Randomized trial comparing R-CHOP versus high-dose sequential chemotherapy in high-risk patients with diffuse large B-cell lymphomas

Sergio Cortelazzo, Corrado Tarella, Alessandro Massimo Gianni, Marco Ladetto, A. Barbui, A. Rossi, G. Gritti, P. Corradini, Massimo Di Nicola, C. Patti, Antonino Mulè, Manuela Zanni, Valerio Zoli, Atto Billio, Andrea Piccin, Giovanni Negri, C. Castellino, Francesco Di Raimondo, Andres Ferreri, F. BenedettiG. La Nasa, Guido Gini, L. Trentin, Maurizio Frezzato, Leonardo Flenghi, S. Falorio, Marco Chilosi, Riccardo Bruna, Valentina Tabanelli, Stefano Pileri, Arianna Masciulli, F. Delaini, Cristina Boschini, Alessandro Rambaldi

Research output: Contribution to journalArticlepeer-review


Purpose The benefit of high-dose chemotherapy with autologous stem-cell transplantation (ASCT) as first-line treatment in patients with diffuse large B-cell lymphomas is still a matter of debate. To address this point, we designed a randomized phase III trial to compare rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)-14 (eight cycles) with rituximab plus high-dose sequential chemotherapy (R-HDS) with ASCT. Patients and Methods From June 2005 to June 2011, 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index score were randomly assigned to the R-CHOP or R-HDS arm, and 235 were analyzed by intent to treat. The primary efficacy end point of the study was 3-year event-free survival, and results were analyzed on an intent-to-treat basis. Results Clinical response (complete response, 78% v 76%; partial response, 5% v 9%) and failures (no response, 15% v 11%; and early treatment-related mortality, 2% v 3%) were similar after R-CHOP versus R-HDS, respectively. After a median follow-up of 5 years, the 3-year event-free survival was 62% versus 65% (P = 83). At 3 years, compared with the R-CHOP arm, the R-HDS arm had better disease-free survival (79% v 91%, respectively; P = .034), but this subsequently vanished because of late-occurring treatment-related deaths. No difference was detected in terms of progression-free survival (65% v 75%, respectively; P = 12), or overall survival (74% v 77%, respectively; P = 64). Significantly higher hematologic toxicity (P<.001) and more infectious complications (P < 001) were observed in the R-HDS arm. Conclusion In this study, front-line intensive R-HDS chemotherapy with ASCT did not improve the outcome of high-risk patients with diffuse large B-cell lymphomas.

Original languageEnglish
Pages (from-to)4015-4022
Number of pages8
JournalJournal of Clinical Oncology
Issue number33
Publication statusPublished - Nov 20 2016

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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