Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: An open-label, randomised, phase 3 trial (DSHNHL 2002-1)

The Lancet Oncology

Volumn 13, Issue 12, 2012, Pages 1250-1259

  Schmitz, Norbert ^a   Nickelsen, Maike ^a   Ziepert, Marita ^b   Haenel, Mathias ^c   Borchmann, Peter ^d   Schmidt, Christian ^e   Viardot, Andreas ^f   Bentz, Martin ^g   Peter, Norma ^h   Ehninger, Gerhard ⁱ   Doelken, Gottfried ^j   Ruebe, Christian ^k   Truemper, Lorenz ^l   Rosenwald, Andreas ^m   Pfreundschuh, Michael ^k   Loeffler, Markus ^b   Glass, Bertram ^a  

^a DEPARTMENT OF CARDIOLOGY   (Germany)

^b UNIVERSITY OF LEIPZIG   (Germany)

^c Municipal Hospital Chemnitz   (Germany)

^d UNIVERSITY OF COLOGNE   (Germany)

^e UNIVERSITY OF MUNICH   (Germany)

^f UNIVERSITY OF ULM   (Germany)

^g Municipal Hospital   (Germany)

^h Carl Thiem Hospital   (Germany)

ⁱ UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^j UNIVERSITY MEDICINE GREIFSWALD   (Germany)

^k SAARLAND UNIVERSITY   (Germany)

^l UNIVERSITY OF GÖTTINGEN   (Germany)

^m UNIVERSITY OF WÜRZBURG   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; ETOPOSIDE; PREDNISONE; RITUXIMAB; VINCRISTINE;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; ALGORITHM; ANEMIA; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; B CELL LYMPHOMA; BURKITT LYMPHOMA; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG MEGADOSE; EVENT FREE SURVIVAL; FEMALE; FOLLICULAR LYMPHOMA; HEART ARRHYTHMIA; HIGH RISK PATIENT; HUMAN; INFECTION; LARGE CELL LYMPHOMA; MALE; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MENTAL DISEASE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYELODYSPLASTIC SYNDROME; NAUSEA; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORY DYSFUNCTION; SOLID TUMOR; THROMBOCYTOPENIA;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DOXORUBICIN; ETOPOSIDE; FEMALE; HUMANS; LYMPHOMA, B-CELL; MALE; MIDDLE AGED; PREDNISOLONE; VINCRISTINE; YOUNG ADULT;

EID: 84870239168     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(12)70481-3     Document Type: Article

References (37)

1. Ziepert M, Hasenclever D, Kuhnt E, et al. Standard International prognostic index remains a valid predictor of outcome for patients with aggressive CD20+ B-cell lymphoma in the rituximab era. J Clin Oncol 2010, 28:2373-2380.
2. A predictive model for aggressive non-Hodgkin's lymphoma. N Engl J Med 1993, 329:987-994. The International Non-Hodgkin's Lymphoma Prognostic Factors Project.
3. Haioun C, Lepage E, Gisselbrecht C, et al. Benefit of autologous bone marrow transplantation over sequential chemotherapy in poor-risk aggressive non-Hodgkin's lymphoma: updated results of the prospective study LNH87-2. Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol 1997, 15:1131-1137.
4. Gianni AM, Bregni M, Siena S, et al. High-dose chemotherapy and autologous bone marrow transplantation compared with MACOP-B in aggressive B-cell lymphoma. N Engl J Med 1997, 336:1290-1297.
5. Santini G, Salvagno L, Leoni P, et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol 1998, 16:2796-2802.
6. Kluin-Nelemans HC, Zagonel V, Anastasopoulou A, et al. Standard chemotherapy with or without high-dose chemotherapy for aggressive non-Hodgkin's lymphoma: randomized phase III EORTC study. J Natl Cancer Inst 2001, 93:22-30.
7. Gisselbrecht C, Lepage E, Molina T, et al. Shortened first-line high-dose chemotherapy for patients with poor-prognosis aggressive lymphoma. J Clin Oncol 2002, 20:2472-2479. and the Groupe d'Etude des Lymphomes de l'Adulte.
8. Kaiser U, Uebelacker I, Abel U, et al. Randomized study to evaluate the use of high-dose therapy as part of primary treatment for "aggressive" lymphoma. J Clin Oncol 2002, 20:4413-4419.
9. Martelli M, Gherlinzoni F, De Renzo A, et al. Early autologous stem-cell transplantation versus conventional chemotherapy as front-line therapy in high-risk, aggressive non-Hodgkin's lymphoma: an Italian multicenter randomized trial. J Clin Oncol 2003, 21:1255-1262.
10. Milpied N, Deconinck E, Gaillard F, et al. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med 2004, 350:1287-1295. and the Groupe Ouest-Est des Leucémies et des Autres Maladies du Sang.
11. Betticher DC, Martinelli G, Radford JA, et al. Sequential high dose chemotherapy as initial treatment for aggressive sub-types of non-Hodgkin lymphoma: results of the international randomized phase III trial (MISTRAL). Ann Oncol 2006, 17:1546-1552.
12. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002, 346:235-242.
13. Pfreundschuh M, Trümper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol 2006, 7:379-391. and the MabThera International Trial Group.
14. Jaffe ES, Harris NL, Stein H, et al. Pathology and genetics: Neoplasm of hematopoietic and lymphoid tissue. World Health Organization classification of tumours 2001, IARC Press, Lyon. P. Kleihues, L.H. Sobin (Eds.).
15. Pocock SJ Clinical trials 1983, John Wiley & Sons, Chichester.
16. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982, 5:649-655.
17. Schmitz N, Kloess M, Reiser M, et al. Four versus six courses of a dose-escalated cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen plus etoposide (megaCHOEP) and autologous stem cell transplantation: early dose intensity is crucial in treating younger patients with poor prognosis aggressive lymphoma. Cancer 2006, 106:136-145. and the German High-Grade Non Hodgkin's Lymphoma Study Group (DSHNHL).
18. Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. J Clin Oncol 1999, 17:1244-1250. and the NCI Sponsored International Working Group.
19. Common terminology criteria for adverse events v3.0 National Cancer Institute, (accessed Oct 11, 2011). http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
20. O'Brien PC, Fleming TR A multiple testing procedure for clinical trials. Biometrics 1979, 35:549-556.
21. Wunderlich A, Kloess M, Reiser M, et al. Practicability and acute haematological toxicity of 2- and 3-weekly CHOP and CHOEP chemotherapy for aggressive non-Hodgkin's lymphoma: results from the NHL-B trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Ann Oncol 2003, 14:881-893. and the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL).
22. Récher C, Coiffier B, Haioun C, et al. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet 2011, 378:1858-1867. and the Groupe d'Etude des Lymphomes de l'Adulte.
23. Stiff PJ, Unger JM, Cook J, et al. Randomized phase III U.S./Canadian intergroup trial (SWOG S9704) comparing CHOP ± R for eight cycles to CHOP ± R for six cycles followed by autotransplant for patients with high-intermediate (H-Int) or high IPI grade diffuse aggressive non-Hodgkin lymphoma (NHL). Proc Am Soc Clin Oncol 2011, 29. abstr 8001.
24. Le Gouill S, Milpied NJ, Lamy T, et al. First-line rituximab (R) high-dose therapy (R-HDT) versus R-CHOP14 for young adults with diffuse large B-cell lymphoma: preliminary results of the GOELAMS 075 prospective multicenter randomized trial. Proc Am Soc Clin Oncol 2011, 29. abstr 8003.
25. Vitolo U, Chiappella A, Brusamolino E, et al. A randomized multicentre phase III study for first line treatment of young patients with high risk (aaIPI 2-3) diffuse large B-cell lymphoma (DLBCL): rituximab (R) plus dose-dense chemotherapy CHOP-14/MEGACHOP 14 with or without intensified high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Results of DLCL04 trial of Italian lymphoma foundation (FIL). Ann Oncol 2011, 22(suppl 4). abstr 072.
26. Köppler H, Pflüger KH, Eschenbach I, et al. CHOP-VP16 chemotherapy and involved field irradiation for high grade non-Hodgkin's lymphomas: a phase II multicentre study. Br J Cancer 1989, 60:79-82.
27. Schmitz N, Trümper L, Ziepert M, et al. Treatment and prognosis of mature T-cell and NK-cell lymphoma: an analysis of patients with T-cell lymphoma treated in studies of the German High-Grade Non-Hodgkin Lymphoma Study Group. Blood 2010, 116:3418-3425.
28. Pfreundschuh M, Trümper L, Kloess M, et al. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood 2004, 104:626-633. and the German High-Grade Non-Hodgkin's Lymphoma Study Group.
29. Schmitz N, Pfistner B, Sextro M, et al. Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial. Lancet 2002, 359:2065-2071. and the German Hodgkin's Lymphoma Study Group, and the Lymphoma Working Party of the European Group for Blood and Marrow Transplantationand the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation.
30. Adde M, Enblad G, Hagberg H, Sundström C, Laurell A Outcome for young high-risk aggressive B-cell lymphoma patients treated with CHOEP-14 and rituximab (R-CHOEP-14). Med Oncol 2006, 23:283-293.
31. Gang AO, Strøm C, Pedersen M, et al. R-CHOEP-14 improves overall survival in young high-risk patients with diffuse large B-cell lymphoma compared with R-CHOP-14. A population-based investigation from the Danish Lymphoma Group. Ann Oncol 2012, 23:147-153.
32. Held G, Murawski N, Ziepert M, et al. Role of radiotherapy for elderly DLBCL patients in the rituximab (R) era: final results of the RICOVER-60-NO-RX study of the DSHNHL. Haematologica 2012, 97:458. (abstract 1114a).
33. Glass B, Ziepert M, Reiser M, et al. High-dose therapy followed by autologous stem-cell transplantation with and without rituximab for primary treatment of high-risk diffuse large B-cell lymphoma. Ann Oncol 2010, 21:2255-2261. and the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL).
34. Glass B, Kloess M, Bentz M, et al. Dose-escalated CHOP plus etoposide (MegaCHOEP) followed by repeated stem cell transplantation for primary treatment of aggressive high-risk non-Hodgkin lymphoma. Blood 2006, 107:3058-3064. and the German High-Grade Non-Hodgkin Lymphoma Study Group.
35. Lenz G, Wright G, Dave SS, et al. Stromal gene signatures in large-B-cell lymphomas. N Engl J Med 2008, 359:2313-2323. and the Lymphoma/Leukemia Molecular Profiling Project.
36. Johnson NA, Slack GW, Savage KJ, et al. Concurrent expression of MYC and BCL2 in diffuse large B-cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol 2012, 30:3452-3459.
37. Pfreundschuh M, Held G, Zeynalova S, et al. Improved outcome of elderly poor-prognosis DLBCL patients with 6 × CHOP-14 and 8 applications of rituximab (R) given over an extended period: results of the SMARTE-R-CHOP-14 Trial of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Blood 2011, 118:592a.