Italian Study Suggests Benefit of Interim PET Response–Adapted Therapy in High-Risk Advanced Hodgkin Lymphoma
The phase II portion of the Italian HD0801 study suggests that treatment based on positron-emission tomography (PET) performed early in first-line therapy for advanced Hodgkin lymphoma may improve outcome in patients at risk of first-line treatment failure. Zinzani et al reported their findings in the Journal of Clinical Oncology.
Study Details
The study included 519 patients who received initial treatment with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and underwent early ifosfamide-containing salvage treatment followed by stem cell transplantation if they had positive PET results after two cycles of initial chemotherapy (PET2). PET-negative patients were to receive a full six cycles of ABVD. The primary endpoint was 2-year progression-free survival.
Progression-Free Survival
Overall, PET2 was positive in 103 of 512 evaluable patients. Among them, 81 received the study salvage regimen with transplantation, 15 remained on ABVD due to physician’s decision (primarily based on minimally positive PET2), 5 received alternative treatment, and 2 were excluded due to diagnostic error.
Median follow-up after PET2 was 25 months. On intent-to-treat analysis, 2-year progression-free survival was 76% (95% confidence interval [CI] = 66%–84%) among PET2-positive patients irrespective of salvage treatment received and 81% (95% CI = 76%–84%) among PET2-negative patients.
The investigators concluded: “Patients with advanced-stage Hodgkin lymphoma for whom treatment was at high risk of failing appear to benefit from early treatment intensification with autologous transplantation, as indicated by the possibility of successful salvage treatment in more than 70% of PET2-positive patients through obtaining the same 2-year progression-free survival as the PET2-negative subgroup.”
The study was supported by the Italian Lymphoma Foundation.
Pier Luigi Zinzani, MD, of the University of Bologna, is the corresponding author of the Journal of Clinical Oncology article.
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