Phase II fludarabine and cyclophosphamide for the treatment of indolent B cell non-follicular lymphomas: Final results of the LL02 trialof the Gruppo Italiano per lo Studio dei Linfomi (GISL)

Annals of Hematology

Volumn 90, Issue 3, 2011, Pages 323-330

  Ferrario, Andrea ^a   Merli, Francesco ^b   Luminari, Stefano ^c   Stelitano, Caterina ^d   Mannina, Donato ^e   Russo, Mario ^f   Mazza, Patrizio ^g   Marcheselli, Luigi ^c   Goldaniga, Maria Cecilia ^a   Federico, Massimo ^c   Baldini, Luca ^a  

^a UNIVERSITY OF MILAN   (Italy)

^b Servizio di Ematologia   (Italy)

^c UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^d BIANCHI MELACRINO MORELLI HOSPITAL   (Italy)

^e Azienda Ospedaliera Papardo   (Italy)

^f Ospedale S Vincenzo   (Italy)

^g Ospedale Moscati   (Italy)

Author keywords

Chemotherapy; Cyclophosphamide; Fludarabine; Indolent non follicular lymphomas

Indexed keywords

CYCLOPHOSPHAMIDE; FLUDARABINE;

ADULT; AGED; ANEMIA; ARTICLE; BACTERIAL PNEUMONIA; CANCER REGRESSION; CANCER SURVIVAL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATALITY; FEMALE; FOLLOW UP; HEMOLYTIC ANEMIA; HUMAN; INDOLENT NONFOLLICULAR NONHODGKIN LYMPHOMA; INFECTION; KIDNEY FAILURE; LUNG ASPERGILLOSIS; LYMPHOCYTOMA; LYMPHOPLASMACYTIC LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MARGINAL ZONE LYMPHOMA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PANCYTOPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SKIN INFECTION; THROMBOCYTOPENIA;

ADOLESCENT; ADULT; AGED; ANEMIA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; ITALY; LYMPHOMA, B-CELL; MALE; MIDDLE AGED; NEUTROPENIA; REMISSION INDUCTION; THROMBOCYTOPENIA; VIDARABINE; YOUNG ADULT;

EID: 79951682605     PISSN: 09395555     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00277-010-1067-1     Document Type: Article

References (35)

1. Jaffe ES, Harris NL, Stein H, Vardiman JW (2001) World Health Organization classification of tumours of hematopoietic and lymphoid tissues, 3rd edn. IARC, Lyon
2. J Ben-Ezra JS Burke WG Swartz MD Brownell RK Brynes LR Hill, et al. 1989 Small lymphocytic lymphoma: a clinicopathologic analysis of 268 cases Blood 73 579 587 1:STN:280:DyaL1M7jsV2ktA%3D%3D 2644979 (Pubitemid 19060546)
3. B Coiffier C Thieblemont P Felman G Salles F Berger 1999 Indolent non follicular lymphomas: characteristics, treatment, and outcome Semin Hematol 36 198 208 1:STN:280:DyaK1M3lt12ntA%3D%3D 10319388
4. O Landgren H Tilly 2008 Epidemiology, pathology and treatment of non-follicular indolent lymphomas Leuk Lymphoma 49 Suppl 1 35 42 10.1080/10428190802311425 18821431
5. GA Pangalis MK Angelopoulou TP Vassilakopoulos MP Siakantaris C Kittas 1999 B-chronic lymphocytic leukemia, small lymphocytic lymphoma, and lymphoplasmacytic lymphoma, including Waldenstrom's macroglobulinemia: a clinical, morphologic, and biologic spectrum of similar disorders Semin Hematol 36 104 114 1:STN:280:DyaK1M3lt12gtQ%3D%3D 10319379 (Pubitemid 29214064)
6. D Papamichael AJ Norton JM Foran C Mulatero J Mathews JA Amess, et al. 1999 Immunocytoma: a retrospective analysis from St Bartholomew's Hospital-1972 to 1996 J Clin Oncol 17 2847 2853 1:STN:280:DC%2BD3c%2FjtVSqsg%3D%3D 10561361 (Pubitemid 29415243)
7. JE Seng BA Peterson 1997 Indolent B-cell non-Hodgkin's lymphomas Oncology (Williston Park) 11 1883 1894 1:STN:280:DyaK1c%2FpvVGrtA%3D%3D
8. SP Treon 2009 How I treat Waldenström macroglobulinemia Blood 17 2375 2385 10.1182/blood-2009-05-174359
9. N Neparidze MV Dhodapkar 2009 Waldenstrom's macroglobulinemia: recent advances in biology and therapy Clin Adv Hematol Oncol 7 677 681 20040909 687-690
10. L Baldini M Brugiatelli S Luminari M Lombardo F Merli S Sacchi, et al. 2003 Treatment of indolent B-cell nonfollicular lymphomas: final results of the LL01 randomized trial of the Gruppo Italiano per lo Studio dei Linfomi J Clin Oncol 21 1459 1465 1:CAS:528:DC%2BD2cXptlCks7k%3D 10.1200/JCO.2003.07.133 12697867 (Pubitemid 46594096)
11. KR Rai BL Peterson FR Appelbaum J Kolitz L Elias L Shepherd, et al. 2000 Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia N Engl J Med 343 1750 1757 1:CAS:528:DC%2BD3cXptVehs7k%3D 10.1056/NEJM200012143432402 11114313
12. S Johnson AG Smith H Loffler E Osby G Juliusson B Emmerich, et al. 1996 Multicentre prospective randomised trial of fludarabine versus cyclophosphamide, doxorubicin, and prednisone (CAP) for treatment of advanced-stage chronic lymphocytic leukaemia. The French Cooperative Group on CLL Lancet 347 1432 1438 1:CAS:528:DyaK28XjvVSntbw%3D 8676625 (Pubitemid 26161205)
13. M Leporrier S Chevret B Cazin N Boudjerra P Feugier B Desablens, et al. 2001 Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients Blood 98 2319 2325 1:CAS:528:DC%2BD3MXnslCru7w%3D 10.1182/blood.V98.8.2319 11588025
14. B Bellosillo N Villamor D Colomer G Pons E Montserrat J Gil 1999 In vitro evaluation of fludarabine in combination with cyclophosphamide and/or mitoxantrone in B-cell chronic lymphocytic leukemia Blood 94 2836 2843 1:CAS:528:DyaK1MXmslantLo%3D 10515887 (Pubitemid 29477312)
15. SM O'Brien HM Kantarjian J Cortes M Beran CA Koller FJ Giles, et al. 2001 Results of the fludarabine and cyclophosphamide combination regimen in chronic lymphocytic leukemia J Clin Oncol 19 1414 1420 11230486 (Pubitemid 32202548)
16. BD Cheson SJ Horning B Coiffier MA Shipp RI Fisher JM Connors, et al. 1999 Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group J Clin Oncol 17 1244 1253 1:STN:280:DC%2BD3c%2FivF2itg%3D%3D 10561185 (Pubitemid 29162950)
17. EI Kaplan P Meier 1958 Non parametric evaluation from incomplete observations J Am Stat Assoc 53 457 481 10.2307/2281868
18. MM Oken RH Creech DC Tormey J Horton TE Davis ET McFadden, et al. 1982 Toxicity and response criteria of the Eastern Cooperative Oncology Group Am J Clin Oncol 5 649 655 1:STN:280:DyaL3s7kvFOgsw%3D%3D 10.1097/00000421-198212000- 00014 7165009 (Pubitemid 13149996)
19. M Hallek B Schmitt M Wilhelm R Busch A Krober HP Fostitsch, et al. 2001 Fludarabine plus cyclophosphamide is an efficient treatment for advanced chronic lymphocytic leukaemia (CLL): results of a phase II study of the German CLL Study Group Br J Haematol 114 342 348 1:CAS:528:DC%2BD3MXmsVyhu78%3D 10.1046/j.1365-2141.2001.02959.x 11529853 (Pubitemid 32762233)
20. EM Schiavone SM De S Palmieri M Annunziata B Pocali C Copia, et al. 2003 Fludarabine plus cyclophosphamide for the treatment of advanced chronic lymphocytic leukemia Eur J Haematol 71 23 28 1:CAS:528:DC%2BD3sXlvVKntL0%3D 10.1034/j.1600-0609.2003.00087.x 12801295 (Pubitemid 36776048)
21. D Catovsky S Richards E Matutes D Oscier MJ Dyer RF Bezares, et al. 2007 Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial Lancet 370 230 239 1:CAS:528:DC%2BD2sXnvF2gs74%3D 10.1016/S0140-6736(07)61125-8 17658394 (Pubitemid 47069536)
22. BF Eichhorst R Busch G Hopfinger R Pasold M Hensel C Steinbrecher, et al. 2006 Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia Blood 107 885 891 1:CAS:528:DC%2BD28Xht1OnsLc%3D 10.1182/blood-2005-06-2395 16219797 (Pubitemid 43156283)
23. IW Flinn DS Neuberg MR Grever GW Dewald JM Bennett EM Paietta, et al. 2007 Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997 J Clin Oncol 25 793 798 1:CAS:528: DC%2BD2sXjvVKmt7c%3D 10.1200/JCO.2006.08.0762 17283364 (Pubitemid 350002879)
24. CS Tam MM Wolf EH Januszewicz HM Prince D Westerman JF Seymour 2004 Fludarabine and cyclophosphamide using an attenuated dose schedule is a highly effective regimen for patients with indolent lymphoid malignancies Cancer 100 2181 2189 1:CAS:528:DC%2BD2cXksF2rs7g%3D 10.1002/cncr.20234 15139062 (Pubitemid 38580338)
25. IW Flinn JC Byrd C Morrison J Jamison LF Diehl T Murphy, et al. 2000 Fludarabine and cyclophosphamide with filgrastim support in patients with previously untreated indolent lymphoid malignancies Blood 96 71 75 1:CAS:528:DC%2BD3cXksVKjsL0%3D 10891432 (Pubitemid 30456452)
26. HS Hochster MM Oken JN Winter LI Gordon BG Raphael JM Bennett, et al. 2000 Phase I study of fludarabine plus cyclophosphamide in patients with previously untreated low-grade lymphoma: results and long-term follow-up-a report from the Eastern Cooperative Oncology Group J Clin Oncol 18 987 994 1:CAS:528:DC%2BD3cXitVCgsL0%3D 10694548 (Pubitemid 30123774)
27. MA Dimopoulos G Hamilos E Efstathiou I Siapkaras C Matsouka D Gika, et al. 2003 Treatment of Waldenstrom's macroglobulinemia with the combination of fludarabine and cyclophosphamide Leuk Lymphoma 44 993 996 1:CAS:528: DC%2BD3sXit1yqs7k%3D 10.1080/1042819031000077025 12854900 (Pubitemid 36416998)
28. CS Tam JF Seymour HM Prince M Kenealy M Wolf EH Januszewicz, et al. 2006 Treatment-related myelodysplasia following fludarabine combination chemotherapy Haematologica 91 1546 1550 1:CAS:528:DC%2BD28XhtlSltb%2FF 17082012 (Pubitemid 44739896)
29. JO Armitage PP Carbone JM Connors A Levine JM Bennett S Kroll 2003 Treatment-related myelodysplasia and acute leukemia in non-Hodgkin's lymphoma patients J Clin Oncol 21 897 906 10.1200/JCO.2003.07.113 12610191 (Pubitemid 46613489)
30. T Yamauchi BJ Nowak MJ Keating W Plunkett 2001 DNA repair initiated in chronic lymphocytic leukemia lymphocytes by 4-hydroperoxycyclophosphamide is inhibited by fludarabine and clofarabine Clin Cancer Res 7 3580 3589 1:CAS:528:DC%2BD3MXptFaisLk%3D 11705880 (Pubitemid 33069998)
31. CS Tam S O'Brien W Wierda H Kantarjian S Wen KA Do, et al. 2008 Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia Blood 112 975 980 1:CAS:528: DC%2BD1cXpvVOks7c%3D 10.1182/blood-2008-02-140582 18411418
32. CS Tam M Wolf HM Prince EH Januszewicz D Westerman KI Lin, et al. 2006 Fludarabine, cyclophosphamide, and rituximab for the treatment of patients with chronic lymphocytic leukemia or indolent non-Hodgkin lymphoma Cancer 106 2412 2420 1:CAS:528:DC%2BD28Xls1Srurc%3D 10.1002/cncr.21882 16649223 (Pubitemid 43791961)
33. M Hallek G Fingerle-Rowson AM Fink R Busch J Mayer M Hensel, et al. 2009 First-line treatment with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) improves overall survival (OS) in previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL): results of a randomized phase III trial on behalf of an International Group of Investigators and the German CLL Study Group Blood 114 535 10.1182/blood-2009-03-211714 (ASH Annual Meeting Abstracts)
34. T Robak A Dmoszynska P Solal-Céligny K Warzocha J Loscertales J Catalano, et al. 2010 Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia J Clin Oncol 28 1756 1765 1:CAS:528:DC%2BC3cXmtVyhurc%3D 10.1200/JCO.2009.26.4556 20194844
35. L Baldini A Pulsoni G Rossi U Vitolo E Morra B Olivero E Cavalieri F Merli L Rigacci F Nobile A Ferrario L Orsucci M Brugiatelli P Musto G Lambertenghi Deliliers E Gamba 2009 Front-line chemo-immunotherapy rituximab-FC+rituximab maintenance in patients with untreated advanced stage non follicular lymphoma (INFL): update of a prospective study of the Intergruppo Italiano Linfomi and Roche (ML18324) Blood 114 2686 (ASH Annual Meeting Abstracts)