Universität zu Köln

Borchmann, Peter, Haverkamp, Heinz ORCID: 0000-0001-6895-4132, Diehl, Volker, Cerny, Thomas, Markova, Jana, Ho, Anthony D., Eich, Hans-Theodor, Mueller-Hermelink, Hans Konrad, Kanz, Lothar, Greil, Richard, Rank, Andreas, Paulus, Ursula, Smardova, Lenka, Huber, Christoph, Doerken, Bernd, Nerl, Christoph, Krause, Stefan W., Mueller, Rolf-Peter, Fuchs, Michael and Engert, Andreas (2011). Eight Cycles of Escalated-Dose BEACOPP Compared With Four Cycles of Escalated-Dose BEACOPP Followed by Four Cycles of Baseline-Dose BEACOPP With or Without Radiotherapy in Patients With Advanced-Stage Hodgkin's Lymphoma: Final Analysis of the HD12 Trial of the German Hodgkin Study Group. J. Clin. Oncol., 29 (32). S. 4234 - 4243. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 0732-183X

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Abstract

Purpose Eight cycles of BEACOPP(escalated) (escalated dose of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) followed by radiotherapy (RT) to initial bulk or residual tumor mass is the German Hodgkin Study Group standard of care for advanced-stage Hodgkin's lymphoma (HL). However, treatment-related toxicity is a concern, and the role of RT in this setting is unclear. The HD12 study thus aimed to reduce toxicity while maintaining efficacy. Patients and Methods In this prospectively randomized multicenter trial, eight cycles of BEACOPP(escalated) was compared with four cycles of BEACOPP(escalated) followed by four cycles of the baseline dose of BEACOPP (BEACOPP(baseline); 4 + 4), and RT with no RT in the case of initial bulk or residual disease. The study was designed to exclude a difference in 5-year freedom from treatment failure (FFTF) rate of 6%. Results Between January 1999 and January 2003, 1,670 patients age 16 to 65 years were enrolled onto the HD12 study. At 5 years, FFTF was 86.4% in the BEACOPP(escalated) arm and 84.8% in the 4 + 4 arm (difference, -1.6%; 95% CI, -5.2% to 1.9%), and overall survival was 92% versus 90.3% (difference, -1.7%; 95% CI, -4.6% to 1.1%). Deaths related to acute toxicity of chemotherapy were observed in 2.9% of patients (BEACOPP(escalated), n = 19; 4 + 4, n = 27). FFTF was inferior without RT (90.4% v 87%; difference, -3.4%; 95% CI, -6.6% to -0.1%), particularly in patients who had residual disease after chemotherapy (difference, -5.8%; 95% CI, -10.7% to -1.0%), but not in patients with bulk in complete response after chemotherapy (difference, -1.1%; 95% CI, -6.2% to 4%). Conclusion The reduction of BEACOPP to the 4 + 4 regimen did not substantially reduce severe toxicity but might decrease efficacy. Our results do not support the omission of consolidation RT for patients with residual disease. Alternative strategies for improving the risk-to-benefit ratio for patients with advanced HL are needed. J Clin Oncol 29: 4234-4242. (C) 2011 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Borchmann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Haverkamp, Heinz UNSPECIFIED orcid.org/0000-0001-6895-4132 UNSPECIFIED Diehl, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Cerny, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Markova, Jana UNSPECIFIED UNSPECIFIED UNSPECIFIED Ho, Anthony D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Eich, Hans-Theodor UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller-Hermelink, Hans Konrad UNSPECIFIED UNSPECIFIED UNSPECIFIED Kanz, Lothar UNSPECIFIED UNSPECIFIED UNSPECIFIED Greil, Richard UNSPECIFIED UNSPECIFIED UNSPECIFIED Rank, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Paulus, Ursula UNSPECIFIED UNSPECIFIED UNSPECIFIED Smardova, Lenka UNSPECIFIED UNSPECIFIED UNSPECIFIED Huber, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Doerken, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Nerl, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Krause, Stefan W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Rolf-Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchs, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Engert, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-485425
DOI:	10.1200/JCO.2010.33.9549
Journal or Publication Title:	J. Clin. Oncol.
Volume:	29
Number:	32
Page Range:	S. 4234 - 4243
Date:	2011
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	0732-183X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STUDY-GROUP GHSG; POSITRON-EMISSION-TOMOGRAPHY; ELDERLY-PATIENTS; MOPP/ABV HYBRID; INTERGROUP TRIAL; PROGNOSTIC SCORE; CLINICAL-TRIALS; COPP-ABVD; DISEASE; CHEMOTHERAPY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48542