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学科主题: 临床医学
题名:
Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma
作者: Motzer, Robert J.1; Hutson, Thomas E.2; Cella, David3; Reeves, James4; Hawkins, Robert5,6; Guo, Jun11; Nathan, Paul7; Staehler, Michael15; de Souza, Paul16; Merchan, Jaime R.17; Boleti, Ekaterini8; Fife, Kate9; Jin, Jie12; Jones, Robert10; Uemura, Hirotsugu18; De Giorgi, Ugo19; Harmenberg, Ulrika22; Wang, Jinwan13,14; Sternberg, Cora N.20,21; Deen, Keith23; McCann, Lauren23; Hackshaw, Michelle D.23; Crescenzo, Rocco23; Pandite, Lini N.23; Choueiri, Toni K.24,25
刊名: NEW ENGLAND JOURNAL OF MEDICINE
发表日期: 2013-08-22
DOI: 10.1056/NEJMoa1303989
卷: 369, 期:8, 页:722-731
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: FUNCTIONAL ASSESSMENT ; CANCER ; THERAPY ; FATIGUE ; TRIAL
英文摘要:

BACKGROUND

Pazopanib and sunitinib provided a progression-free survival benefit, as compared with placebo or interferon, in previous phase 3 studies involving patients with metastatic renal-cell carcinoma. This phase 3, randomized trial compared the efficacy and safety of pazopanib and sunitinib as first-line therapy.

METHODS

We randomly assigned 1110 patients with clear-cell, metastatic renal-cell carcinoma, in a 1:1 ratio, to receive a continuous dose of pazopanib (800 mg once daily; 557 patients) or sunitinib in 6-week cycles (50 mg once daily for 4 weeks, followed by 2 weeks without treatment; 553 patients). The primary end point was progression-free survival as assessed by independent review, and the study was powered to show the noninferiority of pazopanib versus sunitinib. Secondary end points included overall survival, safety, and quality of life.

RESULTS

Pazopanib was noninferior to sunitinib with respect to progression-free survival (hazard ratio for progression of disease or death from any cause, 1.05; 95% confidence interval [CI], 0.90 to 1.22), meeting the predefined noninferiority margin (upper bound of the 95% confidence interval, <1.25). Overall survival was similar (hazard ratio for death with pazopanib, 0.91; 95% CI, 0.76 to 1.08). Patients treated with sunitinib, as compared with those treated with pazopanib, had a higher incidence of fatigue (63% vs. 55%), the hand-foot syndrome (50% vs. 29%), and thrombocytopenia (78% vs. 41%); patients treated with pazopanib had a higher incidence of increased levels of alanine aminotransferase (60%, vs. 43% with sunitinib). The mean change from baseline in 11 of 14 health-related quality-of-life domains, particularly those related to fatigue or soreness in the mouth, throat, hands, or feet, during the first 6 months of treatment favored pazopanib (P<0.05 for all 11 comparisons).

CONCLUSIONS

Pazopanib and sunitinib have similar efficacy, but the safety and quality-of-life profiles favor pazopanib.

语种: 英语
项目资助者: GlaxoSmithKline Pharmaceuticals
WOS记录号: WOS:000323349300009
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64616
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.Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA
2.Baylor Sammons Canc Center Texas Oncol, Dallas, TX USA
3.Florida Canc Specialists, Ft Myers, FL USA
4.Univ Manchester, Manchester, Lancs, England
5.Natl Hlth Serv Fdn Trust, Christie Hosp, Manchester, Lancs, England
6.Mt Vernon Hosp, Northwood HA6 2RN, Middx, England
7.Addenbrookes Hosp, Ctr Oncol, Cambridge, England
8.Univ Glasgow, Inst Canc Sci, Glasgow, Lanark, Scotland
9.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
10.Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Chicago, IL 60611 USA
11.Royal Free Hosp, Dept Oncol, London NW3 2QG, England
12.Peking Univ, Renal Canc & Melanoma Unit, Canc Hosp, Beijing 100871, Peoples R China
13.Chinese Acad Med Sci, Canc Hosp, Beijing 100730, Peoples R China
14.Peking Union Med Coll, Beijing 100021, Peoples R China
15.Univ Munich, Interdisciplinary Ctr Renal Tumors, Dept Urol, Munich, Germany
16.Univ Western Sydney, Canc Res Grp, Sch Med, Mol Med Res Grp, Sydney, NSW, Australia
17.Univ Miami, Sylvester Canc Ctr, Miami, FL USA
18.Kinki Univ, Dept Urol, Fac Med, Osaka, Japan
19.Ist Sci Romagnolo Studio & Cura Tumori, Ist Ricovero & Cura Carattere Sci, Meldola, Italy
20.San Camillo Hosp, Dept Med Oncol, Rome, Italy
21.Forlanini Hosp, Dept Med Oncol, Rome, Italy
22.Karolinska Univ Hosp, Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden
23.GlaxoSmithKline, Collegeville, PA USA
24.Brigham & Womens Hosp, Dana Farber Canc Inst, Dana Farber Harvard Canc Ctr, Kidney Canc Program, Boston, MA 02115 USA
25.Harvard Univ, Sch Med, Boston, MA USA

Recommended Citation:
Motzer, Robert J.,Hutson, Thomas E.,Cella, David,et al. Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma[J]. NEW ENGLAND JOURNAL OF MEDICINE,2013,369(8):722-731.
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