Lancet Oncol:贝伐珠单抗或降低卵巢癌患者生活质量

2013-01-23 Lancet Oncol CMT

  英法等国学者近期发表于《柳叶刀?肿瘤学》(Lancet Oncol)杂志的一项研究表明,对于卵巢癌术后患者,与单纯标准化疗相比,标准化疗联合贝伐珠单抗治疗可能与患者生活质量轻度但显著下降相关。在临床决策时应考虑权衡无进展生存期延长和生活质量下降。   在妇科肿瘤国际合作组卵巢肿瘤7(ICON7)临床试验中,贝伐珠单抗联合一线化疗并单独继续治疗18个周期可改善卵巢癌患者的无进展生存。

  英法等国学者近期发表于《柳叶刀•肿瘤学》(Lancet Oncol)杂志的一项研究表明,对于卵巢癌术后患者,与单纯标准化疗相比,标准化疗联合贝伐珠单抗治疗可能与患者生活质量轻度但显著下降相关。在临床决策时应考虑权衡无进展生存期延长和生活质量下降。

  在妇科肿瘤国际合作组卵巢肿瘤7(ICON7)临床试验中,贝伐珠单抗联合一线化疗并单独继续治疗18个周期可改善卵巢癌患者的无进展生存。对一个高危患者亚组进行的初步分析显示,总生存也有改善。该研究的目的是,描述ICON7临床试验中患者的健康相关生活质量(QOL)状况。

  ICON7是一项随机、多中心、开放标签的Ⅲ期试验。2006年12月18日至2009年2月16日,已接受减瘤术的国际妇产科联盟(FIGO)分期Ⅰ~Ⅳ期高危卵巢上皮癌患者随机(1:1 )接受6个周期的标准化疗(卡铂AUC 5或6,紫杉醇175 mg/m2,共18周)或联合贝伐珠单抗(7.5 mg/kg)静脉注射,化疗结束后贝伐珠单抗继续应用(共54周)。

  结果显示,764名女性被随机分配到标准化疗组,764例被分配到贝伐珠单抗组。基线时,标准化疗组684(90%)名女性和贝伐珠单抗组691(90%)名女性完成了生活质量问卷调查。54周时,502(66%)名贝伐单抗组女性和388(51%)名标准化疗组女性提交了生活质量数据。主要QOL终点采用欧洲癌症研究和治疗组织QOL问卷进行评估。

  18周时所有女性的平均总QOL评分比基线时提高7.2分。54周时,标准化疗组的平均总QOL评分高于贝伐珠单抗组(76.1分 对 69.7 分,差异6.4分,P<0.0001)。


Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: quality-of-life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial

BACKGROUND:
In the Gynecologic Cancer Intergroup International Collaboration on Ovarian Neoplasms 7 (ICON7) trial, bevacizumab improved progression-free survival in patients with ovarian cancer when used in combination with first-line chemotherapy and as a single-drug continuation treatment for 18 cycles. In a preliminary analysis of a high-risk subset of patients, there was also an improvement in overall survival. This study aims to describe the health-related quality-of-life (QoL) outcomes from ICON7.
METHODS:
ICON7 is a randomised, multicentre, open-label phase 3 trial. Between Dec 18, 2006, and Feb 16, 2009, after a surgical procedure aiming to debulk the disease, women with International Federation of Gynecology and Obstetrics (FIGO) high-risk stage I-IV epithelial ovarian cancer were randomly allocated (1:1) by computer program and block randomisation to receive either six cycles of standard chemotherapy (total 18 weeks) with carboplatin (area under the curve 5 or 6) and paclitaxel (175 mg/m(2)) alone or with bevacizumab (7·5 mg/kg) given intravenously with chemotherapy and continued as a single drug thereafter (total 54 weeks). The primary QoL endpoint was global QoL from the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire-core 30 at week 54, analysed by ANOVA and adjusted for baseline score. Analyses were by intention to treat. The ICON7 trial has completed recruitment and remains in follow-up. This study is registered, number ISRCTN91273375.
FINDINGS:
764 women were randomly assigned to the standard chemotherapy group and 764 to the bevacizumab group. At baseline, 684 (90%) of women in the standard chemotherapy group and 691 (90%) of those in the bevacizumab group had completed QoL questionnaires. At week 54, 502 (66%) women in the bevacizumab group and 388 (51%) women in the standard chemotherapy group provided QoL data. Overall, the mean global QoL score improved during chemotherapy by 7·2 points (SD 24·4) when analysed for all women with data at baseline and week 18. The mean global QoL score at 54 weeks was higher in the standard chemotherapy group than in the bevacizumab group (76·1 [SD 18·2] vs 69·7 [19·1] points; difference 6·4 points, 95% CI 3·7-9·0, p<0·0001).
INTERPRETATION:
Bevacizumab continuation treatment seems to be associated with a small but clinically significant decrement in QoL compared with standard treatment for women with ovarian cancer. The trade-off between the prolongation of progression-free survival and the quality of that period of time needs to be considered in clinical practice when making treatment decisions.
FUNDING:
Roche and the National Institute for Health Research through the UK National Cancer Research Network.

    

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    2013-02-14 howi
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    2013-03-01 minlingfeng
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