Randomized Trial Comparing R-CHOP Versus High-Dose Sequential Chemotherapy in High-Risk Patients With Diffuse Large B-Cell Lymphomas

Abstract

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. ResultsClinical 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. ConclusionIn 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.J Clin Oncol 34.

R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma

“…The majority of patients (281 [88%] of 319) reached CR after 4 cycles of R-CHOP, which is 10% more than what is observed in patients with more advanced DLBCL treated with rituximab-combined chemotherapy. 29 Whether or not these patients should receive 4 or 6 cycles of R-CHOP is currently questioned in the ongoing LNH 2009-1B trial (NCT01285765). 30 Thirty-eight patients (12%) had PR after 4 cycles of R-CHOP on the basis of PET visual analysis.…”

FDG-PET–driven consolidation strategy in diffuse large B-cell lymphoma: final results of a randomized phase 2 study

“…[1][2][3][4] The dose-dense induction regimen R-ACVBP improves progressionfree survival (PFS) and overall survival (OS) of patients with 1 risk factor of the age-adjusted international prognosis index (aaIPI) compared with R-CHOP21, 5 but the comparison has not been performed in high-risk patients with 2 or 3 risk factors (aaIPI2-aaIPI3). Conversely, 2 cooperative groups 5,6 reported no benefit of a high-dose R-chemo14 compared with a conventional dose R-CHOP14 induction treatment, suggesting R-CHOP14 induction might be as efficient as and possibly less toxic than R-ACVBP.…”

Customization of therapy for gastroesophageal adenocarcinoma patients

“…Oxaliplatin is equal to cisplatin in the first-line treatment of advanced stage GEAC patients with a better safety profile 65, 66. Today, oxaliplatin most often accompanies to fluoropyrimidines in the first-line treatment of advanced GEAC.…”