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 SalviChiara Rusconi, Monica Tani, Roberto Freilone, Patrizia Pregno, Eugenio Borsatti, Gian Mauro Sacchetti, Lisa Argnani, Alessandro Levis

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Abstract

Purpose The clinical impact of positron emission tomography (PET) evaluation performed early during firstline 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.

Original languageEnglish
Pages (from-to)1376-1385
Number of pages10
JournalJournal of Clinical Oncology
Volume34
Issue number12
DOIs
Publication statusPublished - Apr 20 2016

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Hodgkin Disease
Positron-Emission Tomography
Salvage Therapy
Therapeutics
Disease-Free Survival
Dacarbazine
Ifosfamide
Intention to Treat Analysis
Vinblastine
Autologous Transplantation
Bleomycin
Stem Cell Transplantation
Diagnostic Errors
Doxorubicin
Multicenter Studies
Transplantation
Physicians
Drug Therapy
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Interim positron emission tomography response-adapted therapy in advanced-stage hodgkin lymphoma : Final results of the phase II part of the HD0801 study. / 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.

In: Journal of Clinical Oncology, Vol. 34, No. 12, 20.04.2016, p. 1376-1385.

Research output: Contribution to journalArticle

Zinzani, PL, Broccoli, A, Gioia, DM, Castagnoli, A, Ciccone, G, Evangelista, A, Santoro, A, Ricardi, U, Bonfichi, M, Brusamolino, E, Rossi, G, Anastasia, A, Zaja, F, Vitolo, U, Pavone, V, Pulsoni, A, Rigacci, L, Gaidano, G, Stelitano, C, Salvi, F, Rusconi, C, Tani, M, Freilone, R, Pregno, P, Borsatti, E, Sacchetti, GM, Argnani, L & Levis, A 2016, 'Interim positron emission tomography response-adapted therapy in advanced-stage hodgkin lymphoma: Final results of the phase II part of the HD0801 study', Journal of Clinical Oncology, vol. 34, no. 12, pp. 1376-1385. https://doi.org/10.1200/JCO.2015.63.0699
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. / Interim positron emission tomography response-adapted therapy in advanced-stage hodgkin lymphoma : Final results of the phase II part of the HD0801 study. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 12. pp. 1376-1385.
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abstract = "Purpose The clinical impact of positron emission tomography (PET) evaluation performed early during firstline 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.",
author = "Zinzani, {Pier Luigi} and Alessandro Broccoli and Gioia, {Daniela Maria} and Antonio Castagnoli and Giovannino Ciccone and Andrea Evangelista and Armando Santoro and Umberto Ricardi and Maurizio Bonfichi and Ercole Brusamolino and Giuseppe Rossi and Antonella Anastasia and Francesco Zaja and Umberto Vitolo and Vincenzo Pavone and Alessandro Pulsoni and Luigi Rigacci and Gianluca Gaidano and Caterina Stelitano and Flavia Salvi and Chiara Rusconi and Monica Tani and Roberto Freilone and Patrizia Pregno and Eugenio Borsatti and Sacchetti, {Gian Mauro} and Lisa Argnani and Alessandro Levis",
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T1 - Interim positron emission tomography response-adapted therapy in advanced-stage hodgkin lymphoma

T2 - Final results of the phase II part of the HD0801 study

AU - Zinzani, Pier Luigi

AU - Broccoli, Alessandro

AU - Gioia, Daniela Maria

AU - Castagnoli, Antonio

AU - Ciccone, Giovannino

AU - Evangelista, Andrea

AU - Santoro, Armando

AU - Ricardi, Umberto

AU - Bonfichi, Maurizio

AU - Brusamolino, Ercole

AU - Rossi, Giuseppe

AU - Anastasia, Antonella

AU - Zaja, Francesco

AU - Vitolo, Umberto

AU - Pavone, Vincenzo

AU - Pulsoni, Alessandro

AU - Rigacci, Luigi

AU - Gaidano, Gianluca

AU - Stelitano, Caterina

AU - Salvi, Flavia

AU - Rusconi, Chiara

AU - Tani, Monica

AU - Freilone, Roberto

AU - Pregno, Patrizia

AU - Borsatti, Eugenio

AU - Sacchetti, Gian Mauro

AU - Argnani, Lisa

AU - Levis, Alessandro

PY - 2016/4/20

Y1 - 2016/4/20

N2 - Purpose The clinical impact of positron emission tomography (PET) evaluation performed early during firstline 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.

AB - Purpose The clinical impact of positron emission tomography (PET) evaluation performed early during firstline 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.

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