Wyniki leczenia przewlekłej białaczki szpikowej w trzeciej linii inhibitorami kinaz tyrozynowych drugiej generacji lub ponatynibem
Streszczenie
Rokowanie pacjentów z przewlekłą białaczką szpikową poprawiło się radykalnie od czasu wprowadzenia inhibitorów kinaz tyrozynowych (TKI). Jednakże grupa chorych z opornością/nietolerancją dwóch lub większej liczby linii leczenia wciąż stanowi znaczące wyzwanie terapeutyczne. W badaniu PACE ponatynib stosowano u chorych po nieskutecznym leczeniu dwoma TKI, uzyskując 65% całkowitych odpowiedzi cytogenetycznych (CCyR, complete cytogenetic response), 45% większych odpowiedzi molekularnych (MMR, major molecular response) i 78% 5-letniego przeżycia całkowitego, co dowodzi jego skuteczności w tym wskazaniu. Odsetki MMR, CCyR oraz większych odpowiedzi cytogenetycznych uzyskiwanych w leczeniu trzeciej linii za pomocy TKI drugiej generacji u opornych chorych wynosiły odpowiednio 17–24%, 22–26% oraz 33%, a odpowiedzi były krótkotrwałe. Ponatynib jest skuteczniejszy w terapii trzeciej linii w porównaniu z TKI drugiej generacji i powinien być preferowany zwłaszcza u pacjentów z sekwencyjną opornością na dwa TKI.
Słowa kluczowe: przewlekła białaczka szpikowaleczenie trzeciej liniiponatynibinhibitory kinaz tyrozynowych drugiej generacji
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- Nowell PC, Hungerford DAA. minute chromosome in human chronic granulocytic leukemia. Science. 1960; 132: 1497–1500.
- Rowley JD. Letter: A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature. 1973; 243(5405): 290–293.
- Melo JV, Barnes DJ. Chronic myeloid leukaemia as a model of disease evolution in human cancer. Nat Rev Cancer. 2007; 7(6): 441–453.
- Druker BJ, Lydon NB. Lessons learned from the development of an abl tyrosine kinase inhibitor for chronic myelogenous leukemia. J Clin Invest. 2000; 105(1): 3–7.
- Bower H, Björkholm M, Dickman PW, et al. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016; 34(24): 2851–2857.
- Sasaki K, Strom SS, O'Brien S, et al. Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials. Lancet Haematol. 2015; 2(5): e186–e193.
- Hochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020; 34(4): 966–984.
- Akard LP, Albitar M, Hill CE, et al. The, “hit hard and hit early”napproach to the treatment of chronic myeloid leukemia: implicationsnof the updated National Comprehensive Cancer Network clinicalnpractice guidelines for routine practice. Clin Adv Hematol Oncol. 2013; 11: 421–432.
- Hehlmann R. Chronic myeloid leukemia in 2020. Hemasphere. 2020; 4(5): e468.
- Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016; 30(5): 1044–1054.
- Cortes JE, Mauro MJ, Deininger MWN, et al. Bosutinib vs imatinib for newly diagnosed chronic myeloid leukemia in the BFORE trial: 24-month follow-up. J Clin Oncol. 2018; 36(15_Suppl): 7002–7002.
- Brümmendorf TH, Cortes JE, Milojkovic D, et al. Bosutinib (BOS) versus imatinib for newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML): final 5-year results from the bfore trial. Blood. 2020; 136(Suppl 1): 41–42.
- Scemblix. Summary of products characteristics. 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/scemblix (September 22, 2023).
- Cortes JE, Kim DW, Pinilla-Ibarz J, et al. PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013; 369(19): 1783–1796.
- Réa D, Mauro MJ, Boquimpani C, et al. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021; 138(21): 2031–2041.
- Garg RJ, Kantarjian H, O'Brien S, et al. The use of nilotinib or dasatinib after failure to 2 prior tyrosine kinase inhibitors: long-term follow-up. Blood. 2009; 114(20): 4361–4368.
- Giles FJ, Abruzzese E, Rosti G, et al. Nilotinib is active in chronic and accelerated phase chronic myeloid leukemia following failure of imatinib and dasatinib therapy. Leukemia. 2010; 24(7): 1299–1301.
- Ibrahim AR, Paliompeis C, Bua M, et al. Efficacy of tyrosine kinase inhibitors (TKIs) as third-line therapy in patients with chronic myeloid leukemia in chronic phase who have failed 2 prior lines of TKI therapy. Blood. 2010; 116(25): 5497–5500.
- Stagno F, Breccia M, Annunziata M, et al. Outcome of 82 chronic myeloid leukemia patients treated with nilotinib or dasatinib after failure of two prior tyrosine kinase inhibitors. Haematologica. 2013; 98(3): 399–403.
- Lomaia E, Zaritskey A, Shuvaev V, et al. Efficacy of tyrosine kinase inhibitors in third line therapy in chronic phase chronic myeloid leukemia. Blood. 2015; 126(23): 4051–4051.
- Ribeiro B, Miranda E, Albuquerque Dde, et al. Treatment with dasatinib or nilotinib in chronic myeloid leukemia patients who failed to respond to two previously administered tyrosine kinase inhibitors — a single center experience. Clinics. 2015; 70(8): 550–555.
- Ongoren S, Eskazan AE, Suzan V, et al. Third-line treatment with second-generation tyrosine kinase inhibitors (dasatinib or nilotinib) in patients with chronic myeloid leukemia after two prior TKIs: real-life data on a single center experience along with the review of the literature. Hematology. 2018; 23(4): 212–220.
- Cortes JE, Khoury HJ, Kantarjian HM, et al. Long‐term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J Hematol. 2016; 91(12): 1206–1214.
- Brümmendorf TH, Cortez JE, Goh YT, et al. 2152 Bosutinib for previously treated patients with Philadelphia chromosome-positive leukemia: ≥8-year update of a phase 1/2 study. 62nd ASH Annual Meeting and Exposition. December 5–8, 2020. https://ash.confex.com/ash/2020/webprogram/Paper137208.html (July 11, 2023).
- Cortes JE, Kim DW, Pinilla-Ibarz J, et al. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018; 132(4): 393–404.
- Januzzi JL, Garasic JM, Kasner SE, et al. Correction: Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee. J Hematol Oncol. 2022; 15(1): 33.
- Cortes J, Apperley J, Lomaia E, et al. Ponatinib dose-ranging study in chronic-phase chronic myeloid leukemia: a randomized, open-label phase 2 clinical trial. Blood. 2021; 138(21): 2042–2050.
- Sacha T, Szczepanek E, Dumnicka P, et al. The outcomes of ponatinib therapy in patients with chronic myeloid leukemia resistant or intolerant to previous tyrosine kinase inhibitors, treated in poland within the donation program. Clin Lymphoma Myeloma Leuk. 2022; 22(6): 405–415.
- Jabbour EJ, Sasaki K, Haddad FG, et al. The outcomes of patients with chronic myeloid leukemia treated with third-line BCR::ABL1 tyrosine kinase inhibitors. Am J Hematol. 2023; 98(4): 658–665.
- Propensity score matching. https://en.wikipedia.org/wiki/Propensity_score_matching (July 11, 2023).
- Lipton JH, Bryden P, Sidhu MK, et al. Comparative efficacy of tyrosine kinase inhibitor treatments in the third-line setting, for chronic-phase chronic myelogenous leukemia after failure of second-generation tyrosine kinase inhibitors. Leuk Res. 2015; 39(1): 58–64.
- Hochhaus A, Réa D, Boquimpani C, et al. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL. Leukemia. 2023; 37(3): 617–626.
- Yeung DT, Shanmuganathan N, Hughes TP. Asciminib: a new therapeutic option in chronic-phase CML with treatment failure. Blood. 2022; 139(24): 3474–3479.