Observational Study on Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer Patients

Mustacchi, Giorgio; Puglisi, Fabio; Molino, A.; Crivellari, Diana; Ghiotto, Cristina; Ferro, Antonella; Brunello, Antonella; Saracchini, Silvana; Turazza, Monica; Cretella, Elisabetta; Iop, Aldo; Malagoli, Maria; Stefani, Micaela

doi:10.2217/fon.15.34

Cited by 10 publications

(8 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Moreover, the reliance of some studies on published costing data outside their jurisdiction for costing parameters, given its low transferability, may result in unreliable results. Furthermore, it is noted that there may be a difference in the costing data between the actual costs and the costs obtained from published studies since, in reality, approximately 14-17% of HER2-positive EBC patients are not provided with adjuvant trastuzumab [52], specifically for those with advanced age and who have co-morbidities, and about 15% discontinue the adjuvant treatment due to its cardiotoxicity [53]. Nonetheless, the overall input data sources of majority of the studies were of acceptable quality.…”

Section: Discussionmentioning

confidence: 99%

Economic evaluation of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer: systematic review and quality assessment

Genuino

Gloria

Chaikledkaew

et al. 2020

Expert Review of Pharmacoeconomics & Outcomes Research

View full text Add to dashboard Cite

Introduction: As the availability of new economic evaluations (EE) on adjuvant trastuzumab therapy for early-stage breast cancer (EBC) with HER2-positive since last search and other EEs missed warrant a more extensive review, this study aimed to systematically review EEs of adjuvant trastuzumab compared with chemotherapy alone for HER2-positive EBC. Area covered: The search was performed in February 2019 using MEDLINE and Scopus. Reviewers independently selected studies based on eligibility criteria, extracted data, assessed quality of reporting, and appraised quality of data sources. Expert opinion: 22 studies were included which were from high-income (HICs) and upper-middle income countries (UMICs). Incremental cost-effectiveness ratios (ICERs) from HICs were within their costeffectiveness thresholds and ranged from 6,018 to 78,929 USD per quality-adjusted life year (QALY) gained. ICERs from UMICs mostly exceeded their thresholds ranging from 3,526 to 174,901 USD per QALY gained. Evidence shows cost-effectiveness of trastuzumab for HER2-positive EBC in HICs. There were no methodological variations. The extent and adequacy of reporting were high. The quality of data sources was moderate to high. The quality of future EEs can be improved by enhancing the reporting quality, by using context-based data and real-world efficacy data, which would impact cost-effectiveness.

show abstract

Section: Discussionmentioning

confidence: 99%

Economic evaluation of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer: systematic review and quality assessment

Genuino

Gloria

Chaikledkaew

et al. 2020

Expert Review of Pharmacoeconomics & Outcomes Research

View full text Add to dashboard Cite

show abstract

“…The use rate of trastuzumab in clinical practice was also examined by real-world studies. The real-world evidence from western populations reported a use rate of trastuzumab from 49% to 83%, [15][16][17][18][19] but always with disparities between different races or socioeconomic status. 19,20 In contrast, the use rate of trastuzumab in China was relatively low.…”

Section: Discussionmentioning

confidence: 99%

Prognostic nomogram for patients with non-metastatic HER2 positive breast cancer in a prospective cohort

et al. 2019

View full text Add to dashboard Cite

A nomogram is a reliable tool to generate individualized risk prediction by combining prognostic factors. We aimed to construct a nomogram for predicting the survival in patients with non-metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer in a prospective cohort. Methods: We analyzed 1304 consecutive patients who were diagnosed with non-metastatic HER2 positive breast cancer between January 2008 and December 2016 in our institution. Independent prognostic factors were identified to build a nomogram using the COX proportional hazard regression model. The prediction of the nomogram was evaluated by concordance index (C-index), calibration and subgroup analysis. External validation was performed in a cohort of 6379 patients from the Surveillance, Epidemiology, and End Results (SEER) database. Results: Through the COX proportional hazard regression model, five independent prognostic factors were identified. The nomogram predicting overall survival achieved a C-index of 0.78 in the training cohort and 0.74 in the SEER cohort. The calibration plot displayed favorable accordance between the nomogram prediction and the actual observation for 3-year overall survival in both cohorts. The quartiles of the nomogram score classified patients into subgroups with distinct overall survival. Conclusion: We developed and validated a novel nomogram for predicting overall survival in patients with nonmetastatic HER2 positive breast cancer, which presented a favorable discrimination ability. This model may assist clinical decision making and patient-clinician communication in clinical practice.

show abstract

“…An observational study assessing the real-life use of adjuvant trastuzumab in 1245 patients with HER2-positive breast cancer reported a relapse rate of 10.9 % in trastuzumab-treated patients versus 22.6 % in untreated patients (median follow-up 37.4 and 62.1 months, respectively), with lower DFS in relapsed versus non-relapsed patients [ 39 ]. The relapse rate at 5 years was 17 %, which is in line with the BCIRG 006 study and other observational studies, but much lower than that reported in the HERA study [ 39 ].…”

Section: Discussionmentioning

confidence: 99%

Long-term Follow-up Data from Pivotal Studies of Adjuvant Trastuzumab in Early Breast Cancer

et al. 2016

View full text Add to dashboard Cite

The addition of adjuvant trastuzumab therapy for 1 year to standard chemotherapy significantly improved disease-free survival and overall survival versus chemotherapy alone in a number of pivotal early breast cancer studies. Here we review long-term follow-up data on the efficacy, cardiac safety, and general safety of trastuzumab in these pivotal studies. We also evaluate ongoing phase II/III adjuvant trials with newer HER2-targeted agents and the efficacy and safety of the recently developed subcutaneous (SC) formulation of trastuzumab in early breast cancer. Long-term follow-up data confirm the significant survival benefit afforded by the addition of trastuzumab to chemotherapy in patients with HER2-positive disease, with an acceptable safety profile. Long-term cardiac safety data suggest that the incidence of cardiac adverse events is maintained at a relatively low level with continued follow-up. At this present time, 1 year of trastuzumab treatment remains the standard of care in HER2-positive early breast cancer. Future adjuvant trastuzumab treatment strategies should focus on reducing cardiotoxicity, particularly in elderly patients, by identifying potential predictive biomarkers of cardiac dysfunction. Clinicians must also decide whether to omit trastuzumab in women who would achieve little benefit from treatment to avoid cardiotoxicity.

show abstract

Observational Study on Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer Patients

Abstract: Relapse rates are lower in clinical setting compared to clinical trials. Overall, AT is effective in HER2-positive early-stage breast cancer patients.

Cited by 10 publications

References 27 publications

Economic evaluation of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer: systematic review and quality assessment

Economic evaluation of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer: systematic review and quality assessment

Prognostic nomogram for patients with non-metastatic HER2 positive breast cancer in a prospective cohort

Long-term Follow-up Data from Pivotal Studies of Adjuvant Trastuzumab in Early Breast Cancer

Contact Info

Product

Resources

About