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. 2024 Mar 26:14:1362641.
doi: 10.3389/fonc.2024.1362641. eCollection 2024.

Sacituzumab Govitecan for the treatment of advanced triple negative breast cancer patients: a multi-center real-world analysis

Roberta Caputo #  1 , Giuseppe Buono #  1 , Michela Piezzo  1 , Claudia Martinelli  2   3 , Daniela Cianniello  1 , Alessandro Rizzo  4 , Francesco Pantano  5 , Nicoletta Staropoli  6 , Rodolfo Cangiano  7 , Salvatore Turano  8 , Ida Paris  9 , Francesco Nuzzo  1 , Alessandra Fabi  10 , Michelino De Laurentiis  1
Affiliations

Sacituzumab Govitecan for the treatment of advanced triple negative breast cancer patients: a multi-center real-world analysis

Roberta Caputo et al. Front Oncol. .

Abstract

Objective: The objective of this multicenter, observational, retrospective analysis was to evaluate the safety and efficacy of sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) patients managed according to common clinical practice in Italy.

Methods: Data were retrieved by 7 sites. Triple-negative BC was defined by the lack of expression of estrogen receptor (ER <1%), progesterone receptor (PgR <1%) and human-epidermal growth factor receptor-2 (HER2 0, 1+, 2+ ISH-not amplified) according to standard ASCO-CAP criteria. Demographic and clinical characteristics were collected. Premedication, dose modifications and treatment schedule were based on the approved label of the product. Adverse events (AEs) were assessed according to NCI-CTCAE v5.0.

Results: Fifty-seven eligible patients who received sacituzumab govitecan for mTNBC were included. Median age was 53 years (range 25-75). Approximately 70% of patients had an initial diagnosis of TNBC. Median time from the diagnosis of metastatic BC to start of sacituzumab govitecan was 17 months (range 0-97) and median number of previous therapies was 3 (range 1-7). The most common sites of metastasis were lymph nodes (63.1% of patients), lung (57.9%), bone (50.8%) and liver (38.6%). Eight (14.0%) patients had a disease-free interval ≤12 months. A total of 32 (56.1%) deaths were observed and the median overall survival (OS) was 12.43 months (95% CI, 7.97 months-not reached). At a median follow-up of 10.6 months, 45 patients (78.9%) had progression and the median progression-free survival (PFS) was 4.9 months (95% CI, 3.7-7.1 months). Partial tumour response was observed in 19 patients (33.3%), stable disease in 16 (28.1%) and disease progression in 22 patients (38.6%). The most common treatment-related AEs were anemia (66.6% of patients), alopecia (66.6%), neutropenia (59.6%), nausea (42.1%) and diarrhea (38.6%). Neutropenia was the most common serious treatment-related AE: 21.0% and 8.7% of patients experienced grade 3 or 4 neutropenia, respectively. Twenty-two patients (38.6%) reduced the dose and 5.3% permanently discontinued treatment.

Conclusion: The results of this real-world analysis showed that both safety and efficacy of sacituzumab govitecan in mTNBC patients are consistent with that previously reported in regulatory trials. The use of premedication and supportive measures was associated with a satisfactory toxicity profile.

Keywords: Italy; Sacituzumab govitecan; metastatic breast cancer; retrospective study; triple negative.

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Conflict of interest statement

RC had consulting or advisory role for: Eli Lilly, Novartis, Roche, Pfizer, Gilead, Seagen, MSD, Daichii Sankyo, Veracyte, Astra Zeneca, Exact Science, Pierre Fabre, Menarini, and received travel accommodation, registration for international congresses from: Novartis, Lilly, Gilead. GB received speaker’s honoraria, consulting honoraria, and advisory board honoraria from: Novartis, GSK, Eli-Lilly, Pfizer, AstraZeneca, Roche, Daiichi Sankyo, Seagen, Gilead, Exact Science and Genetic. AR had consulting, advisory role or lectures for: Gilead, GSK, and received travel accomodations from: Gilead, MSD and Lilly. Ida Paris had consulting or participation in advisory boards for: Seagen, Novartis, Lilly, AstraZeneca, Gilead, MSD, Pfzer, Roche, Gentili, received travel accommodation, registration for international congresses from Novartis, Lilly, Roche and Gilead, and received funding for organization of scientific events from Novartis, Lilly, Roche and Gentili. AF had consulting or advisory role, and received travel accommodation or funding for scientifc meetings from: Roche, Novartis, Lilly, Pfizer, MSD, Dompè, Pierre Fabre, Eisai, Sophos, Epionpharma, Gilead, Seagen, Astra Zeneca and Exact Science. Michelino De Laurentiis received speaker’s honoraria, consulting honoraria, and advisory board honoraria from: Novartis, Eli Lilly, Pfizer, Roche, Sophos, Genetic, Menarini, Daiichi-Sankyo, Seagen, Pierre Fabre, GSK and Takeda. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be constructed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier estimate of progression-free survival up to 18 months. Full line shows the median value and shaded space shows the 95% CI.
Figure 2
Figure 2
Kaplan-Meier estimate of overall survival up to 24 months. Full line shows the median value and shaded space shows the 95% CI.
See this image and copyright information in PMC

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References

    1. Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, et al. . The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. (2007) 13:2329–34. doi: 10.1158/1078-0432.CCR-06-1109 - DOI - PubMed
    1. Li Y, Zhang H, Merkher Y, Chen L, Liu N, Leonov S, et al. . Recent advances in therapeutic strategies for triple-negative breast cancer. J Hematol Oncol. (2022) 15:121. doi: 10.1186/s13045-022-01341-0 - DOI - PMC - PubMed
    1. Hallett R, Dvorkin-Gheva A, Bane A, Hassell J. A gene signature for predicting outcome in patients with basal-like breast cancer. Sci Rep. (2012) 2:227. doi: 10.1038/srep00227 - DOI - PMC - PubMed
    1. MacDonald I, Nixon NA, Khan OF. Triple-negative breast cancer: a review of current curative intent therapies. Curr Oncol. (2022) 9:4768–78. doi: 10.3390/curroncol29070378 - DOI - PMC - PubMed
    1. Spring LM, Nakajima E, Hutchinson J, Viscosi E, Blouin G, Weekes C, et al. . Sacituzumab govitecan for metastatic triple-negative breast cancer: clinical overview and management of potential toxicities. Oncologist. (2021) 26:827–34. doi: 10.1002/onco.13878 - DOI - PMC - PubMed