Reduced Treatment Intensity in Patients with Early-Stage Hodgkin's Lymphoma

被引:661
作者
Engert, Andreas [1 ]
Pluetschow, Annette [1 ]
Eich, Hans Theodor [2 ]
Lohri, Andreas [18 ]
Doerken, Bernd [3 ]
Borchmann, Peter [1 ]
Berger, Bernhard [4 ]
Greil, Richard [19 ]
Willborn, Kay C. [6 ]
Wilhelm, Martin [7 ]
Debus, Juergen [8 ]
Eble, Michael J. [10 ]
Soekler, Martin [5 ]
Ho, Antony [9 ]
Rank, Andreas [11 ]
Ganser, Arnold [12 ]
Truemper, Lorenz [13 ]
Bokemeyer, Carsten [14 ]
Kirchner, Hartmut [15 ]
Schubert, Joerg [16 ]
Kral, Zdenek [20 ,21 ]
Fuchs, Michael [1 ]
Mueller-Hermelink, Hans-Konrad [17 ]
Mueller, Rolf-Peter [2 ]
Diehl, Volker [1 ]
机构
[1] Univ Cologne, Dept Internal Med, German Hodgkin Study Grp, Cologne, Germany
[2] Univ Cologne, Dept Radiat Oncol, Cologne, Germany
[3] Charite, Dept Hematol & Oncol, D-13353 Berlin, Germany
[4] Univ Tubingen, Dept Radiat Oncol, Tubingen, Germany
[5] Univ Tubingen, Dept Internal Med 2, Tubingen, Germany
[6] Pius Hosp Oldenburg, Klin Strahlentherapie & Internist Onkol, Oldenburg, Germany
[7] Schwerpunkt Hamatol Onkol, Med Klin 5, Klinikum Nurnberg Nord, Nurnberg, Germany
[8] Heidelberg Univ, Dept Radiat Oncol, Heidelberg, Germany
[9] Heidelberg Univ, Dept Internal Med 5, Heidelberg, Germany
[10] Rhein Westfal TH Aachen, Dept Radiotherapy, Aachen, Germany
[11] Univ Munich, Univ Hosp Grosshadern, Dept Internal Med 3, Munich, Germany
[12] Hannover Med Sch, Dept Hematol Hemostasis Oncol & Stem Cell Transpl, D-3000 Hannover, Germany
[13] Univ Gottingen, Dept Hematol & Oncol, Gottingen, Germany
[14] Univ Med Ctr Hamburg, Dept Oncol Hematol & Bone Marrow Transplantat, Hamburg, Germany
[15] Siloah Clin, Dept Hematol Oncol, Hannover, Germany
[16] Evangel Krankenhaus Hamm, Med Klin, Abt Hamatoonkol, Hamm, Germany
[17] Univ Wurzburg, Inst Pathol, D-8700 Wurzburg, Germany
[18] Swiss Grp Clin Canc Res, Bern, Switzerland
[19] Salzburg Univ, Dept Med 3, A-5020 Salzburg, Austria
[20] Univ Hosp, Dept Internal Med Hematooncol, Brno, Czech Republic
[21] Masaryk Univ, Fac Med, Brno, Czech Republic
关键词
POSITRON-EMISSION-TOMOGRAPHY; INVOLVED-FIELD RADIOTHERAPY; COMBINED-MODALITY THERAPY; RADIATION-THERAPY; PROGNOSTIC SCORE; 2ND MALIGNANCY; CLINICAL-TRIAL; CYCLES; CHEMOTHERAPY; DISEASE;
D O I
10.1056/NEJMoa1000067
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Whether it is possible to reduce the intensity of treatment in early (stage I or II) Hodgkin's lymphoma with a favorable prognosis remains unclear. We therefore conducted a multicenter, randomized trial comparing four treatment groups consisting of a combination chemotherapy regimen of two different intensities followed by involved-field radiation therapy at two different dose levels. METHODS We randomly assigned 1370 patients with newly diagnosed early-stage Hodgkin's lymphoma with a favorable prognosis to one of four treatment groups: four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by 30 Gy of radiation therapy (group 1), four cycles of ABVD followed by 20 Gy of radiation therapy (group 2), two cycles of ABVD followed by 30 Gy of radiation therapy (group 3), or two cycles of ABVD followed by 20 Gy of radiation therapy (group 4). The primary end point was freedom from treatment failure; secondary end points included efficacy and toxicity of treatment. RESULTS The two chemotherapy regimens did not differ significantly with respect to freedom from treatment failure (P = 0.39) or overall survival (P = 0.61). At 5 years, the rates of freedom from treatment failure were 93.0% (95% confidence interval [CI], 90.5 to 94.8) with the four-cycle ABVD regimen and 91.1% (95% CI, 88.3 to 93.2) with the two-cycle regimen. When the effects of 20-Gy and 30-Gy doses of radiation therapy were compared, there were also no significant differences in freedom from treatment failure (P = 1.00) or overall survival (P = 0.61). Adverse events and acute toxic effects of treatment were most common in the patients who received four cycles of ABVD and 30 Gy of radiation therapy (group 1). CONCLUSIONS In patients with early-stage Hodgkin's lymphoma and a favorable prognosis, treatment with two cycles of ABVD followed by 20 Gy of involved-field radiation therapy is as effective as, and less toxic than, four cycles of ABVD followed by 30 Gy of involved-field radiation therapy. Long-term effects of these treatments have not yet been fully assessed. (Funded by the Deutsche Krebshilfe and the Swiss Federal Government; ClinicalTrials.gov number, NCT00265018.)
引用
收藏
页码:640 / 652
页数:13
相关论文
共 31 条
[1]  
[Anonymous], NCCN CLIN PRACT GUID
[2]   Prospective clinical trial comparing chemotherapy, radiotherapy and combined therapy in the treatment of early stage Hodgkin's disease with bulky disease [J].
Aviles, A ;
Delgado, S .
CLINICAL AND LABORATORY HAEMATOLOGY, 1998, 20 (02) :95-99
[3]  
BLOOMFIELD CD, 1982, CANCER TREAT REP, V66, P835
[4]   INCIDENCE OF 2ND CANCERS IN PATIENTS TREATED FOR HODGKINS-DISEASE [J].
BOIVIN, JF ;
HUTCHISON, GB ;
ZAUBER, AG ;
BERNSTEIN, L ;
DAVIS, FG ;
MICHEL, RP ;
ZANKE, B ;
TAN, CTC ;
FULLER, LM ;
MAUCH, P ;
ULTMANN, JE .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1995, 87 (10) :732-741
[5]  
BONADONNA G, 1975, CANCER, V36, P252, DOI 10.1002/1097-0142(197507)36:1<252::AID-CNCR2820360128>3.0.CO
[6]  
2-7
[7]   Chemotherapy alone for early Hodgkin's lymphoma: An emerging option [J].
Canellos, GP .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (21) :4574-4576
[8]   CLINICAL STAGE-I AND HODGKIN STAGE-II DISEASE - A SPECIFICALLY TAILORED THERAPY ACCORDING TO PROGNOSTIC FACTORS [J].
CARDE, P ;
BURGERS, JMV ;
HENRYAMAR, M ;
HAYAT, M ;
SIZOO, W ;
VANDERSCHUEREN, E ;
MONCONDUIT, M ;
NOORDIJK, EM ;
LUSTMANMARECHAL, J ;
TANGUY, A ;
DEPAUW, B ;
COSSET, JM ;
CATTAN, A ;
SCHNEIDER, M ;
THOMAS, J ;
MEERWALDT, JH ;
SOMERS, R ;
TUBIANA, M .
JOURNAL OF CLINICAL ONCOLOGY, 1988, 6 (02) :239-252
[9]   State-of-the-art therapeutics: Hodgkin's lymphoma [J].
Connors, JM .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (26) :6400-6408
[10]  
Eghbali H, 2005, BLOOD, V106, p240A