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Results of a phase 3 trial suggest rituximab maintenance after transplant can prolong survival in non-elderly patients with mantle cell lymphoma (MCL).
Compared to patients who did not receive maintenance, those who received rituximab every other month for 3 years after autologous transplant had superior event-free survival (EFS), progression-free survival (PFS), and overall survival (OS).
Researchers reported these results in NEJM. The study was funded by Roche and Amgen.
“We demonstrate, with this study, that treatment with immunotherapy can delay the onset of relapse and prolong the survival of patients,” said study author Steven Le Gouill, MD, PhD, of CHU de Nantes in France.*
“It is clear that the use of rituximab maintenance after chemotherapy in this type of lymphoma will become a new standard of treatment.”
Dr Le Gouill and his colleagues began this study with 299 MCL patients. Their median age was 57 (range, 27-65), and 79% were male. Most had Ann Arbor stage IV disease (84%), followed by III (10%), and II (6%).
According to MIPI, 53% of patients had low-risk disease, 27% had intermediate-risk MCL, and 19% had high-risk disease. Ninety-four percent of patients had an ECOG performance status score below 3.
Treatment
Patients first received 4 courses of induction with R-DHAP (rituximab, dexamethasone, cytarabine, and a platinum derivative [carboplatin, oxaliplatin, or cisplatin]).
The overall response rate was 94%, with 41% (n=124) achieving a complete response (CR) and 36% (n=107) achieving an unconfirmed CR.
Twenty patients who had an insufficient response then received 4 courses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Eleven of these patients went on to receive an autologous hematopoietic stem cell transplant (HSCT).
In all, 257 patients (86%) underwent autologous HSCT. The conditioning regimen was R-BEAM (rituximab, carmustine, etoposide, cytarabine, and melphalan).
Sixty-five percent of patients (n=168) achieved a CR after HSCT, and 24% (n=61) had an unconfirmed CR.
Up to 3 months after HSCT, patients were randomized to observation (n=120) or to receive rituximab (375 mg/m2) every 2 months for 3 years (n=120).
The researchers said there were no significant differences between these 2 groups regarding characteristics at study enrollment or the patients’ disease status at randomization.
Results
The median follow-up from randomization was 50.2 months (range, 46.4 to 54.2). The median EFS, PFS, and OS were not reached in either group.
The 4-year EFS was 79% in the rituximab group and 61% in the observation group (P=0.001). The 4-year PFS was 83% and 64%, respectively (P<0.001). And the 4-year OS was 89% and 80%, respectively (P=0.04).
Of the 11 patients who received R-CHOP before randomization, 4 were randomized to the rituximab group and 7 to the observation group.
One patient in the rituximab group relapsed and died. The other 3 were still alive and disease-free at the final analysis.
In the observation group, 4 patients had relapsed but were alive as of the final analysis, while 3 patients had died.
There were 59 patients who did not undergo randomization (due to disease progression, death, HSCT ineligibility, toxic effects, and other reasons).
For these patients, the median PFS was 11.0 months, and the median OS was 30.6 months. 
*Quote has been translated from French.
Results of a phase 3 trial suggest rituximab maintenance after transplant can prolong survival in non-elderly patients with mantle cell lymphoma (MCL).
Compared to patients who did not receive maintenance, those who received rituximab every other month for 3 years after autologous transplant had superior event-free survival (EFS), progression-free survival (PFS), and overall survival (OS).
Researchers reported these results in NEJM. The study was funded by Roche and Amgen.
“We demonstrate, with this study, that treatment with immunotherapy can delay the onset of relapse and prolong the survival of patients,” said study author Steven Le Gouill, MD, PhD, of CHU de Nantes in France.*
“It is clear that the use of rituximab maintenance after chemotherapy in this type of lymphoma will become a new standard of treatment.”
Dr Le Gouill and his colleagues began this study with 299 MCL patients. Their median age was 57 (range, 27-65), and 79% were male. Most had Ann Arbor stage IV disease (84%), followed by III (10%), and II (6%).
According to MIPI, 53% of patients had low-risk disease, 27% had intermediate-risk MCL, and 19% had high-risk disease. Ninety-four percent of patients had an ECOG performance status score below 3.
Treatment
Patients first received 4 courses of induction with R-DHAP (rituximab, dexamethasone, cytarabine, and a platinum derivative [carboplatin, oxaliplatin, or cisplatin]).
The overall response rate was 94%, with 41% (n=124) achieving a complete response (CR) and 36% (n=107) achieving an unconfirmed CR.
Twenty patients who had an insufficient response then received 4 courses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Eleven of these patients went on to receive an autologous hematopoietic stem cell transplant (HSCT).
In all, 257 patients (86%) underwent autologous HSCT. The conditioning regimen was R-BEAM (rituximab, carmustine, etoposide, cytarabine, and melphalan).
Sixty-five percent of patients (n=168) achieved a CR after HSCT, and 24% (n=61) had an unconfirmed CR.
Up to 3 months after HSCT, patients were randomized to observation (n=120) or to receive rituximab (375 mg/m2) every 2 months for 3 years (n=120).
The researchers said there were no significant differences between these 2 groups regarding characteristics at study enrollment or the patients’ disease status at randomization.
Results
The median follow-up from randomization was 50.2 months (range, 46.4 to 54.2). The median EFS, PFS, and OS were not reached in either group.
The 4-year EFS was 79% in the rituximab group and 61% in the observation group (P=0.001). The 4-year PFS was 83% and 64%, respectively (P<0.001). And the 4-year OS was 89% and 80%, respectively (P=0.04).
Of the 11 patients who received R-CHOP before randomization, 4 were randomized to the rituximab group and 7 to the observation group.
One patient in the rituximab group relapsed and died. The other 3 were still alive and disease-free at the final analysis.
In the observation group, 4 patients had relapsed but were alive as of the final analysis, while 3 patients had died.
There were 59 patients who did not undergo randomization (due to disease progression, death, HSCT ineligibility, toxic effects, and other reasons).
For these patients, the median PFS was 11.0 months, and the median OS was 30.6 months.
*Quote has been translated from French.
Results of a phase 3 trial suggest rituximab maintenance after transplant can prolong survival in non-elderly patients with mantle cell lymphoma (MCL).
Compared to patients who did not receive maintenance, those who received rituximab every other month for 3 years after autologous transplant had superior event-free survival (EFS), progression-free survival (PFS), and overall survival (OS).
Researchers reported these results in NEJM. The study was funded by Roche and Amgen.
“We demonstrate, with this study, that treatment with immunotherapy can delay the onset of relapse and prolong the survival of patients,” said study author Steven Le Gouill, MD, PhD, of CHU de Nantes in France.*
“It is clear that the use of rituximab maintenance after chemotherapy in this type of lymphoma will become a new standard of treatment.”
Dr Le Gouill and his colleagues began this study with 299 MCL patients. Their median age was 57 (range, 27-65), and 79% were male. Most had Ann Arbor stage IV disease (84%), followed by III (10%), and II (6%).
According to MIPI, 53% of patients had low-risk disease, 27% had intermediate-risk MCL, and 19% had high-risk disease. Ninety-four percent of patients had an ECOG performance status score below 3.
Treatment
Patients first received 4 courses of induction with R-DHAP (rituximab, dexamethasone, cytarabine, and a platinum derivative [carboplatin, oxaliplatin, or cisplatin]).
The overall response rate was 94%, with 41% (n=124) achieving a complete response (CR) and 36% (n=107) achieving an unconfirmed CR.
Twenty patients who had an insufficient response then received 4 courses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Eleven of these patients went on to receive an autologous hematopoietic stem cell transplant (HSCT).
In all, 257 patients (86%) underwent autologous HSCT. The conditioning regimen was R-BEAM (rituximab, carmustine, etoposide, cytarabine, and melphalan).
Sixty-five percent of patients (n=168) achieved a CR after HSCT, and 24% (n=61) had an unconfirmed CR.
Up to 3 months after HSCT, patients were randomized to observation (n=120) or to receive rituximab (375 mg/m2) every 2 months for 3 years (n=120).
The researchers said there were no significant differences between these 2 groups regarding characteristics at study enrollment or the patients’ disease status at randomization.
Results
The median follow-up from randomization was 50.2 months (range, 46.4 to 54.2). The median EFS, PFS, and OS were not reached in either group.
The 4-year EFS was 79% in the rituximab group and 61% in the observation group (P=0.001). The 4-year PFS was 83% and 64%, respectively (P<0.001). And the 4-year OS was 89% and 80%, respectively (P=0.04).
Of the 11 patients who received R-CHOP before randomization, 4 were randomized to the rituximab group and 7 to the observation group.
One patient in the rituximab group relapsed and died. The other 3 were still alive and disease-free at the final analysis.
In the observation group, 4 patients had relapsed but were alive as of the final analysis, while 3 patients had died.
There were 59 patients who did not undergo randomization (due to disease progression, death, HSCT ineligibility, toxic effects, and other reasons).
For these patients, the median PFS was 11.0 months, and the median OS was 30.6 months.
*Quote has been translated from French.