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学科主题: 临床医学
题名:
Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial
作者: Herbst, Roy S.1; Sun, Yon2; Eberhardt, Wilfried E. E.3; Germonpre, Paul4; Saijo, Nagahiro5; Zhou, Caicun6; Wang, Jie7; Li, Longyun8; Kabbinavar, Fairooz9; Ichinose, Yukito10; Qin, Shukui11; Zhang, Li12; Biesma, Bonne13; Heymach, John V.1; Langmuir, Peter14; Kennedy, Sarah J.15; Tada, Hiroomi14; Johnson, Bruce E.16
刊名: LANCET ONCOLOGY
发表日期: 2010-07-01
DOI: 10.1016/S1470-2045(10)70132-7
卷: 11, 期:7, 页:619-626
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology
研究领域[WOS]: Oncology
关键词[WOS]: QUALITY-OF-LIFE ; III TRIAL ; FUNCTIONAL ASSESSMENT ; TUMOR-GROWTH ; SUPPORTIVE CARE ; GEFITINIB ; CHEMOTHERAPY ; CARBOPLATIN ; PACLITAXEL ; THERAPY
英文摘要:

Background Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and rearranged during transfection (RET) tyrosine kinases. In a randomised phase 2 study in patients with previously treated non-small-cell lung cancer (NSCLC), adding vandetanib 100 mg to docetaxel significantly improved progression-free survival (PFS) compared with docetaxel alone, including a longer PFS in women. These results supported investigation of the combination in this larger, definitive phase 3 trial (ZODIAC).

Methods Between May, 2006, and April, 2008, patients with locally advanced or metastatic (stage IIIB-IV) NSCLC after progression following first-line chemotherapy were randomly assigned 1:1 through a third-party interactive voice system to receive vandetanib (100 mg/day) plus docetaxel (75 mg/m(2) intravenously every 21 days; maximum six cycles) or placebo plus docetaxel. The primary objective was comparison of PFS between the two groups in the intention-to-treat population. Women were a coprimary analysis population. This study has been completed and is registered with ClinicalTrials.gov, number NCT00312377.

Findings 1391 patients received vandetanib plus docetaxel (n=694 [197 women]) or placebo plus docetaxel (n=697 [224 women]). Vandetanib plus docetaxel led to a significant improvement in PFS versus placebo plus docetaxel (hazard ratio [HR] 0-79, 97.58% CI 0.70-0.90; p<0.0001); median PFS was 4.0 months in the vandetanib group versus 3.2 months in placebo group. A similar improvement in PFS with vandetanib plus docetaxel versus placebo plus docetaxel was seen in women (HR 0.79, 0-62-1.00, p=0-024); median PFS was 4.6 months in the vandetanib group versus 4.2 months in the placebo group. Among grade 3 or higher adverse events, rash (63/689 [9%] vs 7/690 [1%]), neutropenia (199/689 [29%] vs 164/690 [24%]), leukopenia (99/689 [14%] vs 77/690 [11%]), and febrile neutropenia (61/689 [9%] vs 48/690 [7%]) were more common with vandetanib plus docetaxel than with placebo plus docetaxel. The most common serious adverse event was febrile neutropenia (46/689 [7%] in the vandetanib group vs 38/690 [6%] in the placebo group).

Interpretation The addition of vandetanib to docetaxel provides a significant improvement in PFS in patients with advanced NSCLC after progression following first-line therapy.

语种: 英语
项目资助者: AstraZeneca
WOS记录号: WOS:000279860300015
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/51540
Appears in Collections:北京大学临床肿瘤学院_期刊论文

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作者单位: 1.Univ Texas MD Anderson Canc Ctr, Dept Thorac Head & Neck Med Oncol, Houston, TX 77030 USA
2.Canc Hosp, Beijing, Peoples R China
3.Univ Duisburg Essen, W German Tumor Ctr, Dept Med Canc Res, Essen, Germany
4.Univ Antwerp Hosp, Antwerp, Belgium
5.Kinki Univ, Sch Med, Osaka 589, Japan
6.Tongji Univ, Sch Med, Shanghai Pulm Hosp, Shanghai 200092, Peoples R China
7.Peking Univ, Beijing Canc Hosp & Inst, Sch Oncol, Beijing 100871, Peoples R China
8.Peking Union Med Coll, Beijing 100021, Peoples R China
9.Univ Calif Los Angeles, Jonsson Comprehens Canc Ctr, Los Angeles, CA 90024 USA
10.Kyushu Natl Canc Ctr, Fukuoka, Japan
11.Nanjing Bayi Hosp, Nanjing, Peoples R China
12.Sun Yat Sen Univ, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China
13.Jeroen Bosch Ziekenhuis, Afdeling Longziekten, sHertogenbosch, Netherlands
14.AstraZeneca, Wilmington, DE USA
15.AstraZeneca, Macclesfield, Cheshire, England
16.Dana Farber Canc Inst, Boston, MA 02115 USA

Recommended Citation:
Herbst, Roy S.,Sun, Yon,Eberhardt, Wilfried E. E.,et al. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial[J]. LANCET ONCOLOGY,2010,11(7):619-626.
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