scholarly journals Comparative effectiveness of trastuzumab emtansine versus lapatinib plus capecitabine for HER2+ metastatic breast cancer

2020 ◽  
Author(s):  
Sreeram V Ramagopalan ◽  
Riccardo Pisoni ◽  
Aleksandr Zenin ◽  
Lokendra Singh Rathore ◽  
Joshua Ray ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Comparative Effectiveness ◽  
Metastatic Breast ◽  
World Population ◽  
Trastuzumab Emtansine ◽  
Line Treatment ◽  
Second Line

Aim: To investigate the comparative effectiveness of trastuzumab emtansine (T-DM1) in a real-world population of HER2+ metastatic breast cancer (mBC) patients. Materials and methods: The Flatiron Health database was used to identify a cohort of HER2+ mBC patients who received first-line trastuzumab treatment and T-DM1 or lapatinib plus capecitabine as second-line treatment. Overall survival was compared between the two groups. Results: Three hundred and forty-five patients with HER2+ mBC received second-line T-DM1 and 65 lapatinib plus capecitabine. Overall survival was longer in patients treated with T-DM1 than those treated with lapatinib plus capecitabine (adjusted hazard ratio: 0.61; 95% CI: 0.41–0.91). Conclusion: Real-world data supports the effectiveness of T-DM1 in the second-line treatment of HER2+ mBC patients.

scholarly journals First- and second-line treatment strategies for hormone-receptor (HR)-positive HER2-negative metastatic breast cancer: A real-world study

The Breast ◽  
2021 ◽  
Vol 57 ◽  
pp. 104-112
Author(s):  
Debora Basile ◽  
Lorenzo Gerratana ◽  
Carla Corvaja ◽  
Giacomo Pelizzari ◽  
Giorgia Franceschin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Hormone Receptor ◽  
Treatment Strategies ◽  
Metastatic Breast ◽  
Line Treatment ◽  
Second Line

scholarly journals Evaluation of biosimilar trastuzumab MYL-1401O in HER2-positive early-stage and metastatic breast cancer in real-life data

2021 ◽  
Author(s):  
Kadir Eser ◽  
Emel Sezer ◽  
Vehbi Erçolak ◽  
Ali İnal
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Targeted Therapy ◽  
Neoadjuvant Chemotherapy ◽  
Real World ◽  
Metastatic Breast ◽  
Line Treatment ◽  
Second Line ◽  
Cardiac Safety ◽  
Her2 Positive

Abstract Background The trastuzumab biosimilar MYL-1401O has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) as non-dual HER2 therapy. Here, we present the first real-world comparison of MYL-1401O versus RTZ with single/dual HER2-targeted therapy for the neoadjuvant, adjuvan and palliative first-/second-line treatment with HER2-positive early breast cancer (EBC) and metastatic breast cancer (MBC) patients in two tertiary hospitals in Turkey. Methods We retrospectively investigated medical records in the Severance Breast Cancer Registry in Turkey. We identified patients with HER2-positive EBC (n=159) who had received neoadjuvant chemotherapy (n= 92) with RTZ or MYL-1401O±pertuzumab and adjuvant chemotherapy (n=67) with RTZ or MYL-1401O plus taxan between january 2018 and jun 2021. Stage IV MBC (n=53) who had received palliative first-line treatment with RTZ or MYL-1401O, and docetaxel±pertuzumab (THP) or second-line treatment with RTZ or MYL-1401O, and taxan between january 2018 and jun 2021. Primary endpoints were pathological complete response in neoadjuvant grup (pCR) and progression-free survival (PFS) in adjuvant and metastatic grup. Secondary endpoints in the metastatic patient group (MBC) was overall response rate (ORR), disease control rate (DCR) and cardiac safety. Results The rate of achieving pCR in the group receiving neoadjuvant chemotherapy was similar between MYL and RTZ (62.7% [37/59] and 55.9% [19/34] p=0.509). Median PFS similar in EBC-adjuvant group, 12-24-36 months PFS respectively 96.3%, 84.7%, 71.5% in patients with MYL and 100%, 88.5%, 64.8% in patients with RTZ (95% CI p=0.577). Median PFS similar in metastatic group, 23.0 (9.8-16.1) months in patients with MYL-1401O and 23 (19.9-26.0) months in patients with RTZ (95% CI p=0.270). The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups. Conclusion These real-world data suggest that biosimilar trastuzumab MYL-1401O has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients when administered as part of single/dual HER2-targeted therapy with chemotherapy in the neoadjuvant, adjuvant or palliative setting.

scholarly journals Clinical benefit of treatment after trastuzumab emtansine for HER2-positive metastatic breast cancer: a real-world multi-centre cohort study in Japan (WJOG12519B)

Breast Cancer ◽  
2021 ◽  
Author(s):  
Takamichi Yokoe ◽  
Sasagu Kurozumi ◽  
Kazuki Nozawa ◽  
Yukinori Ozaki ◽  
Tetsuyo Maeda ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cohort Study ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Treatment Strategies ◽  
Metastatic Breast ◽  
Trastuzumab Emtansine ◽  
Breast Cancer Patients ◽  
Her2 Positive

Abstract Background Trastuzumab emtansine (T-DM1) treatment for human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer after taxane with trastuzumab and pertuzumab is standard therapy. However, treatment strategies beyond T-DM1 are still in development with insufficient evidence of their effectiveness. Here, we aimed to evaluate real-world treatment choice and efficacy of treatments after T-DM1 for HER2-positive metastatic breast cancer. Methods In this multi-centre retrospective cohort study involving 17 hospitals, 325 female HER2-positive metastatic breast cancer patients whose post-T-DM1 treatment began between April 15, 2014 and December 31, 2018 were enrolled. The primary end point was the objective response rate (ORR) of post-T-DM1 treatments. Secondary end points included disease control rate (DCR), progression-free survival (PFS), time to treatment failure (TTF), and overall survival (OS). Results The median number of prior treatments of post-T-DM1 treatment was four. The types of post-T-DM1 treatments included (1) chemotherapy in combination with trastuzumab and pertuzumab (n = 102; 31.4%), (2) chemotherapy concomitant with trastuzumab (n = 78; 24.0%), (3), lapatinib with capecitabine (n = 63; 19.4%), and (4) others (n = 82; 25.2%). ORR was 22.8% [95% confidence interval (CI): 18.1–28.0], DCR = 66.6% (95% CI 60.8–72.0), median PFS = 6.1 months (95% CI 5.3–6.7), median TTF = 5.1 months (95% CI 4.4–5.6), and median OS = 23.7 months (95% CI 20.7–27.4). Conclusion The benefits of treatments after T-DM1 are limited. Further investigation of new treatment strategies beyond T-DM1 is awaited for HER2-positive metastatic breast cancer patients.

scholarly journals Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917)

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Takahiro Nakayama ◽  
Tetsuhiro Yoshinami ◽  
Hiroyuki Yasojima ◽  
Nobuyoshi Kittaka ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Metastatic Breast ◽  
Trastuzumab Emtansine ◽  
Her2 Positive ◽  
The Real ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Abstract Background Trastuzumab emtansine (T-DM1) is a second-line standard therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Evidence regarding post–T-DM1 treatments is currently lacking. We evaluated the effectiveness of post–T-DM1 drug therapy in patients with HER2-positive, unresectable and/or metastatic breast cancer. Methods In this multicenter, retrospective, observational study, real-world clinical data of female patients with HER2-positive breast cancer who had a history of T-DM1 treatment were consecutively collected from five sites in Japan. We investigated the effectiveness of post–T-DM1 therapy by evaluating the real-world progression-free survival (rwPFS), time to treatment failure (TTF), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Tumor response was assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines. Subgroup and exploratory analyses according to background factors were also undertaken. Results Of the 205 patients who received T-DM1 treatment between 1 January 2014 and 31 December 2018, 128 were included in this study. Among the 128 patients analyzed, 105 (82%) patients received anti-HER2 therapy and 23 (18%) patients received regimens without anti-HER2 therapy. Median (95% confidence interval [CI]) rwPFS, TTF, and OS were 5.7 (4.8–6.9) months, 5.6 (4.6–6.4) months, and 22.8 (18.2–32.4) months, respectively. CBR and ORR (95% CI) were 48% (38.8–56.7) and 23% (15.1–31.4), respectively. Cox-regression analysis showed that an ECOG PS score of 0, a HER2 immunohistochemistry score of 3+, recurrent type, ≥12 month duration of T-DM1 therapy, and anti-HER2 therapy were independent variables for rwPFS. An exploratory subgroup analysis of regimens after T-DM1 showed that those with anti-HER2 therapy had a median rwPFS of 6.3 and those without anti-HER2 therapy had a median rwPFS of 4.8 months. Conclusions In the real-world setting in Japan, several post–T-DM1 regimens for patients with unresectable and/or metastatic HER2-positive breast cancer, including continuation of anti-HER2 therapy, showed some effectiveness; however, this effectiveness was insufficient. Novel therapeutic options are still needed for further improvement of PFS and OS in later treatment settings. Trial registration UMIN000038296; registered on 15 October 2019.

scholarly journals Cost Effectiveness Analysis of Eribulin Mesylate as a Treatment for Metastatic Breast Cancer in Spain: Management in the Later Line of Therapy

10.36469/9834 ◽  
2015 ◽  
Vol 3 (2) ◽  
pp. 180-193
Author(s):  
Gabriel Tremblay ◽  
Unnati Majethia ◽  
Ilias Kontoudis ◽  
Jesús De Rosendo
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Metastatic Breast ◽  
Sensitivity Analyses ◽  
Line Treatment ◽  
Second Line ◽  
Life Years ◽  
Third Line ◽  
Third Line Treatment

Background: Two thirds (62%) of metastatic breast cancer (MBC) patients in Western Europe have human epidermal growth factor receptor 2 (HER2)-negative disease, for which anthracyclines and taxanes are recommended as first-line treatments, followed by microtubule-targeting agents such as capecitabine, vinorelbine and/or eribulin. The study objective was to compare the cost-effectiveness of eribulin in Spain as a second-line treatment for HER2-negative MBC with its current status as a third-line treatment for patients who have received capecitabine. Methods: A Markov model was developed from the perspective of the Spanish healthcare system. The model had three health states: Stable; Progression and Death. In Stable, patients received eribulin or: capecitabine and vinorelbine for HER2-negative patients; primary treatment of physician’s choice (TPC) for post-capecitabine patients. In Progression, all patients received secondary TPC. Model inputs were overall survival, progression-free survival and costs relating to chemotherapies, grade 3/4 adverse events and healthcare utilization. Sensitivity analyses were conducted to identify uncertainty. Results: As second-line treatment, Eribulin was associated with a greater incremental benefit in life years (LYs) and quality-adjusted life years (QALYs) than capecitabine and vinorelbine. Erubilin as third-line treatment was associated with greater benefit in life years (LYs) and QALYs than TPC. The incremental cost-effectiveness ratios (ICERs) for eribulin were higher in the second-line than the third-line setting in terms of LYs (€35,149 versus €24,884) and QALYs (€37,152 versus €35,484). In both settings, deterministic sensitivity analyses demonstrated that the ICER is most sensitive to the eribulin price. Conclusion: Eribulin is cost-effective as second-line treatment for HER2-negative MBC patients in Spain; albeit, slightly less so than as third-line treatment for MBC patients who have received capecitabine (an ICER per QALY difference of €1,668). This difference may fall within the margin of error for the model and could potentially be addressed by a minor reduction in the eribulin price.

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