RITUXIMAB MAINTENANCE IMPROVED PROGRESSION-FREE SURVIVAL AND REDUCED THE INCIDENCE OF TRANSFORMATION IN PATIENTS WITH FOLLICULAR LYMPHOMA
(Abstract release date: 05/19/16)
EHA Library. Kusano Y. 06/09/16; 132709; E1160
Dr. Yoshiharu Kusano
Contributions
Contributions
Abstract
Abstract: E1160
Type: Eposter Presentation
Background
Follicular lymphoma (FL) is incurable disease even in rituximab era. Continuous exposure by anti-CD20 antibody after the induction therapy was considered to improve prognosis of patients with FL. Several phase II and III trials demonstrated that progression-free survival (PFS) is upgraded by rituximab maintenance. Transformed FL is known as rare but has a negative impact on prognosis of FL patients. It has not been known the relationship between rituximab maintenance and the incident rate of transformation.
Aims
We analyzed our data to clarify the efficacy and safety of rituximab maintenance in FL patients and to verify whether rituximab maintenance is associated with the incidence of transformed FL.
Methods
We retrospectively analyzed patients aged over 18 who were diagnosed with previous untreated FL grade 1, 2, and 3a in single cancer institute hospital from 2005. Chemo-sensitive patients had given four weekly rituximab infusions every 6 months for two years if we had informed consent. Basically, R-CVP was used except when FL had a feature of (i) bulky disease (≥ 7 cm), (ii) maximum of standardized uptake value ≥ 10 measured by PET scan, and (iii) clinical aggressive manifestations. The primary efficacy endpoint is the incidence of transformation during rituximab maintenance phase. Secondary endpoints are the 5-year PFS, time to next treatment (TNT), and overall survival (OS) and adverse events (AEs) during maintenance phase. Estimates of survival were analyzed by using log rank test and by Cox hazard model. Analysis of contingency table was done by Fisher’s exact test.
Results
A total of 217 patients achieved at least stable disease by R-CVP/R-CHOP. Overall 217, 162 received maintenance group and 49 were observed after induction therapy. Baseline characteristics of both groups were similar except R-CHOP ratio. At the median follow-up of 68.4 months, 5-year PFS was 78.4% (95%CI: 70.0-84.9) in the maintenance group and 38.8% (95%CI: 16.2-43.3) in the observation group (P < 0.0001). Five-year TNT was 70.6% (95%CI: 71.2-86.0) in the maintenance group and 47.6% (95%CI: 22.9-50.9) in the observation group (P < 0.0001). The 5-year OS was 95.3% (95%CI: 89.5-97.9) in the maintenance group and 94.8% (95%CI: 71.2-92.7) in the observation group (P = 0.96). Backward stepwise selection method in Cox hazard model demonstrated four factors that had a positive impact on PFS independently: rituximab maintenance (HR: 0.34, 95%CI: 0.19-0.61; P < 0.01); non-bulky disease (HR: 0.41, 95%CI: 0.22-0.76; P < 0.01); no transformation (HR: 0.41, 95%CI: 0.22-0.65; P < 0.01); and β2 microglobulin < 2 (HR: 0.33, 95%CI: 0.19-0.59; P < 0.01). On the other hand, 27 patients experienced transformation after R-CVP/R-CHOP. Of 27, 7 (4.7%) in the maintenance group and 16 (28%) in the observation group were transformed (Figure, P < 0.01), whereas 7 (3.4%) in the R-CVP group and 16 (6.6%) in the R-CHOP group were transformed (P < 0.01). Additionally, rituximab maintenance reduced the incidence of transformed FL regardless of induction therapy. In the R-CVP group, the incidence of transformation was 0.67% in the maintenance arm versus 4% in the observation arm, (P < 0.01), while in R-CHOP group, that was 10.7% in the maintenance arm versus 17.9% in the observation arm (P = 0.23). The most common AE was infusion reaction (13%). One patient quit maintenance at the first cycles due to severe infusion reaction.
Conclusion
Rituximab maintenance was beneficial for only PFS at the median follow-up of 5 years. However, rituximab maintenance diminished the incidence of transformed FL significantly and tolerate.
Session topic: E-poster
Keyword(s): Follicular lymphoma, Maintenance, Rituximab, Transformation
Type: Eposter Presentation
Background
Follicular lymphoma (FL) is incurable disease even in rituximab era. Continuous exposure by anti-CD20 antibody after the induction therapy was considered to improve prognosis of patients with FL. Several phase II and III trials demonstrated that progression-free survival (PFS) is upgraded by rituximab maintenance. Transformed FL is known as rare but has a negative impact on prognosis of FL patients. It has not been known the relationship between rituximab maintenance and the incident rate of transformation.
Aims
We analyzed our data to clarify the efficacy and safety of rituximab maintenance in FL patients and to verify whether rituximab maintenance is associated with the incidence of transformed FL.
Methods
We retrospectively analyzed patients aged over 18 who were diagnosed with previous untreated FL grade 1, 2, and 3a in single cancer institute hospital from 2005. Chemo-sensitive patients had given four weekly rituximab infusions every 6 months for two years if we had informed consent. Basically, R-CVP was used except when FL had a feature of (i) bulky disease (≥ 7 cm), (ii) maximum of standardized uptake value ≥ 10 measured by PET scan, and (iii) clinical aggressive manifestations. The primary efficacy endpoint is the incidence of transformation during rituximab maintenance phase. Secondary endpoints are the 5-year PFS, time to next treatment (TNT), and overall survival (OS) and adverse events (AEs) during maintenance phase. Estimates of survival were analyzed by using log rank test and by Cox hazard model. Analysis of contingency table was done by Fisher’s exact test.
Results
A total of 217 patients achieved at least stable disease by R-CVP/R-CHOP. Overall 217, 162 received maintenance group and 49 were observed after induction therapy. Baseline characteristics of both groups were similar except R-CHOP ratio. At the median follow-up of 68.4 months, 5-year PFS was 78.4% (95%CI: 70.0-84.9) in the maintenance group and 38.8% (95%CI: 16.2-43.3) in the observation group (P < 0.0001). Five-year TNT was 70.6% (95%CI: 71.2-86.0) in the maintenance group and 47.6% (95%CI: 22.9-50.9) in the observation group (P < 0.0001). The 5-year OS was 95.3% (95%CI: 89.5-97.9) in the maintenance group and 94.8% (95%CI: 71.2-92.7) in the observation group (P = 0.96). Backward stepwise selection method in Cox hazard model demonstrated four factors that had a positive impact on PFS independently: rituximab maintenance (HR: 0.34, 95%CI: 0.19-0.61; P < 0.01); non-bulky disease (HR: 0.41, 95%CI: 0.22-0.76; P < 0.01); no transformation (HR: 0.41, 95%CI: 0.22-0.65; P < 0.01); and β2 microglobulin < 2 (HR: 0.33, 95%CI: 0.19-0.59; P < 0.01). On the other hand, 27 patients experienced transformation after R-CVP/R-CHOP. Of 27, 7 (4.7%) in the maintenance group and 16 (28%) in the observation group were transformed (Figure, P < 0.01), whereas 7 (3.4%) in the R-CVP group and 16 (6.6%) in the R-CHOP group were transformed (P < 0.01). Additionally, rituximab maintenance reduced the incidence of transformed FL regardless of induction therapy. In the R-CVP group, the incidence of transformation was 0.67% in the maintenance arm versus 4% in the observation arm, (P < 0.01), while in R-CHOP group, that was 10.7% in the maintenance arm versus 17.9% in the observation arm (P = 0.23). The most common AE was infusion reaction (13%). One patient quit maintenance at the first cycles due to severe infusion reaction.
Conclusion
Rituximab maintenance was beneficial for only PFS at the median follow-up of 5 years. However, rituximab maintenance diminished the incidence of transformed FL significantly and tolerate.
Session topic: E-poster
Keyword(s): Follicular lymphoma, Maintenance, Rituximab, Transformation
Abstract: E1160
Type: Eposter Presentation
Background
Follicular lymphoma (FL) is incurable disease even in rituximab era. Continuous exposure by anti-CD20 antibody after the induction therapy was considered to improve prognosis of patients with FL. Several phase II and III trials demonstrated that progression-free survival (PFS) is upgraded by rituximab maintenance. Transformed FL is known as rare but has a negative impact on prognosis of FL patients. It has not been known the relationship between rituximab maintenance and the incident rate of transformation.
Aims
We analyzed our data to clarify the efficacy and safety of rituximab maintenance in FL patients and to verify whether rituximab maintenance is associated with the incidence of transformed FL.
Methods
We retrospectively analyzed patients aged over 18 who were diagnosed with previous untreated FL grade 1, 2, and 3a in single cancer institute hospital from 2005. Chemo-sensitive patients had given four weekly rituximab infusions every 6 months for two years if we had informed consent. Basically, R-CVP was used except when FL had a feature of (i) bulky disease (≥ 7 cm), (ii) maximum of standardized uptake value ≥ 10 measured by PET scan, and (iii) clinical aggressive manifestations. The primary efficacy endpoint is the incidence of transformation during rituximab maintenance phase. Secondary endpoints are the 5-year PFS, time to next treatment (TNT), and overall survival (OS) and adverse events (AEs) during maintenance phase. Estimates of survival were analyzed by using log rank test and by Cox hazard model. Analysis of contingency table was done by Fisher’s exact test.
Results
A total of 217 patients achieved at least stable disease by R-CVP/R-CHOP. Overall 217, 162 received maintenance group and 49 were observed after induction therapy. Baseline characteristics of both groups were similar except R-CHOP ratio. At the median follow-up of 68.4 months, 5-year PFS was 78.4% (95%CI: 70.0-84.9) in the maintenance group and 38.8% (95%CI: 16.2-43.3) in the observation group (P < 0.0001). Five-year TNT was 70.6% (95%CI: 71.2-86.0) in the maintenance group and 47.6% (95%CI: 22.9-50.9) in the observation group (P < 0.0001). The 5-year OS was 95.3% (95%CI: 89.5-97.9) in the maintenance group and 94.8% (95%CI: 71.2-92.7) in the observation group (P = 0.96). Backward stepwise selection method in Cox hazard model demonstrated four factors that had a positive impact on PFS independently: rituximab maintenance (HR: 0.34, 95%CI: 0.19-0.61; P < 0.01); non-bulky disease (HR: 0.41, 95%CI: 0.22-0.76; P < 0.01); no transformation (HR: 0.41, 95%CI: 0.22-0.65; P < 0.01); and β2 microglobulin < 2 (HR: 0.33, 95%CI: 0.19-0.59; P < 0.01). On the other hand, 27 patients experienced transformation after R-CVP/R-CHOP. Of 27, 7 (4.7%) in the maintenance group and 16 (28%) in the observation group were transformed (Figure, P < 0.01), whereas 7 (3.4%) in the R-CVP group and 16 (6.6%) in the R-CHOP group were transformed (P < 0.01). Additionally, rituximab maintenance reduced the incidence of transformed FL regardless of induction therapy. In the R-CVP group, the incidence of transformation was 0.67% in the maintenance arm versus 4% in the observation arm, (P < 0.01), while in R-CHOP group, that was 10.7% in the maintenance arm versus 17.9% in the observation arm (P = 0.23). The most common AE was infusion reaction (13%). One patient quit maintenance at the first cycles due to severe infusion reaction.
Conclusion
Rituximab maintenance was beneficial for only PFS at the median follow-up of 5 years. However, rituximab maintenance diminished the incidence of transformed FL significantly and tolerate.
Session topic: E-poster
Keyword(s): Follicular lymphoma, Maintenance, Rituximab, Transformation
Type: Eposter Presentation
Background
Follicular lymphoma (FL) is incurable disease even in rituximab era. Continuous exposure by anti-CD20 antibody after the induction therapy was considered to improve prognosis of patients with FL. Several phase II and III trials demonstrated that progression-free survival (PFS) is upgraded by rituximab maintenance. Transformed FL is known as rare but has a negative impact on prognosis of FL patients. It has not been known the relationship between rituximab maintenance and the incident rate of transformation.
Aims
We analyzed our data to clarify the efficacy and safety of rituximab maintenance in FL patients and to verify whether rituximab maintenance is associated with the incidence of transformed FL.
Methods
We retrospectively analyzed patients aged over 18 who were diagnosed with previous untreated FL grade 1, 2, and 3a in single cancer institute hospital from 2005. Chemo-sensitive patients had given four weekly rituximab infusions every 6 months for two years if we had informed consent. Basically, R-CVP was used except when FL had a feature of (i) bulky disease (≥ 7 cm), (ii) maximum of standardized uptake value ≥ 10 measured by PET scan, and (iii) clinical aggressive manifestations. The primary efficacy endpoint is the incidence of transformation during rituximab maintenance phase. Secondary endpoints are the 5-year PFS, time to next treatment (TNT), and overall survival (OS) and adverse events (AEs) during maintenance phase. Estimates of survival were analyzed by using log rank test and by Cox hazard model. Analysis of contingency table was done by Fisher’s exact test.
Results
A total of 217 patients achieved at least stable disease by R-CVP/R-CHOP. Overall 217, 162 received maintenance group and 49 were observed after induction therapy. Baseline characteristics of both groups were similar except R-CHOP ratio. At the median follow-up of 68.4 months, 5-year PFS was 78.4% (95%CI: 70.0-84.9) in the maintenance group and 38.8% (95%CI: 16.2-43.3) in the observation group (P < 0.0001). Five-year TNT was 70.6% (95%CI: 71.2-86.0) in the maintenance group and 47.6% (95%CI: 22.9-50.9) in the observation group (P < 0.0001). The 5-year OS was 95.3% (95%CI: 89.5-97.9) in the maintenance group and 94.8% (95%CI: 71.2-92.7) in the observation group (P = 0.96). Backward stepwise selection method in Cox hazard model demonstrated four factors that had a positive impact on PFS independently: rituximab maintenance (HR: 0.34, 95%CI: 0.19-0.61; P < 0.01); non-bulky disease (HR: 0.41, 95%CI: 0.22-0.76; P < 0.01); no transformation (HR: 0.41, 95%CI: 0.22-0.65; P < 0.01); and β2 microglobulin < 2 (HR: 0.33, 95%CI: 0.19-0.59; P < 0.01). On the other hand, 27 patients experienced transformation after R-CVP/R-CHOP. Of 27, 7 (4.7%) in the maintenance group and 16 (28%) in the observation group were transformed (Figure, P < 0.01), whereas 7 (3.4%) in the R-CVP group and 16 (6.6%) in the R-CHOP group were transformed (P < 0.01). Additionally, rituximab maintenance reduced the incidence of transformed FL regardless of induction therapy. In the R-CVP group, the incidence of transformation was 0.67% in the maintenance arm versus 4% in the observation arm, (P < 0.01), while in R-CHOP group, that was 10.7% in the maintenance arm versus 17.9% in the observation arm (P = 0.23). The most common AE was infusion reaction (13%). One patient quit maintenance at the first cycles due to severe infusion reaction.
Conclusion
Rituximab maintenance was beneficial for only PFS at the median follow-up of 5 years. However, rituximab maintenance diminished the incidence of transformed FL significantly and tolerate.
Session topic: E-poster
Keyword(s): Follicular lymphoma, Maintenance, Rituximab, Transformation
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