1. Interim Positron Emission Tomography Response–Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study
- Author
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Caterina Stelitano, Alessandro Levis, Antonio Castagnoli, Gian Mauro Sacchetti, Daniela Gioia, Giovannino Ciccone, Vincenzo Pavone, Umberto Vitolo, Lisa Argnani, Ercole Brusamolino, Maurizio Bonfichi, Andrea Evangelista, Flavia Salvi, Roberto Freilone, Pier Luigi Zinzani, Gianluca Gaidano, Armando Santoro, Umberto Ricardi, Francesco Zaja, Giuseppe Rossi, Chiara Rusconi, Luigi Rigacci, Monica Tani, Eugenio Borsatti, Alessandro Pulsoni, Antonella Anastasia, Alessandro Broccoli, Patrizia Pregno, Zinzani, PIER LUIGI, Broccoli, Alessandro, Gioia, Daniela Maria, Castagnoli, Antonio, Ciccone, Giovannino, Evangelista, Andrea, Santoro, Armando, Ricardi, Umberto, Bonfichi, Maurizio, Brusamolino, Ercole, Rossi, Giuseppe, Anastasia, Antonella, Zaja, Francesco, Vitolo, Umberto, Pavone, Vincenzo, Pulsoni, Alessandro, Rigacci, Luigi, Gaidano, Gianluca, Stelitano, Caterina, Salvi, Flavia, Rusconi, Chiara, Tani, Monica, Freilone, Roberto, Pregno, Patrizia, Borsatti, Eugenio, Sacchetti, Gian Mauro, Argnani, Lisa, Levis, Alessandro, and Zinzani, Pier Luigi
- Subjects
Male ,Cancer Research ,Time Factors ,Adolescent ,Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Disease Progression ,Disease-Free Survival ,Female ,Hodgkin Disease ,Humans ,Italy ,Kaplan-Meier Estimate ,Middle Aged ,Neoplasm Staging ,Patient Selection ,Predictive Value of Tests ,Risk Assessment ,Risk Factors ,Salvage Therapy ,Treatment Outcome ,Young Adult ,Drug Substitution ,Positron-Emission Tomography ,Stem Cell Transplantation ,Oncology ,Salvage therapy ,Predictive Value of Test ,Evaluable Patient ,chemistry.chemical_compound ,0302 clinical medicine ,Medicine ,Vinblastine ,030220 oncology & carcinogenesis ,Radiology ,Human ,medicine.drug ,medicine.medical_specialty ,Time Factor ,Dacarbazine ,Bleomycin ,03 medical and health sciences ,Antineoplastic Combined Chemotherapy Protocol ,business.industry ,Risk Factor ,Surgery ,Transplantation ,Regimen ,chemistry ,ABVD ,business ,030215 immunology - 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.
- Published
- 2016