Interim Positron Emission Tomography Response-Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study
Pier Luigi Zinzani, Alessandro Broccoli, Daniela Maria Gioia, Antonio Castagnoli, Giovannino Ciccone, Andrea Evangelista, Armando Santoro, Umberto Ricardi, Maurizio Bonfichi, Ercole Brusamolino, Giuseppe Rossi, Antonella Anastasia, Francesco Zaja, Umberto Vitolo, Vincenzo Pavone, Alessandro Pulsoni, Luigi Rigacci, Gianluca Gaidano, Caterina Stelitano, Flavia Salvi, Chiara Rusconi, Monica Tani, Roberto Freilone, Patrizia Pregno, Eugenio Borsatti, Gian Mauro Sacchetti, Lisa Argnani, Alessandro Levis, Pier Luigi Zinzani, Alessandro Broccoli, Daniela Maria Gioia, Antonio Castagnoli, Giovannino Ciccone, Andrea Evangelista, Armando Santoro, Umberto Ricardi, Maurizio Bonfichi, Ercole Brusamolino, Giuseppe Rossi, Antonella Anastasia, Francesco Zaja, Umberto Vitolo, Vincenzo Pavone, Alessandro Pulsoni, Luigi Rigacci, Gianluca Gaidano, Caterina Stelitano, Flavia Salvi, Chiara Rusconi, Monica Tani, Roberto Freilone, Patrizia Pregno, Eugenio Borsatti, Gian Mauro Sacchetti, Lisa Argnani, Alessandro Levis
Abstract
Purpose: The clinical impact of positron emission tomography (PET) evaluation performed early during first-line therapy in patients with advanced-stage Hodgkin lymphoma, in terms of providing a rationale to shift patients who respond poorly onto a more intensive regimen (PET response-adapted therapy), remains to be confirmed.
Patients and methods: The phase II part of the multicenter HD0801 study involved 519 patients with advanced-stage de novo Hodgkin lymphoma who received an initial treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and who underwent an early ifosfamide-containing salvage treatment followed by stem-cell transplantation if they showed a positive PET evaluation after two cycles of chemotherapy (PET2). The primary end point was 2-year progression-free survival calculated for both PET2-negative patients (who completed a full six cycles of ABVD treatment) and PET2-positive patients. Overall survival was a secondary end point.
Results: In all, 103 of the 512 evaluable patients were PET2 positive. Among them, 81 received the scheduled salvage regimen with transplantation, 15 remained on ABVD (physician's decision, mostly because of minimally positive PET2), five received an alternative treatment, and two were excluded because of diagnostic error. On intention-to-treat analysis, the 2-year progression-free survival was 76% for PET2-positive patients (regardless of the salvage treatment they received) and 81% for PET2-negative patients.
Conclusion: 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.
Trial registration: ClinicalTrials.gov NCT00784537.
© 2016 by American Society of Clinical Oncology.
Source: PubMed