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Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone Outside German Hodgkin Study Grou

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Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone Outside German Hodgkin Study Grou Hematology Meeting Reports 2009;3(3):126–128 SESSION IX xS. Luminari1 Bleomycin, etoposide, doxorubicin, M. Federico1 xA. Montanini1 cyclophosphamide, vincristine, procarbazine, E. Iannitto2 and prednisone outside German Hodgkin Study G. Polimeno3 P.G. Gobbi4 Group: the Italian experience 1Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia; Hodgkin lymphoma (HL) is one been raised, however, and further 2Divisione di Ematologia e Trapianto di Midollo Osseo, of the most treatable adult can- trials designed to identify a thera- Policlinico di Palermo; cers, with long-term cure rates of py with the best risk-to-benefit 3U.O Semplice di more than 80% achieved even in ratio have been initiated by sever- Oncoematologia, Divisione 1,2 di Medicina, Ospedale patients with advanced disease. al Cooperative Groups. One trial “F. Miulli”, Acquaviva delle The combination of doxorubicin, by the European Organization for Fonti (BA); bleomycin, vinblastine, and Research and Treatment of 4 Medicina Interna e dacarbazine (ABVD), is currently Cancer (EORTC) is currently Oncologia Medica, Università di Pavia, IRCCS Policlinico considered to be the standard recruiting and randomizes San Matteo, Pavia, Italy treatment for HL worldwide.3 As patients with advanced HL an improvement on the ABVD between 4 escalated plus 4 stan- combination, other regimens, dard courses of BEACOPP versus including Stanford V, MOPPEB- 8 courses of ABVD. VCAD, EVA, VEBEP, and To date, two trials have been ChlVPP/ABVVP, have been pro- completed in Italy and their posed but none have so far been results recently disclosed. These demonstrated to be more effective trials were conducted independ- than ABVD.4-9 In 1990, the ently by Gruppo Italiano per lo German Hodgkin Study Group Studio dei Linfomi (GISL) (GHSG) developed a dose-esca- (HD2000 study11), and by lated and accelerated combined Fondazione Michelangelo (FM), modality regimen consisting of Gruppo Italiano Terapie bleomycin, etoposide, doxoru- Innovative nei Linfomi (GITIL) bicin, cyclophosphamide, vin- and Intergruppo Italiano Linfomi cristine, procarbazine, and pred- (IIL).12 In both cases, patients with nisone (BEACOPP), plus radia- advanced HL with slight differ- tion therapy (RT). The HD9 trial ences were enrolled. In the GISL compared cyclophosphamide, trial a third arm was included, vincristine, procarbazine, and consisting of an alternating hybrid prednisone, plus doxorubicin, regimen developed by the same bleomycin, vinblastine, dacar- group (COPPEBVCAD, CEC: bazine (COPP/ABVD) with both cyclophosphamide, lomustine, standard BEACOPP and escalated vindesine, melphalan, prednisone, BEACOPP. This trial demonstrat- epidoxirubicin, vincristine, pro- ed the superiority of escalated carbazine, vinblastine, and BEACOPP, both in terms of fail- bleomycin).5,6 In the FM-GITIL- ure free survival (FFS) and over- IIL trial the use of a high-dose sal- all survival (OS).10 Concern about vage was considered as a pre- the toxicity of BEACOPP has planned treatment for both arms. | 126 | 7th Meeting New Insights in Hematology, Venice, Italy, 26-29 April In the GISL trial, patients were randomly COPP in the GISL and FM-GITIL-IIL trials, assigned to receive 6 courses of ABVD, 4 respectively. After a median follow-up of 41 escalated plus 2 standard courses of BEA- months for the GISL trial and 30 months for COPP, or 6 courses of CEC, and randomiza- the FM-GITIL-IIL trial, both trials showed tion was stratified by stage (IIB vs. III vs. IV). comparable survival data. The estimated 5- In the FM-GITIL-IIL trial patients were strati- year FFS, progression free survival (PFS) and fied and randomized to receive 6-8 courses of OS rates of the two trials are summarized in ABVD or 4 courses of escalated plus 4 cours- Table 2. Patients randomized to BEACOPP es of standard BEACOPP. The adoption of a had a better PFS than those allocated to less intensive BEACOPP schedule was shared ABVD. The PFS increased by 13% and 16% in by the two Italian trials and also by the ongo- the GISL and FM-GITIL-IIL trial, respective- ing EORTC trial, due to concerns regarding the ly. No differences were found in terms of OS. safety profile associated with 8 full courses of Additional multivariate analysis was per- escalated BEACOPP. RT was allowed in both formed for the HD2000 study to analyze the trials and delivered to sites of initial bulky dis- role of confounding factors. The better results ease or residual masses. obtained with BEACOPP in terms of the FFS Both Italian trials commenced in 2000 and did not change when the therapy was adjusted were closed in 2007. The GISL study enrolled by the international prognostic score (IPS ≥3 307 patients, with 103, 102, and 102 allocated vs. 0-2). A PFS analysis adjusted for IPS to the ABVD, BEACOPP, and CEC treatment showed a HR of 0.46 (95% CI, 0.24-0.88) arms, respectively. A total of 321 patients were associated with BEACOPP, with a risk reduc- enrolled in the FM-GITIL-IIL trial, 166 tion in progression of 54% in comparison with patients in the ABVD and 155 in the BEA- ABVD. The magnitude of the improved results COPP arm. The baseline characteristics of for BEACOPP over ABVD was more evident patients randomized in both trials are present- in patients with a high IPS (IPS 3-7). ed in Table 1. Overall, the response rates are In terms of safety, the BEACOPP regimen similar in both trials, with CR rates of 84% and used in the HD2000 study resulted in higher 77% for ABVD and 91% and 85% for BEA- rates of grade III-IV neutropenia (54%) and of Table 1. Patient characteristics in each treatment arm of the two Table 2. Estimate of 5 year survival rates by treatment arm in the Italian trials. two Italian trials. GISL trial FM-GITIL-IIL trial GISL trial FM-GITIL-IIL trial ABVD BEACOPP ABVD BEACOPP ABVD BEACOPP ABVD BEACOPP (n=99) (n=98) (n=166) (n=155) (n=99) (n=98) (n=166) (n=155) Characteristic % % Variable % % Age ≥45 yr 18 17 23 20 Failure 65 78 69 78 free survival Male gender 43 60 60 57 Progression 68 81 69 85 Nodular sclerosis 81 84 78 81 free survival histology Overall 84 92 86 87 Bulky disease 31 37 55 61 survival International ≥3 30 43 54 55 prognostic score Hematology Meeting Reports 2009;3(3) | 127 | S. Luminari et al. severe infections (14%), compared with minimal acute and delayed toxicity, is current- ABVD (34% and 2%, respectively). In the ly therefore a concrete possibility and is being GISL trial BEACOPP chemotherapy had to be investigated in several ongoing trials, the discontinued in 3 patients due to one case each results of which will probably allow the use of of viral infection, candidiasis and hepatic dys- the BEACOPP regimen only in patients not function. In the FM-GITIL-IIL trial, BEA- achieving an early response with the less toxic COPP chemotherapy had to be discontinued in and more manageable ABVD. 4 patients due to grade III-IV infections. Interestingly, the adoption of a modified schedule did not substantially affect the effica- References cy of BEACOPP. In particular, the CR rates in 1. Bonadonna G, Zucali R, Monfardini S, et al. the GISL and FM-GITIL-IIL trials compare Combination chemotherapy of Hodgkin's disease with favorably with the 96% reported by the GHSG adriamycin, bleomycin, vinblastine, and imidazole car- boxamide versus MOPP. Cancer 1975;36:252-9. for 8 cases treated with escalated BEACOPP. 2. Canellos GP, Anderson JR, Propert KJ, et al. Chemotherapy of advanced Hodgkin's disease with Similarly, patients treated with BEACOPP in MOPP, ABVD, or MOPP alternating with ABVD. N the GISL trial achieved a 5-year PFS rate of Engl J Med 1992;327:1478-84. 3. Santoro A, Bonadonna G, Valagussa P, et al. Long-term 81% and in the FM-GITIL-IIL trial achieved a results of combined chemotherapy-radiotherapy approach in Hodgkin's disease: superiority of ABVD plus 5-year FFP rate of 85%, which are between the radiotherapy versus MOPP plus radiotherapy. J Clin 75% and 85% 5-year FFTF rates previously Oncol 1987;5:27-37. 4. Horning SJ, Hoppe RT, Breslin S, et al. Stanford V and observed for standard-dose and escalated-dose radiotherapy for locally extensive and advanced BEACOPP10, respectively. As far as treat- Hodgkin's disease: mature results of a prospective clini- cal trial. J Clin Oncol 2002;20:630-7. ment-related toxicity is concerned, patients 5. Gobbi PG, Pieresca C, Federico M, et al. MOPP/EBV/ CAD hybrid chemotherapy with or without limited radio- treated with BEACOPP had more frequent therapy in advanced or unfavorably presenting Hodgkin's severe events than the control arm, both in disease: a report from the Italian Lymphoma Study Group. J Clin Oncol 1993;11:712-9. terms of neutropenia and infections. Overall, 6. Gobbi PG, Pieresca C, Ghirardelli ML, et al. Long-term results from MOPPEBVCAD chemotherapy with the adoption of a modified, less intensive optional limited radiotherapy in advanced Hodgkin's dis- schedule apparently increased the safety of the ease. Blood 1998;91:2704-12. 7. Canellos GP, Gollub J, Neuberg D, et al. Primary sys- BEACOPP regimen. Thus far, few cases of sec- temic treatment of advanced Hodgkin's disease with EVA ondary acute leukemia have been observed (etoposide, vinblastine, doxorubicin): 10-year follow-up. Ann Oncol 2003;14:268-72. among patients treated with BEACOPP outside 8. Viviani S, Bonfante V, Santoro A, et al. Long-term results of an intensive regimen: VEBEP plus involved-field of the GHSG, although a longer follow-up is radiotherapy in advanced Hodgkin's disease. Cancer J necessary to account for late relapses and sec- Sci Am 1999;5:275-82.
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