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A phase II study of the efficacy and safety of AMG 102 in patients with metastatic renal cell carcinoma.

Abstract：

OBJECTIVE:• To evaluate the efficacy and safety of single-agent AMG 102, an investigational, fully human monoclonal antibody to hepatocyte growth factor/scatter factor (HGF/SF), in renal cell carcinoma (RCC). PATIENTS AND METHODS:• This open-label phase II study included patients ≥ 18 years old with histologically confirmed, advanced or metastatic RCC (mRCC) and Eastern Cooperative Oncology Group performance status 0 to 2. AMG 102 was administered i.v. at 10 or 20 mg/kg once every 2 weeks. • A two-stage design was used at each dose level and the primary endpoint was objective best confirmed response (by Response Evaluation Criteria in Solid Tumours) at any time. RESULTS:• Sixty-one patients with mRCC enrolled and received AMG 102 (40 at 10 mg/kg; 21 at 20 mg/kg). Overall, 70.5% were men, median age was 59 years (range, 39 to 84 years), and 92% had received previous anti-vascular endothelial growth factor therapy. RCC histologies were: clear cell (75.4%), papillary (11.5%), chromophobe (4.9%) and unclassified (8.2%). • One confirmed partial response occurred at 10 mg/kg, maintained for over 2.5 years; 26 patients (43%) had stable disease, 10 (16%) for ≥ 32 weeks. The median profression-free survival was 3.7 months at 10 mg/kg and 2.0 months at 20 mg/kg. The commonest adverse events were oedema (45.9%), fatigue (37.7%) and nausea (27.9%). Grade 3 or 4 adverse events occurred in 33% of patients, the most common being oedema (9.8%). • Baseline levels of plasma HGF/SF and soluble c-Met as well as archival-tumour c-Met did not correlate with measures of efficacy. CONCLUSION:• Single-agent AMG 102 was tolerable, but it is unclear if AMG 102 was growth inhibitory in this population of patients with mRCC.

journal_name

BJU Int

journal_title

BJU international

authors

Schöffski P,Garcia JA,Stadler WM,Gil T,Jonasch E,Tagawa ST,Smitt M,Yang X,Oliner KS,Anderson A,Zhu M,Kabbinavar F

doi

10.1111/j.1464-410X.2010.09947.x

subject

Has Abstract

pub_date

2011-09-01 00:00:00

pages

679-86

issue

5

eissn

1464-4096

issn

1464-410X

journal_volume

108

pub_type

杂志文章

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