A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109

Lida A. Mina, Menggang Yu, Cynthia Johnson, Cyndi Burkhardt, Kathy Miller, Robin Zon

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Purpose: Angiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. Patients and Methods: Patients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS). Results: Eighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 %) patients reporting Grade 3 toxicity. Seven (39 %) patients discontinued therapy due to adverse events including hypertension (N = 2), GI toxicity (N = 1), sensory neuropathy (N = 1), rash (N = 1), pain (N = 1) and wound complication (N = 1). Given the lack of clear efficacy and increased toxicity, accrual was terminated. Conclusion: The combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended.

Original languageEnglish
Pages (from-to)1307-1310
Number of pages4
JournalInvestigational New Drugs
Volume31
Issue number5
DOIs
StatePublished - Oct 2013

Fingerprint

Vascular Endothelial Growth Factor A
Breast Neoplasms
Disease-Free Survival
Bevacizumab
sorafenib
Drug Therapy
Exanthema
Neoplasm Metastasis
Hypertension
Safety
Pain
Wounds and Injuries
Neoplasms

Keywords

  • Bevacizumab
  • Metastatic breast cancer
  • Sorafenib

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer : Hoosier Oncology Group Study BRE06-109. / Mina, Lida A.; Yu, Menggang; Johnson, Cynthia; Burkhardt, Cyndi; Miller, Kathy; Zon, Robin.

In: Investigational New Drugs, Vol. 31, No. 5, 10.2013, p. 1307-1310.

Research output: Contribution to journalArticle

Mina, Lida A. ; Yu, Menggang ; Johnson, Cynthia ; Burkhardt, Cyndi ; Miller, Kathy ; Zon, Robin. / A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer : Hoosier Oncology Group Study BRE06-109. In: Investigational New Drugs. 2013 ; Vol. 31, No. 5. pp. 1307-1310.
@article{5e014415947f41f182b7de8bae44bf7b,
title = "A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109",
abstract = "Purpose: Angiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. Patients and Methods: Patients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS). Results: Eighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 {\%}) patients reporting Grade 3 toxicity. Seven (39 {\%}) patients discontinued therapy due to adverse events including hypertension (N = 2), GI toxicity (N = 1), sensory neuropathy (N = 1), rash (N = 1), pain (N = 1) and wound complication (N = 1). Given the lack of clear efficacy and increased toxicity, accrual was terminated. Conclusion: The combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended.",
keywords = "Bevacizumab, Metastatic breast cancer, Sorafenib",
author = "Mina, {Lida A.} and Menggang Yu and Cynthia Johnson and Cyndi Burkhardt and Kathy Miller and Robin Zon",
year = "2013",
month = "10",
doi = "10.1007/s10637-013-9976-1",
language = "English",
volume = "31",
pages = "1307--1310",
journal = "Investigational New Drugs",
issn = "0167-6997",
publisher = "Kluwer Academic Publishers",
number = "5",

}

TY - JOUR

T1 - A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer

T2 - Hoosier Oncology Group Study BRE06-109

AU - Mina, Lida A.

AU - Yu, Menggang

AU - Johnson, Cynthia

AU - Burkhardt, Cyndi

AU - Miller, Kathy

AU - Zon, Robin

PY - 2013/10

Y1 - 2013/10

N2 - Purpose: Angiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. Patients and Methods: Patients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS). Results: Eighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 %) patients reporting Grade 3 toxicity. Seven (39 %) patients discontinued therapy due to adverse events including hypertension (N = 2), GI toxicity (N = 1), sensory neuropathy (N = 1), rash (N = 1), pain (N = 1) and wound complication (N = 1). Given the lack of clear efficacy and increased toxicity, accrual was terminated. Conclusion: The combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended.

AB - Purpose: Angiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. Patients and Methods: Patients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS). Results: Eighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 %) patients reporting Grade 3 toxicity. Seven (39 %) patients discontinued therapy due to adverse events including hypertension (N = 2), GI toxicity (N = 1), sensory neuropathy (N = 1), rash (N = 1), pain (N = 1) and wound complication (N = 1). Given the lack of clear efficacy and increased toxicity, accrual was terminated. Conclusion: The combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended.

KW - Bevacizumab

KW - Metastatic breast cancer

KW - Sorafenib

UR - http://www.scopus.com/inward/record.url?scp=84884818834&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84884818834&partnerID=8YFLogxK

U2 - 10.1007/s10637-013-9976-1

DO - 10.1007/s10637-013-9976-1

M3 - Article

C2 - 23812905

AN - SCOPUS:84884818834

VL - 31

SP - 1307

EP - 1310

JO - Investigational New Drugs

JF - Investigational New Drugs

SN - 0167-6997

IS - 5

ER -