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. 2024 Dec 18;10(1):105.
doi: 10.1038/s41523-024-00713-8.

Clinico-pathological predictors of radiologic complete response to first-line anti-HER2 therapy in metastatic breast cancer

Linda Cucciniello  1   2 , Eva Blondeaux  3 , Claudia Bighin  4 , Simona Gasparro  5 , Stefania Russo  6 , Arianna Dri  1   2 , Palma Pugliese  7 , Andrea Fontana  8 , Enrico Cortesi  9 , Antonella Ferzi  10 , Ferdinando Riccardi  11 , Valentina Sini  12 , Luca Boni  3 , Alessandra Fabi  5   13 , Filippo Montemurro  14   15 , Michelino De Laurentiis  16 , Grazia Arpino  17 , Lucia Del Mastro  4   18 , Lorenzo Gerratana #  19   20 , Fabio Puglisi #  1   2
Affiliations

Clinico-pathological predictors of radiologic complete response to first-line anti-HER2 therapy in metastatic breast cancer

Linda Cucciniello et al. NPJ Breast Cancer. .

Abstract

This study aimed to identify the clinico-pathological variables predictive of radiologic complete response (rCR) to first-line anti-HER2 therapy in patients with HER2-positive metastatic breast cancer. Patients were selected from the database of the GIM14 study and classified according to the best radiologic response obtained to first-line anti-HER2 therapy and upon time-to-treatment-discontinuation (TTD). A total of 545 patients were included in the analysis. Eighty patients experienced a rCR to first-line anti-HER2 therapy with a TTD > 3 months and HER2 Immunohistochemistry score 3+, presence of non-visceral metastases and 1 metastatic site were significantly associated with higher odds of obtaining a CR. Of the 80 patients achieving a rCR, 56 experienced a CR with a TTD > 18 months, with anti-HER2 therapy being the only variable significantly associated with a higher probability of achieving such sustained CR.

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Conflict of interest statement

Competing interests: E.B.: grants from Gilead to institution; personal fees from Eli Lilly; C.B.: fees or honoraria from Novartis, Roche and Eli Lilly; A.F.: advisory boards: Roche, Novartis, Eli Lilly, Pfizer, MSD, Pierre Fabre, Eisai, Gilead, Seagen, AstraZeneca, Exact Sciences; consulting fees: Dompé Farmaceutici S.p.A.; F.M.: consulting fees: Roche, Novartis, AstraZeneca, Daiichy Sankyo, SeaGen, MSD, Eli Lilly, Pfizer, and Pierre Fabre; travel grants: Roche and AstraZeneca; from May 15th, 2023, F.M. is Roche employee (all the disclosed activities are outside the submitted work); M.D.L.: speaker’s honoraria, consulting honoraria, and advisory board honoraria: Novartis, Eli Lilly, Pfizer, Roche, Sophos, Genetic, Menarini, Daiichi-Sankyo, Seagen, Pierre Fabre, GSK and Takeda; G.A.: research and medical writing: AstraZeneca; advisory boards, travel grants, activities as a speaker, consultancy: AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Exact Science, Novartis, Roche, Seagen, Viatris; L.D.M.: institutional grants: Eli Lilly, Novartis, Roche, Daiichi Sankyo, Seagen, Astra Zeneca, Gilead, Pierre Fabre; consulting fees: Eli Lilly, Gilead, Daiichi Sankyo; payment or honoraria for lectures, presentations, speakers bureaus: Roche, Novartis, Pfizer, Eli Lilly, AstraZeneca, MSD, Seagen, Gilead, Pierre Fabre, Eisai, Exact Sciences, Ipsen, GSK, Agendia, Menarini Stemline; support for attending meetings and/or travel: Roche, Pfizer, Eisai, Daiichi Sankyo, AstraZeneca, Gilead; Participation on a Data Safety Monitoring Board or Advisory Board: Novartis, Roche, Eli Lilly, Pfizer, Daiichi Sakyo, Exact Sciences, Gilead, Pierre Fabre, Eisai, AstraZeneca, Agendia, GSK, Seagen, Olema, MSD, Menarini Stemline; L.G.: consulting or advisory role: AstraZeneca, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Incyte, Novartis, Pfizer, Merck Sharp & Dohme, Menarini Stemline, Abbvie; research funding: Menarini Silicon Biosystems Patents, Royalties; travel expenses: Menarini Stemline; F.P.: honoraria for advisory boards, activities as a speaker, travel grants, research grants from Amgen, AstraZeneca, Daiichi Sankyo, Celgene, Eisai, Eli Lilly, Exact Sciences, Gilead, Ipsen, Menarini, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seagen, Takeda, Viatris; research funding from AstraZeneca, Eisai, Roche, outside the submitted work. The remaining authors have no conflict to disclose.

Figures

Fig. 1
Fig. 1. The strobe diagram summarizing the process for the identification of eligible patients.
As summarized, 3423 patients were enrolled in the GIM14 BIO-META study, but after excluding those with HER2-negative MBC, as well as those treated with ET, those with TTD < 3 months and the ones with missing data regarding best radiological response, 545 patients were ultimately considered eligible for this analysis. MBC metastatic breast cancer, ET endocrine therapy, TTD time-to-treatment discontinuation.
Fig. 2
Fig. 2. Forest plot of subgroup analysis.
In detail, the three forest plots represented in this figure are referred to all patients with rCR (A), in patients with rCR and treated with trastuzumab-pertuzumab (B), and in patients with CR and TTD >18 months (C). rCR radiologic complete response, CR complete response, TTD time-to-treatment discontinuation.
Fig. 3
Fig. 3. Kaplan Meyer curves reporting the overall survival in all patients with HER2-positive MBC considered in the present analysis.
MBC metastatic breast cancer, PD disease progression, CR complete response, PR partial response, SD stable disease.
Fig. 4
Fig. 4. Kaplan Meyer curves reporting the overall survival amongst patients with HER2-positive MBC experiencing a radiologic complete response with a TTD > 18 months.
MBC metastatic breast cancer, TTD time-to-treatment discontinuation, CR complete response, PR partial response, SD stable disease.
See this image and copyright information in PMC

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