BEACOPP, a new dose-escalated and accelerated regimen, is at least as effective as COPP/ABVD in patients with advanced-stage Hodgkin's lymphoma: Interim report from a trial of the German Hodgkin's Lymphoma Study Group

被引:143
作者
Diehl, V [1 ]
Franklin, J [1 ]
Hasenclever, D [1 ]
Tesch, H [1 ]
Pfreundschuh, M [1 ]
Lathan, B [1 ]
Paulus, U [1 ]
Sieber, M [1 ]
Rueffer, JU [1 ]
Sextro, M [1 ]
Engert, A [1 ]
Wolf, J [1 ]
Hermann, R [1 ]
Holmer, L [1 ]
Stappert-Jahn, U [1 ]
Winnerlein-Trump, E [1 ]
Wulf, G [1 ]
Krause, S [1 ]
Glunz, A [1 ]
von Kalle, K [1 ]
Bischoff, H [1 ]
Haedicke, C [1 ]
Duehmke, E [1 ]
Georgii, A [1 ]
Loeffler, M [1 ]
机构
[1] Univ Cologne, Dept Internal Med, Cologne, Germany
关键词
D O I
10.1200/JCO.1998.16.12.3810
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: The HD9 trial aims to evaluate whether moderate dose escalation and/or acceleration of standard polychemotherapy is beneficial for advanced-stage Hodgkin's disease (HD). Two variants of a novel bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) scheme (standard and escalated dose) are compared with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP)/doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Patients and Methods: The randomized,three-arm trial recruited patients in stages IIB and IIIA with risk factors and stages IIIB and IV. BEACOPP in baseline dose contains all drug dosages of COPP/ABVD (except vincristine and procarbazine) rearranged in a shorter, 3-week cycle. Escalated BEACOPP uses higher doses of cyclophosphamide, doxorubicin, and etoposide with granulocyte colony-stimulating factor (G-CSF) support. After eight chemotherapy cycles, initial bulky and residual disease is irradiated. The trial is monitored and analyzed by means of a sequential strategy. Results: An interim analysis with 505 assessable patients and a median follow-up of 23 months showed a significant inferiority (according to sequential monitoring strategy) of the COPP/ABVD regimen in progression rate and freedom from treatment failure (FFTF) compared with the pooled results of both BEACOPP variants. The 24-month FFTF rate was 75% for COPP/ABVD and 84% for BEACOPP pooled (P = .034). There was 12% progressive disease with COPP/ABVD and 6% with BEACOPP pooled. Differences in survival were not significant in sequential analysis. The acute toxicity of baseline BEACOPP resembled that of COPP/ABVD; escalated BEACOPP showed increased but manageable hematologic toxicity. Conclusion: Combined with local irradiation, BEACOPP in one or both variants shows superior disease control compared with COPP/ABVD, with acceptable acute toxicity. Further follow-up is required to assess the effect of dosage and the effect on survival and late toxicities. (C) 1998 by American Society of Clinical Oncology.
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页码:3810 / 3821
页数:12
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