Efficacy and Safety of Trastuzumab Emtansine in Her2 Positive Metastatic Breast Cancer: Real-World Experience

Bahçeci, Aykut; Paydaş, Semra; Ak, Naziye; Ferhatoğlu, Ferhat; Saip, Pınar; Şeydaoğlu, Gülşah; Bilici, Mehmet; Şimşek, Melih; Tekin, Salim Başol; Çalıkuşu, Züleyha; Yavuz, Sinan; Şahin, Ahmet Bilgehan; Çubukçu, Erdem; Evrensel, Türkkan; Değirmencioğlu, Serkan; Demıray, Atıke Gokçen; Yumuk, Perran Fulden; Alan, Özkan; Çıkman, Duygu İlke; Demirelli, Fuat; Köstek, Osman; Gökyer, Ali; Doğan, Mutlu; Bal, Öznur; Çakar, Burcu; Gökmen, Erhan; Yamaç, Deniz; Korkmaz, Taner; Aliyev, Altay; Keskin, Özge; Urvay, Semiha; Büyükşimşek, Mahmut; Karadeniz, Cemile; Yıldız, Birol; Çınkır, Havva Yeşil; Demir, Hacer; Beypınar, İsmail; Karaçin, Cengiz; Eser, Kadir; Baykara, Meltem; Kılıçkap, Saadettin; Okutur, Kerem; Bulut, Gülcan; Alkan, Ali; Arpaci, Erkan; Pilancı, Kezban Nur; Demir, Atakan; Işik, Deniz; Yıldırım, Nilgün

doi:10.1080/07357907.2021.1933011

Cited by 11 publications

(27 citation statements)

References 12 publications

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“…In the EMILIA study, which included 991 patients receiving trastuzumab and taxane, mPFS was reported as 9.6 months in advanced breast cancer patients [12]. In a multicenter study including 441 patients, mPFS was reported as 9 months while PFS was reported as 10 months in another study conducted in Italy [13,14]. In our study, mPFS was found to be 10.4 months, similar to previous studies.…”

Section: Discussionsupporting

confidence: 88%

Efficacy and safety of trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer: a single center study

Çavdar¹,

Karaboyun²,

İriağaç³

et al. 2022

Iberoam J Med

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Introduction: Trastuzumab emtansine (T-DM1) is one of the effective treatment options in human epidermal growth factor receptor 2 (HER2) positive breast cancer patients. In this study, we aimed to find the effect of T-DM1 on survival, its tolerability and prognostic factors of T-DM1 treatment. Material and methods: The study was designed as a single-center, retrospective study that included patients treated in the oncology department of a university hospital in Turkey. HER2-positive patients with metastatic breast cancer who had a progression response to trastuzumab and taxane treatment and received T-DM1 treatment for at least 2 months between 2016-2022 were included in the study. Adverse events were defined according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE). Kaplan-Meier methodology and Cox proportional hazard modelling were used for survival analyses. Results: The median progression-free survival (mPFS) for T-DM1 was 10.4 months and the median overall survival (mOS) was 22 months. In the created univariate cox regression model, liver metastasis, ECOG performance status, and pre-treatment serum CA 15-3 were found to be factors associated with PFS. Liver metastasis (HR=2.54, p=0.019), ECOG performance status (HR=4.66, p=0.002), and serum CA 15-3 (HR= 2.55, p=0.041) maintained their statistical significance for PFS in the established multivariate analysis. In the regression analysis for OS, only ECOG performance status (HR= 2.61, p=0.023) was found to be prognostic. While toxicity occurred in 46 (82.1%) of the patients, grade 3-4 toxicity developed in 10 (17.9%) patients. The most common side effects were anemia, thrombocytopenia, fatigue and nausea. Conclusions: T-DM1 is a safe and tolerable agent that prolongs survival. Liver metastasis, ECOG performance status, and pre-treatment serum CA 15-3 levels are independent prognostic factors for patients using T-DM1.

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Section: Discussionsupporting

confidence: 88%

Efficacy and safety of trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer: a single center study

Çavdar¹,

Karaboyun²,

İriağaç³

et al. 2022

Iberoam J Med

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“…1016/j.esmoop.2022.100561). [7][8][9][10] Although the retrospective nature of some real-world studies may limit availability of safety data, findings from these studies have generally been comparable to those reported in clinical trials.…”

Section: Discussionmentioning

confidence: 68%

“…5,6 Real-world analyses of T-DM1 have generally aligned with results from these clinical trials, providing further evidence for use of this agent in previously treated mBC. [7][8][9][10] KAMILLA (NCT01702571) is a multicenter, phase IIIb trial of T-DM1 in patients with HER2-positive mBC or locally advanced BC, and was conducted as a post-approval safety measure to fulfill a commitment to the European Medicines Agency (EMA). KAMILLA comprises two cohorts: a larger global cohort 1 (n ¼ 2002 treated patients), and a smaller Asia cohort 2 (n ¼ 181 treated patients).…”

Section: Introductionmentioning

confidence: 99%

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Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer

Wuerstlein¹,

Ellis²,

Montemurro³

et al. 2022

ESMO Open

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“…Additional data for the use of trastuzumab emtansine in patients previously treated with HER2-targeted therapy plus chemotherapy will be obtained from real-world life studies. The Bahceci cohort [ 59 ] with 414 patients treated with T-DM1 in different lines, including anti HER2 therapy, shows an overall survival of 41 months, similar in first and second lines. However, in this cohort, there was a 30% of patients that are previously treated with lapatinib combinations and only 1% with pertuzumab combination.…”

Section: Advanced Breast Cancermentioning

confidence: 99%

Her2-Positive Cancers and Antibody-Based Treatment: State of the Art and Future Developments

Morales

Gasol

Sanchez

2021

Cancers

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HER2 positive breast cancer represent about 20% of all breast cancer subtypes and it was considered the subtype with the worst prognosis until the discovery of therapies directed against the HER2 protein. The determination of the status of the HER2 must be very precise and well managed to identify this subtype, and there are very specific and updated guides that allow its characterization to be adjusted. Treatment in local disease has been considerably improved with less aggressive and highly effective approaches and very high cure rates. In metastatic disease, average median survival rates of 5 years have been achieved. New highly active molecules have also been discovered that allow disease control in very complicated situations. This article reviews all these options that can be used for the management of this disease.

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Efficacy and Safety of Trastuzumab Emtansine in Her2 Positive Metastatic Breast Cancer: Real-World Experience

Cited by 11 publications

References 12 publications

Efficacy and safety of trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer: a single center study

Efficacy and safety of trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer: a single center study

Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer

Her2-Positive Cancers and Antibody-Based Treatment: State of the Art and Future Developments

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