Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of HER2-Overexpressing Metastatic Breast Cancer

PURPOSE: To evaluate the efficacy and safety of first-line, single-agent trastuzumab in women with HER2-overexpressing metastatic breast cancer. PATIENTS AND METHODS: One hundred fourteen women with HER2-overexpressing metastatic breast cancer were randomized to receive first-line treatment with trastuzumab 4 mg/kg loading dose, followed by 2 mg/kg weekly, or a higher 8 mg/kg loading dose, followed by 4 mg/kg weekly. RESULTS: The objective response rate was 26% (95% confidence interval [CI], 18.2% to 34.4%), with seven complete and 23 partial responses. Response rates in 111 assessable patients with 3+ and 2+ HER2 overexpression by immunohistochemistry (IHC) were 35% (95% CI, 24.4% to 44.7%) and none (95% CI, 0% to 15.5%), respectively. The clinical benefit rates in assessable patients with 3+ and 2+ HER2 overexpression were 48% and 7%, respectively. The response rates in 108 assessable patients with and without HER2 gene amplification by fluorescence in situ hybridization (FISH) analysis were 34% (95% CI, 23.9% to 45.7%) and 7% (95% CI, 0.8% to 22.8%), respectively. Seventeen (57%) of 30 patients with an objective response and 22 (51%) of 43 patients with clinical benefit had not experienced disease progression at follow-up at 12 months or later. The most common treatment-related adverse events were chills (25% of patients), asthenia (23%), fever (22%), pain (18%), and nausea (14%). Cardiac dysfunction occurred in two patients (2%); both had histories of cardiac disease and did not require additional intervention after discontinuation of trastuzumab. There was no clear evidence of a dose-response relationship for response, survival, or adverse events. CONCLUSION: Single-agent trastuzumab is active and well tolerated as first-line treatment of women with metastatic breast cancer with HER2 3+ overexpression by IHC or gene amplification by FISH.

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Efficacy and safety of adding an agent to bevacizumab/taxane regimens for the first-line treatment of Her2-negative patients with locally recurrent or metastatic breast cancer: results from seven randomized controlled trials

OncoTargets and Therapy ◽

10.2147/ott.s103954 ◽

2016 ◽

Vol Volume 9 ◽

pp. 3771-3781 ◽

Cited By ~ 3

Author(s):

Xiao-Qun Liu ◽

Xiangdong Liu ◽

Tiankui Qiao ◽

Wei Chen ◽

Sujuan Yuan

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

Controlled Trials ◽

Line Treatment ◽

Efficacy And Safety ◽

First Line ◽

Randomized Controlled ◽

Locally Recurrent ◽

First Line Treatment

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Phase II Study of Single-Agent Pegylated Liposomal Doxorubicin HCl (PLD) in Metastatic Breast Cancer After First-Line Treatment Failure

Oncology Research and Treatment ◽

10.1159/000080363 ◽

2004 ◽

Vol 27 (5) ◽

pp. 441-446 ◽

Cited By ~ 7

Author(s):

B. Mlineritsch ◽

P. Mayer ◽

C. Rass ◽

E. Reiter ◽

G. Russ ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Liposomal Doxorubicin ◽

Phase Ii Study ◽

Single Agent ◽

Metastatic Breast ◽

Pegylated Liposomal Doxorubicin ◽

Line Treatment ◽

First Line ◽

First Line Treatment

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Open label, comparative, randomised, multicentre study of trastuzumab given with docetaxel versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for Her2neu+++ metastatic breast cancer patients

http://isrctn.org/> ◽

10.1186/isrctn13770586 ◽

2012 ◽

Author(s):

J.G.M. Klijn

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Single Agent ◽

Metastatic Breast ◽

Line Treatment ◽

Breast Cancer Patients ◽

First Line ◽

Open Label ◽

Single Agent Therapy ◽

First Line Treatment

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Single-agent docetaxel (TXT) as first-line treatment in metastatic breast cancer (MBC)

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.11515 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 11515-11515

Author(s):

D. Guarneri ◽

R. Ratti ◽

A. Venturino ◽

G. Addamo ◽

Z. Coccorullo ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Single Agent ◽

Metastatic Breast ◽

Line Treatment ◽

First Line ◽

Group 2 ◽

Agent Treatment ◽

First Line Treatment ◽

Group 1

11515 Background: Historically anthracyclines have been considered the most active agents in metastatic breast cancer (MBC). Docetaxel (TXT) has challenged this belief. Aims: Evaluate response rates, toxicity and time to progression in patients with MBC receiving single agent TXT as first line treatment. Methods: MBC patients received first line single agent treatment according to one of the following schedules: TXT 35 mg/m2 iv weekly for 6 wks q 8 wks (Group 1) or TXT 100 mg/m2 iv day 1 q 3 weeks (Group 2). Adjuvant chemotherapy was FAC (600,50,600) day 1 q 21 days for 6 courses in all cases so treated. Results: Conclusions: It appears that results with single agent TXT obtained in clinical practice are comparable to those reported in Phase II-III trials (Group 1 and Group 2, respectively ) using the same regimens. [Table: see text] No significant financial relationships to disclose.

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Efficacy and safety of bevacizumab in combination with docetaxel for the first-line treatment of elderly patients with locally recurrent or metastatic breast cancer: Results from AVADO

European Journal of Cancer ◽

10.1016/j.ejca.2011.06.018 ◽

2011 ◽

Vol 47 (16) ◽

pp. 2387-2395 ◽

Cited By ~ 61

Author(s):

Xavier Pivot ◽

Andreas Schneeweiss ◽

Shailendra Verma ◽

Christoph Thomssen ◽

José Luis Passos-Coelho ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Elderly Patients ◽

Metastatic Breast ◽

Line Treatment ◽

Efficacy And Safety ◽

First Line ◽

Locally Recurrent ◽

First Line Treatment

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Current problems in the first-line treatment of metastatic breast cancer: focus on the role of docetaxel

Clinical Management Issues ◽

10.7175/cmi.v4i3.526 ◽

2010 ◽

Vol 4 (3) ◽

pp. 97-107

Author(s):

Filippo Montemurro

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Complete Remission ◽

Liver Metastases ◽

Single Agent ◽

Metastatic Breast ◽

Line Treatment ◽

First Line ◽

First Line Treatment

Metastatic breast cancer is a very heterogeneous disease, both from a clinical and a biological point of view. Despite being still incurable, the expanding therapeutic repertoire has determined a progressive increase in median survival. We describe the clinical course of a 67-year-old woman with a locally advanced, hormone-receptor positive breast cancer with synchronous liver metastases. Single-agent docetaxel at the dose of 100 mg/m2 for 8 cycles determined a pathological complete remission in the breast and a near complete remission of liver metastases. After more than 4 years from diagnosis, the patient is alive and without signs of tumour progression. Based on this clinical case, we discuss management issues like the choice of the initial treatment, the use of monochemotherapy vs polychemotherapy, the worth of surgery of the primary tumour in patients with stage IV disease, and the issue of maintenance endocrine therapy. Furthermore, we reviewed the pivotal role of docetaxel in the management of advanced breast cancer. Whether monochemotherapy or polychemotherapy is felt to be an adequate choice in the clinical practice, docetaxel qualifies as one of the most active and manageable agents. Single agent activity ranging from 20-48% in terms of response rate has been reported in several clinical trials in patients treated in various clinical settings. Docetaxel-based combinations with other cytotoxic agents have become established in the first line treatment both in patients with anthracycline-resistant and anthracycline-sensitive metastatic breast cancer. Finally, docetaxel has been shown to be an optimal companion drug for biologically targeted agents like trastuzumab or bevacizumab, resulting in further treatment options.

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