Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Feb 5:13:2023-7-5.
doi: 10.7573/dic.2023-7-5. eCollection 2024.

Efficacy and activity of treatments after progression from palbociclib plus endocrine therapy in patients with HR+/HER2- metastatic breast cancer: a prospective, monocentric study

Raffaella Palumbo  1 , Erica Quaquarini  1 , Giuseppe Saltalamacchia  1   2 , Alberto Malovini  3 , Pietro Lapidari  1   2 , Barbara Tagliaferri  1 , Ludovica Mollica  1   2 , Cristina Maria Teragni  1 , Chiara Barletta  1   2 , Laura Deborah Locati  1   2 , Federico Sottotetti  1
Affiliations

Efficacy and activity of treatments after progression from palbociclib plus endocrine therapy in patients with HR+/HER2- metastatic breast cancer: a prospective, monocentric study

Raffaella Palumbo et al. Drugs Context. .

Abstract

Background: Breast cancer is the most frequent tumour worldwide, and the HR+/HER2- subtype is the most common. For this tumour type, endocrine therapy (ET) is the mainstay of treatment. The association of ET and CDK4/6 inhibitors (CDK4/6i) represents the gold standard for first-line or second-line therapies. However, the optimal therapeutic strategy after CDK4/6i progression is still a matter of debate, with several randomized clinical trials still ongoing.

Patients and methods: This is an observational, prospective, real-world study including women with HR+/HER2- metastatic breast cancer progressing to palbociclib plus ET. Patients received either ET or chemotherapy (CT). The primary objective was the evaluation of efficacy of the different therapeutic strategies after palbociclib in terms of median progression-free survival 2. Secondary objectives were the activity of therapeutic strategies measured with the clinical benefit rate, evaluation of the parameters used for the treatment choice, and progression-free survival 1 related to palbociclib plus ET treatment.

Results: Overall, 48 patients (median age 53, range 33-78 years) were included. The median progression-free survival 2 was of 5 months in the overall cohort (95% CI 4-48 months) with a statistically significant difference between the two therapeutic strategies adopted (ET versus CT, 10 months versus 5 months, respectively). Regarding secondary objectives, the clinical benefit rate was 55.2% in the CT cohort and 50% in ET. Moreover, women treated with CT had a greater number of visceral metastases and a shorter median progression-free survival 1 than patients who received ET.

Conclusions: ET and CT represent two possible therapeutic alternatives for patients progressing on CDK4/6i plus ET. The choice is based on clinical parameters, with a potential preference for ET.

Keywords: endocrine resistance; metastatic breast cancer; palbociclib; post-progression; therapeutic strategies.

PubMed Disclaimer

Conflict of interest statement

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2023/11/dic.2023-7-5-COI.pdf

Figures

Figure 1
Figure 1
Flow diagram showing patients included in the final analysis of the study.
Figure 2
Figure 2
Kaplan–Meier curve describing the progression-free survival profile of patients who started the therapy at PD.
Figure 3
Figure 3
Kaplan–Meier curve describing the progression-free survival profile of the analysed cohort (patients who started the therapy at PD) by type of therapy at PD.
Figure 4
Figure 4
Clinical benefit rate between the two cohorts (ET versus CT) based on the type of treatment. CR, complete response; PD, disease progression; PR, partial response; SD, stable disease.
See this image and copyright information in PMC

References

    1. Sung MA, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71:209–249. doi: 10.3322/caac.21660. - DOI - PubMed
    1. Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC4) Ann Oncol. 2018;29:1634–1657. doi: 10.1093/annonc/mdy192. - DOI - PMC - PubMed
    1. National Comprehensive Cancer Network. NCC clinical practice guidelines in oncology. Breast Cancer Version 4. 2020 doi: 10.6004/jnccn.2020.0016. - DOI - PubMed
    1. Rugo H, Rumble B, Macrae E, et al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American Cancer Society of Clinical Oncology guideline. J Clin Oncol. 2016;34:3069–3103. doi: 10.1200/JCO.2016.67.1487. - DOI - PubMed
    1. Tryfonidis K, Zardavas D, Katzenellenbogen BS, et al. Endocrine treatment in breast cancer: cure, resistance and beyond. Cancer Treat Rev. 2016;50:68–81. doi: 10.1016/j.ctrv.2016.08.008. - DOI - PubMed