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Two front-line treatment regimens for patients with high-risk diffuse large B-cell lymphomas (DLBCL) produced comparable outcomes, according to new data.
Patients who received rituximab combined with high-dose sequential chemotherapy (R-HDS) plus autologous stem-cell transplantation (ASCT) had similar results in terms of overall response rate and long-term outcomes, compared to patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
It was presumed that event-free survival would be improved with chemotherapy and ASCT, but that result was not observed at 3-year follow up, wrote Sergio Cortelazzo, MD, of Humanitas Gavazzeni, Bergamo, Italy, and coauthors.
“Our results indicate that CHOP chemotherapy, optimally supplemented by eight doses of rituximab, remains the standard of care also for this group of patients at higher risk for disease resistance or recurrence,” they wrote in a study published online ahead of print in the Journal of Clinical Oncology (J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980).
The benefit of R-HDS chemotherapy with ASCT as front-line therapy for this patient population is still a matter of debate. To address that issue, Dr. Cortelazzo and his colleagues conducted a phase III randomized trial in which 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index (IPI) score were assigned to receive either R-CHOP or R-HDS.
The primary efficacy endpoint was 3-year, event-free survival, and the results were analyzed on an intent-to-treat basis.
At a median follow-up of 5 years (range, 0.05-9.49), with an intent-to-treat analysis, the 3-year, event-free survival was 62% (95% CI, 54%-71%) for the R-CHOP arm, compared with 65% (95% CI, 56% to 74%) for those treated with R-HDS (P = .83; hazard ratio, 0.99; 95% CI, 0.66-1.48).
There was no difference in event-free survival even when analyzed within the IPI subgroups.
The 3-year progression free survival also did not significantly differ between groups; 65% in the R-CHOP arm (95% CI, 57% to 74%) versus 75% (95% CI, 67%-83%; P = .119) for the R-HDS arm in the whole population, as well as within IPI subgroups.
Of note, the 3-year disease-free survival was better in the R-HDS group (79% vs. 91%, respectively; P = .034), but this difference subsequently disappeared with longer follow-up.
Grade 3-4 hematologic toxicity was lower in the R-CHOP arm compared with the R-HDS arm, with at least one episode of neutropenia in 34% versus 84% of patients (P less than .001), anemia in 15% versus 71% of patients (P less than .001), and thrombocytopenia in 5% versus 86% (P less than .001).
The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo had no relevant disclosures. Several coauthors indicated relationships with industry.
Two front-line treatment regimens for patients with high-risk diffuse large B-cell lymphomas (DLBCL) produced comparable outcomes, according to new data.
Patients who received rituximab combined with high-dose sequential chemotherapy (R-HDS) plus autologous stem-cell transplantation (ASCT) had similar results in terms of overall response rate and long-term outcomes, compared to patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
It was presumed that event-free survival would be improved with chemotherapy and ASCT, but that result was not observed at 3-year follow up, wrote Sergio Cortelazzo, MD, of Humanitas Gavazzeni, Bergamo, Italy, and coauthors.
“Our results indicate that CHOP chemotherapy, optimally supplemented by eight doses of rituximab, remains the standard of care also for this group of patients at higher risk for disease resistance or recurrence,” they wrote in a study published online ahead of print in the Journal of Clinical Oncology (J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980).
The benefit of R-HDS chemotherapy with ASCT as front-line therapy for this patient population is still a matter of debate. To address that issue, Dr. Cortelazzo and his colleagues conducted a phase III randomized trial in which 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index (IPI) score were assigned to receive either R-CHOP or R-HDS.
The primary efficacy endpoint was 3-year, event-free survival, and the results were analyzed on an intent-to-treat basis.
At a median follow-up of 5 years (range, 0.05-9.49), with an intent-to-treat analysis, the 3-year, event-free survival was 62% (95% CI, 54%-71%) for the R-CHOP arm, compared with 65% (95% CI, 56% to 74%) for those treated with R-HDS (P = .83; hazard ratio, 0.99; 95% CI, 0.66-1.48).
There was no difference in event-free survival even when analyzed within the IPI subgroups.
The 3-year progression free survival also did not significantly differ between groups; 65% in the R-CHOP arm (95% CI, 57% to 74%) versus 75% (95% CI, 67%-83%; P = .119) for the R-HDS arm in the whole population, as well as within IPI subgroups.
Of note, the 3-year disease-free survival was better in the R-HDS group (79% vs. 91%, respectively; P = .034), but this difference subsequently disappeared with longer follow-up.
Grade 3-4 hematologic toxicity was lower in the R-CHOP arm compared with the R-HDS arm, with at least one episode of neutropenia in 34% versus 84% of patients (P less than .001), anemia in 15% versus 71% of patients (P less than .001), and thrombocytopenia in 5% versus 86% (P less than .001).
The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo had no relevant disclosures. Several coauthors indicated relationships with industry.
Two front-line treatment regimens for patients with high-risk diffuse large B-cell lymphomas (DLBCL) produced comparable outcomes, according to new data.
Patients who received rituximab combined with high-dose sequential chemotherapy (R-HDS) plus autologous stem-cell transplantation (ASCT) had similar results in terms of overall response rate and long-term outcomes, compared to patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
It was presumed that event-free survival would be improved with chemotherapy and ASCT, but that result was not observed at 3-year follow up, wrote Sergio Cortelazzo, MD, of Humanitas Gavazzeni, Bergamo, Italy, and coauthors.
“Our results indicate that CHOP chemotherapy, optimally supplemented by eight doses of rituximab, remains the standard of care also for this group of patients at higher risk for disease resistance or recurrence,” they wrote in a study published online ahead of print in the Journal of Clinical Oncology (J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980).
The benefit of R-HDS chemotherapy with ASCT as front-line therapy for this patient population is still a matter of debate. To address that issue, Dr. Cortelazzo and his colleagues conducted a phase III randomized trial in which 246 high-risk patients with a high-intermediate (56%) or high (44%) International Prognostic Index (IPI) score were assigned to receive either R-CHOP or R-HDS.
The primary efficacy endpoint was 3-year, event-free survival, and the results were analyzed on an intent-to-treat basis.
At a median follow-up of 5 years (range, 0.05-9.49), with an intent-to-treat analysis, the 3-year, event-free survival was 62% (95% CI, 54%-71%) for the R-CHOP arm, compared with 65% (95% CI, 56% to 74%) for those treated with R-HDS (P = .83; hazard ratio, 0.99; 95% CI, 0.66-1.48).
There was no difference in event-free survival even when analyzed within the IPI subgroups.
The 3-year progression free survival also did not significantly differ between groups; 65% in the R-CHOP arm (95% CI, 57% to 74%) versus 75% (95% CI, 67%-83%; P = .119) for the R-HDS arm in the whole population, as well as within IPI subgroups.
Of note, the 3-year disease-free survival was better in the R-HDS group (79% vs. 91%, respectively; P = .034), but this difference subsequently disappeared with longer follow-up.
Grade 3-4 hematologic toxicity was lower in the R-CHOP arm compared with the R-HDS arm, with at least one episode of neutropenia in 34% versus 84% of patients (P less than .001), anemia in 15% versus 71% of patients (P less than .001), and thrombocytopenia in 5% versus 86% (P less than .001).
The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo had no relevant disclosures. Several coauthors indicated relationships with industry.
Key clinical point:
Major finding: At a median follow-up of 5 years, the 3-year event-free survival was similar for both groups: 62% versus 65% (P = .83).
Data source: A randomized phase III trial that included 246 patients with diffuse large B-cell lymphomas.
Disclosures: The study was supported in part by the Associazione Italiana Lotta alla Leucemia sezione di Bergamo, the Associazione Italiana per la Ricerca sul Cancro, Ministero Istruzione, Universita e Ricerca and unrestricted grants from Roche SpA and Amgen, Italy. Dr Cortelazzo has no disclosures. Several coauthors indicate relationships with industry.