scholarly journals Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Soong June Bae ◽  
Jee Hung Kim ◽  
Sung Gwe Ahn ◽  
Hei-Cheul Jeung ◽  
Joohyuk Sohn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Targeted Therapy ◽  
Real World ◽  
Metastatic Breast ◽  
Line Treatment ◽  
Cardiac Safety ◽  
First Line ◽  
Her2 Positive ◽  
First Line Treatment

BackgroundThe trastuzumab biosimilar CT-P6 has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC). Here, we present the first real-world comparison of CT-P6 versus RTZ with dual HER2-targeted therapy for the neoadjuvant and palliative first-line treatment with HER2-positive EBC and metastatic breast cancer (MBC) patients in two tertiary hospitals in Korea.MethodsWe retrospectively investigated medical records in the Severance Breast Cancer Registry in Korea. We identified patients with HER2-positive EBC (n=254) who had received neoadjuvant chemotherapy with RTZ or CT-P6, plus pertuzumab, carboplatin and docetaxel (TCHP) and untreated stage IV MBC (n=103) who had received palliative first-line treatment with RTZ or CT-P6, plus pertuzumab and docetaxel (THP) between May 2014 and December 2019. The primary endpoints were pathologic complete response (pCR) in the EBC and progression-free survival (PFS) in the MBC cohort. Overall survival (OS), overall response rate (ORR), disease control rate (DCR), and cardiac safety were secondary endpoints.ResultsA similar percentage of EBC patients achieved a pCR with CT-P6 versus RTZ (74.4% [93/125]) vs 69.8% [90/129], p=0.411). For patients with MBC, median follow-up duration was 23.0 and 41.0 months for CT-P6 and RTZ groups, respectively; median PFS did not differ significantly between two groups (13.0 vs 18.0 months, 95% confidence intervals (CIs) 0.0-26.6 vs 11.3-24.7, p=0.976). The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups.ConclusionsThese real-world data suggest that biosimilar trastuzumab CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.

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.

Efficacy of pertuzumab in combination with trastuzumab and a taxane in first-line treatment for metastatic breast cancer (MBC): A multicenter, retrospective, observational study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12504-e12504 ◽  
Author(s):  
Teresa Gamucci ◽  
Lucia Mentuccia ◽  
Isabella Sperduti ◽  
Alain Gelibter ◽  
Loretta D'Onofrio ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Rank Test ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

e12504 Background: Pertuzumab (P) , Trastuzumab (T) and Docetaxel (D) is standard first-line treatment in patients (pts) with HER2 + metastatic breast cancer (MBC). This multicenter retrospetive observational study was performed to evaluate the activity of P and T in combination with D or Paclitaxel (Tx) in real world HER2 + MBC pts. Methods: We identified HER2 + MBC pts treated with P, T and D or Ptx optionally followed by P, T and endocrine therapy (ET) maintenance in hormone positive (HR+) BC, in 17 Italian cancer centres between 09/2012 and 08/2016. Overall Survival (OS) and Progression Free Survival (PFS) were calculated by the Kaplan-Meier product-limit method. Log-rank test was used to assess differences between subgroups. Results: 191 pts were included in our analysis. Pts characteristics: median age 54 years (range 29-80); PS 0 in 127 (67%) pts and PS 1 in 54 (28%); 107 (56%) had visceral metastases (mts), 23 (12%) only bone mts and 28 (15%) brain mts, 130 (68%) were ER/PgR +. 76 pts (40%) were metastatic at diagnosis; 148 (78) were treated with D while 43 (22%) with Tx. The ORR was 78% (CI 95% 72-84), RC 18% and RP 60%, only 10 (5%) had PD. To date, of the 54 pts treated with ET maintenance, 26% had a further improvement of response (7 pts had RC). At median follow-up of 17 months (mo) (range 6- 52), median PFS was 20 mo (95% CI 14-26) and median OS at 2 years was 80%. No differences in PFS were found for age (p = 0.92), PS (p = 0.18), receptor status (p = 0.57), visceral mts (p = 0.54) and chemotherapy (cht) type (p = 0.47), whereas number of mts site (1 vs > 1) affected PFS (28 vs 16 mo, p = 0.002). Moreover median PFS in naïve pts and in pts pretreated with only cht was 28 mo (95% CI, 20-36) and 27 mo (95% CI, 16-38) respectively, whereas in pts pretreated with T it was 12 mo (95% CI 16-38 p 0.002). In HR+ pts ET maintenance together with P and T had an impact on PFS (28 vs 15 mo, p = 0.01). Conclusions: Our analysis confirms, in real world HER2 MBC pts, the efficacy of P, T and a taxane combination in first line treatment; in this population PFS was shorter in pts pretreated with T. ET maintenance in association with P and T in HR+ pts improved PFS. Data collection is ongoing and update results will be presented.

scholarly journals Treatment patterns and clinical outcomes in patients with metastatic breast cancer treated with palbociclib-based therapies: Real-world data in the Han population

2020 ◽  
Author(s):  
Hongnan Mo ◽  
Fei Ma ◽  
Qing Li ◽  
Pin Zhang ◽  
Peng Yuan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Propensity Score ◽  
Real World ◽  
Metastatic Breast ◽  
Treatment Patterns ◽  
Line Treatment ◽  
First Line ◽  
Han Population ◽  
First Line Treatment

Abstract Background: Palbociclib combined with endocrine therapy has become the standard treatment for estrogen receptor-positive (ER+) metastatic breast cancer. However, little is known about the effectiveness of diverse palbociclib-based regimens other than letrozole and fulvestrant in the real-world clinical setting. This study aimed to reveal the treatment patterns and clinical outcomes in Han patients in routine clinical practice.Methods: The clinical data of patients with ER+ metastatic breast cancer treated with palbociclib were collected from the China National Cancer Center database. The efficacy profile of palbociclib in this Han population was evaluated, especially in patients younger than 40 years, in those with bone-only metastasis, for various regimen combinations, and as different treatment lines. Propensity score matching was employed to match patients with or without previous everolimus treatment. Results: A total of 186 patients from 89 cities in 18 provinces in China were enrolled. The median progression-free survival (PFS) was similar among different palbociclib-combined groups (P=0.566): 10.0 months (95% confidence interval [CI] 3.8–16.1) in the exemestane plus palbociclib group, 9.7 months (95% CI 6.3–13.1) in the letrozole plus palbociclib group, 7.8 months (95% CI 5.5–10.2) in the fulvestrant plus palbociclib group, 7.2 months (95% CI 3.2–11.3) in the toremifene plus palbociclib group, and 6.1 months (95% CI 1.2–11.0) in the anastrozole plus palbociclib group. Kaplan-Meier analysis revealed that patients with bone-only metastasis (median PFS: 8.8 vs. 7.8 months; P=0.023) and those who received palbociclib as first-line treatment (median PFS: 14.0 months, 95% CI 11.4–16.6; P<0.001) had prolonged PFS compared with other patients. Patients pretreated with everolimus had significantly worse PFS (3.4 months, 95% CI 0.7–6.1) than those in the everolimus-naïve group (8.8 months, 95% CI 6.6–11.0, P=0.001) in the whole population. After propensity score matching, patients pretreated with everolimus had inferior PFS (4.4 months, 95% CI 0.5–8.2) compared with everolimus-naïve patients (6.1 months, 95% CI 4.7–7.5, P=0.439). Conclusions: Various palbociclib-based regimens have promising efficacy in real-world settings, even in patients with bone-only metastasis. Palbociclib resistance is more common in patients pretreated with everolimus, and in the settings of subsequent treatment compared with first-line treatment.

Sign in / Sign up

Export Citation Format

Share Document