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Very High Risk Hodgkins Disease ABVD Plus BEAM Followed by Autologous Stem Cell Transplantation and Radiotherapy Versus Intensive Chemotherapy and RT Interim Results of the GOELAMS H97-GM Multicentric Randomized Trial



Very High Risk Hodgkins Disease ABVD Plus BEAM Followed by Autologous Stem Cell Transplantation and Radiotherapy Versus Intensive Chemotherapy and RT Interim Results of the GOELAMS H97-GM Multicentric Randomized Trial



Blood 100(11): Abstract No. 811



Patients (pts) with very high risk HD were defined as those having a mediastinal mass ratio (MMR) gtoreq.45 and/or gtoreq5 involved nodal areas (INA) and/or CS IV with gtoreq2 non-contiguous visceral sites. From Apr. 1, 1997 to March. 31, 2002, among 152 pts recruited in 20 centres, 113 have completed treatment (TT). Initial characteristics were: sex M 72, F 41; age 18-60, median 33; histology NS 95; INA gtoreq5: 58; MMR gtoreq.45: 54; involved visceral sites gtoreq2: 29. In the ASCT arm, 60 pts received 4 ABVD cycles (i.v., mg/m2 D1 and D15 q.4 wk: adriamycin 25, bleomycin 10, vinblastine 6, dacarbazine 375, plus methylprednisolone 120). Peripheral stem cells were then harvested after cyclophosphamide 4g/m2. Pts in partial (PR) or complete remission (CR) received a cycle of BEAM (i.v. mg/m2: BCNU 300 D1, etoposide 200 D2 to D5, aracytine 400 D2 to D5, melphalan 140 D6) before ASCT. RT (36 Gy) was then given on INA with an initial diameter of gtoreq5 cm. In the INT.CT arm, 53 pts received 3 monthly cycles of VABEM (i.v. mg/m2: vindesine continuous infusion (c.i.) 1 D1 to D5, adriamycin c.i. 33 D1 to D3, BCNU 140 D3, etoposide 200 D3 to D5 plus methylprednisolone 120 D1 to D5) and G-CSF. Pts in PR or CR received involved-field RT (20 Gy) plus 16 Gy on INA with an initial diameter of gtoreq5 cm. Results were evaluated on April 30, 2002 (median follow-up 24 months ). After completion of TT, CR rates were 90.0% in the ASCT arm and 84.9% in the INT.CT arm (p= ns); 3 pts deceased from post-CT aplasia (INT.CT arm) and 11 pts failed: 6 in the ASCT arm and 5 in the INT-CT arm. Eight pts relapsed after a median duration of 8 months of CR, 5 in the ASCT arm (2 deceased) and 3 in the INT.CT arm. At 4 years (15 pts at risk) freedom from progression rates were 75.3% in the ASCT arm and 81.4% in the INT.CT arm (p = ns) while survival rates were 87.6% and 87.2% respectively (p= ns). In this very high risk subset of pts with HD, results of 3 cycles of intensive CT followed by RT and those of 4 cycles of ABVD plus BEAM/ASCT followed by RT were so far similar.

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