Maintenance Therapy with Rituximab for Follicular Lymphoma Is Cost-Effective – A Canadian Perspective.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 343-343 ◽  
Author(s):  
Bridget Maturi ◽  
Joseph R. Mikhael ◽  
William C.N. Dunlop ◽  
Dominic T. Tilden ◽  
Lisa Wong
Keyword(s):  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Induction Therapy ◽  
Drug Acquisition ◽  
Progression Free Survival ◽  
Cost Effective ◽  
Health State ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
Canadian Perspective

Abstract Background: Rituximab maintenance therapy has been shown to significantly improve overall survival (OS) (p<0.0111) and progression free survival (PFS) (p<0.0001) compared to observation alone in patients with relapsed/refractory follicular lymphoma (van Oers MHJ et al, et al. Blood. 2006 [Epub ahead of print]).The objective of this analysis was to estimate the cost-effectiveness, from a Canadian perspective, of rituximab maintenance therapy versus observation alone (OA) in relapsed/refractory follicular lymphoma patients following response to induction therapy with or without rituximab, based on data from the European Organisation for Research and Treatment of Cancer (EORTC) 20981 study (Clinical Study Report 1016350). Methods: The impact of rituximab maintenance therapy (375 mg/m2 every 3 months until progression or for 2 years) compared with OA was evaluated using a lifetime, health-state transition model. All patients entered the model following response to chemotherapy +/− rituximab as induction therapy (progression-free health state [PFHS]). The model simulates the movement of patients from PFHS to either progressed health state (PHS) or death based on the data from the study. PFS and OS following rituximab maintenance were extrapolated from 2-year Kaplan-Meier curves from the study data using a Weibull distribution. In the base case model, the PFS and OS benefits of rituximab maintenance therapy were conservatively assumed to last only 5 years. Quality of life utility values for the health states in the model were derived from a study of 165 patients using the EQ-5D questionnaire. Direct annual medical costs including drug acquisition, administration and preparation were estimated from published sources. All costs are reported in 2005 Canadian dollars (CAD). Costs and outcomes were discounted at a rate of 5%. In order to address uncertainty in point estimates, one-way sensitivity analyses were also performed. Results: From the model, the estimated life-time incremental PFS for rituximab maintenance therapy was a 1.4 year increase over OA (3.1 vs 1.7 years). OS of rituximab maintenance patients was 0.9 years longer than in OA patients (5.6 vs 4.7 years). Total cost for rituximab maintenance therapy was estimated to be CAD34,748, with the majority of costs related to drug acquisition (CAD18,652). Rituximab maintenance resulted in a gain of 0.8 Quality Adjusted Life Years (QALYs) (4.0 vs [OA] 3.2 QALYs) at an incremental cost of CAD17,136. The incremental cost effectiveness ratio (ICER) of rituximab maintenance vs OA is, therefore, estimated to be CAD20,428 per QALY gained. The ICER of rituximab maintenance was sensitive to the duration of treatment benefit and frequency of subsequent treatment. Conclusions: In patients responding to induction therapy, rituximab maintenance therapy improves overall survival and progression-free survival compared with observation alone. This pharmacoeconomic model demonstrates that maintenance therapy with rituximab is a cost-effective approach for the management of patients with follicular lymphoma.

The MAXIMA Study: Safety of Rituximab (MabThera®) Maintenance Therapy in Patients with Follicular Non-Hodgkin’s Lymphoma Who Have Responded to Induction Therapy.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4475-4475 ◽  
Author(s):  
Michael K. Wenger ◽  
Robin Foa ◽  
Luca Arcaini ◽  
Andrej Vranovský ◽  
Valentina Ivanova ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Induction Therapy ◽  
Survival Benefit ◽  
Progression Free Survival ◽  
Rapid Infusion ◽  
Free Survival ◽  
True Incidence ◽  
Rituximab Maintenance ◽  
Wide Range

Abstract Five randomised trials have reported that rituximab maintenance therapy leads to a progression free survival advantage in indolent NHL, with the largest trial (EORTC 20981) showing a progression-free survival benefit of 3 years in patients with follicular lymphoma compared to observation, and a significant overall survival benefit approximately halving the hazard of death. The primary objective of the current study, which involves 23 countries, initiated in August 2006, and aiming to recruit approximately 500 patients, is to extend the safety database for rituximab maintenance within a less stringent setting, allowing for a wide range of induction therapies. The study also examines the ‘real life’ safety associated with rapid-infusion of rituximab. The sample size has been calculated to detect at least one rare event with a true incidence of 0.32% with 80% power. Patients with first line or relapsed/refractory follicular lymphoma achieving a response after rituximab containing induction therapy are eligible to receive rituximab at the standard dose of 375 mg/m2 every eight weeks for 2 years. One-hundred-and-thirty-nine patients have been enrolled to date for whom demographic data is available: Median age of the patient population is 56 years [range: 29 to 82]. Forty-eight percent of the patients are male. Fifty-nine percent of the patients have no relevant medical history except for NHL. Among those who do, cardiovascular diseases is the most common. Most patients (∼ 74%) have a pre-induction FLIPI score of 2 or less. Thirty-five and 49% of the patients, respectively, have grade 1 or 2 follicular NHL. Most patients (75%) have received one line of treatment (including present study induction) since diagnosis, but some patients have received up to 4 previous lines of treatment. Sixty-two percent of the patients received an anthracycline-based regimen in combination with rituximab as induction therapy, whilst 25% and 9% respectively received an alkylating-based or purine analogue-based regimen. Ninety-four patients have received at least one infusion of rituximab as maintenance therapy, less than 40% of these patients having received two or more infusions to date. In total, 162 infusions of rituximab have been administered, 25% (40/162) of these having been administered as rapid infusion. Twenty events unrelated to study medication have been reported in 9 patients, with most of these events (19/20) being CTC grade 1 or 2. There was one patient who experienced a CTC grade 1 infusion related adverse event (erythema) which was not associated with rapid infusion. At the time of the report, there were no SAEs in the clinical database, but 4 SAEs had been reported to Roche, including 1 death resulting from pre-existing cardiac arrhythmia and not related to rituximab. Based on this initial sample, there does not appear to be any safety issue associated with 2-monthly rituximab maintenance therapy, whether administered as rapid infusion or not.

A Phase IIIb Study of Rituximab Maintenance Therapy in Patients with Follicular Non-Hodgkin’s Lymphoma Who Have Responded to Induction Therapy - MAXIMA-Protocol.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4706-4706 ◽  
Author(s):  
Manfred Hensel ◽  
Mathias Witzens-Harig ◽  
Peter Dreger ◽  
Anthony D. Ho ◽  
Daniel Thurley ◽  
...  
Keyword(s):  
Overall Survival ◽  
Complete Remission ◽  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Induction Therapy ◽  
Randomized Trials ◽  
Phase Iii ◽  
First Line ◽  
Free Survival ◽  
Rituximab Maintenance

Abstract Five randomized trials (four Phase III and one phase II) have confirmed that rituximab maintenance therapy provides clinical meaningful improvements in terms of Progression Free Survival, Event Free Survival and response duration for patients. Two studies have also found an overall survival advantage for rituximab maintenance therapy (Hoechster et al. 2005, van Oers et al. 2005) and a third study could demonstrate a strong trend towards overall survival advantage (Dreyling et al. 2006). A Cochrane meta-analysis of several randomised Phase III trials (Schulz et al. 2005) demonstrated that rituximab plus-chemotherapy for first-line treatment of Follicular Lymphoma is superior to chemotherapy alone and significantly prolongs overall survival. To further broaden the available basis for maintenance treatment in the first-line and relapsed setting, the MAXIMA (MAintenance rituXImab in Follicular LymphoMA) trial has been started in August 2006 and will last 5 years. Patients with first line or relapsed/refractory advanced Follicular Lymphoma are included in this trial. In total 500 patients are planned for this international trial running in 23 countries. Patients who achieve a Complete Remission, Complete Remission unconfirmed or Partial Remission after rituximab containing induction therapy (rituximab with or without chemotherapy) are eligible to enter the study to receive rituximab maintenance therapy administered at the standard dose of 375 mg/m2 every 2 months for 2 years. This regimen is also investigated in the ongoing PRIMA study, and also in an ongoing SAKK study which investigates the benefit of rituximab maintenance therapy for up to five years. The previous five randomized trials did not detect significant safety issues for rituximab maintenance therapy. The main objective of the MAXIMA trial is to confirm this safety data in a wider patient population. Secondary objectives of the study include standard time dependent parameters (PFS, EF, OS). In addition, the effect of rituximab maintenance therapy on improving response quality (PR =&gt;CR) after induction therapy will be evaluated.

scholarly journals Rituximab Maintenance for a Maximum of 5 Years After Single-Agent Rituximab Induction in Follicular Lymphoma: Results of the Randomized Controlled Phase III Trial SAKK 35/03

2016 ◽  
Vol 34 (5) ◽  
pp. 495-500 ◽  
Author(s):  
Christian Taverna ◽  
Giovanni Martinelli ◽  
Felicitas Hitz ◽  
Walter Mingrone ◽  
Thomas Pabst ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Progression Free Survival ◽  
Short Term ◽  
End Points ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
End Point ◽  
Unacceptable Toxicity

Purpose Rituximab maintenance therapy has been shown to improve progression-free survival in patients with follicular lymphoma; however, the optimal duration of maintenance treatment remains unknown. Patients and Methods Two hundred seventy patients with untreated, relapsed, stable, or chemotherapy-resistant follicular lymphoma were treated with four doses of rituximab monotherapy in weekly intervals (375 mg/m2). Patients achieving at least a partial response were randomly assigned to receive maintenance therapy with one infusion of rituximab every 2 months, either on a short-term schedule (four administrations) or a long-term schedule (maximum of 5 years or until disease progression or unacceptable toxicity). The primary end point was event-free survival (EFS). Progression-free survival, overall survival (OS), and toxicity were secondary end points. Comparisons between the two arms were performed using the log-rank test for survival end points. Results One hundred sixty-five patients were randomly assigned to the short-term (n = 82) or long-term (n = 83) maintenance arms. Because of the low event rate, the final analysis was performed after 95 events had occurred, which was before the targeted event number of 99 had been reached. At a median follow-up period of 6.4 years, the median EFS was 3.4 years (95% CI, 2.1 to 5.3) in the short-term arm and 5.3 years (95% CI, 3.5 to not available) in the long-term arm (P = .14). Patients in the long-term arm experienced more adverse effects than did those in the short-term arm, with 76% v 50% of patients with at least one adverse event (P < .001), five versus one patient with grade 3 and 4 infections, and three versus zero patients discontinuing treatment because of unacceptable toxicity, respectively. There was no difference in OS between the two groups. Conclusion Long-term rituximab maintenance therapy does not improve EFS, which was the primary end point of this trial, or OS, and was associated with increased toxicity.

Cost-effectiveness of rituximab maintenance therapy for patients with follicular lymphoma: The Spanish perspective

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8092-8092
Author(s):  
J. Gómez Codina ◽  
M. Provencio ◽  
A. Rueda ◽  
F. Capote ◽  
F. Carbonell ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Maintenance Treatment ◽  
Progression Free Survival ◽  
Base Case ◽  
Health States ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
Life Years

8092 Background: In patients with relapsed or refractory follicular lymphoma (FL) who attain a response with either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) alone or Rituximab + CHOP, maintenance treatment with Rituximab has shown to significantly improve overall survival (OS) (85% at 3 years vs. 77%, p=0.011) and progression free survival (PFS) (51,5 vs. 14.9 months, p<0.001) as compared to observation alone (OA). We analyzed the cost-effectiveness, from a Spanish perspective, of Rituximab maintenance therapy (375mg/m2 every 3 months until progression or for 2 years) versus OA according to the population and data described for the European Organization for Research Treatment of Cancer (EORTC) 20981 study (van Oers MHJ Blood 2006). Methods: Incremental cost-effectiveness was assessed through a deterministic, three health states model (disease-free, progression and death) transition model. Base case model: PFS and OS were extrapolated from EORTC 20981 data using a Weibull distribution, Rituximab maintenance benefit was assumed to last 5 years, 10 years time horizon, 3.5% discount rate on costs and benefits, and Spanish National Health Service perspective (direct costs only). Resource use was estimated from a Spanish expert panel and EORTC 20981 study. Unit costs were obtained from local databases (May 2006 €). Health states utility values were derived from an ad hoc study. Sensitivity analyses were performed for all mentioned variables. Results: For the base case, more quality-adjusted life years (QALY), life-years (LY) and progression-free survival years per patient on maintenance therapy were obtained versus OA (incremental values of 0.85, 0.94 and 1.46, respectively). Total cost per patient was higher with Rituximab than with OA (+8,026€). Incremental cost per QALY gained was 9,358€, with a cost per LY gained of 8.493€ and a cost per PFS year gained of 5,485€. In the sensitivity analysis, values ranged between 7.263€ and 22.160€ per QALY gained. Conclusions: This study confirms that in patients with relapsed /refractory FL who attain a response with further therapy, maintenance treatment with Rituximab compared to observation alone is cost-effective. No significant financial relationships to disclose.

Maintenance Therapy for Patients with Mantle Cell Lymphoma (MCL) - a Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1802-1802 ◽  
Author(s):  
Liat Vidal ◽  
Anat Gafter-Gvili ◽  
Martin H. Dreyling ◽  
Michael Unterhalt ◽  
Pia Raanani ◽  
...  
Keyword(s):  
Systematic Review ◽  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Interferon Alfa ◽  
Event Free Survival ◽  
First Line ◽  
Free Survival ◽  
Rituximab Maintenance

Abstract Background: MCL is characterized by a dismal long term prognosis with a median overall survival of 3-5 years. Rituximab maintenance treatment (MR) improves survival of patients with follicular lymphoma, and its effect was assessed for MCL patients in several trials with inconsistent results. Other agents as bortezomib were also evaluated as maintenance therapy for MCL. Aims: We performed a systematic review and meta-analysis of RCTs in order to assess the effect of maintenance therapy on clinical outcomes of patients with MCL. Methods: We included RCTs that compared any type of maintenance to no maintenance or a different maintenance for patients with MCL, either in first line or relapsed disease. In July 2016 we searched The CochraneLibrary, MEDLINE, conference proceedings, and databases of ongoing trials. Two reviewers independently assessed the qualityof the trials and extracted data. The primary outcome wasall cause mortality. Secondary outcomes included progression free survival (PFS) and infectious adverse events. Relative risk (RR) for dichotomous data and hazard ratio (HR) for time to event datawere estimated and pooled using random-effects model. Results We identified 6 trials that reported relevant outcomes, conducted between the years 1998 to 2012 and randomizing 857 patients with MCL. Most patients were males, with a median age ranging from 57 to 70 years, and predominantly good performance status. Ninety-six percent of the patients received their first line of treatment. MIPI score was reported in three trials: 20 to 42 percent of patients had a high MIPI score. Induction therapy included rituximab in all trials. In five trials chemotherapy induction was applied and consisted of fludarabine, cyclophosphamide (FC) and mitoxantrone (Forstpointner, Blood 2006), cyclophosphamide, vincristine, adriamycin, prednisone (CHOP) or FC in one trial (Kluin-Nelemans et al.), bendamustine (Rummel et al.), DHAP followed by autologous stem cell transplantation (ASCT) (Le Gouill et al.), and CHOP/cytarabine followed by ASCT (Doorduijn et al.); in one trial rituximab was given alone (Ghielmini et al.). Maintenance consisted of rituximab in five trials and bortezomib in one trial (Doorduijn et al.). The control group received no maintenance in two trials and interferon alfa in one trial. All included trials were judged at low risk of selection bias, none were blinded. No statistically significant effect on mortality rate was shown with rituximab maintenance therapy compared to no maintenance or interferon alfa RR 0.72, 95% CI 0.50 to 1.04, I2 of heterogeneity 57%, 751 patients. The RR of mortality with bortezomib maintenance was 0.67, 95% CI 0.12 to 3.71, but that is based on only 60 patients. PFS improved with rituximab maintenance compared to no maintenance or interferon alfa: HR 0.59, 95% CI 0.46 to 0.75. With bortezomib maintenance vs. no maintenance the HR of event free survival was 0.84, 95% CI 0.32 to 2.20. There was no statistically significant difference in infection rate with or without maintenance (RR 0.80, 95% CI 0.37 to 1.69, 419 patients). Conclusions Maintenance therapy improved PFS of patients with MCL, but no survival benefit could be shown. The pooled analysis is based mainly on the results of rituximab maintenance as data of the effect of bortezomib maintenance is scarce. The absence of significant increase of infection rate as opposed to maintenance rituximab in follicular lymphoma might be attributed to the small sample size. Based on these results patients treated for both first line and relapsed/refractory MCL should receive rituximab maintenance after achieving response to induction. Table disease control (*progression free survival, **event free survival) of patients with MCL who responded to induction and treated with rituximab maintenance compared to observation or interferon alfa. Table. disease control (*progression free survival, **event free survival) of patients with MCL who responded to induction and treated with rituximab maintenance compared to observation or interferon alfa. Disclosures Dreyling: Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Clinical outcome of patients with follicular lymphoma receiving chemoimmunotherapy in the PRIMA study is not affected by FCGR3A and FCGR2A polymorphisms

Blood ◽  
2012 ◽  
Vol 120 (13) ◽  
pp. 2650-2657 ◽  
Author(s):  
Hervé Ghesquières ◽  
Guillaume Cartron ◽  
John Francis Seymour ◽  
Marie-Hélène Delfau-Larue ◽  
Fritz Offner ◽  
...  
Keyword(s):  
Single Nucleotide Polymorphisms ◽  
Follicular Lymphoma ◽  
Response Rate ◽  
Single Agent ◽  
Progression Free Survival ◽  
Nucleotide Polymorphisms ◽  
Single Nucleotide ◽  
Free Survival ◽  
Rituximab Maintenance

Abstract In patients with follicular lymphoma treated with single-agent rituximab, single nucleotide polymorphisms in the FCGR3A gene are known to influence response and progression-free survival. The prognostic role of FCGR3A and FCGR2A polymorphisms in patients with follicular lymphoma treated with rituximab and chemotherapy combination remains controversial and has not been evaluated in the context of rituximab maintenance. FCGR3A and FCGR2A single nucleotide polymorphisms were evaluated in, respectively, 460 and 455 patients treated in the PRIMA study to investigate whether these were associated with response rate and patient outcome after rituximab chemotherapy induction and 2-year rituximab maintenance. In this representative patient cohort, complete and unconfirmed complete responses after rituximab chemotherapy were observed in 65%, 67%, 66% (P = .86) and 60%, 72%, 66% (P = .21) of FCGR3A VV, VF, FF and FCGR2A HH, HR, RR carriers, respectively. After 2 years of rituximab maintenance (or observation), response rates did not differ among the different genotypes. Progression-free survival measured from either treatment initiation or randomization to observation or maintenance was not influenced by these polymorphisms. These data indicate that FCGR3A and FCGR2A polymorphisms do not influence response rate and outcome when rituximab is combined with chemotherapy or used as maintenance treatment. The PRIMA study is registered at www.clinicaltrials.gov as NCT00140582.

scholarly journals Rituximab Maintenance Benefits Less for Follicular Lymphoma Patients with Low Risk of the Follicular Lymphoma International Index

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3544-3544
Author(s):  
Tingyu Wang ◽  
Ru Li ◽  
Rui Lv ◽  
Ying Yu ◽  
Jiawen Chen ◽  
...  
Keyword(s):  
High Risk ◽  
Follicular Lymphoma ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Low Risk ◽  
Control Group ◽  
Intermediate Risk ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
Risk Patients

Abstract Background Follicular lymphoma (FL) is an incurable indolent disease with a heterogeneous course. The Follicular Lymphoma International Prognostic Index (FLIPI) is the most commonly used prognostic system to predict survival. Rituximab-based immunochemotherapy is now the standard choice for the first-line therapy of FL, followed by rituximab maintenance (RM) in patients with response, which prolongs the progression-free survival (PFS). However, the role of RM in different FLIPI risk groups has never been studied as we know. In this study, we aimed to illustrate the effect of RM in FLIPI risk groups. Methods Newly diagnosed FL patients at our center were enrolled in this analysis. All the patients received the rituximab-based chemoimmunotherapy induction regimens. Response assessments were determined according to Lugano's 2014 criteria. Patients who didn't respond to induction were excluded. Categorical variables were compared using Fisher's exact test. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method and compared with the log-rank test. Results From May 2003 to September 2020, 203 newly diagnosed FL were included. 192 patients (95.0%) achieved remission (complete response, CR/partial response, PR) after immunochemotherapy induction, of whom 96 patients continued rituximab maintenance therapies every 3 months for 1-2 years (RM group) (median 7 times，range 4 to 12). 96 patients received no maintenance or fewer than 4 times (control group) (median 0 times, range 0-3). There were no significant differences in baseline characteristics other than the Ann Arbor stage and pathological grade. The RM group patients were more likely to be at low grade (71.8% vs 54.9%, P = 0.042) and advanced stage (90.6% vs 78.7% , P = 0.027) (Table 1). After a median follow-up of 36.4 months (95% confidence interval [CI], 32.2 to 40.6), median OS and PFS were not reached. The 5-year OS rates and PFS rates were 95.1% (95%CI, 90.2%-100%) and 83.0% (95%CI, 75%-91%)(Fig 1). And RM significantly prolonged the PFS, with 5-year PFS rates 92.2% (95%CI, 85.1%-99.3%) and 70.3%(95%CI, 55%-85.6%) (P = 0.0003) (Fig 2). According to FLIPI risk stratification, patients were classified into low-risk, intermediate-risk, and high-risk groups. The 5-year PFS rates were 97.7% (95%CI, 93.2%-100%), 84.7% (95%CI, 70.4%-99%), and 67.8% (95%CI, 49%-86.6%), respectively (Fig 3). For low-risk patients, there was no significant difference in PFS for the RM group vs the control group. However, for both intermediate risk and high-risk patients, PFS was significantly longer in the RM group compared to the control group (P &lt; 0.0001). The PFS rates at 5 years in intermediate-risk patients were 100% and 77.8% (95%CI, 40.8%-92.6%), for the RM group vs control group, high risk 76.4% (95%CI, 54.3%-98.5%), and 54.9% (95%CI, 21.6%-88.2%), respectively (Fig 4). Conclusion Standard rituximab maintenance significantly prolongs progression-free survival in FLIPI intermediate risk and high-risk patients with FL, but not in the FLIPI low risk group. Figure 1 Figure 1. Disclosures Wang: AbbVie: Consultancy; Astellas Pharma, Inc.: Research Funding.

scholarly journals Lenalidomide Plus Rituximab Chemotherapy for Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas

2021 ◽  
Vol 1 (11) ◽  
Author(s):  
Sara D. Khangura ◽  
Andrea Ryce
Keyword(s):  
Adverse Events ◽  
Follicular Lymphoma ◽  
Progression Free Survival ◽  
Cost Effective ◽  
Pharmaceutical Manufacturer ◽  
Controlled Trials ◽  
Private Industry ◽  
Free Survival ◽  
Randomized Controlled ◽  
Economic Analyses

Data from 2 randomized controlled trials indicated a statistically significant benefit in progression-free survival and overall survival for patients with follicular lymphoma who received R2 as compared to patients who received rituximab plus placebo or R-CHOP. The frequency of all types of adverse events in patients receiving R2 as compared to rituximab plus placebo or R-CHOP was comparable, but patients receiving R2 experienced more severe adverse events. Two economic analyses concluded that R2 was cost-effective for the treatment of patients with follicular lymphoma as compared to rituximab plus placebo (UK and Dutch contexts). Evidence identified in this review was mostly limited to that describing patients with follicular lymphoma. Most evidence identified in this review was generated with support and/or funding from a private industry pharmaceutical manufacturer.

Meta Analysis: Rituximab as Maintenance Therapy for Patients with Follicular Lymphoma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3408-3408
Author(s):  
Liat Vidal ◽  
Anat Gafter-Gvili ◽  
Martin Dreyling ◽  
Michele Ghielmini ◽  
Shu Fang Hsu-Schmitz ◽  
...  
Keyword(s):  
Overall Survival ◽  
Maintenance Therapy ◽  
Follicular Lymphoma ◽  
Induction Therapy ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Separate Analysis ◽  
Newly Diagnosed ◽  
Single Infusion ◽  
Number Of Patients

Abstract Background: Rituximab in combination with chemotherapy improves overall survival (OS) compared to chemotherapy alone when used for induction therapy, for patients with newly diagnosed and relapsed indolent lymphoma. Randomized controlled trials (RCTs) have demonstrated that maintenance treatment with rituximab (MR) prolongs progression free survival but evidence of effect on OS is lacking. Objectives: to evaluate the effects of MR on OS in patients with follicular lymphoma (FL). Methods: Systematic review and meta-analysis of RCTs that assessed MR for patients with B cell FL. Electronic databases of medical journals and ongoing trials were searched. Relative risks (RR) for dichotomous outcomes with 95% confidence intervals (CI) were pooled using Mantel-Haenszel method. Treatment effect on OS was estimated as hazard ratios (HRs) using methods described by Parmar et al. (Stat Med1998;17:2815–34) Results: 266 titles and abstracts were screened. Five trials fulfilled inclusion criteria (table). 1053 adult patients were randomized between the years 1998–2004. The median follow up ranged between 26 to 41 months. The minimal requirement for inclusion was either a stable disease after induction (3 trials) or partial remission (2 trials). Overall survival: Four trials (895 patients) were included in analysis of OS. The Hainsworth trial (JCO2006; 23: 1088–1095) was omitted for analysis of OS due to design issues (MR versus retreatment at progression). Patients treated with MR had a significantly better OS compared to observation (HR 0.53, 95% CI 0.39, 0.73). Adverse events: Patients treated with MR had more infectious related adverse effects compared to observation (RR 1.99, 95% CI 1.21, 3.27). Conclusions: MR improves OS compared to observation in patients with refractory/relapsed FL who responded to induction therapy. Pooled HR of OS with MR treatment versus observation for patients with FL. n number of events; N number of patients evaluated. Rituximab as maintenance therapy for patients with follicular lymphoma Overall survival Rituximab as maintenance therapy for patients with follicular lymphoma Overall survival Description of included trials Trial ID No. randomized patients Type of lymphoma Induction therapy Rituximab maintenance protocol *Separate analysis was possible for patients with FL. Y years, SLL small lymphocytic lymphoma, MCL mantle cell lymphoma, CVP cyclophosphamide, vincristine, prednisone, FC fludarabine, cyclophosphamide, FCM fludarabine, cyclophosphamide, mitoxantrone, CHOP cyclophosphamide, doxorubicin, vincristine, prednisone Hainsworth 2005 90 Previously treated FL, SLL Rituximab Weekly for 4 weeks every 6 months for 2y Hochster 2005 304 Untreated FL, SLL* CVP Weekly for 4 weeks every 6 months for 2y Hochster 2007 69 Untreated FL, SLL FC Same as above Forstpointner 2006 195 Relapsed FL, MCL* FCM+/− rituximab Weekly for 4 weeks, at 3 and 9 months Ghielmini 2004 151 Newly diagnosed and relapsed FL Rituximab A single infusion every 2 months for four doses van Oers 2006 334 Relapsed FL CHOP+/− rituximab A single infusion every 3 months for 2y

Management of Grade 3B Follicular Lymphoma (FL) Outside Clinical Trials: A Multicentric Retrospective Analysis on Behalf of Fondazione Italiana Linfomi (FIL)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2716-2716
Author(s):  
Barbara Botto ◽  
Federica Cavallo ◽  
Manuela Zanni ◽  
Antonella Anastasia ◽  
Chiara Rusconi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Follicular Lymphoma ◽  
Retrospective Analysis ◽  
Progression Free Survival ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
First Line Treatment

Abstract Introduction: Follicular lymphoma grade 3 is recognized as a distinct entity in the World Health Organization classification of lymphoma. It is further classified into grade 3a and 3b depending on percentage of centroblasts. There is no consensus about its clinical course because some studies indicate an indolent behavior but others describe a more aggressive. Large systematic studies are missing in particular for 3b follicular lymphoma which is often considered as a separate entity. Methods: We performed a retrospective multicentric study on a group of 3b FL patients diagnosed in nine Italian FIL centers between November 2002 and January 2015. Planned inclusion criteria at enrollment were first line Rituximab containing regimen treatment and diagnostic samples availability for central pathologic review. Aim of the study was to determine clinical response, OS and PFS. Tumor response was based on the International Working Group response criteria. Survival analysis was performed with Kaplan-Meier method. Results: We enrolled a total of 51 patients, 50 evaluable for response at the time of analysis; median age was 62 yrs (range 48-71), 29 (56%) in stage III-IV, 10 (20%) with B symptoms. First line treatment was R-CHOP in the majority of patients 47 (92%), R-Bendamustine and R-CVP in 2 (4%) respectively. Seven patients (14%) received Rituximab maintenance after first line, six (12%) underwent high dose chemotherapy and autologous stem cell transplant (ASCT) as consolidation therapy and 5 (10%) were treated with local radiotherapy on residual disease. We observed CR in 48 patients (96%), PR in 1 (2%), PD in 1(2%). Ten patients relapsed or progressed after first line treatment and four of them died, three for progressive disease and one due to senile dementia while in CR. No relapses were recorded in pts receiving Rituximab maintenance but the advantage was not statistically significant and the number of patients receiving maintenance was low. With a median follow up of 63 months from diagnosis (IQR 33-82), 3-yrs PFS and OS rates were 82% and 93% (fig 1 and 2) with the evidence of a plateau in both survival curves after 5 years observation. Central pathologic review is ongoing. Conclusion: With the limit of a retrospective analysis our study confirms the clinical benefit of a combined modality treatment with Rituximab plus antracycline-containing chemotherapy in patients with 3b FL. Our results compare favorably with those previously reported in studies without Rituximab, that failed to show a plateau with 3-yrs PFS ranging between 22% and 52%. This results need to be confirmed with a longer follow up and after the planned pathologic review. Figure 1. Progression-Free Survival. Median Follow-up 62 months (IQR 33-82). Figure 1. Progression-Free Survival. Median Follow-up 62 months (IQR 33-82). Figure 2. Overall Survival. Median Follow-up 63 months. Figure 2. Overall Survival. Median Follow-up 63 months. Disclosures No relevant conflicts of interest to declare.

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