Risk of Congestive Heart Failure in Early Breast Cancer Patients Undergoing Adjuvant Treatment With Trastuzumab: A Meta-Analysis

Long, Huidong; Lin, Yingsong; Zhang, Juanjuan; Zhong, Wen‐Zhao; Ren, Zheng

doi:10.1634/theoncologist.2015-0424

Cited by 42 publications

(33 citation statements)

References 34 publications

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“…We updated the previous meta-analyses by including new and latest RCTs with the longest follow up period report to date [28][29][30][31]35]. Our results were consistent with the results of previous meta-analyses [14][15][16][17][18][19][20] which showed risk reduction for death and recurrence by about 30% to 34% and 36% to 50%, respectively. Likewise, our pooled results showed increasing risk of CHF and LVEF decline by about 3.71 and 2.17 times, respectively, which corresponded with previous meta-analyses results of 2.45 to 7.60 times for CHF and 1.88 to 2.45 times for LVEF decline.…”

Section: Discussionsupporting

confidence: 82%

“…As for our knowledge, there were seven meta-analyses (N = 4-6 randomized controlled trials, RCTs) [14][15][16][17][18][19][20] and three systematic reviews only (N = 5-6 RCTs) [21][22][23]. Results of the seven metaanalyses [14][15][16][17][18][19][20] indicated that adjuvant trastuzumab with chemotherapy in treating HER2-positive EBC patients significantly improved the OS and DFS when compared to chemotherapy alone with a reduction in the risk of mortality ranging from about 30% to 34%, and a reduction in the risk of recurrence ranging from 34% to 50%. However, none of them comprehensively explored which prognostic factors (i.e., cycle regimen, type of administration, and the combined chemotherapy type) might affect both the relative treatment efficacy and safety.…”

Section: Introductionmentioning

confidence: 99%

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Adjuvant trastuzumab regimen for HER2-positive early-stage breast cancer: a systematic review and meta-analysis

Genuino¹,

Chaikledkaew

Reungwetwattana

et al. 2019

Expert Review of Clinical Pharmacology

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Objective: Breast cancer remains to be the globally leading female cancer. About 15% to 20% of breast cancers have human epidermal growth factor receptor 2 (HER2)-positive tumors – a more aggressive breast cancer subtype with shortened survival. In the light of new and updated trial data on trastuzumab therapy for HER2-positive early-stage breast cancer (EBC), we conducted a systematic review and meta-analysis to update the pooling of its relative treatment effects.Methods: Systematic search was performed through Pubmed and Scopus to identify studies comparing survival outcomes and risks of heart toxicity effects of adjuvant trastuzumab with chemotherapy versus chemotherapy alone for HER2-positive EBC patients.Results: Based on the eight included studies in the review, combining trastuzumab with chemotherapy continues to show lowered death and relapse risks by one-third. The decision to initiate trastuzumab, however, needs to be prudently deliberated as two to three times more cardiotoxicity risk was shown to be associated with its use.Conclusion: Administering adjuvant trastuzumab in a weekly cycle concurrently with anthracycline-taxane chemotherapy regimen appears to be a preferable option to optimize its favorable effect in improving DFS and to prevent significantly higher risk for cardiotoxic effects.

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Section: Discussionsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Adjuvant trastuzumab regimen for HER2-positive early-stage breast cancer: a systematic review and meta-analysis

Genuino¹,

Chaikledkaew

Reungwetwattana

et al. 2019

Expert Review of Clinical Pharmacology

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“…In addition, significant decline in LVEF was more common AC-DH group than the TCH group (18.6% vs. 9.4%, p<0.001), with a rate of 11.2% in the AC-D group (28). A subsequent meta-analysis of adjuvant treatment trials (n=18,111) confirmed that adjuvant trastuzumab is associated with an increased risk of grade 3 and 4 CHF [RR 3.04 (95 % CI 1.12 to 7.85; p<0.00001)], but absolute rates are still low (29). The majority of episodes of LVEF decline do not progress to clinical CHF, instead resolving quickly after cessation of therapy (often with medical intervention).…”

Section: Incidence Timing and Risk Factors For Trastuzumab-related mentioning

confidence: 99%

Incidence, Diagnosis, and Treatment of Cardiac Toxicity From Trastuzumab in Patients With Breast Cancer

Nowsheen

Viscuse

O’Sullivan

et al. 2017

Curr Breast Cancer Rep

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Purpose of review Treatment with trastuzumab is a cornerstone of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer treatment, but carries an unfortunate risk of toxicity to the cardiovascular system. Here we review recent findings on trastuzumab-associated cardiotoxicity, focusing on its incidence, diagnosis, and treatment. Recent findings Screening with multigated acquisition scan (MUGA) or echocardiogram (ECHO) is recommended to assess cardiac function prior to and during trastuzumab therapy. Because trastuzumab-induced cardiotoxicity is typically reversible, cessation of trastuzumab and/or administration of first line heart failure agents effectively restores cardiac function in most cases. Severe trastuzumab-induced cardiotoxicity is rare enough that the risk-benefit ratio still weighs in favor of its use in the vast majority of patients with HER2+ breast cancer. Summary An improved understanding of the pathophysiology underlying trastuzumab-induced cardiotoxicity and the identification of patients at highest risk will allow us to continue to safely administer trastuzumab in patients with breast cancer.

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“…Left ventricular systolic dysfunction is the most concerning cardiac toxicity associated with trastuzumab, particularly when it is administered in combination with an anthracycline [7]. Adjuvant clinical trials of trastuzumab have reported severe heart failure in 1.44-4% of patients; the overall risk ratio (RR) of high-grade heart failure was reported to be 3.04-fold higher with trastuzumab than without [9,10]. Moreover, up to 19% of patients were reported to have developed a significant decline in left ventricular ejection fraction (LVEF) [9,11].…”

Section: Introductionmentioning

confidence: 99%

Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study

et al. 2020

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Introduction Although the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation. Objective In this prespecified analysis, we compared the cardiac safety of the trastuzumab biosimilar ABP 980 (KAN-JINTI™) and the trastuzumab reference product (RP; Herceptin ®) in the phase III LILAC study (ClinicalTrials.gov identifier NCT01901146). Methods In the neoadjuvant phase of LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to ABP 980 (n = 364) or trastuzumab RP (n = 361) plus paclitaxel (every 3 weeks [Q3W] or every week [QW]) for four cycles. After surgery, patients continued treatment Q3W for up to 1 year; ABP 980-treated patients continued ABP 980 (ABP 980/ABP 980; n = 364), and trastuzumab RP-treated patients either continued on the RP (trastuzumab RP/trastuzumab RP; n = 190) or switched to ABP 980 (trastuzumab RP/ABP 980; n = 171). Cardiac safety was monitored by computerized 12-lead electrocardiogram, and left ventricular ejection fraction (LVEF) was assessed by two-dimensional (2D) echocardiogram. LVEF decline was defined as LVEF value decrease from study baseline by ≥ 10 percentage points and to < 50%. Results Over the entire study, 22 (3.1%) patients had protocol-defined LVEF decline; no meaningful between-group differences were observed (ABP 980/ABP 980: 2.8%; trastuzumab RP/trastuzumab RP: 3.3%; trastuzumab RP/ABP 980: 3.5%). The incidence of cardiac adverse events was low and comparable in the treatment groups. One grade 3 cardiac failure event reported in the trastuzumab RP/ABP 980 arm, and another in the trastuzumab RP/trastuzumab RP arm, were coincident with LVEF decline. One patient discontinued the investigational product during the adjuvant phase because of cardiac failure. Conclusion These prespecified analyses confirm the tolerability of ABP 980 and demonstrate clinical similarity of ABP 980 and trastuzumab RP with respect to cardiac safety. No new cardiac safety signals were observed whether patients were receiving ABP 980 or switched from the RP to ABP 980.

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Risk of Congestive Heart Failure in Early Breast Cancer Patients Undergoing Adjuvant Treatment With Trastuzumab: A Meta-Analysis

Cited by 42 publications

References 34 publications

Adjuvant trastuzumab regimen for HER2-positive early-stage breast cancer: a systematic review and meta-analysis

Adjuvant trastuzumab regimen for HER2-positive early-stage breast cancer: a systematic review and meta-analysis

Incidence, Diagnosis, and Treatment of Cardiac Toxicity From Trastuzumab in Patients With Breast Cancer

Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study

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