A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma.

A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Research Abstract Details 

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A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Abstract Text:

Kimberly A Varker,Jennifer E Biber,Cheryl Kefauver,Rhonda Jensen,Amy Lehman,Donn Young,Haifeng Wu,Gregory B Lesinski,Kari Kendra,Helen X Chen,Michael J Walker,William E Carson,

BACKGROUND: Vascular endothelial growth factor (VEGF) is a proangiogenic molecule produced by melanoma cells. We hypothesized that administration of bevacizumab (Bev), a monoclonal antibody that neutralizes VEGF, with low-dose interferon alfa-2b (IFN-alpha2b), an inhibitor of basic fibroblast growth factor (FGF), would lead to the regression of metastatic melanoma. METHODS: Patients with metastatic melanoma were randomized to receive Bev (15 mg/kg intravenously every 2 weeks) with or without low-dose IFN-alpha2b (1 MU/m2 subcutaneously daily). Patients exhibiting a clinical response or stable disease after 12 weeks were treated until disease progression. RESULTS: Thirty-two patients (16 per arm) were accrued (18 male, 14 female; mean age 57.5 years). Both regimens were well tolerated. Six patients developed easily managed exacerbations of preexisting hypertension. Two patients developed grade 3 proteinuria that resolved after a treatment break. IFN-alpha2b therapy was associated with grade 1 to 2 constitutional symptoms. Arterial thromboembolic complications were observed in three patients (two mild myocardial infarctions, one transient ischemic attack), all of whom had risk factors. One patient (Bev plus IFN-alpha2b arm) had locally recurrent scalp disease that partially responded to therapy. Eight patients (five Bev, three Bev plus IFN-alpha2b) had prolonged disease stabilization (24 to 146 weeks). Plasma levels of VEGF and FGF did not correlate with any clinical parameter. The patient with the longest period of stable disease had the highest baseline VEGF and FGF. CONCLUSIONS: Bev was well tolerated at this dose and prolonged disease stabilization was achieved in one-quarter of metastatic melanoma patients. Low-dose IFN-alpha2b did not augment the activity of Bev.

A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Publishing Authors By Initials

KA Varker,JE Biber,C Kefauver,R Jensen,A Lehman,D Young,H Wu,GB Lesinski,K Kendra,HX Chen,MJ Walker,WE Carson,

For similar neoplasms: neoplasms by site: skin neoplasms research abstracts see: neoplasms: neoplasms by site: skin neoplasms research

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A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Journal Published:

PUBLICATION TYPE: Research Support, N.I.H., Extr

Journal: Annals of surgical oncology

VOLUME: 14

Page Numbers: 2367-76

Journal Abbreviation: Ann. Surg. Oncol.

ISSN: 1068-9265

DAY: 30

MONTH: 05

YEAR: 2007

A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 9420840

A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Keywords Mesh Terms:

KEYWORDS: Skin Neoplasms

MESH TERMS: pathology

Chemical & Substance for Abstract: A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Information

Substance Name: Interferon Alfa-2b

Registry Number: 99210-65-8

Grant and Affiliation Information for A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma.

AFFILIATION: Division of Surgical Oncology, The Ohio State University Comprehensive Cancer Center, N924 Doan Hall, 410 W 10th Avenue, Columbus, Ohio 43210, USA.

Country: United States

AGENCY: United States NCI

GRANT: U01 CA-076576-06

ACRONYM: CA

MEDLINETA: Ann Surg Oncol

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