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Randomized Trial Comparing R-CHOP Versus High-Dose Sequential Chemotherapy in High-Risk Patients With Diffuse Large
Sergio Cortelazzo1, Corrado Tarella1, Alessandro Massimo Gianni1
1Sergio Cortelazzo, Atto Billio, Andrea Piccin, and Giovanni Negri, Ospedale Centrale di Bolzano, Bolzano; Corrado Tarella and Riccardo Bruna, Azienda Ospedaliera Ordine Mauriziano and University of Turin; Marco Ladetto and Manuela Zanni, Azienda Ospedaliera Universitaria (AOU) Città della Salute e della Scienza, Turin; Alessandro Massimo Gianni, Paolo Corradini, and Massimo Di Nicola, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, University of Milano; Andrés J.M. Ferreri, IRCCS San Raffaele Scientific Institute; Valentina Tabanelli and Stefano Pileri, Istituto Europeo di Oncologia; Alessandro Rambaldi, University of Milano, Milan; Anna Maria Barbui, Andrea Rossi, Giuseppe Gritti, Arianna Masciulli, Federica Delaini, Cristina Boschini, and Alessandro Rambaldi, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo; Caterina Patti and Antonino Mulé, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo; Valerio Zoli, Ospedale San Camillo Forlanini, Rome; Claudia Castellino, Ospedale S. Croce e Carle, Cuneo; Francesco Di Raimondo, AOU Policlinico Vittorio Emanuele University of Catania, Catania; Fabio Benedetti, University of Verona; Marco Chilosi, Azienda Ospedaliera Universitaria Integrata Verona, Verona; Giorgio La Nasa, Ospedale Binaghi, Cagliari; Guido Gini, Ospedali Riuniti, Ancona; Livio Trentin, Azienda Ospedaliera-Università di Padova, Padua; Maurizio Frezzato, Ospedale San Bortolo, Vicenza; Leonardo Flenghi, Azienda Ospedaliera di Perugia, Perugia; and Simona Falorio, Ospedale Civile Spirito Santo, Pescara, Italy.
High-dose chemotherapy with autologous stem-cell transplantation (ASCT) did not improve outcomes for high-risk diffuse large B-cell lymphoma patients. This randomized trial found no significant difference in event-free survival between R-HDS and R-CHOP treatments.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- High-dose chemotherapy with autologous stem-cell transplantation (ASCT) is debated as a first-line treatment for diffuse large B-cell lymphomas (DLBCL).
- Risk stratification using the International Prognostic Index (IPI) is crucial for treatment decisions in DLBCL.
Purpose of the Study:
- To compare the efficacy and safety of rituximab plus high-dose sequential chemotherapy with ASCT (R-HDS) versus rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)-14 as first-line treatment in high-risk DLBCL patients.
Main Methods:
- A randomized phase III trial involving 246 high-risk DLBCL patients (high-intermediate or high IPI score).
- Patients were assigned to either R-CHOP-14 (8 cycles) or R-HDS with ASCT.
- The primary endpoint was 3-year event-free survival, analyzed on an intent-to-treat basis.
Main Results:
- No significant difference in 3-year event-free survival (62% vs. 65%, P=.83) between R-CHOP and R-HDS arms.
- While R-HDS showed initially better disease-free survival, this benefit was negated by late treatment-related deaths.
- R-HDS arm experienced significantly higher hematologic toxicity and infectious complications (P<.001).
Conclusions:
- Front-line intensive R-HDS chemotherapy with ASCT does not improve outcomes for high-risk DLBCL patients.
- Standard R-CHOP-14 remains a comparable first-line option with a potentially better safety profile.
- Further research may explore optimizing ASCT strategies or alternative novel therapies for high-risk DLBCL.
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