scholarly journals Anti-HER2 Therapy Beyond Second-Line for HER2- Positive Metastatic Breast Cancer: A Short Review and Recommendations for Several Clinical Scenarios from a Spanish Expert Panel

Breast Care ◽  
2016 ◽  
Vol 11 (2) ◽  
pp. 133-138 ◽  
Author(s):  
Noelia Martínez-Jañez ◽  
Ignacio Chacón ◽  
Ana de Juan ◽  
Luis Cruz-Merino ◽  
Sònia del Barco ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Treatment Options ◽  
Objective Response ◽  
Local Treatment ◽  
Metastatic Breast ◽  
Line Treatment ◽  
Second Line ◽  
Her2 Positive ◽  
Clinical Scenarios

Background: The aim of this project was to provide an expert opinion regarding anti-human epidermal growth factor receptor 2 (HER2) therapy beyond second-line treatment of metastatic breast cancer (mBC). Methods: A group of experts discussed specific issues concerning anti-HER2 therapy in late-line settings in mBC. Results: Trastuzumab emtansine (T-DM1) or dual HER2 blockade appeared to be good options for HER2-positive mBC after ≥ 2 HER2-targeted therapies. Once an objective response has been achieved with anti-HER2-containing therapy, the anti-HER2 agent can be continued until progression of the disease, unacceptable toxicity or patient decision. mBC treated with ≥ 3 consecutive lines of anti-HER therapy, ≥ 1 being a dual HER2 blockade and with early progression of disease during a fourth or later-line treatment, are clinically resistant to anti-HER therapy. For progression of metastasis in the brain after anti-HER2 therapy, lapatinib and chemotherapy appear to be a good alternative after best local treatment. Conclusions: Further clinical trials are needed to provide valuable knowledge about the best treatment options in the later settings of mBC.

scholarly journals Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Yi Li ◽  
Yixuan Qiu ◽  
Huihui Li ◽  
Ting Luo ◽  
Wei Li ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Brain Metastases ◽  
Objective Response ◽  
Metastatic Breast ◽  
Second Line ◽  
Her2 Positive ◽  
Real World Data ◽  
Clinical Trial Registration ◽  
Line Therapy

IntroductionPyrotinib plus capecitabine has been approved in China for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Meanwhile, vinorelbine is another important chemotherapy option for MBC available in oral and intravenous forms. Thus, pyrotinib plus vinorelbine may represent a new treatment option, particularly for patients with failed capecitabine treatment. This study reported the first real-world data for pyrotinib plus vinorelbine therapy in HER2+ MBC.MethodsHER2+ MBC patients (n = 97) treated with pyrotinib plus vinorelbine in six institutions across China from May 2018 to June 2020 were enrolled. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and toxicity profiles were determined.ResultsSixty-seven percent of patients received more than two lines of systematic therapy. Nearly all patients (97.9%) had received trastuzumab and 50.5% were administered lapatinib. When combined with pyrotinib, 74.2% received oral and 25.8% received intravenous vinorelbine. Median PFS (mPFS) was 7.8 (range, 4.7–10.8) months for all patients. The mPFS in patients administered pyrotinib as second-line therapy and third-or-higher-line therapy were 12.0 and 6.4 months, respectively. Patients who received pyrotinib plus oral or intravenous vinorelbine had similar mPFS (7.8 vs. 6.4 months, p = 0.871). The 23 patients with brain metastases had mPFS of 6.3 (range, 3.4–9.2) months. Lapatinib-naïve patients had significantly longer PFS than lapatinib-treated patients (10.8 months vs. 5.6 months, p = 0.020). Median OS was not achieved. The ORR for 96 patients was 34.3%. Common grade 3 and 4 adverse events were diarrhea (22.7%), neutropenia (7.2%), and leukopenia (4.1%).ConclusionsPyrotinib plus vinorelbine therapy demonstrated promising effects in HER2+ MBC with tolerable toxicity, particularly in patients with second-line treatment and without prior lapatinib treatment, as well as in patients with brain metastases. Oral vinorelbine is a useful alternative to the intravenous form when combined with pyrotinib.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT04517305].

RIBBON-2: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy for Second-Line Treatment of Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer

2011 ◽  
Vol 29 (32) ◽  
pp. 4286-4293 ◽  
Author(s):  
Adam M. Brufsky ◽  
Sara Hurvitz ◽  
Edith Perez ◽  
Raji Swamy ◽  
Vicente Valero ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Objective Response ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety ◽  
Epidermal Growth

Purpose This phase III study compared the efficacy and safety of bevacizumab combined with standard chemotherapy regimens versus chemotherapy alone as second-line treatment of patients with human epidermal growth factor receptor 2 (HER2) –negative metastatic breast cancer. Patients and Methods Patients were randomly assigned 2:1 to chemotherapy + bevacizumab or to chemotherapy + placebo. Before random assignment, investigators chose capecitabine, a taxane (paclitaxel, nab-paclitaxel, or docetaxel), gemcitabine, or vinorelbine. Dosing for bevacizumab or placebo was 15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks, depending on chemotherapy regimen. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, PFS by chemotherapy cohort, objective response rate (ORR), duration of objective response, 1-year survival rate, and safety. Results RIBBON-2 enrolled 684 patients (225, chemotherapy + placebo; 459, chemotherapy + bevacizumab). The combination of bevacizumab with chemotherapy demonstrated a statistically significant benefit. Median PFS increased from 5.1 to 7.2 months (stratified hazard ratio for PFS, 0.78; 95% CI, 0.64 to 0.93; P = .0072). The 10% improvement in ORR between the placebo- and bevacizumab-containing arms (39.5% v 29.6%; P = .0193), although not statistically significant, was consistent with previous trials. There was no statistically significant difference in overall survival. The most common grade ≥ 3 adverse events (AEs) related to bevacizumab treatment were hypertension (9.0%) and proteinuria (3.1%). There was an increased number of AEs leading to study discontinuation in the chemotherapy + bevacizumab arm compared with the chemotherapy + placebo arm (13.3% v 7.2%). Conclusion The combination of bevacizumab with commonly used chemotherapies improved PFS in the second-line treatment of patients with HER2-negative metastatic breast cancer, with a safety profile comparable with that in prior phase III studies.

scholarly journals Second-Line Treatment of Her2-Positive Metastatic Breast Cancer: Trastuzumab beyond Progression or Lapatinib? A Population Based Cohort Study

PLoS ONE ◽  
2015 ◽  
Vol 10 (9) ◽  
pp. e0138229 ◽  
Author(s):  
Ariel Hammerman ◽  
Sari Greenberg-Dotan ◽  
Ilan Feldhamer ◽  
Haim Bitterman ◽  
Rinat Yerushalmi
Keyword(s):  
Breast Cancer ◽  
Cohort Study ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Population Based ◽  
Line Treatment ◽  
Second Line ◽  
Her2 Positive

Real-world effectiveness of post-T-DM1 treatments in HER2-positive metastatic breast cancer: KBCSG-TR1917 observational study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13020-e13020
Author(s):  
Norikazu Masuda ◽  
Tetsuhiro Yoshinami ◽  
Hiroyuki Yasojima ◽  
Nobuyoshi Kittaka ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Treatment Options ◽  
Objective Response ◽  
Metastatic Breast ◽  
Investigational Drug ◽  
Current Standard ◽  
Her2 Positive

e13020 Background: For patients with HER2-positive, unresectable and/or metastatic breast cancer (HER2+ mBC), T-DM1 is now the standard of care after trastuzumab and/or pertuzumab-based therapy. On the other hand, there is limited evidence after T-DM1 treatment. To clarify the treatment options and the effectiveness of drug therapy just after T-DM1 (post–T-DM1 therapy), we performed a multicenter observational study in patients with HER2+ mBC. Methods: This study enrolled consecutive patients who met eligibility criteria; Japanese female patients with HER2+ mBC, 20 years of age or older, who received at least one subsequent drug treatment except for an investigational drug after discontinuing T-DM1 between Jan 2014 and Dec 2018. To investigate the effectiveness of post–T-DM1 therapy, the real-world progression-free survival (rwPFS), time to treatment failure (TTF), overall survival (OS), objective response rate (ORR) and clinical benefit rate (CBR) were evaluated. Tumor response was exactly assessed by investigators according to RECISTv1.1. Results: Of 205 patients who were treated with T-DM1 at five institutions, 138 patients were enrolled and 128 patients were included in the analysis (data-cut off: Jul 31 2019). The median age of the patients was 59 years (range 27–84), and the median duration of T-DM1 treatment was 5.1 months (range 0.0–41.4). Ninety-two patients (71.9%) had an ECOG PS score of 0 or 1. Of the 128 patients, 34 (26.6%) patients received lapatinib + capecitabine therapy, 35 (27.3%) trastuzumab-based therapy (excluding pertuzumab), 36 (28.1%) pertuzumab-containing therapy, and 23 (18.0%) other therapy except for anti-HER2 therapy. In the 111 patients with measurable lesions, ORR was 22.5% (95% CI: 15.1–31.4). The median rwPFS was 5.7 months (95% CI: 4.8–6.9), median TTF 5.6 months (95% CI: 4.6–6.4), median OS 22.8 months (95% CI: 18.2–32.4), and the CBR was 47.7% (95% CI: 38.8–56.7) in the 128 patients. Conclusions: We clarified that the effectiveness of post–T-DM1 therapy was limited among the current standard treatment options. Therefore, to improve the prognosis in the later settings of HER2+ mBC, novel treatment options are warranted in the future. Clinical trial information: UMIN000038296 .

Efficacy and safety of trastuzumab plus vinorelbine as second-line treatment for women with HER2-positive metastatic breast cancer beyond disease progression

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1094-1094 ◽  
Author(s):  
T. Bachelot ◽  
L. Mauriac ◽  
C. Delcambre ◽  
P. Maillart ◽  
C. Veyret ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Disease Progression ◽  
Interim Analysis ◽  
Metastatic Breast ◽  
Loading Dose ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Her2 Positive

1094 Background: There is increasing evidence that women with HER2-positive metastatic breast cancer (MBC) benefit from continued trastuzumab (H) therapy beyond disease progression (PD). In a Phase II multicentre 2-step trial we evaluated women for their response to second-line treatment with H + vinorelbine (N) following PD after receiving first-line H + taxane for HER2-positive MBC. Methods: Women aged =18 years with HER2-positive MBC received H (8 mg/kg loading dose followed by 6 mg/kg q3w or 4 mg/kg loading dose followed by 2 mg/kg qw) + N (30 mg/m2 days 1 and 8 q3w) until PD. The primary end point was overall response rate (ORR); secondary end points included time to progression, time to treatment failure, overall survival and safety. Data from a planned interim analysis are presented. Results: Seventeen out of a planned 50 patients (pts) were enrolled between June 2003 and October 2006, with a mean age of 54 years (range 42–70). Nine pts had hormone receptor-positive disease at baseline and 17 pts had HER2-positive disease (16 pts IHC 3+; 1 pt IHC 2+ and CISH+). Pts had previously received H in combination with paclitaxel (9 pts) or docetaxel (8 pts) as first-line therapy for MBC. Pts received a median of 6 treatment cycles with H + N (range 2–14), with 2 pts receiving H q3w and 15 pts receiving H qw. ORR was 29%, with 2 pts showing a complete response, 3 pts experiencing a partial response and 4 pts achieving stable disease lasting 6 months. Eight pts experienced PD. Re-treatment with H + N was well tolerated beyond PD, with grade 3/4 haematological toxicities being the most common serious adverse events, leading to a delay and dose reduction of N. No relevant cardiac toxicities were reported, with only 2 grade 1 cardiac events. All pts withdrew, 14 due to PD. Conclusions: This interim analysis indicates that treatment with Herceptin plus chemotherapy beyond PD is active (ORR 29%) and well tolerated, and provides further evidence that re-treatment with H is a promising therapeutic option. Pt accrual is ongoing and updated results will be presented. No significant financial relationships to disclose.

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