ABVD is associated with severe toxicity in older patients, particularly due to bleomycin-induced lung toxicity (BLT). Therefore, the use of bleomycin has been questioned in older HL patients, especially in early-stage HL. We therefore analyzed feasibility, toxicity and efficacy of ABVD or AVD in 287 older early-stage favorable HL patients. We included patients ≥60 years of age in the GHSG HD10 and HD13 trials randomized to either 2 cycles ABVD (n=137) or AVD (n=82), each followed by involved-field radiotherapy (IF-RT), and patients randomized to 4xABVD+IF-RT (n=68). Patients had a median age of 65 years (range 60-75) and comparable patient and disease characteristics. Rates of grade III-IV adverse events were similar in patients receiving 2xAVD and 2xABVD (40% and 39%, respectively), but considerably higher in patients receiving 4xABVD (65%). Similarly, BLT was rare in patients receiving 2xABVD/AVD, but occurred in 7/69 (10%) of the patients randomized to 4xABVD with three lethal events. In conclusion, no effects of bleomycin on toxicity rates were detectable in older patients receiving 2 cycles of chemotherapy. However, we found a high risk of severe toxicity of bleomycin in older HL patients receiving more than two cycles of ABVD. The trials are registered to www.clinicaltrials.gov and www.isrctn.com with the numbers NCT00265018 (HD10) and ISRCTN63474366 (HD13).
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