HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes

Robert, Nicholas J.; Goertz, Hans Peter; Chopra, Puneet; Jiao, Xiaolong; Yoo, Bongin; Patt, Debra A.; Antao, Vincent

doi:10.1007/s40801-016-0102-5

Cited by 31 publications

(20 citation statements)

References 18 publications

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“…PERUSE findings complement results from the CLEOPATRA trial, indicating that findings from a phase III trial can be replicated in the routine clinical practice setting. The results also expand upon recently published retrospective and real-world studies of patients treated with pertuzumab, trastuzumab and the investigator's chosen taxane in the United States, Italy and Turkey, which reported median PFS ranging from 17 to 29 months [14][15][16][17]. Strengths of PERUSE results compared with previous reports include the prospective nature of the study, the larger proportion of patients treated with paclitaxel instead of docetaxel, the more rigorous data collection and the regular schedule of tumour assessment according to RECIST (version 1.1).…”

Section: Discussionsupporting

confidence: 79%

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Bachelot¹,

Ciruelos²,

Schneeweiß³

et al. 2019

Annals of Oncology

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See Appendix for individual names.Background: Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab in this setting. Patients and methods:In the ongoing multicentre single-arm phase IIIb PERUSE study, patients with inoperable HER2-positive advanced breast cancer (locally recurrent/metastatic) (LR/MBC) and no prior systemic therapy for LR/MBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab [8 mg/kg loading dose, then 6 mg/kg every 3 weeks (q3w)] and pertuzumab (840 mg loading dose, then 420 mg q3w) until disease progression or unacceptable toxicity. The primary end point was safety. Secondary end points included overall response rate (ORR) and progression-free survival (PFS). Results:Overall, 1436 patients received at least one treatment dose (initially docetaxel in 775 patients, paclitaxel in 589, nabpaclitaxel in 65; 7 discontinued before starting taxane). Median age was 54 years; 29% had received prior trastuzumab. Median treatment duration was 16 months for pertuzumab and trastuzumab and 4 months for taxane. Compared with docetaxel-containing therapy, paclitaxel-containing therapy was associated with more neuropathy (all-grade peripheral neuropathy 31% versus 16%) but less febrile neutropenia (1% versus 11%) and mucositis (14% versus 25%). At this preliminary analysis (52 months' median follow-up), median PFS was 20.6 [95% confidence interval (CI) 18.9-22.7] months overall (19.6, 23.0 and 18.1 months with docetaxel, paclitaxel and nab-paclitaxel, respectively). ORR was 80% (95% CI 78%-82%) overall (docetaxel 79%, paclitaxel 83%, nab-paclitaxel 77%).Conclusions: Preliminary findings from PERUSE suggest that the safety and efficacy of first-line pertuzumab, trastuzumab and taxane for HER2-positive LR/MBC are consistent with results from CLEOPATRA. Paclitaxel appears to be a valid alternative taxane backbone to docetaxel, offering similar PFS and ORR with a predictable safety profile.ClinicalTrials.gov: NCT01572038.

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Section: Discussionsupporting

confidence: 79%

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Bachelot¹,

Ciruelos²,

Schneeweiß³

et al. 2019

Annals of Oncology

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“…The most frequent side effects in our study were fatigue and arthralgia/myalgia, with the rates of 75% and 64.3, respectively compared to 37.6% and 15% in CLEOPATRA, 26% and 6% in a retrospective analysis by Placido et al, respectively (12,17). In our study, neuropathy occurred in 8 (28.6%) patients, with the 5 (17.8%) of them being grade 3 compared to 11 (2.7%) patients in CLEOPATRA phase III trial, 60 (18.4%) patients in a retrospective analysis by Esin et al, and 89 (33.5%) patients in another study including 266 patients (18,19). As compared with literature, hematological side effects in our study were observed to be relatively at low rates, with 3 (10.7%) of the patients experiencing grade 1 thrombocytopenia compared to 25 (7.8%) of those in the study by Esin et al, with only 3 of them being grade 3-4 (19).…”

Section: Discussionsupporting

confidence: 48%

“…This rate was only 1% in NEOSPHERE trial that investigated the efficacy of pertuzumab in neoadjuvant setting. In a retrospective study by Robert et al, 2 (0.8%) patients had Left Ventricular Dysfunction (LVD), whereas 8 (2.5%) patients experienced LVD in the study by Esin et al (18)(19)(20)(21).…”

Section: Discussionmentioning

confidence: 98%

Treatment Outcomes of HER-2 Positive Metastatic Breast Cancer Patients Treated with Pertuzumab in the First Line Setting- Real Life Experience

Hacioglu¹,

Şahin²

2019

Van Med J

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Objective: Pertuzumab, a new recombinant humanized monoclonal antibody, has been developed to inhibit the formation of HER2:HER3 heterodimerization. The clinical benefit of pertuzumab therapy in HER2 positive metastatic Breast Cancer (mBC) patients in the first-line setting has been shown in previous phase III studies. Herein we aimed to analyze the efficacy and toxicity profile of pertuzumab in patients with HER2 positive mBC. Materials and Methods:This was a retrospective study of 28 patients with mBC followed from two different centers in Turkey. All patients were treated with pertuzumab in the first line setting, with a combination including trastuzumab and docetaxel. Treatment outcomes along with drug efficacy and safety were retrospectively analyzed. Results: At a median follow-up time of 10.1 (2.4-25.2) months, among the 28 patients, 1 (3.6%) case of death and 2 (7.1%) cases of progression occurred. The median age was determined as 47 (18-74) years. Excluding 1 patient, all had (96.4%) de-novo metastatic disease at presentation. The median number of treatment cycles was 7 (4 -12) for docetaxel, 18 (4 -35) for pertuzumab + trastuzumab, and 10 (1 -29) for the maintenance therapy (pertuzumab + trastuzumab). The most common side effects were fatigue (75%) and arthralgia/myalgia (64.3%). Grade 3 or 4 toxicity was observed to be very infrequent as follows: neutropenia; grade 3 in 4 (14%) patients and grade 4 in 1 (3.6%) patient, neuropathy; grade 3 in 5 (17.8%) patients. Conclusion: Even with a small sample size, our results confirm that pertuzumab + trastuzumab + docetaxel combination therapy in the first line setting for HER2 positive mBC patients is the standard of care, with acceptable toxicity profile.Key Words: Metastatic breast cancer, HER2 positive, pertuzumab, progression free survival, overall survival, toxicity ÖZET Amaç: Pertuzumab HER2:HER3 heterodimerizasyon oluşumunu inhibe eden, yeni geliştirilen bir rekombinant humanize monoklonal antikordur. Daha önce yapılan faz III çalışmalarda, HER2 pozitif metastatik Meme Kanseri (mMK) hastalarında pertuzumabın klinik faydası gösterilmiştir. Biz de bu çalışmada HER2 pozitif mMK'li hastalarda pertuzumabın etkinlik ve toksisite profilini analiz etmeyi amaçladık. Gereç ve Yöntemler: Çalışmamızda Türkiye'deki iki farklı merkezden takip edilen 28 mMK hastasının retrospektif verileri incelenmiştir. Tüm hastalar birinci basamakta pertuzumab ile tedavi edilmişti. İlaç etkinliği ve güvenliği ile birlikte tedavi sonuçları retrospektif olarak analiz edildi. Bulgular: Ortanca 10.1 (2.4-25.2) ay takip süresince, toplam 28 hastada, 1 (%3.6) ölüm vakası ve 2 (%7.1) progresyon vakası gerçekleşti. Ortanca yaş 47 (18-74) olarak saptandı. Bir hasta hariç, hastaların hepsi (%96.4) de-novo metastatikti. Ortanca kür sayıları; dosetaksel için 7 (4 -12), pertuzumab + trastuzumab için 18 (4 -35) ve idame pertuzumab + trastuzumab için 10 (1 -29) olarak saptandı. En sık görülen yan etkiler; yorgunluk (%75) ve artralji-myaljiydi (%64.3). Grade 3-4 yan etkiler çok nadir görülmekle birl...

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“…Other groups have looked at local or regional tethered observational data regarding efficacy of dual HER2 blockade. A real-world study from 2017 found a mPFS of 16.9 months among 266 patients with HER2-positive mBC receiving first-line trastuzumab and pertuzumab [ 13 ]. The majority of patients (n = 249) received a taxane as the chemotherapy-backbone.…”

Section: Discussionmentioning

confidence: 99%

Dual HER2 blockade in the first-line treatment of metastatic breast cancer - A retrospective population-based observational study in Danish patients

et al. 2020

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Objectives Randomized clinical trials do not include a population that truly reflects a real-world population, due to their inclusion and exclusion criteria. This leads to concerns about the applicability of these studies in a clinical practice. In the present study, we aim to describe the clinical and demographic characteristics, treatment patterns, and clinical outcomes in a population of patients with HER2-positive metastatic breast cancer who received pertuzumab and trastuzumab as first-line treatment in a real-world setting. Methods The database of the Danish Breast Cancer Group was used to assemble data on patients included in the period April 2013 to August 2017. The primary endpoints were overall survival (OS) and progression-free survival (PFS). Results A cohort of 291 patients with a median age of 58 years was registered. Hereof 112 (38%) patients with de novo disease (primary disseminated) and 179 (62%) with recurrence. The median follow-up for OS was 24.1 months. The median OS was 41.8 months (95% CI, 37.7 to NE) and the median PFS was 15.8 months (95% CI, 14.0 to 19.9). For de novo patients alone, the median OS was not reached whereas the median PFS was 17.9 months (95% CI, 14.3 to 27.3). Hazard ratios for patients receiving vinorelbine showed comparable results as for the whole population. Conclusion This heterogeneous patient population in a real-world setting had a PFS comparable with what could be expected from the related randomized trial. The de novo patients had better OS and PFS as compared to patients with recurrence.

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HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes

Cited by 31 publications

References 18 publications

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Treatment Outcomes of HER-2 Positive Metastatic Breast Cancer Patients Treated with Pertuzumab in the First Line Setting- Real Life Experience

Dual HER2 blockade in the first-line treatment of metastatic breast cancer - A retrospective population-based observational study in Danish patients

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