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. 2023 Dec 15:13:1203684.
doi: 10.3389/fonc.2023.1203684. eCollection 2023.

The effectiveness and safety of palbociclib and ribociclib in stage IV HR+/HER-2 negative breast cancer: a nationwide real world comparative retrospective cohort study

Nour Hisham Al-Ziftawi  1 , Shereen Elazzazy  2 , Mohammed Fasihul Alam  3 , Asrul Shafie  4 , Anas Hamad  2   5 , Salha Bbujassoum  6 , Mohamed Izham Mohamed Ibrahim  5
Affiliations

The effectiveness and safety of palbociclib and ribociclib in stage IV HR+/HER-2 negative breast cancer: a nationwide real world comparative retrospective cohort study

Nour Hisham Al-Ziftawi et al. Front Oncol. .

Abstract

Introduction: Palbociclib and ribociclib are indicated in the first-line treatment of hormonal receptor-positive HER-2 negative (HR+/HER2- negative) advanced breast cancer. Although randomized-controlled trials (RCTs) proved their clinical efficacy, there are no observational studies yet to validate the clinical findings in the real-world. Therefore, this study aimed to evaluate and compare the clinical effectiveness and safety profiles of palbociclib and ribociclib in Qatar.

Materials and methods: A retrospective observational study was conducted on HR+/HER-2-negative stage-IV breast cancer patients receiving palbociclib or ribociclib in the state of Qatar. Clinical data were collected from the National Center for Cancer Care and Research (NCCCR) in Qatar using Cerner®. Primary outcomes were progression-free-survival (PFS) and overall-survival (OS) generated by Kaplan-Meier curves. Moreover, safety profiles of both two treatments were evaluated.

Results: The data from 108 patients were included in the final analysis. There was no statistically significant difference in PFS between the palbociclib and ribociclib groups; PFS was 17.85 versus 13.55 months, respectively(p> 0.05). Similarly, there was no statistically significant difference in OS between the two medications, 29.82 versus 31.72 months, respectively(p>0.05). Adverse events were similar between the two groups. Neutropenia was the most common side effect in the study population accounting for 59.3% of the patients.

Conclusions: Therefore, both treatments have similar efficacy and safety profiles. Further research on a larger-scale population and longer follow-up period is recommeneded.

Keywords: CDK4/6 cell cycle inhibitors; HR+/HER-2 negative; advanced breast cancer (ABC); cyclin-dependent-kinase 4/6 inhibitors; effectiveness & efficiency (E&E).

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier’s survival curves of the progression-free survival for palbociclib and ribociclib.
Figure 2
Figure 2
Kaplan-Meier’s survival curves of the overall survival for palbociclib and ribociclib.
See this image and copyright information in PMC

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