Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 4/2013

01-04-2013 | Original Article

The Breast Avastin Trial: phase II study of bevacizumab maintenance therapy after induction chemotherapy with docetaxel and capecitabine for the first-line treatment of patients with locally recurrent or metastatic breast cancer

Authors: G. Bisagni, A. Musolino, M. Panebianco, A. De Matteis, F. Nuzzo, A. Ardizzoni, S. Gori, T. Gamucci, R. Passalacqua, R. Gnoni, G. Moretti, C. Boni

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2013

Login to get access

Abstract

Background

Therapeutic approach for patients with metastatic breast cancer (MBC) is still controversial. This study was conducted to assess the efficacy and safety of bevacizumab in combination with docetaxel plus capecitabine as first-line treatment for MBC. The feasibility of bevacizumab maintenance therapy in this setting was also evaluated.

Patients and methods

In this single-arm, multicenter phase II study, patients received bevacizumab 15 mg/kg and docetaxel 60 mg/m2 on day 1, plus capecitabine 900 mg/m2 twice daily on days 1–14 every 21 days. Treatment was administered for up to 6 cycles, then bevacizumab continued until progressive disease. The primary end point was progression-free survival (PFS); secondary end points were tumor response rate, overall survival, and toxicity.

Results

Seventy-nine eligible patients were treated with bevacizumab in combination with docetaxel plus capecitabine. The overall response rate was 61 %, with a complete response rate of 8 % and a median duration of response of 10 months. At a median follow-up of 28 months, the median PFS was 11 months. Fifty-two (65 %) patients received bevacizumab maintenance therapy for a median duration of 7 months (range 1 to 33+). Neutropenia was the most common grade 3–4 toxicity (28.1 % of patients), and two fatal adverse events occurred (septic shock and gastrointestinal perforation).

Conclusions

Bevacizumab in combination with docetaxel and capecitabine demonstrates significant activity and quite acceptable toxicity profile as first-line treatment of MBC. Subsequent maintenance therapy with bevacizumab is feasible for a long period of stable disease. Results deserve confirmation.
Literature
1.
Ferlay J, Shin HR, Bray F et al. GLOBOCAN 2008 (2010) Cancer incidence and mortality worldwide: IARC CancerBase No. 10 [Internet]. International Agency for Research on Cancer. In. Lyon, France
2.
Chia SK, Speers CH, D’Yachkova Y et al (2007) The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer 110:973–979PubMedCrossRef
3.
Dawood S, Broglio K, Gonzalez-Angulo AM et al (2008) Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol 26:4891–4898PubMedCrossRef
4.
O’Shaughnessy J, Miles D, Vukelja S et al (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812–2823PubMedCrossRef
5.
Albain KS et al (2008) Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 26(24):3950–3957PubMedCrossRef
6.
Carrick S, Parker S, Thornton CE, Ghersi D, Simes J, Wilcken N (2009) Single agent versus combination chemotherapy for metastatic breast cancer (ReviewThe). Cochrane Library 2009, Issue 1
7.
Verma S, Clemons M (2007) First-line treatment options for patients with HER-2 negative metastatic breast cancer: the impact of modern adjuvant chemotherapy. Oncologist 12:785–797PubMedCrossRef
8.
9.
Valachis A, Polyzos NP, Patsopoulos NA, Georgoulias V, Mavroudis D, Mauri D (2010) Bevacizumab in metastatic breast cancer: a meta-analysis of randomized controlled trials. Breast Cancer Res Treat 122:1–7PubMedCrossRef
10.
Miller K, Wang M, Gralow J et al (2007) Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357:2666–2676PubMedCrossRef
11.
Miles DW, Chan A, Dirix LY et al (2010) Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 28:3239–3247PubMedCrossRef
12.
Gennari A, Amadori D, De Lena M et al (2006) Lack of benefit of maintenance paclitaxel in first-line chemotherapy in metastatic breast cancer. J Clin Oncol 24:3912–3918PubMedCrossRef
13.
Nooij MA, de Haes JC, Beex LV et al (2003) Continuing chemotherapy or not after the induction treatment in advanced breast cancer patients: clinical outcomes and oncologists’ preferences. Eur J Cancer 39:614–621PubMedCrossRef
14.
Patel JD, Hensing TA, Rademaker A et al (2009) Phase II study of pemetrexed and carboplatin plus bevacizumab with maintenance pemetrexed and bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer. J Clin Oncol 27:3284–3289PubMedCrossRef
15.
Wolmark N Yothers G O’Connell MJ et al (2009) A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: results of NSABP protocol C-08. J Clin Oncol 27:LBA4
16.
Miller VA, O’Connor P, Soh C et al (2009) A randomized, double-blind, placebo-controlled, phase IIIb trial (ATLAS) comparing bevacizumab (B) therapy with or without erlotinib (E) after completion of chemotherapy with B for first-line treatment of locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). J Clin Oncol 27:LBA8002
17.
Miller AB, Hoogstraten B, Staquet M, Winkler A (1981) Reporting results of cancer treatment. Cancer 47:207–214PubMedCrossRef
18.
National Cancer Institute. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). National Cancer Institute 2006
19.
Miles D, Chan A, Romieu G et al (2008) Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol 26:LBA1011
20.
Lueck H, Minckwitz GV, Du Bois A et al (2006) Epirubicin/paclitaxel (EP) versus capecitabine/paclitaxel (XP) in first-line metastatic breast cancer (MBC): a prospective, randomized multicentre phase III study of the AGO breast cancer study group. J Clin Oncol 24:517CrossRef
21.
Perez EA (2007) Novel enhanced delivery taxanes: an update. Semin Oncol 34(3):suppl 1–5
22.
Lebowitz PF, Eng-Wong J, Swain SM et al (2004) A phase II trial of neoadjuvant docetaxel and capecitabine for locally advanced breast cancer. Clin Cancer Res 10:6764–6769PubMedCrossRef
23.
Cancer Folkman J (2005) Principles and practice of oncology. Lippincott, Williams & Wilkins, Philadelphia
24.
Gray R, Bhattacharya S, Bowden C et al (2009) Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol 27:4966–4972PubMedCrossRef
25.
Robert NJ, Dieras V, Glaspy J et al (2011) RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 29:1252–1260PubMedCrossRef
26.
Perez EA, Hillman DW, Dentchev T et al (2010) North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer. Ann Oncol 21:269–274PubMedCrossRef
27.
Cacheux W, Boisserie T, Staudacher L, Vignaux O, Dousset B, Soubrane O, Terris B, Mateus C, Chaussade S, Goldwasser F (2008) Reversible tumor growth acceleration following bevacizumab interruption in metastatic colorectal cancer patients scheduled for surgery. Ann Oncol 19:1651–1661CrossRef
28.
Richard M, Zuniga (2010) Rebound tumour progression after the cessation of bevacizumab therapy in patients with recurrent high-grade glioma. J Neurooncol 99:237–242CrossRef
29.
A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast cancer After First-line Chemotherapy and Bevacizumab Treatment. ClinicalTrials.gov identifier: NCT01250379
30.
A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer. ClinicalTrials.gov identifier: NCT01200212
Metadata
Title
The Breast Avastin Trial: phase II study of bevacizumab maintenance therapy after induction chemotherapy with docetaxel and capecitabine for the first-line treatment of patients with locally recurrent or metastatic breast cancer
Authors
G. Bisagni
A. Musolino
M. Panebianco
A. De Matteis
F. Nuzzo
A. Ardizzoni
S. Gori
T. Gamucci
R. Passalacqua
R. Gnoni
G. Moretti
C. Boni
Publication date
01-04-2013
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 4/2013
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-013-2100-6

Other articles of this Issue 4/2013

Cancer Chemotherapy and Pharmacology 4/2013 Go to the issue

Short Communication

Genetic basis for the increased expression of vacuolar H+ translocating ATPase genes upon imatinib treatment in human lymphoblastoid cells

Letter to the Editor

Clusterin inhibition to enhance tumor chemosensitivity in systemic tumors

Original Article

A phase I study of hepatic arterial infusion of nab-paclitaxel in combination with intravenous gemcitabine and bevacizumab for patients with advanced cancers and predominant liver metastases

Original Article

A phase I study of tasisulam sodium using an albumin-tailored dose in Japanese patients with advanced solid tumors

Erratum

Erratum to: Pharmacokinetic–pharmacodynamic relationship of bosutinib in patients with chronic-phase chronic myeloid leukemia

Letter to the Editor

Reply to: Clusterin inhibition to enhance tumor chemosensitivity in systemic tumors
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits