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Role of palbociclib in the treatment of hormone receptor-positive HER2-negative metastatic breast cancer. Generalizing results of randomized trials and real clinical practice

https://doi.org/10.21518/2079-701X-2019-10-56-62

Abstract

Palbociclib is the first-in-class drug of CDK 4/6 inhibitors group. The use of palbociclib in combination with endocrinotherapy (ET) opens up new possibilities for the treatment of metastatic hormone receptor-positive (HRP+) HER2-negative (HER2-) breast cancer (mBC). Palbociclib has gained world attention and is included in all clinical guidelines, both international and domestic, as a new standard of first- and second-line therapy of HRP+ HER2- mBC. The article presents the updated results of PALOMA-2 and PALOMA-3 studies and the results of use of palbociclib in combination with ET in real clinical practice.

About the Authors

L. G. Zhukova
State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.
Russian Federation

Dr. of Sci. (Med.), Professor of RAS, Deputy Director of Oncology, State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of Moscow Healthcare Department.



E. I. Khatkova
Federal State Budgetary Institution «National Medical Research Center for Children’s Hematology, Oncology and Immunology named after Dmitry Rogachev» of the Ministry of Health of the Russian Federation.
Russian Federation

Resident Medical Practitioner, Federal State Budgetary Institution «Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology» of the Ministry of Health of the Russian Federation.



P. S. Feoklistova
State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.
Russian Federation

Cand. of Sci. (Med.), Head of Chemotherapy Department, State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.



K. S. Grechukhina
State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.
Russian Federation

Resident Medical Practitioner, Chemotherapy Department, State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.



S. A. Smolin
State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.
Russian Federation

Resident Medical Practitioner, Chemotherapy Department, State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.



E. A. Arutyunyan
State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.
Russian Federation

Oncologist, Chemotherapy Department, State Budgetary Health Institution «Loginov Moscow Clinical Research Center» of the Moscow Department of Health.



E. M. Kolyago
Federal State Budgetary Institution «National Medical Research Center for Children’s Hematology, Oncology and Immunology named after Dmitry Rogachev» of the Ministry of Health of the Russian Federation.
Russian Federation

Resident Medical Practitioner, Federal State Budgetary Institution «Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology» of the Ministry of Health of the Russian Federation.



References

1. Siegel R.L., Miller K.D., Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67(1):7–30. doi: 10.3322/caac.21387.

2. Harbour J.W., Luo R.X., Dei Santi A., Postigo A.A., Dean D.C. Cdk phosphorylation triggers sequential intramolecular interactions that progressively block Rb functions as cells move through G1. Cell. 1999 Sep 17;98(6):859-69. PMID: 10499802.

3. Fry D.W., Harvey P.J., Keller P.R., Elliott W.L., Meade M., Trachet E., Albassam M., Zheng X., Leopold W.R., Pryer N.K., Toogood P.L. Specific inhibition of cyclin-dependent kinase 4/6 by PD 0332991 and associated antitumor activity in human tumor xenografts. Molecular Cancer Therapeutics. 2004;11(3):1427–1438. PMID: 15542782.

4. Slamon D.J., Crown J., Lang I., Kulyk S.O., Schmidt M., Thummala R. P-A., Voytko N.L., Randolph S., Kim S., Huang X., Bartlett C.H., Schnell P., Finn R.S. Long-term safety profile of palbociclib (P) in combination with letrozole (L) as first-line treatment for postmenopausal patients with ER+ and HER2- advanced breast cancer (ABC) (PALOMA-1/TRIO-18). Journal of Clinical Oncology. 2015 May 20;33(15_suppl):570-570. doi: 10.1200/jco.2015.33.15_suppl.570.

5. Finn R.S., Martin M., Rugo H.S., Jones S., Seock- Ah Im, Gelmon K., Harbeck N., Lipatov O.N., Walshe J.M. et al. Palbociclib and Letrozole in Advanced Breast Cancer. The New England Journal of Medicine. 2016;375:1925-1936. doi: 10.1056/NEJMoa1607303.

6. Rugo H.S., Finn R.S., Diéras V., Ettl J., Lipatov O., Joy A.A., Harbeck N., Castrellon A., Iyer S., Lu D.R., Mori A., Gauthier E.R., Huang Bartlett C., Gelmon K.A., Slamon D.J. Palbociclib plus letrozole as first-line therapy in estrogen receptorpositive/ human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719–729. doi: 10.1007/s10549-018-05125-4.

7. Cristofanilli M., Turner N.C., Bondarenko I., Ro J., Im S.A., Masuda N., Colleoni M., DeMichele A., Loi S., Verma S., Iwata H., Harbeck N., Zhang K., Theall K.P., Jiang Y., Bartlett C.H., Koehler M., Slamon D. 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. The Lancet Oncology. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0.

8. Turner N.C., Slamon D.J., Ro J., Bondarenko I., Im S.-A., Masuda N., Colleoni M., DeMichele A., Loi S., Verma S., Iwata H., Harbeck N., Loibl S., André F., Puyana Theall K., Huang X., Giorgetti C., Huang Bartlett C., and Cristofanilli M. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018;379:1926-36. doi: 10.1056/NEJMoa1810527.

9. Varella L., Eziokwu A.S., Jia X., Kruse M., Moore H.C., Budd G.T., Abraham J., Montero, A.J. Realworld clinical outcomes and toxicity in metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast cancer research and treatment 2019;1-6. doi. org/10.1007/s10549-019-05176-1.

10. Trial registration: http://clinicaltrials.gov: NCT03425838 (8 February 2018). EudraCTnumber: 2017–002334-23 (29 September 2017).

11. McShane T.M., Wolfe T.A. and Ryan J.C. Updates on managing advanced breast cancer with palbociclib combination therapy. Therapeutic Advances in Medical Oncology. 2018;10:1-17. doi: 10.1177/1758835918793849.

12. Turner N.C., Finn R.S., Martin M., Im S.-A DeMichele., Ettl A.J., Die´ras V., Moulder S., Lipatov O., Colleoni M., Cristofanilli M., Lu D.R., Mori A., Giorgetti C., Iyer S., Huang Bartlett C., Gelmon K.A. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Annals of Oncology. 2018;29:669-680. doi:10.1093/annonc/mdx797.


Review

For citations:


Zhukova LG, Khatkova EI, Feoklistova PS, Grechukhina KS, Smolin SA, Arutyunyan EA, Kolyago EM. Role of palbociclib in the treatment of hormone receptor-positive HER2-negative metastatic breast cancer. Generalizing results of randomized trials and real clinical practice. Meditsinskiy sovet = Medical Council. 2019;(10):56-62. (In Russ.) https://doi.org/10.21518/2079-701X-2019-10-56-62

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ISSN 2079-701X (Print)
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