Long-term durable remission by cladribine followed by rituximab in patients with hairy cell leukaemia: update of a phase II trial

British Journal of Haematology

Volumn 174, Issue 5, 2016, Pages 760-766

  Chihara, Dai ^a   Kantarjian, Hagop ^a   O'Brien, Susan ^a   Jorgensen, Jeffrey ^a   Pierce, Sherry ^a   Faderl, Stefan ^a   Ferrajoli, Alessandra ^a   Poku, Rebecca ^a   Jain, Preetesh ^a   Thompson, Phillip ^a   Brandt, Mark ^a   Luthra, Rajyalakshmi ^a   Burger, Jan ^a   Keating, Michael ^a   Ravandi, Farhad ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

cladribine; Hairy cell leukaemia; phase II study; rituximab

Indexed keywords

CLADRIBINE; RITUXIMAB;

ADULT; AGED; ARTICLE; CANCER RECURRENCE; CELLULITIS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FAILURE FREE SURVIVAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HAIRY CELL LEUKEMIA; HUMAN; HYPERBILIRUBINEMIA; LEUKEMIA REMISSION; MAJOR CLINICAL STUDY; MALE; MINIMAL RESIDUAL DISEASE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RASH; VERY ELDERLY;

EID: 84987720558     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/bjh.14129     Document Type: Article

References (36)

1. Arons, E., Suntum, T., Stetler-Stevenson, M. & Kreitman, R.J. (2009) VH4-34 + hairy cell leukemia, a new variant with poor prognosis despite standard therapy. Blood, 114, 4687–4695.
2. Arons, E., Still, K., Davies, S., Zhou, H. & Kreitman, R.J. (2014) Minimal Residual Disease By Patient-Specific Taqman Real Time PCR in Newly Diagnosed Hairy Cell Leukemia Patients Randomized to Initial Vs Delayed Rituximab in Combination with Cladribine. Blood, 124, 1747–1747.
3. Cervetti, G., Galimberti, S., Andreazzoli, F., Fazzi, R., Cecconi, N., Caracciolo, F. & Petrini, M. (2008) Rituximab as treatment for minimal residual disease in hairy cell leukaemia: extended follow-up. British Journal of Haematology, 143, 296–298.
4. Chow, K.U., Sommerlad, W.D., Boehrer, S., Schneider, B., Seipelt, G., Rummel, M.J., Hoelzer, D., Mitrou, P.S. & Weidmann, E. (2002) Anti-CD20 antibody (IDEC-C2B8, rituximab) enhances efficacy of cytotoxic drugs on neoplastic lymphocytes in vitro: role of cytokines, complement, and caspases. Haematologica, 87, 33–43.
5. Cornet, E., Delmer, A., Feugier, P., Garnache-Ottou, F., Ghez, D., Leblond, V., Levy, V., Maloisel, F., Re, D., Zini, J.M., Troussard, X. & French Society of Haematology. (2014a) Recommendations of the SFH (French Society of Haematology) for the diagnosis, treatment and follow-up of hairy cell leukaemia. Annals of hematology, 93, 1977–1983.
6. Cornet, E., Tomowiak, C., Tanguy-Schmidt, A., Lepretre, S., Dupuis, J., Feugier, P., Devidas, A., Mariette, C., Leblond, V., Thieblemont, C., Validire-Charpy, P., Sutton, L., Gyan, E., Eisenmann, J.C., Cony-Makhoul, P., Ysebaert, L., Troussard, X. & for the Société Française d'Hématologie. (2014b) Long-term follow-up and second malignancies in 487 patients with hairy cell leukaemia. British Journal of Haematology, 166, 390–400.
7. Dearden, C.E., Else, M. & Catovsky, D. (2011) Long-term results for pentostatin and cladribine treatment of hairy cell leukemia. Leukaemia & Lymphoma, 52, 21–24.
8. Else, M., Ruchlemer, R., Osuji, N., Del Giudice, I., Matutes, E., Woodman, A., Wotherspoon, A., Swansbury, J., Dearden, C. & Catovsky, D. (2005) Long remissions in hairy cell leukemia with purine analogs: a report of 219 patients with a median follow-up of 12.5 years. Cancer, 104, 2442–2448.
9. Else, M., Dearden, C.E., Matutes, E., Garcia-Talavera, J., Rohatiner, A.Z., Johnson, S.A., O'Connor, N.T., Haynes, A., Osuji, N., Forconi, F., Lauria, F. & Catovsky, D. (2009) Long-term follow-up of 233 patients with hairy cell leukaemia, treated initially with pentostatin or cladribine, at a median of 16 years from diagnosis. British Journal of Haematology, 145, 733–740.
10. Else, M., Dearden, C.E. & Catovsky, D. (2015) Long-term follow-up after purine analogue therapy in hairy cell leukaemia. Best Pract Res Clin Haematol, 28, 217–229.
11. Flinn, I.W., Kopecky, K.J., Foucar, M.K., Head, D., Bennett, J.M., Hutchison, R., Corbett, W., Cassileth, P., Habermann, T., Golomb, H., Rai, K., Eisenhauer, E., Appelbaum, F., Cheson, B. & Grever, M.R. (2000) Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin. Blood, 96, 2981–2986.
12. Forconi, F., Sozzi, E., Cencini, E., Zaja, F., Intermesoli, T., Stelitano, C., Rigacci, L., Gherlinzoni, F., Cantaffa, R., Baraldi, A., Gallamini, A., Zaccaria, A., Pulsoni, A., Gobbi, M., Tassi, M., Raspadori, D., Leoncini, L., Rinaldi, A., Sabattini, E., Bertoni, F., Pileri, S.A. & Lauria, F. (2009) Hairy cell leukemias with unmutated IGHV genes define the minor subset refractory to single-agent cladribine and with more aggressive behavior. Blood, 114, 4696–4702.
13. Getta, B., Woo, K.M., Devlin, S., Park, J.H., Abdel-Wahab, O. & Tallman, M.S. (2015) Hairy Cell Leukemia Variant Has Similar Survival to Classical Disease Despite Poorer Responses to Initial Therapy: A 30-Year Experience from Memorial Sloan Kettering Cancer Center. Blood (ASH Annual Meeting Abstracts), 126, 1476.
14. Goodman, G.R., Burian, C., Koziol, J.A. & Saven, A. (2003) Extended follow-up of patients with hairy cell leukemia after treatment with cladribine. Journal of Clinical Oncology, 21, 891–896.
15. Gooley, T.A., Leisenring, W., Crowley, J. & Storer, B.E. (1999) Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine, 18, 695–706.
16. Jaffe, E., Harris, N., Stein, H. & Vardiman, J. (2001) WHO Classification Tumors of Hematopoietic and Lymphoid Tissues. International Agency for Research on Cancer (IARC),Lyon, France.
17. Jones, G., Parry-Jones, N., Wilkins, B., Else, M., Catovsky, D. & British Committee for Standards in, H (2012) Revised guidelines for the diagnosis and management of hairy cell leukaemia and hairy cell leukaemia variant*. British Journal of Haematology, 156, 186–195.
18. Kaplan, E.L. & Meier, P. (1958) Nonparametric estimation from incomplete observations. Journal of American Statistical Association, 53, 457–481.
19. Kraut, E.H., Bouroncle, B.A. & Grever, M.R. (1989) Pentostatin in the treatment of advanced hairy cell leukemia. Journal of Clinical Oncology, 7, 168–172.
20. Kreitman, R.J., Wilson, W., Calvo, K.R., Arons, E., Roth, L., Sapolsky, J., Zhou, H., Raffeld, M. & Stetler-Stevenson, M. (2013) Cladribine with immediate rituximab for the treatment of patients with variant hairy cell leukemia. Clinical Cancer Research, 19, 6873–6881.
21. Leclerc, M., Suarez, F., Noel, M.P., Vekhoff, A., Troussard, X., Claisse, J.F., Thieblemont, C., Maloisel, F., Beguin, Y., Tamburini, J., Barbe, C. & Delmer, A. (2015) Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Annals of hematology, 94, 89–95.
22. Matutes, E., Wotherspoon, A. & Catovsky, D. (2003) The variant form of hairy-cell leukaemia. Best Pract Res Clin Haematol, 16, 41–56.
23. Piro, L.D., Carrera, C.J., Carson, D.A. & Beutler, E. (1990) Lasting remissions in hairy-cell leukemia induced by a single infusion of 2-chlorodeoxyadenosine. New England Journal of Medicine, 322, 1117–1121.
24. Ravandi, F., Jorgensen, J.L., O'Brien, S.M., Verstovsek, S., Koller, C.A., Faderl, S., Giles, F.J., Ferrajoli, A., Wierda, W.G., Odinga, S., Huang, X., Thomas, D.A., Freireich, E.J., Jones, D., Keating, M.J. & Kantarjian, H.M. (2006) Eradication of minimal residual disease in hairy cell leukemia. Blood, 107, 4658–4662.
25. Ravandi, F., O'Brien, S., Jorgensen, J., Pierce, S., Faderl, S., Ferrajoli, A., Koller, C., Challagundla, P., York, S., Brandt, M., Luthra, R., Burger, J., Thomas, D., Keating, M. & Kantarjian, H. (2011) Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood, 118, 3818–3823.
26. Robak, T. (2006) Current treatment options in hairy cell leukemia and hairy cell leukemia variant. Cancer Treatment Reviews, 32, 365–376.
27. Robak, T., Matutes, E., Catovsky, D., Zinzani, P.L., Buske, C. & Committee, E.G. (2015) Hairy cell leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 26, v100–v107.
28. Rosenberg, J.D., Burian, C., Waalen, J. & Saven, A. (2014) Clinical characteristics and long-term outcome of young hairy cell leukemia patients treated with cladribine: a single-institution series. Blood, 123, 177–183.
29. Sigal, D.S., Sharpe, R., Burian, C. & Saven, A. (2010) Very long-term eradication of minimal residual disease in patients with hairy cell leukemia after a single course of cladribine. Blood, 115, 1893–1896.
30. Swerdlow, S., Campo, E., Harris, N., Swerdlow, S., Campo, E. & Harris, N. (2008) WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. International Agency for Research on Cancer, Lyon, France.
31. Tallman, M.S., Hakimian, D., Kopecky, K.J., Wheaton, S., Wollins, E., Foucar, K., Cassileth, P.A., Habermann, T., Grever, M., Rowe, J.M. & Peterson, L.C. (1999) Minimal residual disease in patients with hairy cell leukemia in complete remission treated with 2-chlorodeoxyadenosine or 2-deoxycoformycin and prediction of early relapse. Clinical Cancer Research, 5, 1665–1670.
32. Thomas, D.A., O'Brien, S., Bueso-Ramos, C., Faderl, S., Keating, M.J., Giles, F.J., Cortes, J. & Kantarjian, H.M. (2003) Rituximab in relapsed or refractory hairy cell leukemia. Blood, 102, 3906–3911.
33. Thorselius, M., Walsh, S.H., Thunberg, U., Hagberg, H., Sundstrom, C. & Rosenquist, R. (2005) Heterogeneous somatic hypermutation status confounds the cell of origin in hairy cell leukemia. Leukemia research, 29, 153–158.
34. Tiacci, E., Trifonov, V., Schiavoni, G., Holmes, A., Kern, W., Martelli, M.P., Pucciarini, A., Bigerna, B., Pacini, R., Wells, V.A., Sportoletti, P., Pettirossi, V., Mannucci, R., Elliott, O., Liso, A., Ambrosetti, A., Pulsoni, A., Forconi, F., Trentin, L., Semenzato, G., Inghirami, G., Capponi, M., Di Raimondo, F., Patti, C., Arcaini, L., Musto, P., Pileri, S., Haferlach, C., Schnittger, S., Pizzolo, G., Foa, R., Farinelli, L., Haferlach, T., Pasqualucci, L., Rabadan, R. & Falini, B. (2011) BRAF mutations in hairy-cell leukemia. New England Journal of Medicine, 364, 2305–2315.
35. Tiacci, E., Schiavoni, G., Martelli, M.P., Boveri, E., Pacini, R., Tabarrini, A., Zibellini, S., Santi, A., Pettirossi, V., Fortini, E., Ascani, S., Arcaini, L., Inghirami, G., Paulli, M. & Falini, B. (2013) Constant activation of the RAF-MEK-ERK pathway as a diagnostic and therapeutic target in hairy cell leukemia. Haematologica, 98, 635–639.
36. Zinzani, P.L., Pellegrini, C., Stefoni, V., Derenzini, E., Gandolfi, L., Broccoli, A., Argnani, L., Quirini, F., Pileri, S. & Baccarani, M. (2010) Hairy cell leukemia: evaluation of the long-term outcome in 121 patients. Cancer, 116, 4788–4792.