Abstract 5442
Background
HER2-targeted therapy was a paradigm shift for breast cancer. However, the optimal duration of adjuvant trastuzumab remain unknown. This issue is important in lower and middle-income countries such as Brazil where financial resources are scarce. The aim of this study is to determine which patients will benefit most with the addition of Pertuzumab to trastuzumab [T+P], trastuzumab for 12 months [T12] or trastuzumab for 6 months [T6].
Methods
Individual data meta-analysis was performed using 5 studies (Persephone, Phare, Horg, Aphinity and Katherine) for the intention to treat (ITT) population. Through pooled analyzes of the Persephone, Phare and Horg studies, we compared 12 months and 6 months of trastuzumab. The comparison between T+P and T6 was performed through an indirect comparison using Bayesian methodology. For cost-effectiveness analysis, we compared the treatment lining up in pairs exclusively considering the data from the Aphinity (T+P vs T12), Persephone (T12 vs T6) and Katherine (T12 vs T-DM1), setting a 30 years period of time and costs of adjuvant treatments and after progression in the Brazilian perspective.
Results
Individual data were analyzed from 12,753 patients. Patients who progressed in a 4-year period were 7.1% for T + P, 10.2% for T12 (HR 1.37, 95% CI 1.16-1.63) and 12.9% for T6 (HR 1.73, 95% CI 1.45-2.06). Regarding DFS in the N+ subgroup, T+P showed HR 0.77 (95% CI 0.62-0.96) and 0.74 (95% CI 0.49-1.11) compared to T12 and T6, respectively. Among patients N-, T+P compared to T12 showed a HR 1.13 (95%CI 0.68-1.86) and compared to T6 HR 0.83 (95%CI 0.45-1.52). ER+ patients, T+P showed HR 0.86 (95%CI 0.66-1.13) compared to T12 and HR 0.74 (95%CI 0.49-1.11) to T6. Among ER-, the values were HR 0.76 (95%CI 0.56-1.04) and HR 0.59 (95%CI 0.41-0.85), respectively. In the cost-effectiveness analysis, T+P demonstrated an ICER of $ 332,903 compared to T12, while T12 set side by side of T6 resulted in $ 42,774. In the subgroup N+, T+P presented $ 308,019 when compared to T12. T-DM1 was considered a cost-effective treatment with $ 3,031 compared to T12.
Conclusions
The combination T+P presented an benefit in the subgroup N+, but it was not considered cost-effective. T6 may be considered a therapeutic option in low budget scenarios for patients HR+/N-.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4022 - Ribociclib (RIB) plus letrozole (LET) in male patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) from the CompLEEment-1 trial
Presenter: Mario Campone
Session: Poster Display session 2
Resources:
Abstract
3599 - Comparative effectiveness of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US real-world clinical practices
Presenter: Rachel Layman
Session: Poster Display session 2
Resources:
Abstract
901 - Pharmacokinetics (PK), safety, and efficacy of [fam-] trastuzumab deruxtecan with OATP1B/CYP3A inhibitors in subjects with HER2-expressing advanced solid tumors
Presenter: Yung-Jue Bang
Session: Poster Display session 2
Resources:
Abstract
2777 - A Phase 2 study of abemaciclib in patients (pts) with brain metastases (BM) secondary to non-small cell lung cancer (NSCLC) or melanoma (MEL).
Presenter: Solmaz Sahebjam
Session: Poster Display session 2
Resources:
Abstract
3980 - Ribociclib (RIB) + letrozole (LET) in patients (pts) with visceral metastases (VM) or bone-only metastases (BOM) in hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC): Subgroup analysis from the CompLEEment-1 trial
Presenter: Michelino De Laurentiis
Session: Poster Display session 2
Resources:
Abstract
4024 - Ribociclib (RIB) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) and central nervous system (CNS) metastases: Subgroup analysis from the phase 3b CompLEEment-1 trial
Presenter: Paul Cottu
Session: Poster Display session 2
Resources:
Abstract
2151 - Clinical outcome and toxicity data in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy in a real-world clinical setting.
Presenter: Elena Fountzilas
Session: Poster Display session 2
Resources:
Abstract
3994 - Safety and efficacy of Ribociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Interim results from the Italian cohort of the CompLEEment-1 (C-1) study.
Presenter: Michele De Laurentiis
Session: Poster Display session 2
Resources:
Abstract
1370 - Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results
Presenter: Javier Salvador
Session: Poster Display session 2
Resources:
Abstract
1109 - First Canadian Interim Analysis from the Phase IIIb CompLEEment-1 Ribociclib + Letrozole HR+ HER2- Advanced Breast Cancer Trial
Presenter: Cristiano Ferrario
Session: Poster Display session 2
Resources:
Abstract