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La información contenida en este sitio internet está dirigida exclusivamente al profesional sanitario facultado para prescribir o dispensar medicamentos en España (requiere una formación especializada para su correcta interpretación).

Pierre Fabre Ibérica S.A. promueve la prescripción de sus productos farmacéuticos en condiciones establecidas en su ficha técnica.

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heading-Nerlynx-Neratinib--HER2-Breast-Cancer-2

Posibles escenarios clínicos

Dé un paso más para alcanzar protección adicional con NERLYNX

Nerlynx-Neratinib--HER2+/HR+ early breast cancer- Adjuvant treatment history

Resumen de los posibles contextos clínicos teniendo en cuenta los avances terapéuticos y reconociendo los diferentes niveles de evidencia para el uso de NERLYNX.³⁷

QT, quimioterapia; CMi, cáncer de mama en estadio inicial; HER2+, receptor 2 del factor de crecimiento epidérmico humano positivo; RH, receptor de hormonas; pCR, respuesta patológica completa; T-DM1, trastuzumab emtansina.

*Tras el tratamiento a base de trastuzumab del Cmi HER2+, después de la integración con las pautas de tratamiento existentes y una evaluación cuidadosa de la relación beneficio/riesgo para cada paciente.³⁷

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Este medicamento está sujeto a seguimiento adicional.

Referencias

1. Chan A, et al. Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial. Clin Breast Cancer. 2021;21(1):80–91.

2. Chan A, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17(3):367−377.

3. Martin M, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688−1700.

4. Holmes FA, et al. Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer. Final overall survival analysis from the randomized phase 3 ExteNET trial. Presented at the San Antonio Breast cancer Symposium. December 8-11, 2020. #PD3-03.

5. Nerlynx (neratinib 40 mg film-coated tablets) Summary of Product Characteristics, 2023. Available at: https://campuspierrefabre.com/wp-content/uploads/2023/07/NERLYNX_Ficha-te%CC%81cnica_-26.05.2023.pdf Accessed: July 2023.

6. Cameron D, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the Herceptin Adjuvant (HERA) trial. Lancet. 2017;389:1195–1205.

7. Von Minckwitz G, et al. Trastuzumab Emtansine for residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019;380:617–628.

8. Cortazar P, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;383(9938):164−172

9. Collins DM, et al. Preclinical Characteristics of the Irreversible Pan-HER Kinase Inhibitor Neratinib Compared with Lapatinib: Implications for the Treatment of HER2-Positive and HER2-Mutated Breast Cancer. Cancers. 2019;11(6);737. doi:10.3390/cancers11060737.

10. Feldinger K and Kong A. Profile of neratinib and its potential in the treatment of breast cancer. Breast Cancer: Targets Ther. 2015;7:147–162.

11. Kourie HR, et al. Emerging treatments for HER2-positive early-stage breast cancer: focus on neratinib. OncoTargets Ther. 2017;10:3363–3372.

12. Wissner A and Mansour TS. The development of HKI-272 and related compounds for the treatment of cancer. Arch Pharm (Weinheim). 2008;341(8):465–477.

13. Canoici A, et al. Neratinib overcomes trastuzumab resistance in HER2 amplified breast cancer. Oncotarget. 2013;4(10):1592–1605.

14. Rabindran SK, et al. Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res. 2004;64(11):3958–3965.

15. Iqbal N and Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748.

16. Gutierrez C and Schiff R. HER 2: Biology, Detection, and Clinical Implications. Arch Pathol Lab Med. 2011;135(1):55–62.

17. Giuliano M, et al. Bidirectional Crosstalk between the Estrogen Receptor and Human Epidermal Growth Factor Receptor 2 Signaling Pathways in Breast Cancer: Molecular Basis and Clinical Implications. Breast Care. 2013;8:256–262.

18. Shou J, et al. Mechanisms of Tamoxifen Resistance: Increased Estrogen Receptor-HER2/neu Cross-Talk in ER/HER2–Positive Breast Cancer. J Natl Cancer Inst. 2004;96(12):926–935.

19. Harari D and Yarden Y. Molecular mechanisms underlying ErbB2/HER2 action in breast cancer. Oncogene. 2000;19:6102–6114.

20. Paplomata E, et al. Systemic Therapy For Early-Stage HER2-Positive Breast Cancers: Time for a Less-Is-More Approach? Cancer. 2015;121(4):517–526.

21. Barcenas CH, et al. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial. Ann Oncol. 2020;31(9):1223−1230.

22. European Medicines Agency Public Assessment Report (EPAR). Nerlynx EMA/CHMP/525204/2018.

23. Barcenas CH, et al. CONTROL trial Supplementary Table S7, available at Ann Oncol online.

24. Cancer.Net. Doctor-Approved Patient Information from ASCO on Diarrhoea. Available at: https://www.cancer.net/coping-with-cancer/physical-emotional and-social-effects-cancer/managing-physical-side-effects/diarrhoea. Accessed: June 2020.

25. National Cancer Institute. Diarrhoea and Cancer Treatment. Available at: https://www.cancer.gov/about-cancer/treatment/side-effects/diarrhoea. Accessed: June 2020.

26. Chan A, et al. Effect of prophylaxis or neratinib dose escalation on neratinib-associated diarrhoea and tolerability in patients with HER2-positive early stage breast cancer: phase II CONTROL trial. Poster P5-14-03 presented at SABCS 2019.

27. Mortimer J, et al. Patterns of occurrence and implications of neratinib-associated diarrhoea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019;21(1):32. Electronic Supplementary Material.

28. Pinter M, et al. Cancer and liver cirrhosis: implications on prognosis and management. ESMO Open. 2016:1(2)e000042. eCollection 2016.

29. Breastcancer.org. How to read hormone receptor test results. Available at: https://www.breastcancer.org/symptoms/diagnosis/hormone_status/read_results. Accessed: March 2021.

30. National Cancer Institute. Cancer Stat Facts: Female Breast Cancer Subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed: June 2021.

31. Perez EA, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011;29:3366–3373.

32. Perez EA, et al. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32:3744–3752.

33. Goldhirsch A, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomized controlled trial. Lancet. 2013;382:1021–1028.

34. Von Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377:122–131.

35. Piccart M, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years’ Follow-Up. J Clin Oncol. 2021. doi:10.1200/JCO.20.01204. [Online ahead of print].

36. Piccart-Gebhart MJ, et al. Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer. N Engl J Med. 2005;353(16):1659–1672.

37. Untch M, et al. How to Optimise Extended Adjuvant Treatment with Neratinib for HER2+ Early Breast Cancer Patients. Oncol Ther J. 2021.

Este es un sitio web internacional de NERLYNX^®. IMPORTANTE: la información de este sitio web se basa en el resumen europeo de las características del producto. La información de prescripción y las indicaciones pueden variar según el país. Debe consultar la información de prescripción de su país. Tenga en cuenta que no nos hacemos responsables del acceso a dicha información, que puede no cumplir con la regulación o el uso en su país.

Última actualización: 08/2023

Profesionales sanitarios​

Personal no sanitarios

Posibles escenarios clínicos

Dé un paso más para alcanzar protección adicional con NERLYNX

Profesionales sanitarios