Antroji (ir tolesnės) autologinės KKLT mielominei ligai gydyti. Indrė Klimienė, Vilniaus Universiteto Ligoninė Santariškių Klinikos.

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1 Antroji (ir tolesnės) autologinės KKLT mielominei ligai gydyti. Indrė Klimienė, Vilniaus Universiteto Ligoninė Santariškių Klinikos.

2 2

3 Gydymo Evoliucija Milestone 1962 Melphalan-prednisone (MP) Notes Introduction of melphalan in the 1960s was associated with improved survival. More intense chemotherapy regimens increased response rates, but with no improvement in survival compared to melphalan and prednisone Autologous SCT Several randomized trials demonstrated a survival advantage for this modality compared to conventional chemotherapy (CCT). However, other trials either have failed to demonstrate an overall survival advantage or have demonstrated equivalent benefit from early or late ASCT Thalidomide (Thalomid) Thalidomide has demonstrated improved response rates and progression-free survival rates Pomalidomide compared to dexamethasone alone. When added to MP, it improves survival compared to MP alone. Carfilzomib 2003 Bortezomib (Velcade) Bortezomib has improved survival compared to high-dose dexamethasone in patients with relapsed myeloma Tandem autologous SCT Tandem SCT has improved survival compared with single transplantation, albeit in those failing to achieve a very good partial response to first transplantation Lenalidomide (Revlimid) Lenalidomide and dexamethasone have improved survival compared with dexamethasone in relapsed myeloma in phase III trials : Prepublished online November 1, 2007; doi: /blood Improved survival in multiple myeloma and the impact of novel therapies Shaji K. Kumar, S. Vincent Rajkumar, Angela Dispenzieri, Martha Q. Lacy, Suzanne R. Hayman, Francis K. Buadi, Steven R. Zeldenrust, David Dingli, Stephen J. Russell, John A. Lust, Philip R. Greipp, Robert A. Kyle and Morie A. Gertz

4 Pagrindiniai mielominės ligos gydymo principai: Pilna remisija; EFS ir OS prailginimas; Gyvenimo kokybės pagerinimas. 4

5 Pirminio gydymo metodai: Viena autologinė KKLT; Tandeminės autologinės KKLT; Alogeninė KKLT (eksperimentinis gydymas); Autologinė KKLT + nemieloabliacinė alogeninė KKLT (eksperimentinis gydymas); Standartinių dozių chemoterapija. 5

6 Chemo vs transplantas: TYPE OF RESPONSE CONVENTIONAL DOSE (N = 100) P< 0,001 HIGH DOSE (N = 100) no. of patients Complete 5 22 Very good partial 9 16 Partial Minimal 18 7 Progressive disease MICHEL ATTAL, et al., The New England Journal of Medicine, 1996m

7 Chemo vs transplantas: TRM- 2,7% Abiejose grupėse mirtingumas dėl toksiškumo buvo vienodas. 7 MICHEL ATTAL, et al., The New England Journal of Medicine, 1996m

8 Chemo vs transplantas: Variable Standard Therapy (N=200) Intensive Therapy (N=201) P Value no. of patients (%) Complete response 17 (8) 89 (44) <0.001 Partial response 81 (40) 85 (42) 0.72 Minimal response 35 (18) 7 (3) <0.001 No change 30 (15) 4 (2) Progressive disease 19 (10) 3 (1) Unable to determine 10 (5) 4 (2) Early death 8 (4) 9 (4) 8 J. Anthony Child, n engl j med, 2003

9 Chemo vs transplantas: 9 J. Anthony Child, n engl j med, 2003

10 Chemo vs transplantas: 10 J. Anthony Child, n engl j med, 2003

11 Randomizuoti tyrimai auto KKLT vs chemoterapija: Studija N EFS OS Attal M N Engl J Med Child JA N Engl J Med Palumbo Blood Fermand JPJ Clin Oncol Blade J PETHEMA. Blood Barlogie B. J Clin Oncol. 2006

12 Chemo vs transplantas: 12 John Koreth,et al. Biology of Blood and Marrow Transplantation 2007

13 Chemo vs transplantas: 13 John Koreth,et al. Biology of Blood and Marrow Transplantation 2007

14 Chemo vs transplantas: 14 John Koreth,et al. Biology of Blood and Marrow Transplantation 2007

15 Išvada: Iki dabar DDT + auto KKLT yra standartinis gydymo metodas naujai nustatytai mielominei ligai gydyti, pacientams iki 65m. 15

16 Viena vs Tandem transplantacija: 16 Attal M, Harousseau JL, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 2003

17 Viena vs Tandem transplantacija: 17 Michele Cavo, et al., Journal of clinical oncology 2007

18 Viena vs Tandem transplantacija: 18 Michele Cavo, et al., Journal of clinical oncology 2007

19 Viena vs Tandem transplantacija: 19 Michele Cavo, et al., Journal of clinical oncology 2007

20 Išvados: Šiuo metu nėra pakankamai duomenų, įrodančių iš anksto suplanuotos dvigubos auto KKLT naudą. Naudinga tuomet, kai po I auto KKLT pasiekiama < VGPR. Iki šiol tai yra standartas (nuo 2003m.). 20

21 Antrinio gydymo metodai: Standartinių dozių chemoterapija; Antroji auto KKLT iki šiol nėra standartinis gydymo metodas. 21

22 Transplantacija recidyvo metu: 22 Autologous Retransplantation for Patients With Recurrent Multiple Myeloma, Leopold Sellner, MD., et al., Cancer 2013.

23 Transplantacija recidyvo metu: Overall survival for MM patients undergoing a second ASCT as salvage therapy according to the achievement of at least very good partial response. Progression-free survival for MM patients undergoing a second ASCT as salvage therapy according to the achievement of at least very good partial response. 23 Second Autologous Stem Cell Transplantation as Salvage Therapy for Multiple Myeloma: Impact on Progression-Free and Overall Survival Victor H. Jimenez-Zepeda et al., Biol Blood Marrow Transplant 2012.

24 Transplantacija recidyvo metu: 24 Navneet Ramesh, Emilie Lemieux, V. H. Jimenez- Leopold Sellner, Zepeda, Žmonių skaičius CR 31,00% - 7,70% 12,90% VGPR 87 % 20,00% 93 % 67,00% 97,4 % 39,70% 84,4 % 8,80% PR 36,00% 26,00% 50,00% 58,70% SD 6,00% 1,30% 4,10% PD 1,00% 1,30% 5,70% Minimal response 9,80% Vidutinis amžius antros transplantacijos metu, (m.) Vidutinis folow up nuo dgn pradžios (mėn) 129 Vidutinis laikas iki antros transplantacijos, (mėn.) Median PFS, (mėn.) 10, ,3 15,2 Median OS, nuo antros transplantacijos, (m.) 2,75 4 5,9 3,53 Nuo dgn pradžios (m.) 8,5 10 Mirtys dėl transplantacijos % Tai yra saugu 4 0 2,6 3 Tandem neįraukti Ir single, ir tandem Tandem neįtraukti Ir single, ir tandem Kondicionavimas MEL % Mel % Mel % Emilie Lemieux, et al., Biol Blood Marrow Transplant, 2013 Victor H. Jimenez-Zepeda, et al., Blood and Marrow Transplantation, 2012 Leopold Sellner, et al., Cancer, 2013 Navneet Ramesh, Bone Marrow Transplantation 2013

25 Antroji transplantacija: Progression-free and overall survival rates. 25 Autologous Stem Cell Transplantation: An Effective Salvage Therapy in Multiple Myeloma, Emilie Lemieux et al., Biol Blood Marrow Transplant 2013

26 Antrosios transplantacijos atlikimo laikas: Nėra randomizuotų studijų lyginančių planuotą tandeminę auto KKLT su gelbstinčia II auto KKLT esant recidyvui; Tricot et al. 1995: gelbstinti II auto KKLT yra naudinga jei remisijos trukmė > 12mėn. ir normalus ß-2 mikroglobulinas; 26

27 27 Mūsų rezultatai:

28 28 Mūsų rezultatai:

29 Išvados: Po gelbstinčios transplantacijos galima tikėtis panašaus laiko iki progresijos kaip ir po I transplantacijos. Mūsų rekomendacija- atlikti gelbstinčią transplantaciją jei remisija truko >12 mėn. Jei po transplantacijos nepasiekiamas VGPR atsakas, rekomenduojama skirti palaikomajam gydymui talidomidą (6-12 mėn). 29

30 Ačiū

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