Abstract
6506 Background: Early stage Hodgkin’s lymphoma (HL) in stages I-II without risk factors currently is successfully treated with combined modality of chemotherapy (usually ABVD) followed by involved field irradiation (IF) in most study groups, reaching complete remission rates higher than 90%. In the HD10 trial the GHSG investigated if the number of ABVD cycles as well as IF-radiotherapy (RT) dose could be safely reduced. Methods: 1131 patients (pts) with early stage disease (stage I,II without risk factors) were randomized between 4 cycles vs. 2 cycles of ABVD and 30 Gy IF vs. 20 Gy IF in a 2x2 factorial design between 5/1998 and 5/2002. Primary endpoint was freedom from treatment failure (FFTF). Results: The second interim analysis conducted in August 2003 comprised of 847 pts (75%) that were well balanced between treatments arms concerning baseline characteristics. Complete remission rates were high with 98.4% of all pts while progressive disease or no change was observed in 0.9% of cases. Relapse rate was 2.5%, thirteen patients died during the study (1.5%). The most common WHO grade 3/4 toxicity during CT was leukopenia with 19% (4xABVD: 22%, 2xABVD: 15%). RT was well tolerated with dysphagia in 2.3%. So far ten secondary neoplasias were reported: 1AML, 4 NHL and 5 solid tumors. FFTF after a median observation time of two years was 96.6% with no statistical differences between CT of 4xABVD vs. 2xABVD or RT of 30Gy IF vs. 20Gy IF. Overall survival was 98.5% without any statistical differences in CT and RT comparisons either. Conclusions: Further analysis will show if these promising interim results will allow to reduce further therapy intensity in combined modality treatment of early stage HL both in terms of the composition of drugs (ABVD->AV in HD13) as well as RT dose. No significant financial relationships to disclose.
Published Version
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