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Blood, 1 April 2007, Vol. 109, No. 7, pp. 2759-2766.
Prepublished online as a Blood First Edition Paper on November 28, 2006; DOI 10.1182/blood-2006-07-035709.


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CLINICAL TRIALS AND OBSERVATIONS

Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON)

Leo F. Verdonck1, Annelise Notenboom2, Daphne D. de Jong3, Marius A. MacKenzie4, Gregor E. G. Verhoef9, Mark H. H. Kramer5, Gert J. Ossenkoppele6, Jeanette K. Doorduijn7, Pieter Sonneveld7, and Gustaaf W. van Imhoff8

1 Department of Hematology, University Medical Center, Utrecht, The Netherlands; 2 HOVON Data Center, Erasmus Medical Center, Rotterdam, The Netherlands; 3 Department of Pathology, Netherlands Cancer Institute, Amsterdam; 4 Department of Hematology, University Medical Center, Nijmegen, The Netherlands; 5 Department of Internal Medicine, Meander Medical Center, Amersfoort, The Netherlands; 6 Department of Hematology, Vrije Universiteit (VU) Medical Center, Amsterdam, The Netherlands; 7 Department of Hematology, Erasmus Medical Center, Rotterdam, The Netherlands; 8 Department of Hematology, University Medical Center, Groningen, The Netherlands; 9 Department of Hematology, University Hospital Gasthuisberg, Leuven, Belgium

Optimal dose and timing of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy for aggressive non-Hodgkin lymphoma (NHL) is still an unresolved issue. We assessed whether dose intensifications with cyclophosphamide and doxorubicin might improve outcome in younger patients with intermediate-risk aggressive NHL. Previously untreated patients were assigned to receive either 8 courses of standard CHOP (n = 239) or 6 courses of intensified (I)–CHOP (n = 238). Although there was a tendency in favor of I-CHOP for overall survival (OS), disease-free survival (DFS), and event-free survival (EFS), the differences were not significant. However, although these analyses were not planned, when the intermediate-risk group was divided into low-intermediate- and high-intermediate-risk patients according to the International Prognostic Index (IPI), low-intermediate-risk patients had improved 6-year OS (67% vs 52%; P = .05), DFS (58% vs 45%; P = .06), and EFS (41% vs 30%; P = .21) when they were treated with I-CHOP compared with standard CHOP. On the other hand, high-intermediate-risk patients seem to have no benefit from I-CHOP. Although clinically relevant side effects occurred more often in the I-CHOP arm, treatment-related mortality was similar. These data suggest that I-CHOP might be preferable to standard CHOP in younger patients with low-intermediate-risk aggressive NHL.


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