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High-risk Hodgkins disease ABVD chemotherapy followed by beam-conditioned autologous stem cell transplantation and focal radiotherapy versus intensive chemotherapy followed by involved field RT Two-year results of the Goelams H97-GM multicentric randomized trial



High-risk Hodgkins disease ABVD chemotherapy followed by beam-conditioned autologous stem cell transplantation and focal radiotherapy versus intensive chemotherapy followed by involved field RT Two-year results of the Goelams H97-GM multicentric randomized trial



Blood 96(11 Part 1): 791a, November 16



Patients (pts) with high-risk HD were defined as those having mediastinal mass ratio gtoreq.45 and/or gtoreq2 non-contiguous visceral sites and/or gtoreq 5 involved nodal areas. From 01/04/1997 to 30/06/2000, among 82 pts recruited in 16 clinical centers, 60 have completed their treatment. Their initial characteristics were: CS IA-IIA 6, IB-IIB 8, IIIA 9, IIIB 13, IVA 8, IVB 16; sex M 37, F 23; age 18-59, median 46.5; histology NS 49. Pts were randomized in two arms, ASCT and INT.CT. In the ASCT arm (32 pts), pts received 4 ABVD cycles (i.v. mg/m2 D1 and D15 each 4 wk: adriamycin 25, bleomycin 10, vinblastine 6, dacarbazine 375, plus methylprednisolone 120); peripheral stem cells were then harvested after cyclophosphamide 4 g/m2; pts who have entered in complete remission (CR) or partial remission (PR) after ABVD 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; focal RT (36 Gy) was then given on nodal sites which had an initial diameter gtoreq 5 cm. In the INT.CT arm (28 pts), pts received 3 cycles of VABEM (i.v. mg/m2 each 4 w: 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 from D8 to gtoreq500 PMN); pts who entered in PR or CR were then given IF-RT 20 Gy plus 16 Gy on nodes with an initial diameter gtoreq 5 cm. Results were evaluated on July 15th, 2000; the median follow-up was 20 months in the two groups. One pt deceased from post-CT aplasia (INT.CT arm). After completion of treatment, there was 53 CR (90% and 87% in ASCT and INT.CT arms, respectively) and 7 failures: 3 pts in the ASCT arm (2 deceased) and 4 pts in the INT.CT arm (1 deceased). Three pts have relapsed after 2, 5 and 10 months of CR, respectively; all belonged to the ASCT arm; 2 of them deceased. The 2-year survival rates were 90.7% in the ASCT arm and 90.9% in the INT.CT arm. Conclusion: At 2 years, the results of 3 cycles of an intensive CT followed by an IF-RT are similar to those of 4 ABVD cycles followed by a BEAM-conditionned ASCT for high-risk HD. More pts and longer follow-up are needed to confirm these preliminary results.

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Accession: 035038116

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