Dataset Information

Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China.

ABSTRACT:

Background

Real-world data of Palbociclib are insufficient in China. This study aimed to investigate the treatment pattern and real-world outcomes in hormone receptor positive and human epidermal growth factor 2 receptor negative (HR+/HER2-) metastatic breast cancer (MBC) patients treated with Palbociclib in the northwest of China.

Methods

HR+/HER2- MBC patients who received Palbociclib in 8 centers from July 2017 to September 2019 were retrospectively included in this study. Real-world objective response rate (ORR), progression-free survival (PFS) and safety profiles were analyzed. The survival curves were plotted by the Kaplan-Meier method to analyze PFS, which was verified by the log-rank test.

Results

In total, 211 women were eligible for the analysis. A total of 85 patients (40.3%), 78 (37.0%), and 48 (22.7%) received Palbociclib in the first-, second-, third- or later-line setting, respectively. 46 patients achieved partial response and 145 patients experienced stable disease, with an ORR of 21.8% and a disease control rate of 90.5%. Following a median follow-up period of 14.2 months, the median PFS was 12.2 months (95% confidence interval, 10.1-14.3 m), and the median overall survival was not reached. Early Palbociclib initiation, sensitivity or acquired resistance to endocrine therapy, estrogen receptor and progesterone receptor double positivity, less than 3 metastatic sites, without visceral metastasis, bone metastasis only, without prior chemotherapy or endocrine therapy were associated with a prolonged PFS in MBC (All P < 0.05). The most common grade 3 or 4 adverse events (AE) was neutropenia (36.5%), and the most common nonhematologic AE was fatigue (10.9%). No patient experienced AE leading to treatment discontinuation.

Conclusion

Palbociclib plus endocrine therapy exhibited favorable effectiveness and manageable toxicities in the real-world setting, supporting their use in Chinese patients with HR+/HER2 - MBC.

SUBMITTER: Yang J

PROVIDER: S-EPMC9885675 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China.

Yang Jiao J Zhao Bing B Ling Xiaoling X Li Donghui D Zhao Jiuda J Lv Yonggang Y Wang Guangxi G Liu Xinlan X Li Nanlin N Yang Jin J

BMC cancer 20230130 1

<h4>Background</h4>Real-world data of Palbociclib are insufficient in China. This study aimed to investigate the treatment pattern and real-world outcomes in hormone receptor positive and human epidermal growth factor 2 receptor negative (HR+/HER2-) metastatic breast cancer (MBC) patients treated with Palbociclib in the northwest of China.<h4>Methods</h4>HR+/HER2- MBC patients who received Palbociclib in 8 centers from July 2017 to September 2019 were retrospectively included in this study. Real ...[more]

PMID: 36717797

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Project description:BackgroundThe CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials.Patients and methodsThis is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B).ResultsIn total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47-79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6-32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively.ConclusionsOur data indicate that palbociclib plus ET is active and safe in HR+/HER2- MBC, also suggesting a better performance of the combinations in earlier treatment lines.

Project description:BackgroundPalbociclib is the first cyclin dependent kinase 4/6 (CDK4/6) inhibitor approved in China to be combined with endocrine therapy (ET) for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. However, palbociclib has only been used in China for a short amount of time, and there is limited data on its real-world applications. This study observed the efficacy and safety of palbociclib plus ET in a real-world setting in southwest China and we hope to provide some references for the treatment of patients with breast cancer in China.MethodsThis was an observational study of patients with HR+/HER2- advanced breast cancer (ABC) who received palbociclib plus ET. The primary endpoint of the study was progression-free survival (PFS) and the 6- and 12-month progression-free rates. The secondary endpoint included the objective response rate (ORR) and the clinical benefit rate (CBR).ResultsA total of 64 patients were enrolled in this study, and 54.7% of them received palbociclib plus ET as the first-line treatment for ABC. The median PFS was 21.6 months (95% CI: 11.2-32.0 months) after a median follow-up period of 13.8 months (95% CI: 11.9-15.7 months). The 6-month progression-free rate was 75.4%, and 48.9% of patients remained progression-free at 12 months. Overall, the ORR was 21.6% and the CBR was 76.5%. Patients with the molecular typing of Luminal A (P=0.035), a lower Ki67 level (P<0.001), sensitivity or acquired resistance to ET (P=0.003), less than 3 visceral metastases lesions (P=0.001), and those who received palbociclib plus ET as first-line or second-line of treatment for ABC (P=0.001) showed longer PFS. A total of 53.1% of patients had grade 3-4 adverse events (AEs), but only 4.7% of patients experienced permanent discontinuation of treatment due to intolerable AEs.ConclusionsThe efficacy of palbociclib plus ET is worthy of recognition and the toxicity was acceptable in this study, which is similar to previously reported data from randomized clinical trials and other real-world evidence. Treatment for ABC using palbociclib plus ET should be recommended more widely in China due to the efficacy and safety.

Project description:BackgroundIn recent years, the combination of CDK4/6 inhibitors (CDK4/6i) and endocrine therapy (ET) has emerged as the standard first-line treatment for hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) patients. However, the comparison between the efficacy of CDK4/6i has been poorly explored before. Moreover, it remains unclear about the optimal choice of CDK4/6i in the first-line treatment for HR+/HER2- MBC patients in Asian, especially Chinese populations.ObjectivesOur study aims to compare the efficacy of three CDK4/6i widely used in the Chinese population (palbociclib, abemaciclib, and dalpiciclib) in the real world.DesignFrom 2020 to 2023, the medical records of patients diagnosed with HR+/HER2- MBC were retrospectively assessed in seven institutions in China. Patients who received first-line palbociclib, abemaciclib, or dalpiciclib plus ET were included.MethodsDemographic and clinical data were retrospectively collected and analyzed. Real-world progression-free survival (rwPFS), overall survival (OS), and objective response rate were used to analyze the clinical outcome.ResultsIn total, 209 HR+/HER2- MBC patients were eligible for this study. Eighty-eight (42.1%), 79 (37.8%), and 42 (20.1%) patients were administered first-line palbociclib, abemaciclib, or dalpiciclib plus ET. The overall median rwPFS was 19 months, with no significant difference between these three CDK4/6i (p = 0.84). The results were similar even after propensity score matching. The median OS was not reached. Cox univariate and multivariate regression analysis identified that higher KI67 index, liver metastasis, and primary endocrine resistance were independent risk factors for rwPFS in patients with initial CDK4/6i plus ET.ConclusionThis study presents a comparison of the real-world efficacy between three CDK4/6i widely used in the Chinese population. Palbociclib, abemaciclib, and dalpiciclib demonstrated comparable efficacy in Chinese patients with advanced HR+/HER2- MBC.Trial registrationClinicalTrials.gov identifier: NCT06344780.

Project description:BackgroundAlthough endocrine therapy (ET) is the preferred option for hormone receptor-positive HER2-negative metastatic breast cancer (HR+/HER2- MBC), chemotherapy (CT) is still commonly used. The objective of this real-world study was to present the actual choice of first-line treatment for patients with HR+/HER2- MBC and evaluate the consistency with guidelines in China.MethodsPatients with HR+/HER2- MBC between 1996 and September 2018 were identified from of the database of Chinese Society of Clinical Oncology Breast Cancer (CSCO BC). The statistical description was conducted to present the first-line treatment. Factors influencing the prescription of ET or CT were obtained using univariate and multivariate analysis. The consistency of the actual treatment with the guideline of Chinese Society of Clinical Oncology Breast Cancer (CSCO BC guideline) was evaluated.ResultsOf 1,877 patients, 662 (35.3%) received ET, and 1,215 (64.7%) received CT. ET proportion was only 25.4% in 1996-2005 and gradually increased to 44.6% in 2016-2018. Aromatase inhibitors (69% of ET) and taxane-based regimens (66% of CT) were the most commonly used ET and CT, respectively. Univariate and multivariate analysis showed that patients with age ≥60, distant relapse-free interval (DRFI) ≥24 months, ER+/PR+, bone metastasis only, or progression on (neo)adjuvant ET were preferably chosen for ET as first-line treatment. Factors associated with preferring CT were de novo stage IV, liver or lung metastasis. 17.2% of patients (322 cases) who had neither visceral metastasis nor progression on (neo)adjuvant ET wrongly received CT instead of ET, which is inconsistent with CSCO BC guideline. More than half of patients receiving CT discontinued their initial treatment due to adverse events and other non-disease progression reasons.ConclusionsAlthough high proportion of HR+/HER2- MBC patients received CT as first-line treatment in China, it is gratifying to see that the proportion of patients receiving ET has gradually increased. Our study revealed that 17.2% of patients were over-treated according to CSCO BC guideline, which may provide data to promote guideline adherence. The clinical application for ET should be appropriately expanded in first-line treatment, especially for patients without visceral disease and proof of endocrine resistance.

Dataset Information

Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China.

Background

Methods

Results

Conclusion

Publications

Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China.

Similar Datasets

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