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.
Summary:A rapid recovery of both neutrophils and platelets is commonly associated with PBPC autograft. 16,19 Thus, any further acceleration induced by growth factor adminisClinical value and costs of G-CSF administration following autograft with mobilized peripheral blood protration may be difficult to assess. In addition, the speed of BM recovery may be variably influenced by other congenitor cells (PBPC) were evaluated in two sequential groups of 20 patients each, treated for lymphoid neofounding factors, such as quantity of progenitor cells reinfused, type of conditioning regimen and previous treatplasms in the period February 1993 to January 1996. One group was given G-CSF (Filgrastim) (5 g/kg/day), ment. [20][21][22] These considerations explain the lack of a definite indication for the use of growth factor following starting on day +1 until ANC was Ͼ500/ l, the other received no G-CSF. All patients were conditioned with PBPC autograft. In this study we have evaluated the role of G-CSF during mitoxantrone 60 mg/m 2 + L-PAM 180 mg/m 2 and received large numbers of PBPC (median of 12 and hematological recovery in two sequential groups of patients autografted with PBPC in the early phases of their disease. 13 × 10 6 CD34 ؉ /kg, respectively). The median time to ANC Ͼ500/ l was 10 days in the G-CSF group vs 14Clinical features of the two groups were indistinguishable; all patients received the same submyeloablative treatment days in controls (P Ͻ 0.0001). G-CSF was associated with a slightly faster platelet recovery (11 vs 13 days to as conditioning and were autografted with large numbers of PBPC. The results indicate an accelerated hemopoietic plts Ͼ20 000/ l, P = 0.09). Median duration of fever (2.5 vs 5 days, P = 0.028), nonprophylactic antibiotics recovery and an overall better tolerability for the group receiving G-CSF following autograft compared to the con-(8 vs 11 days, P = 0.019), and post-transplant hospitalization (13 vs 16 days, P = 0.0028) were also significantly trol group. In addition, G-CSF administration was also associated with reduced costs for patient care during the reduced. The average cost per treatment in the G-CSF group amounted to about US$18 241 as compared to post-graft phase. Both observations support the use of growth factors even in spite of large numbers of PBPC US$21 868 in the control group, implying a cost reduction of approximately 16%. Thus, G-CSF reduced autografted. morbidity with cost containment, supporting its use even if autograft is performed with large quantities of PBPC.Patients and methods Keywords: PBPC autograft; post-graft recovery; G-CSF; economic evaluation Patients Forty patients with lymphoid malignancies were studied. They were autografted with peripheral blood progenitor The efficacy of growth factor administration to accelerate cells (PBPC) during the period between February 1993 and hemopoietic reconstitution following autologous bone marJanuary 1996; the first 20 patients (control group) had no row (BM) transplantation is well established. 1-7 Less hemo...
A brief R-FND induction plus rituximab consolidation achieved excellent results with high CR and PFS rates, supporting the feasibility of this regimen in patients older than 60 years. A short rituximab maintenance did not achieve a statistically significant PFS improvement over observation.
Although sometimes presenting as an indolent lymphoma, mantle cell lymphoma (MCL) is an aggressive disease, hardly curable with standard chemo-immunotherapy. Current approaches have greatly improved patients’ outcomes, nevertheless the disease is still characterized by high relapse rates. Before approval by EMA, Italian patients with relapsed/refractory MCL were granted ibrutinib early access through a Named Patient Program (NPP).An observational, retrospective, multicenter study was conducted. Seventy-seven heavily pretreated patients were enrolled. At the end of therapy there were 14 complete responses and 14 partial responses, leading to an overall response rate of 36.4%. At 40 months overall survival was 37.8% and progression free survival was 30%; disease free survival was 78.6% at 4 years: 11/14 patients are in continuous complete response with a median of 36 months of follow up. Hematological toxicities were manageable, and main extra-hematological toxicities were diarrhea (9.4%) and lung infections (9.0%). Overall, 4 (5.2%) atrial fibrillations and 3 (3.9%) hemorrhagic syndromes occurred.In conclusions, thrombocytopenia, diarrhea and lung infections are the relevant adverse events to be clinically focused on; regarding effectiveness, ibrutinib is confirmed to be a valid option for refractory/relapsed MCL also in a clinical setting mimicking the real world.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.