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Clinical Studies

Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: an extracted individual patient data and trial-level meta-analysis

British Journal of Cancer volume 130, pages 242–250 (2024)Cite this article

Subjects

Abstract

Background

Neoadjuvant immunotherapy (nIO) has emerged as a treatment option for stage II–III triple-negative breast cancer (TNBC). While randomised clinical trials (RCTs) demonstrated pathological complete response rate benefit to nIO added to chemotherapy, additional data on long-term outcomes is warranted. We performed this analysis to evaluate long-term efficacy outcomes of nIO in TNBC.

Methods

We searched databases for RCTs evaluating nIO in early-stage TNBC. A meta-analysis of extracted individual patient data (EIPD) was performed to evaluate EFS and OS, with data from reported Kaplan–Meier plots. Additionally, we conducted a trial-level meta-analysis using fixed and random effects models.

Results

The literature search resulted in four included RCTs with available EFS or OS (KEYNOTE-522, IMpassion031, I-SPY2 and GeparNuevo). EIPD showed that the addition of nIO to chemotherapy provides statistically significant benefits in EFS (HR 0.62, 0.50–0.76; p < 0.001) and OS (HR 0.62, 0.46–0.82, p < 0.001). Number needed to treat to avoid one EFS or OS event in 4 years was 9 and 14, respectively. Trial-level meta-analysis yielded similar results (EFS: HR 0.64, 0.51–0.79; OS: 0.57, 0.37–0.89).

Conclusions

Results show that nIO combined with chemotherapy can provide significant EFS and OS benefits, supporting its use as standard treatment for early-stage TNBC.

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Fig. 1
Fig. 2: Kaplan–Meier plots of extracted IPD of survival outcomes.
Fig. 3: Graphical representation of the trial-level meta-analysis of survival outcomes.

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Code availability

The complete code for this manuscript is available upon reasonable request to the corresponding author.

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Acknowledgements

Partial results of this study have been presented as a poster at the 2023 European Society of Medical Oncology Breast Cancer Annual Congress, on May 11–13, 2023 (P128).

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Authors and Affiliations

  1. Instituto do Câncer do Estado de São Paulo, University of São Paulo, São Paulo, Brazil

    Mateus Trinconi Cunha, Mariana Carvalho Gouveia, Felippe Lazar Neto, Laura Testa, Paulo Marcelo Hoff & Renata Colombo Bonadio

  2. Instituto D’Or de Pesquisa e Ensino (IDOR), São Paulo, Brazil

    Laura Testa, Paulo Marcelo Hoff & Renata Colombo Bonadio

  3. Université Libre de Bruxelles (U.L.B), Hôpital Universitaire de Bruxelles (HUB), Institut Jules Bordet, Brussels, Belgium

    Evandro de Azambuja

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Contributions

MTC, MCG, FLN and RCB were responsible for the conceptualisation of the project. MTC, MCG and RCB were responsible for data collection and curation. MTC, FLN and RCB were responsible for formal analysis, investigation, and methodology. MTC and FLN were responsible for software. MTC was responsible for writing the original draft. RCB, EA and LT were responsible for project supervision. All authors reviewed and edited the manuscript.

Corresponding author

Correspondence to Mateus Trinconi Cunha.

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Competing interests

MTC, MCG, FLN, and PMH declare no competing interests. LT: Consulting or Advisory Role: Lilly, Novartis, MSD, AstraZeneca, Daiichi-Sankyo; Educational Support: Pfizer, Lilly, Zodiac, AstraZeneca; Speaker: Novartis, Roche, Pfizer, Zodiac, Lilly, MSD, AstraZeneca, Daiichi-Sankyo; Institutional Research Funding: Novartis. RCB: Speaker fees and/or honoraria for consulting or advisory functions: Daiichi-Sankyo, Nestle Health Science, Zodiac, Gilead, MSD. Expert testimony: AstraZeneca, Ache, Nestle Health Science. Financial support for educational programs and symposia: AstraZeneca, Daiichi-Sankyo. Institutional—Research grant: Novartis, AstraZeneca. EA: Financial: Honoraria and/or advisory board from Roche/GNE, Novartis, SeaGen, Zodiac, Libbs, Pierre Fabre, Lilly, AstraZeneca, MSD, Gilead Sciences; Travel grants from Roche/GNE and AstraZeneca; Research grant to my institution from Roche/GNE, AstraZeneca, and GSK/Novartis, Gilead Sciences; Non-financial: ESMO director of Membership 2023–2024; BSMO President 2023–2026.

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Cunha, M.T., Gouveia, M.C., Neto, F.L. et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: an extracted individual patient data and trial-level meta-analysis. Br J Cancer 130, 242–250 (2024). https://doi.org/10.1038/s41416-023-02501-w

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