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Cologne high-dose sequential chemotherapy in relapsed and refractory Hodgkins and aggressive non-Hodgkins lymphoma Results of a multicenter phase-II study



Cologne high-dose sequential chemotherapy in relapsed and refractory Hodgkins and aggressive non-Hodgkins lymphoma Results of a multicenter phase-II study



Blood 98(11 Part 1): 681a, November 16



Combination chemotherapy can cure patients (pts) with Hodgkin's disease (HD) or Non-Hodgkin's lymphoma, but those with treatment failure or relapse still have a poor prognosis. High-dose chemotherapy (HDCT) with autologous stem cell support (ASCT) can improve the outcome of these pts as shown in the HR-R1 study of the GHSG/EBMT and the PARMA trial. We thus designed an intensified salvage program with a final myeloablative course. Eligibility criteria include age 18-60 years, histologically proven primary progressive or relapsed HD and NHL. Treatment consists of two cycles DHAP; pts with PR or CR receive cyclophosphamide 4g/m2, followed by PBSC harvest; methotrexate 8g/m2 plus vincristine 1.4mg/m2; and etoposide 2g/m2. The final myeloblative course is BEAM followed by ASCT. 161 pts (median age 36 years, range 18-65) with HD (n=102) or NHL (n=59) have been enrolled. So far 146 pts are available for the final evaluation (97 pts with HD, 49 pts with NHL). At 18 months of median follow-up (range 3-31 months) results are as follows: Response rate (RR) after DHAP: pts with HD: 87% (23% CR, 64% PR); pts with NHL: 69% (10% CR, 59% PR). RR at the final evaluation: pts with HD: 77% (68% CR, 9% PR), pts with NHL 48% (32% CR, 16% PR). PBSC harvest was succesful in 96% of pts. Toxicity was tolerable. FFTF/OS for pts with HD are: early relapse 64%/87%; late relapse 68%/81%; PD: 30%/58%; multiple relapse 55%/88%. FFTF/OS for pts with NHL: relapse: 42%/54%; PD 8%/22%. We conclude that this regimen is feasible, tolerable and highly effective in very poor risk pts with aggressive NHL or HD. In pts with relapsed HD the GHSG/EBMT/EORTC is comparing this regimen in a prospective randomized study (activated 01/2001) with 2 cycles DHAP followed by BEAM (HD-R2 protocol).

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