亡。相比于对照组(中位OS为41.1个月),贝伐珠单抗同步-维持治疗组并未显示出生存优势,中位OS为43.4个月(HR 0.96;95% CI:0.85~1.09;P=0.53);贝伐珠单抗同步治疗组也未观察到OS优势,中位OS为40.8个月(HR 1.06;95% CI:0.94~1.20;P=0.34),见图1A。在探索性分析中,排除那些死于非卵巢癌或卵巢癌相关治疗的患者(n=104),两个试验组分别和对照组相比,OS仍无显著差异,见图1B。当排除对照组进展后交叉接受贝伐珠单抗或二线接受贝伐珠单抗治疗的患者,研究组相比于对照组仍未观察到OS差异,见图1C。在一项探索性亚组分析中,根据分期进行分层,3个治疗组中Ⅲ期患者的OS相似,见图1D;IV期患者中,对照组和贝伐珠单抗同步组患者的中位OS分别为32.6个月和34.5个月(HR 0.99),贝伐珠单抗同步-维持治疗组的中位OS为42.8个月(HR 0.75;95% CI:0.59~0.95),见图1E。



图1. 3个治疗组的OS对比

潜在的预后和预测因素分析:对已知的临床和病理预后因素,包括年龄、GOG PS评分、Ⅲ期、次理想Ⅲ期和Ⅳ期、是否合并腹水、组织学类型、分级、是否接受含贝伐珠单抗方案治疗,结果显示,这些因素均与OS无相关性。在纳入CD31分析的1438例患者中,也未观察到预后或预测因素。在根据外周血和/或肿瘤标本进行基因组分类的1195例患者中,BRCA1/2突变患者,死亡HR为0.62(95% CI:0.52~0.73);非BRCA1/2同源重组修复(HRR)突变型患者,死亡HR为0.65(95% CI:0.51~0.85),见图2A。尽管这些标志物具有预后作用,但并不能预测贝伐珠单抗的疗效,见图2B。



图2. 根据BRCA1/2和同源重组缺陷(HRD)分析OS

结论和讨论

在长期随访中,成熟的OS数据显示,贝伐珠单抗治疗并不能带来OS获益。PFS的临床获益仍然是争议的焦点,很多研究者认为PFS只能反映研究药物使用过程中的临床获益。鉴于GOG-0218研究允许患者进展后交叉接受贝伐珠单抗治疗,因此可能掩盖了潜在的生存获益,因此OS的分析相对而言没有那么重要。目前对于Ⅲ期患者,GOG-0218的研究结果可以指导临床实践,对于Ⅳ期患者,探索性分析观察到的OS获益与ICON7研究的高风险人群分析结果一致。

原始出处:
Krishnansu S. Tewari, et al. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. Journal of Clinical Oncology. Jun 2019.

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    2020-06-09 lidong40
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    2019-07-03 cqykthl

    贝伐珠单抗在卵巢癌中的应用

    0

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    2019-07-03 cqykthl

    贝伐珠单抗

    0

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    2019-07-01 orangesking

    0

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为卵巢癌患者探寻更加优化的腹腔静脉联合化疗

美国临床肿瘤学会(ASCO)年会在芝加哥正式开幕。复旦大学附属中山医院的臧荣余教授携卵巢癌术后腹腔化疗的随机Ⅱ期研究(摘要号5514)亮相ASCO会场,该研究入选年会壁报讨论。

Brit J Cancer:高度和体重指数与BRCA1和BRCA2突变携带者卵巢癌风险

由此可见,我们观察BMI与绝经前BRCA1/2突变携带者卵巢癌风险之间存在正相关,这与一般人群中的结果一致。

2019专家建议:接受贝伐单抗治疗的卵巢癌和宫颈癌患者高血压的管理

贝伐单抗是一种抗血管内皮表皮生长因子的单克隆抗体,应用该药进行联合化疗可严重卵巢癌和宫颈癌患者的生存期。高血压是所有血管生成抑制剂的已知副作用可导致治疗过程中止或在短时间内停止。本文的主要目的是针对接受贝伐单抗治疗的卵巢癌和宫颈癌患者高血压的管理提出指导建议。