Palbociclibe 75mg, 100mg e 125mg e seu processo de padronização no âmbito do Distrito Federal

Authors

  • Juliana Carvalho Rocha Alves da Silva Secretaria de Estado da Saúde do Distrito Federal - SES-DF
  • Marcus Tulio Batista Silva
  • Walleska Fidelis Gomes Borges

DOI:

https://doi.org/10.51208/saudeinovacao.v2i1.53

Keywords:

Palbociclibe, Acesso ao Medicamento, Sistema Único de Saúde

Abstract

The drug called Palbociclib is indicated for the treatment of advanced or metastatic HR (hormone receptor) positive and HER2 (human epidermal growth factor receptor) negative breast cancer, in combination with endocrine therapy: (1) With aromatase inhibitors third-generation (anastrozole, letrozole, or exemestane) as initial endocrine therapy in postmenopausal women; or (2) With fulvestrant in women who have received prior therapy. Standardization of this drug was requested in the List of Medicines of the Federal District (REME-DF). For this, a health technology assessment tool was used, through a bibliographic survey in Medline databases via Pubmed; Embase, Cochrane Library and Biblioteca Virtual em Saúde -  BVS. In view of this request, received by the CCFT, an analysis was carried out considering up-to-date literature on this product. 1446 articles were found, 10 of which were included in this analysis. In conclusion, due to the lack of robust literature regarding quality of life outcomes and high costs, this drug has not been standardized within the Federal District.

References

Pfizer. Bula do medicamento PALBOCICLIBE. Disponível em: https://www.pfizer.com.br/sites/default/files/inline-files/Ibrance_Paciente_20.pdf. Acesso em: 24.11.2021

Cynthia X Ma, MD, PhDJoseph A Sparano, MDSection Editor:Harold J Burstein, MD, PhDDeputy Editor:Sadhna R Vora, MD. Treatment approach to metastatic hormone receptor-positive, HER2-negative breast cancer: Endocrine therapy and targeted agents. Protocol. Literature review current through: May 2021.

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71

Harbeck N, Bartlett M, Spurden D, Hooper B, Zhan L, Rosta E, Cameron C, Mitra D, Zhou A. CDK4/6 inhibitors in HR+/HER2- advanced/metastatic breast cancer: a systematic literature review of real-world evidence studies. Future Oncol. 2021 Jun;17(16):2107-2122. doi: 10.2217/fon-2020-1264. Epub 2021 Mar 5. PMID: 33663223.

Schettini et al., 2020 - Overall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis.

Piezzo M, Chiodini P, Riemma M, Cocco S, Caputo R, Cianniello D, Di Gioia G, Di Lauro V, Rella FD, Fusco G, Iodice G, Nuzzo F, Pacilio C, Pensabene M, De Laurentiis M. Progression-Free Survival and Overall Survival of CDK 4/6 Inhibitors Plus Endocrine Therapy in Metastatic Breast Cancer: A Systematic Review and Meta-Analysis. Int J Mol Sci. 2020 Sep 3;21(17):6400. doi: 10.3390/ijms21176400. PMID: 32899139; PMCID: PMC7503849.

Lee CH, Kang YN, Ho CL, Lin C, Chen PH, Wu YY, Huang TC. Endocrine therapies in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, pretreated, advanced breast cancer: A network meta-analysis. Medicine (Baltimore). 2020 Mar;99(13):e19618. doi: 10.1097/MD.0000000000019618. PMID: 32221087; PMCID: PMC7220437.

Desnoyers A, Nadler MB, Kumar V, Saleh R, Amir E. Comparison of treatment-related adverse events of different Cyclin-dependent kinase 4/6 inhibitors in metastatic breast cancer: A network meta-analysis. Cancer Treat Rev. 2020 Nov;90:102086. doi: 10.1016/j.ctrv.2020.102086. Epub 2020 Aug 17. PMID: 32861975.

Ramos-Esquivel A, Hernández-Romero G, Landaverde DU. Cyclin‑dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor‑positive breast cancer patients: A systematic review and meta‑analysis of randomized clinical trials. Cancer Treat Res Commun. 2020 Apr 23;23:100175. doi: 10.1016/j.ctarc.2020.100175. Epub ahead of print. PMID: 32361352

Liu S, Sun X, Xu X, Lin F. Comparison of Endocrine Therapies in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer: A Network Meta-Analysis. J Breast Cancer. 2020 Oct 15;23(5):460-483. doi: 10.4048/jbc.2020.23.e55. PMID: 33154823; PMCID: PMC7604373.

Bebero, K.G.M.; Marayag, E.J.A.; Regala, E.V.; The effect of addition of cyclindependent kinase 4 & 6 (CDK 4/6) inhibitor to endocrine therapy in the cardiovascular toxicity in advanced breast cancer patients: A systematic review and meta analysis. J. Glob. Oncol. - Volume 5, Issue 0, pp. 134 - published 2019-01-01

Thein KZ, Htut TW, Ball S, Swarup S, Sultan A, Oo TH. Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials. Breast Cancer Res Treat. 2020 Sep;183(2):479-487. doi: 10.1007/s10549-020-05783-3. Epub 2020 Jul 9. PMID: 32647939.

Giuliano M, Schettini F, Rognoni C, Milani M, Jerusalem G, Bachelot T, De Laurentiis M, Thomas G, De Placido P, Arpino G, De Placido S, Cristofanilli M, Giordano A, Puglisi F, Pistilli B, Prat A, Del Mastro L, Venturini S, Generali D. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019 Oct;20(10):1360-1369. doi: 10.1016/S1470-2045(19)30420-6. Epub 2019 Sep 4. PMID: 31494037.

Harbeck N, Iyer S, Turner N, Cristofanilli M, Ro J, André F, Loi S, Verma S, Iwata H, Bhattacharyya H, Puyana Theall K, Bartlett CH, Loibl S. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol. 2016 Jun;27(6):1047-1054. doi: 10.1093/annonc/mdw139. Epub 2016 Mar 30. PMID: 27029704; PMCID: PMC4880065.

Published

2025-07-02