Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study

Heudel, Pierre; Delaloge, Suzette; Parent, D.; Madranges, Nicolas; Lévy, Christelle; Brain, Étienne; Uwer, Lionel; Augereau, Paule; Mailliez, Audrey; Perrin, Christophe; Frenel, Jean‐Sébastien; Sablin, Marie‐Paule; Mouret-Reynier, Marie-Ange; Vermeulin, Thomas; Eymard, Jean‐Christophe; Petit, Thierry; Ferrero, Jean-­Marc; Ilie, Silvia; Gonçalvès, Anthony; Chenuc, G.; Robain, Mathieu; Simon, Gaëtane; Pérol, David

doi:10.21873/anticanres.14381

Cited by 5 publications

(2 citation statements)

References 23 publications

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“…Meanwhile, the ORR of vinorelbine combined with chemotherapy was reported to be 24%-39.4%, and the PFS was between 4.5 and 7.1 months [23,24]. In addition to the above clinical trials, some real-world studies conducted in European countries, such as France and Spain, showed that the PFS of vinorelbine was between 2.7 and 4.9 months, varying with different treatment regimens [25,26]. Oral vinorelbine was recognized in the Chinese mainland in 2015, with little real-world data in this area.…”

Section: Introductionmentioning

confidence: 99%

A Real-World Study on Oral Vinorelbine for the Treatment of Metastatic Breast Cancer

Huang¹,

Bai²,

Xie³

et al. 2022

Oncologie

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Background: Vinorelbine can be used to treat metastatic breast cancer as a single agent or in combination with other chemotherapy agents, although there is little real-world data for its use, particularly the oral form, in China. The current study aimed to explore the efficacy and safety of oral vinorelbine in patients with metastatic breast cancer in real-world clinical practice. Methods: A total of 194 patients with metastatic breast cancer received oral vinorelbine as a treatment between February 2017 and January 2021 at

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Section: Introductionmentioning

confidence: 99%

A Real-World Study on Oral Vinorelbine for the Treatment of Metastatic Breast Cancer

Huang¹,

Bai²,

Xie³

et al. 2022

Oncologie

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“…In this perspective, the Epidemiological Strategy and Medical Economics (ESME) research program has been developed, based on data collected from French Comprehensive Cancer Centers, with the aim to provide independent and high-quality real-world data [ 20 ]. Several studies have already been published so far, mainly focused on the ESME metastatic breast cancer database, with over 22,000 patients included [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ]. Apart from metastatic breast cancer, another data platform has been developed, focusing on ovarian cancers.…”

Section: Introductionmentioning

confidence: 99%

Real-World Data on Newly Diagnosed BRCA-Mutated High-Grade Epithelial Ovarian Cancers: The French National Multicenter ESME Database

Bini

Quesada

Méeus

et al. 2022

Cancers

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Background: In spite of the frequency and clinical impact of BRCA1/2 alterations in high-grade epithelial ovarian cancer (HGEOC), real-world information based on robust data warehouse has been scarce to date. Methods: Consecutive patients with BRCA-mutated HGEOC treated between 2011 and 2016 within French comprehensive cancer centers from the Unicancer network were extracted from the ESME database. The main objective of the study was the assessment of clinicopathological and treatments parameters. Results: Out of the 8021 patients included in the ESME database, 266 patients matching the selection criteria were included. BRCA1 mutation was found in 191 (71.8%) patients, while 75 (28.2%) had a BRCA2 mutation only; 95.5% of patients received a cytoreductive surgery. All patients received a taxane/platinum-based chemotherapy (median = six cycles). Complete and partial response were obtained in 53.3% and 20.4% of the cases, respectively. Maintenance therapy was administered in 55.3% of the cases, bevacizumab being the most common agent. After a median follow up of 51.7 months, a median progression-free survival of 28.6 months (95% confidence interval (CI) [26.5; 32.7]) and an estimated 5-year median overall survival of 69.2% (95% CI [61.6; 70.3]) were reported. Notably, BRCA1- and BRCA2-mutated cases exhibited a trend towards different median progression-free survivals, with 28.0 (95% CI [24.4; 32.3]) and 33.3 months (95% CI [26.7; 46.1]), respectively (p-value = 0.053). Furthermore, five-year OS for BRCA1-mutated patients was 64.5% (95% CI [59.7; 69.2]), while it was 82.5% (95% CI [76.6; 88.5]) for BRCA2-mutated ones (p-value = 0.029). Conclusions: This study reports the largest French multicenter cohort of BRCA-mutated HGEOCs based on robust data from the ESME, exhibiting relevant real-world data regarding this specific population.

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Association between progression-free survival and overall survival in women receiving first-line treatment for metastatic breast cancer: evidence from the ESME real-world database

Courtinard

Gourgou

Jacot

et al. 2023

BMC Med

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Background Overall survival (OS) is the gold standard endpoint to assess treatment efficacy in cancer clinical trials. In metastatic breast cancer (mBC), progression-free survival (PFS) is commonly used as an intermediate endpoint. Evidence remains scarce regarding the degree of association between PFS and OS. Our study aimed to describe the individual-level association between real-world PFS (rwPFS) and OS according to first-line treatment in female patients with mBC managed in real-world setting for each BC subtype (defined by status for both hormone-receptor [HR] expression and HER2 protein expression/gene amplification). Methods We extracted data from the ESME mBC database (NCT03275311) which gathers deidentified data from consecutive patients managed in 18 French Comprehensive Cancer Centers. Adult women diagnosed with mBC between 2008 and 2017 were included. Endpoints (PFS, OS) were described using the Kaplan–Meier method. Individual-level associations between rwPFS and OS were estimated using the Spearman’s correlation coefficient. Analyses were conducted by tumor subtype. Results 20,033 women were eligible. Median age was 60.0 years. Median follow-up duration was 62.3 months. Median rwPFS ranged from 6.0 months (95% CI 5.8–6.2) for HR-/HER2 − subtype to 13.3 months (36% CI 12.7–14.3) for HR + /HER2 + subtype. Correlation coefficients were highly variable across subtypes and first-line (L1) treatments. Among patients with HR − /HER2 − mBC, correlation coefficients ranged from 0.73 to 0.81, suggesting a strong rwPFS/OS association. For HR + /HER2 + mBC patients, the individual-level associations were weak to strong with coefficients ranging from 0.33 to 0.43 for monotherapy and from 0.67 to 0.78 for combined therapies. Conclusions Our study provides comprehensive information on individual-level association between rwPFS and OS for L1 treatments in mBC women managed in real-life practice. Our results could be used as a basis for future research dedicated to surrogate endpoint candidates.

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Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study

Cited by 5 publications

References 23 publications

A Real-World Study on Oral Vinorelbine for the Treatment of Metastatic Breast Cancer

A Real-World Study on Oral Vinorelbine for the Treatment of Metastatic Breast Cancer

Real-World Data on Newly Diagnosed BRCA-Mutated High-Grade Epithelial Ovarian Cancers: The French National Multicenter ESME Database

Association between progression-free survival and overall survival in women receiving first-line treatment for metastatic breast cancer: evidence from the ESME real-world database

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