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
Coralie Courtinard,
Sophie Gourgou,
William Jacot,
Matthieu Carton,
Olivier Guérin,
Laure Vacher,
Aurélie Bertaut,
Marie-Cécile Le Deley,
David Pérol,
Patricia Marino,
Christelle Levy,
Lionel Uwer,
Geneviève Perrocheau,
Renaud Schiappa,
Florence Bachelot,
Damien Parent,
Mathias Breton,
Thierry Petit,
Thomas Filleron,
Agnès Loeb,
Simone Mathoulin-Pélissier,
Mathieu Robain,
Suzette Delaloge,
Carine Bellera
Affiliations
Coralie Courtinard
University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Epicene Team
Sophie Gourgou
Biometrics Unit, Institut du Cancer de Montpellier
William Jacot
University of Montpellier
Matthieu Carton
Department of Biostatistics, Institut Curie
Olivier Guérin
Department of Medical Information, Institut de Cancérologie de L’Ouest Nantes & Angers
Laure Vacher
Department of Medical Oncology, Centre Jean Perrin
Aurélie Bertaut
Department of Biometry, Institut de Cancérologie de Bourgogne
Marie-Cécile Le Deley
Centre Oscar Lambret
David Pérol
Department of Biometry, Centre Léon Bérard, 28 Prom. Léa Et Napoléon Bullukian
Patricia Marino
Institut Paoli-Calmettes
Christelle Levy
Department of Medical Oncology, Centre François Baclesse
Lionel Uwer
Medical Oncology Department, Institut de Cancérologie de Lorraine
Geneviève Perrocheau
Department of Pharmacy, Institut de Cancérologie de L’Ouest Nantes
Renaud Schiappa
Department of Biometry, Centre Antoine Lacassagne
Florence Bachelot
Department of Medical Information, Institut Curie
Damien Parent
Department of Pharmacy, Institut de Cancérologie Jean-Godinot
Mathias Breton
Department of Medical Information, Centre Eugène Marquis
Thierry Petit
Department of Medical Oncology, Institut de Cancérologie Strasbourg Europe (ICANS)
Thomas Filleron
Department of Biometry, Institut Claudius Regaud – IUCT Oncopole
Agnès Loeb
Department of Medical Information, Centre Henri Becquerel
Simone Mathoulin-Pélissier
University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Epicene Team
Mathieu Robain
Unicancer
Suzette Delaloge
Department of Cancer Medicine, Gustave Roussy Cancer Campus
Carine Bellera
University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Epicene Team
Abstract 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.
