|The following article features coverage from the European Hematology Association 2020 virtual meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The 5-year overall survival (OS) rate was significantly higher for patients with advanced Hodgkin lymphoma without evidence of disease on metabolic imaging performed following 2 cycles of first-line chemotherapy who were subsequently treated with 2 cycles of chemotherapy compared to those who received 4 to 6 additional chemotherapy cycles. These findings were presented during the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress.1
An international, multicenter, randomized, open-label, phase 3 trial conducted by the German Hodgkin Study Group evaluated the efficacy and safety of metabolic imaging to direct the number of cycles of intensive chemotherapy with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone in escalated doses (eBEACOPP) administered to patients with advanced Hodgkin lymphoma (HD18; ClinicalTrials.gov Identifier: NCT00515554).2
In that study, adult patients between the ages of 18 and 60 years with newly diagnosed advanced Hodgkin lymphoma underwent 18-fluoro-2-deoxy-D-glucose positron emission tomography (PET)/computed tomography (CT) imaging after 2 cycles of eBEACOPP chemotherapy (PET-2). Those with PET-2-positive disease were randomly assigned to receive 6 additional cycles of eBEACOPP with or without rituximab whereas those with PET-2-negative disease were randomly assigned to receive either 6 (or 4 following a protocol amendment) or 2 additional cycles of eBEACOPP.The primary study endpoint was progression-free survival (PFS) and secondary study endpoints included OS and safety, as well as late toxicity, determined with long-term follow-up.2
Key findings from the final analysis of HD18 revealed that for patients with PET-2-negative disease, the overall number of cycles of eBEACOPP could be reduced from 8/6 to 4 without compromising efficacy. In addition, patients in the subgroup receiving only 4 cycles of eBEACOPP had lower frequencies of severe infections and organ toxicities compared with those receiving a higher number of cycles of eBEACOPP.
In the current analysis, researchers compared the long-term efficacy and safety of 4 cycles of chemotherapy with 8/6 cycles of chemotherapy for the subgroup of PET-2-negative patients enrolled in the HD18 study at a median follow-up of 66 months.1 A key finding was a significantly higher 5-year OS rate in the 474 patients receiving 4 cycles of eBEACOPP (98.1%) compared with the 446 patients receiving 6/8 cycles (95.3%; hazard ratio [HR], 0.36; 95% CI, 0.17-0.74; P =.0038).
This OS difference was mainly attributed to a higher number of treatment-related deaths for patients receiving 6/8 cycles versus 4 cycles of chemotherapy (5 vs 0, respectively). In addition, the 5-year cumulative incidences of leukemia/myelodysplastic syndromes (MDS) were 1.7% in patients who received 6/8 cycles and 0.4% in patients who received 4 cycles (P =.13).
When the analysis was restricted to a comparison of PET-2-negative patients in the post-amendment study population treated with 4 cycles of eBEACOPP (200 patients) compared with 6 cycles (202 patients) at a median follow-up of 61 months, the 5-year OS rates were 97.5% vs 96.3%, respectively (HR, 0.46; 95% CI, 0.14-1.48; P =.18). For those receiving 6 cycles of chemotherapy compared with 4 cycles of chemotherapy, the 5-year cumulative incidences of leukemia/MDS were 1.0% and 0.5%, respectively (P =.58).1
“First-line treatment with 4 cycles of escalated eBEACOPP combines outstanding efficacy with an acceptable safety profile for PET-2-negative patients,” concluded the presenting author, Stefanie Kreissl, MD, from the University Hospital of Cologne in Germany. However, she added that “even with the reduced treatment, treatment burden remains relevant, so future clinical trials should aim at further improving treatment tolerability for this particularly young patient cohort.”
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- Kreissl S, Goergen H, Kobe C, et al. PET-guided treatment in patients with advanced-stage Hodgkin lymphoma: Follow-up analysis of PET-2 negative patients in the HD18 trial by the German Hodgkin Study Group. Presented at: Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress; June 2020. Abstract S222.
- Borchmann P, Goergen H, Kobe C, et al. PET-guided treatment in patients with advanced-stage Hodgkin’s lymphoma (HD18): Final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group. Lancet. 2018;390:2790-2802.