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Immunochemotherapy has become the standard first-line treatment for patients with low-grade and high tumor burden follicular lymphoma (FL).
In recent years, a number of studies have explored the efficacy of the immunomodulator lenalidomide and rituximab combination regimen (R2 regimen) in FL, including three phase II studies (NCT01307605, NCT00695786, NCT01145495) And Phase III RELEVANCE study (NCT01476787, NCT01650701).
A total of 1,030 patients with advanced FL were included in the RELEVANCE study, and they were randomly assigned to receive R2 regimen or immunochemotherapy.
Although the primary endpoint of the study was progression-free survival (PFS), due to the limited median follow-up time (3 years) in the study, the main efficacy index (complete remission at 30 months [CR]) was reported at the end of the study.
The results of the study show that the R2 regimen has similar efficacy to immunochemotherapy, but the data on the safety of the regimen and long-term follow-up data still need to be supplemented.
The MD Anderson Cancer Center recently announced the long-term follow-up results of a Phase II study of the R2 regimen in the treatment of FL.
The main results are now summarized as follows for the reference of readers.
Key points: Long-term follow-up shows that the first-line treatment of FL patients with R2 is safe and effective.
The deeper disease remission brought by the R2 regimen is associated with the better prognosis of FL patients.
Research Method The study is a phase II clinical study (NCT00695786) conducted by MD Anderson Cancer Center.
The study was conducted from July 2008 to April 2012 (data as of May 16, 2020) and included untreated 1- Patients with level 2 and stage III-IV FL received the R2 regimen to explore the efficacy and safety of this regimen in newly-treated FL patients.
The primary endpoint of the study was the overall response rate (ORR), and the secondary endpoint was adverse reactions.
Results of the study 79 patients were included in the study.
The baseline characteristics of the patients are shown in the figure below.
Patients received a median of 6 cycles of treatment (range: 1-12 cycles), 49 patients received 1-6 cycles of treatment, and 30 patients received 7-12 cycles of treatment.
Compared with patients who received 1-6 cycles of treatment, patients who received 7-12 cycles of treatment had higher levels of β2-microglobulin at baseline (46% vs 14%, P=0.
007), and the proportion of >5 lymph nodes was higher.
High (80% vs 49%, P=0.
009), FLIPI-2 score is higher (37% vs 14%, P=0.
03).
The median dose of lenalidomide was 20 mg (range: 5-20 mg), and 24 patients (30%) reduced the therapeutic dose due to adverse reactions.
Seven patients (9%) discontinued treatment after a median treatment of 4 months (range: 1-10 months), and 4 patients discontinued due to adverse reactions (2 cases of arterial thrombosis, 1 case of respiratory failure, 1 case of rash) Treatment, 3 patients stopped treatment due to disease progression.
Forty patients (51%) experienced ≥ grade 3 treatment-related adverse reactions.
Compared with patients who received 7-12 cycles of treatment, patients who received 1-6 cycles of treatment had grade 3-4 neutropenia The incidence of the disease was significantly lower (22% vs 70%, P <0.
001).
The efficacy status of 76 patients can be evaluated, and 3 patients stopped treatment due to adverse reactions before the first efficacy evaluation.
At a median treatment of 6 months (range: 3-18 months), the ORR reached 95% (75/79) and the CR rate reached 86% (68/79).
Thirty-nine patients (49%) achieved CR after 3 cycles of treatment, and 64 (81%) patients achieved CR after 6 cycles of treatment.
Univariate analysis showed that the only factor related to CR was gender (the CR rate of female patients was 97%, and that of male patients was 75%, P=0.
005), the dose adjustment (P=0.
25) and the number of treatment cycles (P=1) The CR rate has no significant effect. At a median follow-up of 103 months (95%CI: 98-108 months), 26 patients (33%) experienced disease progression or death, the median PFS did not reach, and the 8-year PFS rate reached 65% (as shown below).
Twenty-three patients relapsed after receiving the R2 regimen in the first-line treatment, of which 10 patients received immunochemotherapy, 4 patients received rituximab monotherapy, 2 patients continued to receive R2 regimen treatment, and 4 patients entered the clinic In the trial, 3 patients waited for observation, and no patient chose autologous hematopoietic stem cell transplantation as a rescue treatment.
Univariate analysis showed that the baseline characteristics associated with shorter PFS were non-Caucasian (39 months vs.
not achieved, P <0.
001), and treatment failure to achieve CR was associated with shorter PFS (not achieved vs.
19 months, P ＜0.
001) (Figure B below).
Landmark analysis also showed that treatment failure to reach CR was associated with shorter PFS.
The dose reduction of lenalidomide (P=0.
72) and the number of treatment cycles (P=0.
11) were not significantly associated with PFS (Figure C below).
10 patients (13%) developed disease progression (POD24) within 24 months after treatment.
The only factor significantly related to POD24 was that treatment did not reach CR (POD24 incidence: 50% vs 7%, P=0.
005).
The dose reduction of lenalidomide (P=1) and the number of treatment cycles (P=0.
30) had no correlation with POD24.
The latest follow-up showed that 1 patient was lost to follow-up and 4 (5%) patients died (none of them were POD24 patients).
The median OS of the study has not yet been reached, and the 8-year OS rate is 98% (as shown in the figure below).
It is not yet possible to assess the association between survival-related factors and baseline characteristics.
Research conclusions The long-term follow-up confirmed that the R2 regimen is an effective and safe first-line treatment regimen for FL patients.
This program can bring deep relief to FL patients, reduce the rate of early disease progression, and at the same time bring patients a better long-term prognosis.
References Paolo Strati, Preetesh Jain, Ralph J.
Johnson, Sheryl Forbes, et al.
Long-term follow-up of lenalidomide and rituximab as initial treatment of follicular lymphoma.
Blood (2021) 137 (8): 1124–1129.
; https:// doi.
org/10.
1182/blood.
2020007994 stamp "read the original text", we make progress together
In recent years, a number of studies have explored the efficacy of the immunomodulator lenalidomide and rituximab combination regimen (R2 regimen) in FL, including three phase II studies (NCT01307605, NCT00695786, NCT01145495) And Phase III RELEVANCE study (NCT01476787, NCT01650701).
A total of 1,030 patients with advanced FL were included in the RELEVANCE study, and they were randomly assigned to receive R2 regimen or immunochemotherapy.
Although the primary endpoint of the study was progression-free survival (PFS), due to the limited median follow-up time (3 years) in the study, the main efficacy index (complete remission at 30 months [CR]) was reported at the end of the study.
The results of the study show that the R2 regimen has similar efficacy to immunochemotherapy, but the data on the safety of the regimen and long-term follow-up data still need to be supplemented.
The MD Anderson Cancer Center recently announced the long-term follow-up results of a Phase II study of the R2 regimen in the treatment of FL.
The main results are now summarized as follows for the reference of readers.
Key points: Long-term follow-up shows that the first-line treatment of FL patients with R2 is safe and effective.
The deeper disease remission brought by the R2 regimen is associated with the better prognosis of FL patients.
Research Method The study is a phase II clinical study (NCT00695786) conducted by MD Anderson Cancer Center.
The study was conducted from July 2008 to April 2012 (data as of May 16, 2020) and included untreated 1- Patients with level 2 and stage III-IV FL received the R2 regimen to explore the efficacy and safety of this regimen in newly-treated FL patients.
The primary endpoint of the study was the overall response rate (ORR), and the secondary endpoint was adverse reactions.
Results of the study 79 patients were included in the study.
The baseline characteristics of the patients are shown in the figure below.
Patients received a median of 6 cycles of treatment (range: 1-12 cycles), 49 patients received 1-6 cycles of treatment, and 30 patients received 7-12 cycles of treatment.
Compared with patients who received 1-6 cycles of treatment, patients who received 7-12 cycles of treatment had higher levels of β2-microglobulin at baseline (46% vs 14%, P=0.
007), and the proportion of >5 lymph nodes was higher.
High (80% vs 49%, P=0.
009), FLIPI-2 score is higher (37% vs 14%, P=0.
03).
The median dose of lenalidomide was 20 mg (range: 5-20 mg), and 24 patients (30%) reduced the therapeutic dose due to adverse reactions.
Seven patients (9%) discontinued treatment after a median treatment of 4 months (range: 1-10 months), and 4 patients discontinued due to adverse reactions (2 cases of arterial thrombosis, 1 case of respiratory failure, 1 case of rash) Treatment, 3 patients stopped treatment due to disease progression.
Forty patients (51%) experienced ≥ grade 3 treatment-related adverse reactions.
Compared with patients who received 7-12 cycles of treatment, patients who received 1-6 cycles of treatment had grade 3-4 neutropenia The incidence of the disease was significantly lower (22% vs 70%, P <0.
001).
The efficacy status of 76 patients can be evaluated, and 3 patients stopped treatment due to adverse reactions before the first efficacy evaluation.
At a median treatment of 6 months (range: 3-18 months), the ORR reached 95% (75/79) and the CR rate reached 86% (68/79).
Thirty-nine patients (49%) achieved CR after 3 cycles of treatment, and 64 (81%) patients achieved CR after 6 cycles of treatment.
Univariate analysis showed that the only factor related to CR was gender (the CR rate of female patients was 97%, and that of male patients was 75%, P=0.
005), the dose adjustment (P=0.
25) and the number of treatment cycles (P=1) The CR rate has no significant effect. At a median follow-up of 103 months (95%CI: 98-108 months), 26 patients (33%) experienced disease progression or death, the median PFS did not reach, and the 8-year PFS rate reached 65% (as shown below).
Twenty-three patients relapsed after receiving the R2 regimen in the first-line treatment, of which 10 patients received immunochemotherapy, 4 patients received rituximab monotherapy, 2 patients continued to receive R2 regimen treatment, and 4 patients entered the clinic In the trial, 3 patients waited for observation, and no patient chose autologous hematopoietic stem cell transplantation as a rescue treatment.
Univariate analysis showed that the baseline characteristics associated with shorter PFS were non-Caucasian (39 months vs.
not achieved, P <0.
001), and treatment failure to achieve CR was associated with shorter PFS (not achieved vs.
19 months, P ＜0.
001) (Figure B below).
Landmark analysis also showed that treatment failure to reach CR was associated with shorter PFS.
The dose reduction of lenalidomide (P=0.
72) and the number of treatment cycles (P=0.
11) were not significantly associated with PFS (Figure C below).
10 patients (13%) developed disease progression (POD24) within 24 months after treatment.
The only factor significantly related to POD24 was that treatment did not reach CR (POD24 incidence: 50% vs 7%, P=0.
005).
The dose reduction of lenalidomide (P=1) and the number of treatment cycles (P=0.
30) had no correlation with POD24.
The latest follow-up showed that 1 patient was lost to follow-up and 4 (5%) patients died (none of them were POD24 patients).
The median OS of the study has not yet been reached, and the 8-year OS rate is 98% (as shown in the figure below).
It is not yet possible to assess the association between survival-related factors and baseline characteristics.
Research conclusions The long-term follow-up confirmed that the R2 regimen is an effective and safe first-line treatment regimen for FL patients.
This program can bring deep relief to FL patients, reduce the rate of early disease progression, and at the same time bring patients a better long-term prognosis.
References Paolo Strati, Preetesh Jain, Ralph J.
Johnson, Sheryl Forbes, et al.
Long-term follow-up of lenalidomide and rituximab as initial treatment of follicular lymphoma.
Blood (2021) 137 (8): 1124–1129.
; https:// doi.
org/10.
1182/blood.
2020007994 stamp "read the original text", we make progress together
