Abstract P6-17-37: Therapy landscape of patients with metastatic, HER2 positive breast cancer - Data from the real world breast cancer registry PRAEGNANT (NCT02338167)

2019 ◽  
Author(s):  
MP Lux ◽  
AD Hartkopf ◽  
J Huober ◽  
B Volz ◽  
F-A Taran ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Registry ◽  
Real World ◽  
Breast Cancer Data ◽  
Her2 Positive ◽  
The Real ◽  
Cancer Data ◽  
Her2 Positive Breast Cancer ◽  
Breast Cancer Registry ◽  
Positive Breast Cancer

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 Pyrotinib In The Treatment of Women With Advanced HER2- Positive Breast Cancer: A Multicenter, Prospective, Real-World Study

2021 ◽  
Author(s):  
Lili Zhang ◽  
Xiaohong Wu ◽  
Jun Zhou ◽  
Mingzhen Zhu ◽  
Hao Yu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Liver Metastases ◽  
Real World ◽  
Common Adverse Event ◽  
Previous Exposure ◽  
Her2 Positive ◽  
Real World Data ◽  
The Real ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Abstract Background: HER2-positive breast cancer was aggressive, resulting in a poorer prognosis. This multicenter study analyzed the real-world data of women treated with pyrotinib-based therapy, aiming to describe their characteristics, treatment regimens, and to investigate the clinical outcomes.Patients and Methods: A total of 141 patients with HER2-positive breast cancer were enrolled from February 2019 to April 2020. Last follow-up time was February 2021. All patients were treated with pyrotinib-based therapy in 21-day cycles. The primary endpoint was progression-free survival (PFS).Results: The median PFS (mPFS) for pyrotinib-based therapy was 12.0 months (95% CI 8.1-17.8) in all patients. Among the 44 patients with liver metastases, mPFS was 8.7 months (95%CI 6.3-15.4), compared to 12.3 months (95%CI 8.8-23.3) for the 97 patients without liver metastases (P=0.172). In addition, patients receiving pyrotinib-based therapy as their >2 lines treatment had a numerically lower mPFS than those receiving pyrotinib-based therapy as their ≤2 lines treatment (8.4 vs. 15.1 months, P=0.107). The mPFS was 12.2 months (95%CI 7.9-18.8) in patients with previous exposure to trastuzumab and 11.8 months (95%CI 6.8-22.9) in patients without previous exposure to trastuzumab (P=0.732). Moreover, mPFS in patients receiving regimens with and without capecitabine were 15.1 months (95%CI 10.0-18.8) and 8.4 months (95%CI 6.7-22.9), respectively (P=0.070). Furthermore, in patients with brain metastases, estimated 6-month PFS rate was 70.0%, and rate at 12 months was 60.0%. Seventy patients with measurable lesions were evaluable for response. The ORR was 38.57% and DCR was 85.71%. Most common adverse event was diarrhea (85.04%).Conclusion: Pyrotinib-based therapy showed promising efficacy in patients with HER2-positive breast cancer and was well tolerated, especially in patients treated with pyrotinib as ≤2 lines treatment and receiving regimens with capecitabine. The results of the real-world study further confirmed the intriguing efficacy of pyrotinib.

scholarly journals Therapy Landscape in Patients with Metastatic HER2-Positive Breast Cancer: Data from the PRAEGNANT Real-World Breast Cancer Registry

Cancers ◽  
2018 ◽  
Vol 11 (1) ◽  
pp. 10 ◽  
Author(s):  
Michael Lux ◽  
Naiba Nabieva ◽  
Andreas Hartkopf ◽  
Jens Huober ◽  
Bernhard Volz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Eastern Cooperative Oncology Group ◽  
Metastatic Breast ◽  
Her2 Positive ◽  
Real World Data ◽  
World Data ◽  
Cancer Data ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

This study presents comprehensive real-world data on the use of anti-human epidermal growth factor receptor 2 (HER2) therapies in patients with HER2-positive metastatic breast cancer (MBC). Specifically, it describes therapy patterns with trastuzumab (H), pertuzumab + trastuzumab (PH), lapatinib (L), and trastuzumab emtansine (T-DM1). The PRAEGNANT study is a real-time, real-world registry for MBC patients. All therapy lines are documented. This analysis describes the utilization of anti-HER2 therapies as well as therapy sequences. Among 1936 patients in PRAEGNANT, 451 were HER2-positive (23.3%). In the analysis set (417 patients), 53% of whom were included in PRAEGNANT in the first-line setting, 241 were treated with H, 237 with PH, 85 with L, and 125 with T-DM1 during the course of their therapies. The sequence PH → T-DM1 was administered in 51 patients. Higher Eastern Cooperative Oncology Group (ECOG) scores, negative hormone receptor status, and visceral or brain metastases were associated with more frequent use of this therapy sequence. Most patients received T-DM1 after treatment with pertuzumab. Both novel therapies (PH and T-DM1) are utilized in a high proportion of HER2-positive breast cancer patients. As most patients receive T-DM1 after PH, real-world data may help to clarify whether the efficacy of this sequence is similar to that in the approval study.

scholarly journals Real-World Outcomes of Adjuvant Chemotherapy for Node-Negative and Node-Positive HER2-Positive Breast Cancer

2019 ◽  
Vol 17 (1) ◽  
pp. 47-56 ◽  
Author(s):  
Zachary Veitch ◽  
Omar F. Khan ◽  
Derek Tilley ◽  
Domek Ribnikar ◽  
Xanthoula Kostaras ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Real World ◽  
Her2 Positive ◽  
Node Negative ◽  
Node Positive ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

scholarly journals Pyrotinib in the treatment of women with advanced HER2 positive breast cancer: A multicenter, prospective, real-world study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13012-e13012
Author(s):  
Jifeng Feng ◽  
Lili Zhang ◽  
Xiaohong Wu ◽  
Jun Zhou ◽  
Mingzhen Zhu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy Evaluation ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Her2 Breast Cancer ◽  
Positive Breast Cancer

e13012 Background: Pyrotinib is a newly-developed irreversible pan-ErbB receptor tyrosine kinase inhibitor. The efficacy of pyrotinib in patients with different baseline characteristics in the actual clinical practice has been rarely reported. This study analyzed the efficacy and safety of pyrotinib in the real world. Methods: Patients with histologically confirmed advanced HER2 positive breast cancer were included in the analyses. All patients received pyrotinib-based therapy were given pyrotinib once a day in a 21-day cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints included adverse events (AE), objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Results: A total of 132 patients (median age: 52 years [29-78]) were enrolled from February 2019 to March 2020. 94(71.21%) patients had visceral metastatic lesions and 20 (15.15%) had brain metastases. HR+, HR-, or unknown HR status for primary tumor accounted for 56.82%, 42.42%, 0.76%, respectively. 115(87.12%) patients were previously administered with trastuzumab. 96(72.73%) patients received pyrotinib-based therapy as a second or further line of treatment. 94(71.21%) patients initiated pyrotinib treatment at 400 mg. Treatment regimens were pyrotinib plus capecitabine (55.30%), pyrotinib combined with trastuzumab (18.18%), and pyrotinib monotherapy (8.33%), pyrotinib combined with endocrine therapy, radiotherapy or antiangiogenic drugs (3.79%). A total of 132 patients were included in PFS analysis. mPFS was 12.0 months (95%CI 8.1-18.8). mPFS for patients without primary trastuzumab-resistant breast cancer was 14.1 months (95%CI 8.7-23.3). Patients receiving pyrotinib-based therapy as their ≥3 lines treatment had lower mPFS than those receiving pyrotinib-based therapy as their < 3 lines treatment (8.8 vs. 15.1 months, P= 0.119). mPFS in patients receiving regimen with and without capecitabine were 15.1 months and 8.4 months, respectively ( P= 0.081). As of data cutoff, mOS has not yet been reached. Among the 65 patients available for efficacy evaluation, 1 (1.54%) patient achieved complete response (CR), 24 (36.92%) patients had partial response (PR), 30 (46.15%) patients achieved stable disease (SD), and 10 (15.38%) patients had progression disease (PD), resulting in an ORR of 38.46% and DCR of 84.62%. The most common AE was diarrhea (84.17%), but only 5 (4.17%) patients were reported grade ≥ 3 diarrhea which could be well controlled. Other AEs with an incidence higher than 20.00% were anemia (36.67%), leukopenia (25.83%), vomiting (25.00%), neutropenia (22.50%). No treatment-related death occurred. Conclusions: Pyrotinib demonstrated an encouraging efficacy and manageable safety in patients with advanced HER2+ breast cancer. More data would be analyzed and reported in the future. Clinical trial information: ChiCTR1900021819.

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