Combination of palbociclib with adjuvant endocrine therapy for treatment of hormone receptor‑positive and human epidermal growth factor receptor 2‑negative metastatic breast cancer: An experience at two cancer centers in Saudi Arabia

Al-Foheidi,Meteb H.; Albeshri,Asem Mohammed; Moamenkahan,Safwan Noor; Abdullah,Abdulmajid Mohammed; Abualola,Muhannad Sadaqa; Alharbi,Muath Hamed; Refa,Ahmed A.; Bayer,Ali M.; Shaheen,Ahmed Y.; Aga,Syed Sameer; Khan,Muhammad Anwar; Al‑Mansour,Mubarak M.; Ibrahim,Ezzeldin M.

doi:10.3892/mco.2022.2552

Combination of palbociclib with adjuvant endocrine therapy for treatment of hormone receptor‑positive and human epidermal growth factor receptor 2‑negative metastatic breast cancer: An experience at two cancer centers in Saudi Arabia

Authors:
- Meteb H. Al-Foheidi
- Asem Mohammed Albeshri
- Safwan Noor Moamenkahan
- Abdulmajid Mohammed Abdullah
- Muhannad Sadaqa Abualola
- Muath Hamed Alharbi
- Ahmed A. Refa
- Ali M. Bayer
- Ahmed Y. Shaheen
- Syed Sameer Aga
- Muhammad Anwar Khan
- Mubarak M. Al‑Mansour
- Ezzeldin M. Ibrahim
View Affiliations

Affiliations: Princess Noorah Oncology Center, National Guard Health Affairs, King Saud Bin Abdul Aziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Jeddah 21423, Kingdom of Saudi Arabia, Oncology Center, International Medical Center, King Saud Bin Abdul Aziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Jeddah 21423, Kingdom of Saudi Arabia, Department of Basic Medical Sciences, College of Medicine, King Saud Bin Abdul Aziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Jeddah 21423, Kingdom of Saudi Arabia, Department of Basic Medical Sciences, College of Medicine, King Saud Bin Abdul Aziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Jeddah 21423, Kingdom of Saudi Arabia
Published online on: June 1, 2022 https://doi.org/10.3892/mco.2022.2552
Article Number: 119
Copyright: © Al-Foheidi et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

The addition of palbociclib (a cyclin‑dependent kinase 4/6 inhibitor) to endocrine therapy (ET) has been shown to significantly improve progression‑free survival (PFS) and overall survival (OS) among patients with hormone receptor‑positive (HR+) advanced breast cancer. The current study presents the local experience of using palbociclib at two cancer centers in Saudi Arabia. Electronic data of patients with metastatic HR⁺ and human epidermal growth factor receptor 2‑negative breast cancer who progressed after prior ET and received at least one cycle of palbociclib plus ET, were retrospectively reviewed. A total of 97 patients were identified, and their data were included in the analysis. The median age of the patients was 55 years. Patients were heavily pretreated in the metastatic setting (55% received systemic chemotherapy and 49% received two or more lines of prior ET). In total, 29 (30%) and 50 (52%) patients achieved an objective response and clinical benefit, respectively. The median follow‑up time was 31.0 months [95% confidence interval (CI), 16.9‑44.9] and the median PFS time was 16.3 months (95% CI, 11.4‑21.2), with 58% of patients remaining progression‑free at 12 months. Upon multivariate regression analysis, liver involvement was the only significant independent variable that predicted a greater risk of progression or death (hazard ratio, 2.32; 95% CI, 1.22‑4.40; P=0.010). The median OS time was 19.6 months (95% CI, 18.1‑20.9), with 12‑ and 24‑month OS rates of 75 and 30%, respectively. Overall, real‑world data showed that administration of palbociclib in combination with ET in patients with advanced HR⁺ breast cancer achieved a favorable outcome that was comparable to that reported in clinical trials.

View Figures

View References

1	Althubiti MA and Nour Eldein MM: Trends in the incidence and mortality of cancer in Saudi Arabia. Saudi Med J. 39:1259–1262. 2018.PubMed/NCBI View Article : Google Scholar
2	Howlader N, Altekruse SF, Li CI, Chen VW, Clarke CA, Ries LA and Cronin KA: US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 106(dju055)2014.PubMed/NCBI View Article : Google Scholar
3	Global Burden of Disease Cancer Collaboration. Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, et al: Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 29 cancer groups, 1990 to 2016: A systematic analysis for the global burden of disease study. JAMA Oncol. 4:1553–1568. 2018.PubMed/NCBI View Article : Google Scholar
4	Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, Peto R, Pritchard KI, Bergh J, Dowsett M, et al: 20-Year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 377:1836–1846. 2017.PubMed/NCBI View Article : Google Scholar
5	O'Leary B, Finn RS and Turner NC: Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol. 13:417–430. 2016.PubMed/NCBI View Article : Google Scholar
6	Sherr CJ and Roberts JM: CDK inhibitors: Positive and negative regulators of G1-phase progression. Genes Dev. 13:1501–1512. 1999.PubMed/NCBI View Article : Google Scholar
7	Weinberg RA: The retinoblastoma protein and cell cycle control. Cell. 81:323–330. 1995.PubMed/NCBI View Article : Google Scholar
8	Roberto M, Astone A, Botticelli A, Carbognin L, Cassano A, D'Auria G, Fabbri A, Fabi A, Gamucci T, Krasniqi E, et al: CDK4/6 inhibitor treatments in patients with hormone receptor positive, Her2 negative advanced breast cancer: Potential molecular mechanisms, clinical implications and future perspectives. Cancers (Basel). 13(332)2021.PubMed/NCBI View Article : Google Scholar
9	Rugo HS, Diéras V, Gelmon KA, Finn RS, Slamon DJ, Martin M, Neven P, Shparyk Y, Mori A, Lu DR, et al: Impact of palbociclib plus letrozole on patient-reported health-related quality of life: Results from the PALOMA-2 trial. Ann Oncol. 29:888–894. 2018.PubMed/NCBI View Article : Google Scholar
10	Verma S, O'Shaughnessy J, Burris HA, Campone M, Alba E, Chandiwana D, Dalal AA, Sutradhar S, Monaco M and Janni W: Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2. Breast Cancer Res Treat. 170:535–545. 2018.PubMed/NCBI View Article : Google Scholar
11	Booth CM, Karim S and Mackillop WJ: Real-world data: Towards achieving the achievable in cancer care. Nat Rev Clin Oncol. 16:312–325. 2019.PubMed/NCBI View Article : Google Scholar
12	Murthy VH, Krumholz HM and Gross CP: Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA. 291:2720–2726. 2004.PubMed/NCBI View Article : Google Scholar
13	Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, et al: Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 379:1926–1936. 2018.PubMed/NCBI View Article : Google Scholar
14	Turner NC, Ro J, André F, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Huang Bartlett C, Zhang K, et al: Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med. 373:209–219. 2015.PubMed/NCBI View Article : Google Scholar
15	Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, et al: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 45:228–247. 2009.PubMed/NCBI View Article : Google Scholar
16	Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, et al: Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 375:1925–1936. 2016.PubMed/NCBI View Article : Google Scholar
17	Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, et al: Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): Final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 17:425–439. 2016.PubMed/NCBI View Article : Google Scholar
18	Odan N, Kikawa Y, Matsumoto H, Minohata J, Suwa H, Hashimoto T, Okuno T, Miyashita M, Saito M, Yamagami K and Takao S: Real-world outcomes of treating advanced breast cancer patients with palbociclib: A multicenter retrospective cohort study in Japan-the KBCOG-14 study. Breast Cancer (Auckl). 14(1178223420983843)2020.PubMed/NCBI View Article : Google Scholar
19	Vuppalanchi R, Saxena R, Storniolo AMV and Chalasani N: Pseudocirrhosis and liver failure in patients with metastatic breast cancer after treatment with palbociclib. Hepatology. 65:1762–1764. 2017.PubMed/NCBI View Article : Google Scholar
20	No authors listed: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012.
21	Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, et al: MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 35:3638–3646. 2017.PubMed/NCBI View Article : Google Scholar
22	Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, et al: Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 382:514–524. 2020.PubMed/NCBI View Article : Google Scholar
23	He J, Morales DR and Guthrie B: Exclusion rates in randomized controlled trials of treatments for physical conditions: A systematic review. Trials. 21(228)2020.PubMed/NCBI View Article : Google Scholar