<abstract xmlns="http://www.w3.org/1999/xhtml"><sec id="j_fco-2016-0007_s_333_w2aab3b8b8b1b7b1aab1c13b1Aa"><h3>Purpose</h3><p>Adjuvant trastuzumab is currently an internationally standard for the treatment of localised breast cancer that over express HER2 with the most adverse effect being cardiotoxicity. We conducted this study to evaluate the cardiac safety of trastuzumab in clinical practice.</p></sec><sec id="j_fco-2016-0007_s_334_w2aab3b8b8b1b7b1aab1c13b2Aa"><h3>Methods</h3><p>This study is a retrospective observational single institutional study conducted in the Oncology Center of King Abdulla Medical City (KAMC), Makkah, Saudi Arabia, from June 2011 to January 2014. We evaluated the incidence of cardio toxicity and associated risk factors during adjuvant trastuzumab treatment.</p></sec><sec id="j_fco-2016-0007_s_335_w2aab3b8b8b1b7b1aab1c13b3Aa"><h3>Results</h3><p>Of 57 patients, 20 patients (35%) exhibited cardiotoxicity. About 14% of patients had drop of left ventricular ejection fraction (LVEF) below 50%, whilst 10% and 15% drop of LVEF below their baseline levels were found in 30% and 5% of patients, respectively. About 98.3% of our patients have completed treatment, of whom 21% had a provisional interruption because of a fall in LVEF. A definitive trastuzumab discontinuation has been made in 1.75% of cases because of a nonregressive reduction in LVEF. Analysis of risk factors related to trastuzumab cardio toxicity found that patients older than 40 years were more likely to develop cardio toxicity compared to those younger than 40 years. This difference was statistically significant (p = 0.042).</p></sec><sec id="j_fco-2016-0007_s_336_w2aab3b8b8b1b7b1aab1c13b4Aa"><h3>Conclusion</h3><p>In our study, the cardiac safety seems comparable with the literature data. Trastuzumab-related cardiotoxicity is manifested by an asymptomatic decrease in the LVEF and less commonly by clinical heart failure. Most instances are transient, asymptomatic and reversible.</p></sec></abstract>

PurposeAdjuvant trastuzumab is currently an internationally standard for the treatment of localised breast cancer that over express HER2 with the most adverse effect being cardiotoxicity. We conducted this study to evaluate the cardiac safety of trastuzumab in clinical practice.MethodsThis study is a retrospective observational single institutional study conducted in the Oncology Center of King Abdulla Medical City (KAMC), Makkah, Saudi Arabia, from June 2011 to January 2014. We evaluated the incidence of cardio toxicity and associated risk factors during adjuvant trastuzumab treatment.ResultsOf 57 patients, 20 patients (35%) exhibited cardiotoxicity. About 14% of patients had drop of left ventricular ejection fraction (LVEF) below 50%, whilst 10% and 15% drop of LVEF below their baseline levels were found in 30% and 5% of patients, respectively. About 98.3% of our patients have completed treatment, of whom 21% had a provisional interruption because of a fall in LVEF. A definitive trastuzumab discontinuation has been made in 1.75% of cases because of a nonregressive reduction in LVEF. Analysis of risk factors related to trastuzumab cardio toxicity found that patients older than 40 years were more likely to develop cardio toxicity compared to those younger than 40 years. This difference was statistically significant (p = 0.042).ConclusionIn our study, the cardiac safety seems comparable with the literature data. Trastuzumab-related cardiotoxicity is manifested by an asymptomatic decrease in the LVEF and less commonly by clinical heart failure. Most instances are transient, asymptomatic and reversible.

Cardiotoxicity of the adjuvant trastuzumab in a Saudi population: clinical experience of a single institution

Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Mansoura University, Egypt, Mansoura,

Cardiology, King Abdulla Medical City Makkah, Kingdom of

Medical Oncology, Oncology Center of King Abdulla Medical City (KAMC), Makkah, Kingdom of

Forum of Clinical Oncology

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

PurposeAdjuvant trastuzumab is currently an internationally standard for the treatment of localised breast cancer that over express HER2 with the most adverse...

Characteristics	Numbers	%
Age
<40 years	13	25.2
>40 years	44	74.8

Menopausal Status
premenopausal	32	56.4
postmenopausal	22	38.2
perimenopausal	3	5.4

Breast
Right	22	38.2
Left	33	57.4
Bilateral	2	3.4

Tumour size
T1	20	34.6
T2	30	51.9
T3	6	11.7
T4	1	1.8

Lymph nodes
N0	22	8.2
N1	18	30.8
N2	6	11.7
N3	11	19.3

Stage
I	10	17.3
II	30	51.9
III	17	30.8

Hormone receptor status
Positive	34	58.8
Negative	23	41.2

Surgery
MRM	44	76.9
Conservative	13	23.1

Chemotherapy
Anthracycline+taxane	42	73.1
Anthracycline only	10	17.3
Taxane only	5	9.6

Radiotherapy
Yes	44	76.9
No	13	23.1

Risk factor	Group with no cardiac complications % Number		Group with cardiac complications % Number		P value
Age
>40	32.4	12	70	14	0.042
<40	67.6	25	30	6

BMI <25	43.6	16	25	5	0.322
>25	56.4	21	75	15

Hypertension					0.323
Yes	24.3	9	45	9
No	75.7	28	55	11

Diabetes					0.127
Yes	13.5	5	45	9
No	86.5	32	55	11

Chemotherapy
With anthracycline	91.8	33	95	19	1.000
Without anthracycline	8.2	4	5	1

Concomitant radiotherapy
Yes	54	20	75	15	0.323
No	46	13	25	5

Cardiotoxicity criteria	No. patients	Percentage of patients with cardiotoxicity (%)	Percentage of patient total (%)
LVEF decrease <50%	8	40	14

LVEF decrease >10 points below baseline	17	85	30

LVEF decrease > 15 points below baseline	3	15	5%

Cardiotoxicity of the adjuvant trastuzumab in a Saudi population: clinical experience of a single institution

Published Online: Dec 30, 2016

Page range: 1 - 6

Received: Feb 23, 2016

Accepted: Oct 14, 2016

DOI: https://doi.org/10.1515/fco-2016-0007

Keywords
Cardiotoxicity, Adjuvant trastuzumabin, Breast cancer

© 2016 De Gruyter Open

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Characteristics of patients and treatment.

Risk factors in group with and without cardiac complications.

Characteristics of the LVEF decrease in patients with cardiotoxicity (n = 20).

Cardiotoxicity of the adjuvant trastuzumab in a Saudi population: clinical experience of a single institution

Published Online: Dec 30, 2016

Page range: 1 - 6

Received: Feb 23, 2016

Accepted: Oct 14, 2016

DOI: https://doi.org/10.1515/fco-2016-0007

KeywordsCardiotoxicity, Adjuvant trastuzumabin, Breast cancer

© 2016 De Gruyter Open

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Characteristics of patients and treatment.

Risk factors in group with and without cardiac complications.

Characteristics of the LVEF decrease in patients with cardiotoxicity (n = 20).

Keywords
Cardiotoxicity, Adjuvant trastuzumabin, Breast cancer