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. 2023 Mar 8;21(1):87.
doi: 10.1186/s12916-023-02754-5.

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  1   2 , Sophie Gourgou  3   4 , William Jacot  4   5   6 , Matthieu Carton  7 , Olivier Guérin  8 , Laure Vacher  9 , Aurélie Bertaut  10 , Marie-Cécile Le Deley  11 , David Pérol  12 , Patricia Marino  13   14 , Christelle Levy  15 , Lionel Uwer  16 , Geneviève Perrocheau  17 , Renaud Schiappa  18 , Florence Bachelot  19 , Damien Parent  20 , Mathias Breton  21 , Thierry Petit  22 , Thomas Filleron  23 , Agnès Loeb  24 , Simone Mathoulin-Pélissier  1   25 , Mathieu Robain  2 , Suzette Delaloge  26 , Carine Bellera  27   28
Affiliations

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 et al. BMC Med. .

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.

Keywords: Association; Breast cancer; Overall survival; Progression-free survival; Real-word data; Surrogacy.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flow chart ESME, epidemiological strategy and medical economics; mBC, metastatic breast cancer; HR + , presence of hormone receptor; HR − , absence of hormone receptor; HER2 + , human epidermal growth factor receptor 2 (HER2) protein overexpression; HER2 − , no HER2 protein overexpression. TN, triple negative
Fig. 2
Fig. 2
Median survival outcomes (overall survival [OS], real-world progression-free-survival [rwPFS]) in metastatic breast cancer (mBC) patients after diagnosis of mBC, according to first-line treatment by tumor subtype (in months) HR + , presence of hormone receptor; HR − , absence of hormone receptor; HER2 + , human epidermal growth factor receptor 2 (HER2) protein overexpression; HER2 − , no HER2 protein overexpression. CT, chemotherapy only; ET, endocrine therapy only; TT, targeted therapy only; CT& ET, chemotherapy and endocrine therapy; CT and TT, chemotherapy and targeted therapy; ET & TT, endocrine therapy and targeted therapy; CT, TT and ET, chemotherapy, targeted therapy and endocrine therapy. Median estimates are presented in months, with 95% confidence interval (95% CI)
Fig. 3
Fig. 3
Estimated real-world progression-free survival curve, by tumor subtype, for study population (N = 20,033) HR + , presence of hormone receptor; HR − , absence of hormone receptor; HER2 + , human epidermal growth factor receptor 2 (HER2) protein overexpression; HER2 − , no HER2 protein overexpression; TN, triple negative
Fig. 4
Fig. 4
Estimated overall survival curve, by tumor subtype for study population (N = 20,033) OS, overall survival; HR + , presence of hormone receptor; HR − , absence of hormone receptor; HER2 + , human epidermal growth factor receptor 2 (HER2) protein overexpression; HER2 − , no HER2 protein overexpression; TN, triple negative
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References

    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. 10.3322/caac.21660 - DOI - PubMed
    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. 10.3322/caac.21492 - DOI - PubMed
    1. Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, et al. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008–2016. Eur J Cancer. 2020;129:60–70. 10.1016/j.ejca.2020.01.016 - DOI - PubMed
    1. Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, André F, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)†. Ann Oncol. 2020;31(12):1623-49. - PMC - PubMed
    1. Hirschfeld S, Pazdur R. Oncology drug development: United States Food and Drug Administration perspective. Crit Rev Oncol Hematol. 2002;42(2):137–43. 10.1016/S1040-8428(02)00008-2 - DOI - PubMed

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