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Randomized study to evaluate the use of high-dose therapy as part of primary treatment for "aggressive" lymphoma

Kaiser, U ; Uebelacker, L ; Abel, U ; Birkmann, J ; Trumper, L ; Schmalenberg, H ; Karakas, T ; Metzner, B ; Hossfeld, DK and Bischoff, HG , et al. (2002) In Journal of Clinical Oncology 20(22). p.4413-4419
Abstract
Purpose: This trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group compares the use of high-dose therapy (HDT) as part of primary treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus etoposide followed by involved-field (IF) radiotherapy in a randomized, multicenter, phase III study. Patients and Methods: Three hundred twelve patients with "aggressive" non-Hodgkin's lymphoma aged greater than or equal to 60 years with elevated serum lactate dehydrogenase levels were included from 1990 to 1997. Patients with at least a minor response after two cycles of CHOEP (CHOP + etoposide 3 x 100 mg/m(2)) were to receive three further cycles of CHOEP followed by IF radiotherapy (arm A) or one further cycle... (More)
Purpose: This trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group compares the use of high-dose therapy (HDT) as part of primary treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus etoposide followed by involved-field (IF) radiotherapy in a randomized, multicenter, phase III study. Patients and Methods: Three hundred twelve patients with "aggressive" non-Hodgkin's lymphoma aged greater than or equal to 60 years with elevated serum lactate dehydrogenase levels were included from 1990 to 1997. Patients with at least a minor response after two cycles of CHOEP (CHOP + etoposide 3 x 100 mg/m(2)) were to receive three further cycles of CHOEP followed by IF radiotherapy (arm A) or one further cycle of CHOEP followed by autologous stem-cell transplantation and IF radiotherapy (arm B). Results: Among 158 patients randomized to arm B, 103 (65%) received HDT. The complete remission rate at the end of treatment was 62.9% in arm A and 69.9% in arm B. With a median observation time of 45.5 months, overall survival for all 312 patients was 63% after 3 years (63% for arm A, 62% for arm B; P = .68). Event-free survival was 49% for arm A versus 59% for arm B (P = .22). Relapse in arm B was associated with a significantly worse survival rate than relapse in arm A (P < .05). Relapse after HDT occurred early (median interval, 3 months). Six patients developed secondary neoplasia, three in arm A and three in arm B. Conclusion: Results of the randomized trial comparing CHOP-like chemotherapy with early HDT do not support the use of HDT with carmustine, etoposide, cytarabine, and melphalan following shortened standard chemotherapy. (Less)
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publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Clinical Oncology
volume
20
issue
22
pages
4413 - 4419
publisher
American Society of Clinical Oncology
external identifiers
  • pmid:12431962
  • wos:000179267200002
  • scopus:0037111830
ISSN
1527-7755
DOI
10.1200/JCO.2002.07.075
language
English
LU publication?
no
id
c3ac9f80-11f8-4d66-9522-8c076ab60131 (old id 323452)
date added to LUP
2016-04-01 12:22:55
date last changed
2022-03-13 17:11:15
@article{c3ac9f80-11f8-4d66-9522-8c076ab60131,
  abstract     = {{Purpose: This trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group compares the use of high-dose therapy (HDT) as part of primary treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus etoposide followed by involved-field (IF) radiotherapy in a randomized, multicenter, phase III study. Patients and Methods: Three hundred twelve patients with "aggressive" non-Hodgkin's lymphoma aged greater than or equal to 60 years with elevated serum lactate dehydrogenase levels were included from 1990 to 1997. Patients with at least a minor response after two cycles of CHOEP (CHOP + etoposide 3 x 100 mg/m(2)) were to receive three further cycles of CHOEP followed by IF radiotherapy (arm A) or one further cycle of CHOEP followed by autologous stem-cell transplantation and IF radiotherapy (arm B). Results: Among 158 patients randomized to arm B, 103 (65%) received HDT. The complete remission rate at the end of treatment was 62.9% in arm A and 69.9% in arm B. With a median observation time of 45.5 months, overall survival for all 312 patients was 63% after 3 years (63% for arm A, 62% for arm B; P = .68). Event-free survival was 49% for arm A versus 59% for arm B (P = .22). Relapse in arm B was associated with a significantly worse survival rate than relapse in arm A (P &lt; .05). Relapse after HDT occurred early (median interval, 3 months). Six patients developed secondary neoplasia, three in arm A and three in arm B. Conclusion: Results of the randomized trial comparing CHOP-like chemotherapy with early HDT do not support the use of HDT with carmustine, etoposide, cytarabine, and melphalan following shortened standard chemotherapy.}},
  author       = {{Kaiser, U and Uebelacker, L and Abel, U and Birkmann, J and Trumper, L and Schmalenberg, H and Karakas, T and Metzner, B and Hossfeld, DK and Bischoff, HG and Franke, A and Reiser, M and Muller, P and Mantovani, L and Grundeis, M and Rothmann, F and von Seydewitz, CU and Mesters, RM and Steinhauer, EU and Krahl, D and Schumacher, K and Kneba, M and Baudis, M and Schmitz, N and Pfab, R and Koppler, H and Parwaresch, R and Pfreundschuh, M and Havemann, K}},
  issn         = {{1527-7755}},
  language     = {{eng}},
  number       = {{22}},
  pages        = {{4413--4419}},
  publisher    = {{American Society of Clinical Oncology}},
  series       = {{Journal of Clinical Oncology}},
  title        = {{Randomized study to evaluate the use of high-dose therapy as part of primary treatment for "aggressive" lymphoma}},
  url          = {{http://dx.doi.org/10.1200/JCO.2002.07.075}},
  doi          = {{10.1200/JCO.2002.07.075}},
  volume       = {{20}},
  year         = {{2002}},
}