Managing chronic myeloid leukemia for treatment-free remission: a proposal from the GIMEMA CML WP

Author:

Baccarani Michele1,Abruzzese Elisabetta2,Accurso Vincenzo3,Albano Francesco4,Annunziata Mario5,Barulli Sara6,Beltrami Germana7,Bergamaschi Micaela7,Binotto Gianni8,Bocchia Monica9,Caocci Giovanni10,Capodanno Isabella11,Cavazzini Francesco12,Cedrone Michele13,Cerrano Marco14,Crugnola Monica15,D’Adda Mariella16,Elena Chiara17,Fava Carmen14,Fazi Paola2,Fozza Claudio18,Galimberti Sara19,Giai Valentina20,Gozzini Antonella21,Gugliotta Gabriele1,Iurlo Alessandra22,La Barba Gaetano23,Levato Luciano24,Lucchesi Alessandro25,Luciano Luigia26,Lunghi Francesca27,Lunghi Monia28,Malagola Michele29,Marasca Roberto30,Martino Bruno31,Melpignano Angela32,Miggiano Maria Cristina33,Montefusco Enrico34,Musolino Caterina35,Palmieri Fausto36,Pregno Patrizia37,Rapezzi Davide38,Rege-Cambrin Giovanna14,Rupoli Serena39,Salvucci Marzia40,Sancetta Rosaria41,Sica Simona42,Spadano Raffaele43,Stagno Fabio44,Tiribelli Mario45,Tomassetti Simona46,Trabacchi Elena47,Bonifacio Massimiliano48,Breccia Massimo2,Castagnetti Fausto1,Pane Fabrizio26,Russo Domenico29,Saglio Giuseppe14,Soverini Simona1,Vigneri Paolo44,Rosti Gianantonio1

Affiliation:

1. Università di Bologna, Bologna, Italy;

2. Università La Sapienza Roma, Rome, Italy;

3. Policlinico Giaccone, Palermo, Italy;

4. Università Bari, Bari, Italy;

5. Ospedale Cardarelli Napoli, Naples, Italy;

6. Ospedale San Salvatore, Pesaro, Italy;

7. Policlinico San Martino, Genoa, Italy;

8. Università Padova, Padua, Italy;

9. Università Siena, Siena, Italy;

10. Università Cagliari, Cagliari, Italy;

11. Azienda Unità Sanitaria Locale–Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) di Reggio Emilia, Reggio Emilia, Italy;

12. Azienda Ospedaliero Universitaria (AOU) Arcispedale S. Anna Ferrara, Ferrara, Italy;

13. AOU San Giovanni Addolorata, Rome, Italy;

14. Università Torino, Turin, Italy;

15. AOU Parma, Parma, Italy;

16. Azienda Socio Sanitaria Territoriale (ASST) Spedali Civili, Brescia, Italy;

17. Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;

18. Università Sassari, Sassari, Italy;

19. Università Pisa, Pisa, Italy;

20. Azienda Ospedaliera (ASO) SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy;

21. AOU Careggi, Firenze, Italy;

22. Fondazione IRCCS Cà Granda Ospedale Maggiore, Milan, Italy;

23. Ospedale Civile Spirito Santo, Pescara, Italy;

24. AO Pugliese Ciaccio, Catanzaro, Italy;

25. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy;

26. Università Federico II, Naples, Italy;

27. IRCCS San Raffaele, Milan, Italy;

28. AOU Maggiore della Carità, Novara, Italy;

29. Università Brescia, Brescia, Italy;

30. University of Modena and Reggio Emilia, Modena, Italy;

31. Unità Operativa Ematologia Grande Ospedale, Reggio Calabria, Italy;

32. Ospedale A. Perrino, Brindisi, Italy;

33. Ospedale San Bortolo, Vicenza, Italy;

34. AOU S. Andrea, Rome, Italy;

35. Università Messina, Messina, Italy;

36. Azienda Ospedaliera di Rilevo Nazionale (AORN) San Giuseppe (S.G.) Moscati, Avellino, Italy;

37. AOU Città della Salute e della Scienza, Turin, Italy;

38. ASO Croce e Carle, Cuneo, Italy;

39. Università Ancona, Ancona, Italy;

40. Ospedale Santa Maria delle Croci, Ravenna, Italy;

41. ULSS3 Serenissima, Venice, Italy;

42. Fondazione Policlinico Universitario A. Gemelli–IRCCS, Rome, Italy;

43. Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy;

44. Università Catania, Catania, Italy;

45. Università Udine, Udine, Italy;

46. Ospedale degli Infermi, Rimini, Italy;

47. Azienda Unità Sanitaria Locale (AUSL) Ospedale Guglielmo di Saliceto, Piacenza, Italy; and

48. Università Verona, Verona, Italy

Abstract

Abstract Several papers authored by international experts have proposed recommendations on the management of BCR-ABL1+ chronic myeloid leukemia (CML). Following these recommendations, survival of CML patients has become very close to normal. The next, ambitious, step is to bring as many patients as possible into a condition of treatment-free remission (TFR). The Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA; Italian Group for Hematologic Diseases of the Adult) CML Working Party (WP) has developed a project aimed at selecting the treatment policies that may increase the probability of TFR, taking into account 4 variables: the need for TFR, the tyrosine kinase inhibitors (TKIs), the characteristics of leukemia, and the patient. A Delphi-like method was used to reach a consensus among the representatives of 50 centers of the CML WP. A consensus was reached on the assessment of disease risk (EUTOS Long Term Survival [ELTS] score), on the definition of the most appropriate age boundaries for the choice of first-line treatment, on the choice of the TKI for first-line treatment, and on the definition of the responses that do not require a change of the TKI (BCR-ABL1 ≤10% at 3 months, ≤1% at 6 months, ≤0.1% at 12 months, ≤0.01% at 24 months), and of the responses that require a change of the TKI, when the goal is TFR (BCR-ABL1 >10% at 3 and 6 months, >1% at 12 months, and >0.1% at 24 months). These suggestions may help optimize the treatment strategy for TFR.

Publisher

American Society of Hematology

Subject

Hematology

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