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ORIGINAL ARTICLE
Year : 2015  |  Volume : 11  |  Issue : 5  |  Page : 125-127

Herceptin as a single agent in the treatment of patients with metastatic breast cancer


1 Department of Breast Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province 230032; Department of Oncology Surgery, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui Province 233000, China
2 Department of Oncology Surgery, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui Province 233000, China
3 Department of Breast Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province 230032, China

Date of Web Publication31-Aug-2015

Correspondence Address:
Dr. Benzhong Wang
No. 218, Jixi Road, Hefei City, Anhui Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.163868

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 > Abstract 

Objective: The aim of this retrospectively study was to assess the clinical efficacy and toxicity of Herceptin as a single agent in the treatment of patients with metastatic breast cancer (MBC).
Methods: We retrospectively included and analyzed 31 metastasis breast cancer patients in our patient database. All of the included 31 patients were pathology confirmed of breast carcinoma with remote metastases and treated with Herceptin as a single agent. The clinical efficacy and drug-related toxicity were analyzed.
Results: No complete response patients were observed for 31 cases. And 8 (26%) reached partial response 16 (52%) with stable disease. The objective response rate of the 31 patients was 23%. We further divided the 31 cases into three subgroups according to the treatment modality. The objective response rate was 36%, 14%, and 17% for the first-line, second-line, and third-line treatment modality, respectively. The objective response rate was not statistical different among the three subgroups (P > 0.05). The main drug-related adverse event were asthenia, chills, diarrhea, nausea, hypotension and dizziness with their incidence of 68%, 26%, 13%, 10%, 10%, and 6%, respectively, for each patients.
Conclusion: Herceptin as a single agent was effective and safe in the treatment of patients with MBC.

Keywords: Breast cancer, herceptin, metastases, response, toxicity


How to cite this article:
Zhang M, Guo W, Qian J, Wang B. Herceptin as a single agent in the treatment of patients with metastatic breast cancer. J Can Res Ther 2015;11, Suppl S1:125-7

How to cite this URL:
Zhang M, Guo W, Qian J, Wang B. Herceptin as a single agent in the treatment of patients with metastatic breast cancer. J Can Res Ther [serial online] 2015 [cited 2019 Sep 20];11:125-7. Available from: http://www.cancerjournal.net/text.asp?2015/11/5/125/163868


 > Introduction Top


Breast cancer can metastasize anywhere in body but primarily metastasizes to the bone, lungs, regional lymph nodes, liver, and brain, with the most common site being the bone. [1],[2] Treatment of metastatic breast cancer (MBC) depends on the location of the metastatic tumors and includes surgery, radiation, chemotherapy, biological, and hormonal therapy. [3],[4] Despite the advanced treatment modality for breast cancer, the mortality of breast cancer is relatively high in the United States with more than 43000 deaths of MBC each year. [5] Recently, investigators have evaluated the role of several molecular factors which may involve in the tumor cell proliferation or migration. The human epidermal growth factor-2 (HER2) is one of the molecular factors which was shown to be involved in cancer cell proliferation. [4],[6] Thus, the humanized anti-HER2 monoclonal antibody, Herceptin, was developed to target HER2 overexpression breast cancer patients. Here, we present a retrospective study of Herceptin as a single agent in the treatment of patients with MBC to further evaluate the clinical efficacy and toxicity.


 > Methods Top


Patients

We retrospectively included and analyzed 31 metastasis breast cancer patients in our patient database. All of the included 31 patients were pathology confirmed of breast carcinoma with remote metastases and treated with Herceptin as a single agent.

Drug administration and response evaluation

The patients in this retrospective study received Herceptin loading - dose of 4 mg/kg intravenously followed by 2 mg/kg maintenance dose of week intervals. The clinical efficacy was evaluated by response evaluation criteria in solid tumors. [7] Complete response (CR): Disappearance of all target lesions; partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Statistics

All analyses were done using the StatView version 5.0 (SAS Institute Inc., Cary, NC, USA). The objective response was demonstrated by n (%) and compared by Chi-square test with a statistical difference of P < 0.05 by two-tailed test.


 > Results Top


General characteristics of patients

We retrospectively included and analyzed 31 metastasis breast cancer patients in our patient database. All of the included 31 patients were pathology confirmed of breast carcinoma with remote metastases. The median age of the 31 cases was 42 years with its range of 25-72. The median Karnofsky Performance Status (KPS) score was 80 with the range of 70-90. Ten patients had single metastasis tumor, and other 21 had multiple metastases disease. The general characteristics of the 31 subjects are demonstrated in [Table 1].
Table 1: The general characteristics of included 31 cases


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Treatment response

No CR patients were observed for 31 cases. And 8 (26%) reached PR 16 (52%) with SD. The objective response rate of the 31 patients was 23%. We further divided the 31 cases into three subgroups according to the treatment lines. The objective response rate was 36%, 14%, and 17% for the first-line, second-line, and third-line treatment modality, respectively. The objective response rate was not statistically different among the three subgroups (P > 0.05) [Table 2].
Table 2: The response rate of the 31 included patients (n (%))


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Toxicity

The main drug-related adverse events were asthenia, chills, diarrhea, nausea, hypotension, and dizziness with their incidence of 68%, 26%, 13%, 10%, 10%, and 6%, respectively, for each patient. Moreover, the incidence of asthenia, chills, diarrhea, nausea, hypotension, and dizziness was 21%, 6%, 3%, 4%, 3%, and 3%, respectively, for the intravenous drip times [Table 3].
Table 3: The main toxicities related for Herceptin


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 > Discussion Top


According to the cancer statistical analysis, breast cancer is the leading cause of cancer-related death in women age 40 years in developed countries. [8],[9] Several studies had reported that in breast cancer, HER2 overexpression is usually associated with a more aggressive tumor phenotype and poor overall prognosis. [10],[11] Trastuzumab (Herceptin; F. Hoffmann-La Roche, Basel, Switzerland), a humanized monoclonal antibody against the extracellular domain of HER2, is established as the foundation of care for HER2-positive breast cancer and, in MBC, is indicated in combination with taxane chemotherapy or as monotherapy. [12] In the past 20 years, there were two multicenter, prospective, randomized, controlled clinical trials conducted in large numbers of HER2-positive MBC patients: A phase II trial of second- or third-line Herceptin monotherapy; [13] and a phase III first-line Herceptin combination trial. [14] The two published randomized trials showed recombinant humanized anti-HER2 monoclonal antibody, administered as a single agent, produces durable objective responses and is well-tolerated by women with HER2-overexpressing MBC that has progressed after chemotherapy for metastatic disease. [13] In our retrospective studies, we also find that Herceptin as a single agent was effective and safe in the treatment of patients with MBC.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
 > References Top

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Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011;61:69-90.  Back to cited text no. 1
    
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DeSantis C, Ma J, Bryan L, Jemal A. Breast cancer statistics, 2013. CA Cancer J Clin 2014;64:52-62.  Back to cited text no. 2
    
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Moran MS. Radiation therapy in the locoregional treatment of triple-negative breast cancer. Lancet Oncol 2015;16:e113-22.  Back to cited text no. 3
    
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Fedele P, Orlando L, Schiavone P, Calvani N, Caliolo C, Quaranta A, et al. Recent advances in the treatment of hormone receptor positive HER2 negative metastatic breast cancer. Crit Rev Oncol Hematol 2015;94:291-301.  Back to cited text no. 4
    
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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin 2015;65:5-29.  Back to cited text no. 5
    
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Rossi S, Basso M, Strippoli A, Dadduzio V, Cerchiaro E, Barile R, et al. Hormone receptor status and HER2 expression in primary breast cancer compared with synchronous axillary metastases or recurrent metastatic disease. Clin Breast Cancer 2015;pii: S1526-820900074-9.  Back to cited text no. 6
    
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Khokher S, Qureshi MU, Chaudhry NA. Comparison of WHO and RECIST criteria for evaluation of clinical response to chemotherapy in patients with advanced breast cancer. Asian Pac J Cancer Prev 2012;13:3213-8.  Back to cited text no. 7
    
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Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300.  Back to cited text no. 8
    
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Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin 2009;59:225-49.  Back to cited text no. 9
    
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Partridge AH, Gelber S, Piccart-Gebhart MJ, Focant F, Scullion M, Holmes E, et al. Effect of age on breast cancer outcomes in women with human epidermal growth factor receptor 2-positive breast cancer: Results from a herceptin adjuvant trial. J Clin Oncol 2013;31:2692-8.  Back to cited text no. 10
    
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Thierry B, Kurkuri M, Shi JY, Lwin LE, Palms D. Herceptin functionalized microfluidic polydimethylsiloxane devices for the capture of human epidermal growth factor receptor 2 positive circulating breast cancer cells. Biomicrofluidics 2010;4:32205.  Back to cited text no. 11
    
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Untch M, Muscholl M, Tjulandin S, Jonat W, Meerpohl HG, Lichinitser M, et al. First-line trastuzumab plus epirubicin and cyclophosphamide therapy in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: Cardiac safety and efficacy data from the Herceptin, Cyclophosphamide, and Epirubicin (HERCULES) trial. J Clin Oncol 2010;28:1473-80.  Back to cited text no. 12
    
13.
Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999;17:2639-48.  Back to cited text no. 13
    
14.
Dybdal N, Leiberman G, Anderson S, McCune B, Bajamonde A, Cohen RL, et al. Determination of HER2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat 2005;93:3-11.  Back to cited text no. 14
    



 
 
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