scholarly journals Predictors of pathologic complete response to neoadjuvant treatment in HER2-overexpressing breast cancer: a retrospective analysis using real-world data

2022 ◽  
Vol 16 ◽  
Author(s):  
Isabel Saffie V ◽  
Jorge Sapunar Z ◽  
Felipe Buscaglia F ◽  
Felipe Reyes C ◽  
Rodrigo Lagos Ch ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Retrospective Analysis ◽  
Real World ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Real World Data ◽  
World Data

scholarly journals Real-World Comparison of CT-P6 and Reference Trastuzumab for the Treatment of HER2-Positive Early-Stage and Metastatic Breast Cancer

2021 ◽  
Author(s):  
Soong June Bae ◽  
Jee Hung Kim ◽  
Sung Gwe Ahn ◽  
Hei-Cheul Jeung ◽  
Joohyuk Sohn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Early Stage ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Metastatic Breast ◽  
Cardiac Safety ◽  
Her2 Positive ◽  
Real World Data

Abstract Background: Here, we present the first real-world comparison of CT-P6 versus reference trastuzumab (RTZ) for the neoadjuvant treatment of patients with HER2-positive EBC, and for the palliative first-line treatment of patients with HER2-positive metastatic breast cancer (MBC).Methods: We retrospectively identified patients with HER2-positive EBC who had received neoadjuvant treatment with RTZ or CT-P6, plus pertuzumab, carboplatin, and docetaxel, followed by surgery, alongside patients with newly diagnosed HER2-positive MBC who had received palliative treatment with RTZ or CT-P6, plus pertuzumab and docetaxel. The primary endpoints were pathologic complete response (pCR) in the EBC cohort, and progression-free survival (PFS) in the MBC cohort. Results: A similar percentage of patients with EBC achieved a pCR with CT-P6 (74.4% [93/125]) and RTZ (69.8% [90/129]) (p=0.411). For patients with MBC, median PFS did not differ significantly between the two groups (CT-P6: 13.9 months [95% confidence intervals (CIs) not available]; RTZ: 18.4 months [95% CIs 12.5–24.3]; p=0.653). The cardiac safety profiles of CT-P6 and RTZ were similar. Conclusions: These real-world data suggest that CT-P6 has similar effectiveness and cardiac safety to RTZ in patients with HER2-positive EBC and MBC, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.

scholarly journals Neoadjuvant Pertuzumab plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2 Positive Breast Cancer: Real-World Data from a National Institute of Oncology in Poland.

2022 ◽  
Author(s):  
Agnieszka Irena Jagiełło-Gruszfeld ◽  
Magdalena Rosinska ◽  
Malgorzata Meluch ◽  
Katarzyna Pogoda ◽  
Anna Niwińska ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Her2 Positive ◽  
Real World Data ◽  
Cancer Subtypes ◽  
Cancer Management ◽  
Her2 Positive Breast Cancer ◽  
Neoadjuvant Systemic Therapy ◽  
Positive Breast Cancer

Neoadjuvant systemic therapy has now become the the standard in early breast cancer management. Chemotherapy in combination with trastuzumab +/- pertuzumab targeted therapy can improve rates of pathologic complete response (pCR) in patients with HER2-positive breast cancer. Achieving a pCR is considered a good prognostic factor, in particular in patients with more aggressive breast cancer subtypes such as TNBC or HER2 positive cancers. Furthermore, most studies demonstrate that chemotherapy in combination with trastuzumab and pertuzumab is well tolerated. The retrospective analysis presented here concentrates on neoadjuvant therapy with the TCbH-P regimen, with a particular emphasis on patients over 60 years of age. We analysed the factors affecting the achievement of pCR and presented adverse effects of the applied therapies, which opened a discussion about optimizing the therapy of older patients with HER-2 positive breast cancer.

Real-world cost-effectiveness of pertuzumab (P) with trastuzumab + chemo (T+Chemo) in patients (pts) with metastatic breast cancer (MBC): A population-based retrospective cohort study by the Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) collaboration.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1048-1048
Author(s):  
Wei Fang Dai ◽  
Jaclyn Marie Beca ◽  
Chenthila Nagamuthu ◽  
Ning Liu ◽  
Maureen E. Trudeau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Real World ◽  
Retrospective Cohort ◽  
Health Technology ◽  
Population Based ◽  
Net Benefit ◽  
Real World Data ◽  
World Data

1048 Background: Addition of P to T+chemo for MBC pts has been shown to improve overall survival (OS) in a pivotal randomized trial (hazard ratio [HR] = 0.66, 95% CI: 0.52, 0.84) (Baselga et al., NEJM 2012). In Canada, the manufacturer submission to the health technology assessment agency estimated that P produced 0.64 life years gained (LYG) with an incremental cost-effectiveness ratio (ICER) of $187,376/LYG over 10 years (CADTH-pCODR, 2013). This retrospective cohort analysis aims to determine the comparative real-world population-based effectiveness and cost-effectiveness of P among MBC pts in Ontario, Canada. Methods: MBC pts were identified from the Ontario Cancer Registry and linked to the New Drug Funding Program database to identify receipt of treatment between 1/1/2008 and 3/31/2018. Cases received P-T-chemo after universal public funding of P (Nov 2013) and controls received T-chemo before. Demographic (age, socioeconomic, rurality) and clinical (comorbidities, prior adjuvant treatments, prior breast cancer surgery, prior radiation, stage at diagnosis, ER/PR status) characteristics were identified from linked admin databases balanced between cases and controls using propensity score matching. Kaplan-Meier methods and Cox regressions accounting for matched pairs were used to estimate median OS and HR. 5-year mean total costs from the public health system perspective were estimated from admin claims databases using established direct statistical methods and adjusted for censoring of both cost and effectiveness using inverse probability weighting. ICERs and 95% bootstrapped CIs were calculated, along with incremental net benefit (INB) at various willingness-to-pay values using net benefit regression. Results: We identified 1,823 MBC pts with 912 cases and 911 controls (mean age = 55 years), of which 579 pairs were matched. Cases had improved OS (HR = 0.66; 95% CI: 0.57, 0.78), with median 3.4 years, compared to controls median OS of 2.1. P provided an additional 0.63 (95% CI: 0.48 – 0.84) LYG at an incremental cost of $196,622 (95% CI: $180,774, $219,172), with a mean ICER = $312,147/LYG (95% CI: $260,752, $375,492). At threshold of $100,000/LYG, the INB was -$133,632 (95% CI: -$151,525, -$115,739) with < 1% probability of being cost-effective. Key drivers of incremental cost increase between groups included drug and cancer clinic costs. Conclusions: The addition of P to T-chemo for MBC increased survival but at significant costs. The ICER based on direct real-world data was higher than the initial economic model due to higher total costs for pts receiving P. This study demonstrated feasibility to derive ICER from person-level real-world data to inform cancer drug life-cycle health technology reassessment.

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