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765 Dose-Escalation with BEACOPP Escalated Is Superior to ABVD In the Combined-Modality Treatment of Early Unfavorable Hodgkin Lymphoma: Final Analysis of the German Hodgkin Study Group (GHSG) HD14 TrialClinically Relevant Abstract

Program: Oral and Poster Abstracts
Type: Oral
Session: Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Therapy of Hodgkin Lymphoma and Indolent Non-Hodgkin Lymphoma
Monday, December 6, 2010: 5:00 PM
Auditorium - 320 (Orange County Convention Center)

Andreas Engert, MD1, Peter Borchmann, MD2, Annette Pluetschow3*, Bastian von Tresckow2*, Jana Markova, MD4*, Felicitas Hitz5*, Zdenek Kral6*, Richard Greil, MD7, Max S. Topp, MD8, Matthias Villalobos9*, Josee M. Zijlstra10*, Martin Soekler, MD11*, Harald Stein, MD12*, Hans-Theodor Eich13*, Rolf-Peter Mueller13*, Michael Fuchs2* and Volker Diehl, MD14*

1First Department of Internal Medicine, German Hodgkin Study Group (GHSG), University Hospital Cologne, Koln, Germany
2Internal Medicine I, German Hodgkin Study Group, University Hospital Cologne, Cologne, Germany
3Dept. of Internal Medicine I, German Hodgkin Study Group, University Hospital of Cologne, Cologne, Germany
4Department of Clinical Hematology, Third Faculty of Medicine, Charles University Hospital Kralovske Vinohrady, Prague, Czech Republic
5Medical Oncology, Kantonsspital St.Gallen, St.Gallen, Switzerland
6Third Faculty of Medicine, Charles University Prague, Dpt. of Clinical Hematology; University Hospital Kralovske Vinohrady, Prague, Czech Republic
73rd Med. Dept., Laboratory for Immunological and Molecular Cancer Research, University Hospital Salzburg, Salzburg, Austria
8Department of Internal Medicine II, Division of Hematology and Medical Oncology, Wuerzburg University Medical Center, Wuerzburg, Germany
9Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany
10Dept. of Hematology, VU University Medical Center, Amsterdam, Netherlands
11Dept. of Hematology and Oncology, University of Tuebingen, Tuebingen, Germany
12Universitätsklinikum Benjamin Franklin, Berlin, Germany
13Dept. of Radiation Oncology, University Hospital of Cologne, Cologne, Germany
14German Hodgkin Study Group (GHSG), University Hospital of Cologne, Cologne, Germany

Purpose: Combined modality treatment consisting of 4 cycles of chemotherapy and IF-RT is the standard treatment for early unfavorable HL. Overall survival (OS) and freedom from treatment failure (FFTF) at 5 years in this group of patients was 91% and 83%, respectively, in our prior HD8 study. Thus, the rationale for HD14 was to improve on these results by increasing dose intensity using BEACOPP escalated.

Methods: Between January 2003 and July 2008, 1655 patients with histologically confirmed diagnosis of Hodgkin lymphoma in early unfavorable stages were randomized. Patients had to be 16-60 years old and have CS I, IIA with one of the following risk factors: large mediastinal mass (a), extranodal disease (b), elevated ESR (c), or ≥ 3 nodal areas (d), IIB with risk factors c or d). Patients were randomized to either 4 cycles of ABVD (arm A) or 2 cycles BEACOPP escalated followed by 2 cycles ABVD (arm B). All patients received 30Gy IF-RT after chemotherapy. Primary objective was the improvement of FFTF.

Results: The full analysis set comprised 1623 patients (98.1%) who were documented and followed for treatment effects; 818 were in arm A and 805 in arm B. Patient characteristics were well balanced between the two arms with a median age of 33.6 years and most patients in stage IIA (67%). The overall response rate to treatment was 95% in each arm. With a median follow-up of 42.4 months, 20 patients had died in each arm; 19 patients in arm A had secondary neoplasia compared to 16 patients in arm B. Progressive disease was observed in 2.9% versus 0.9% of patients in arms A and B, respectively; early relapse rates were 2.8% versus 0.9%, and late relapse rates were 2.3% versus 0.9%. The estimated 4-year FFTF rate was 89.3% in arm A and 94.7% in arm B (p=0,0001, hazard ratio HR=2.04, 95%-CI: 1.39-2.94). There was no significant difference in overall survival yet (p=0.95). Acute grade III-IV toxicity rates of chemotherapy were higher in arm B (87.1%) than in arm A (50.7%) with leucopenia rates of 79% versus 24%, hair loss 48% versus 24%, thrombocytopenia 22% versus 0.1% and anemia 9% versus 1% in arms B and A respectively. 7.3% of patients had grade III/IV infections in arm B as compared to 3.4% in arm A. However, we observed no differences in treatment-related death or secondary neoplasia rates between treatment arms.

Conclusion: Intensifying treatment for patients with early unfavorable HL using 2 cycles of BEACOPP escalated followed by 2 x ABVD and IFRT results in a significant improvement in tumor control as compared to our prior standard of 4 x ABVD plus IFRT. As defined in the study protocol, this more aggressive treatment was implemented as new standard of care for early unfavorable HL in our follow-up study (GHSG HD17).

Disclosures: Greil: Cephalon: Research Funding.

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