Rituximab maintenance after R-CHOP in the first-line treatment of follicular lymphoma: A GOTEL phase II trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19502-e19502
Author(s):  
A. Rueda ◽  
M. Provencio ◽  
M. Abrio ◽  
J. Gómez-Codina ◽  
M. Llanos ◽  
...  
Keyword(s):  
Overall Survival ◽  
Follicular Lymphoma ◽  
Induction Therapy ◽  
Maintenance Phase ◽  
Severe Toxicity ◽  
Advanced Stage ◽  
Line Treatment ◽  
First Line ◽  
Rituximab Maintenance ◽  
First Line Treatment

e19502 Background: Rituximab maintenance have demonstrated improvements in progression-free and overall survival in relapsed patients with follicular lymphoma (FL). Ongoing trials are evaluating the benefit of rituximab maintenance following treatment of therapy-naive patients (pts) treated with rituximab-containing chemoinmunotherapy induction regimens. Methods: The current study evaluated the activity and toxicity of rituximab maintenance after chemoinmunotherapy in the first line treatment of advanced-stage FL. Pts with advanced stage FL were eligible. The induction treatment consisted in 8 courses of chemoinmunotherapy with R-CHOP (rituximab 375 mg/m2; cyclophosphamide 750 mg/m2; doxorubicin 50 mg/m2 and vincristine 2 mg). Pts entering a complete (CR) or partial remission (PR) received maintenance with 6 doses of rituximab (375 mg/m2/d) to be given every two months after the end of induction therapy. Results: From December 2004 to November 2006, 52 pts were included. Median age was 52 years (range, 36–85) and 26 pts were women. At baseline 32 (62%) pts had stage IV and 20 (38%) stage III. According to the Follicular Lymphoma International Prognostic Index (FLIPI), 8 pts (15%) had low risk disease, 24 pts (46%) intermediate risk, and 20 pts (39%) high risk disease. Six (12%) pts did not receive maintenance (3 pts progressed during induction, 2 pts refused maintenance and 1 pt had severe toxicity to induction). Of the 46 pts included in the maintenance phase, 32 (69%) were in CR/CRu and 14 pts (31%) in PR after induction therapy. Rituximab was well tolerated in the maintenance phase. Only 5 pts didn´t receive the 6 scheduled courses (toxicity: 1; progressive disease: 2; cardiovascular events: 2). Grade 3–4 toxicity occurred as follow: neutropenia in 4 pts (9%), and fever in 1 pt (2%). No severe infections were seen. After maintenance, 40 (87%) pts were in CR/CRu, 4 pts (9%) in PR and 2 (4%) progressed. With a median follow-up of 27 months, progression-free and overall survival at 30 months were 82% and 92%, respectively. Conclusions: Rituximab maintenance after first-line R-CHOP is safe and increase the complete remission rate obtained in the induction phase. No significant financial relationships to disclose.

Impact Of Rituximab Maintenance Schedule On Prognosis In First Line Treatment Of Follicular Lymphoma. Retrospective Analysis From Czech Lymphoma Group (CLG) Database

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4387-4387
Author(s):  
Andrea Janikova ◽  
Zbynek Bortlicek ◽  
Vit Campr ◽  
Leos Kren ◽  
David Belada ◽  
...  
Keyword(s):  
Overall Survival ◽  
Follicular Lymphoma ◽  
Retrospective Analysis ◽  
Research Funding ◽  
Statistical Significance ◽  
Induction Treatment ◽  
Line Treatment ◽  
First Line ◽  
Rituximab Maintenance ◽  
First Line Treatment

Abstract Introduction Results of randomized studies showed benefit of maintenance therapy with monoclonal anti-CD20 antibody (rituximab) in terms of time to progression (PFS) and overall survival (OS) in follicular lymphoma (FL). General recommendation, based on large clinical trial, is to give 2 years of rituximab maintenance á 375mg/m2every 2 months (12 doses) in first line setting. On the other hand, there are various rituximab maintenance schedules; however, the clear comparison of clinical efficacy is missing. Our retrospective analysis compared two different schedule of rituximab maintenance in first-line treatment of FL used in university centers participating on CLG registry. Methods Data were recruited from 1702 FL patients registered in the prospectively maintained multicentric database (Czech Lymphoma Group; CLG). For the analysis, patients with stage II-IV of new diagnosed FL (grade 1-3a) responding (complete or partial remission) to 6-8 cycles first-line RCHOP (rituximab, cyclophosphamide, doxorubicine, vincristine and prednisone) followed with rituximab maintenance (RM) were included. Completed planned maintenance was inclusion criterion. Patients with previous watch and wait or additional first line therapy (radiotherapy, other chemotherapy, transplant therapy) were excluded. Results Totally, 168 evaluable FL patients with median age 57ys (range 28-82) including 70 (41.7%) men treated with RCHOP + RM were found in CLG database. 52/168 patients received totaly 8 doses of rituximab maintenance every 3 months for 2 years (RM8 arm), whereas 47/168 patients were treated with totaly 12 doses (RM12 arm) of rituximab maintenance every 2 months for 2 years. All patients in both subgroups completed planned RM therapy. There was no difference in distribution of age, gender, FLIPI, grade, B-symptoms, bone marrow involvement, performance status, LDH and beta2microglobuline level between both arms. Induction treatment in terms of administered cycles CHOP (6xCHOP in 41/52 and 35/45 pts., for RM8 and RM12 arm) and rituximab doses (8xR in 48/52 and 41/45 pts., for RM8 and RM12 arm) was similar between arms (ns). There were 4/52 (7.7%) and 5/47 (10.6%) relapses in subgroups RM8 and RM12, with no statistical significance. Median PFS was 3.8 (2.1-5.8) years vs. 3.9 (2.4-7.8) years in RM8 and RM12 arms (not significant), and median OS 3.91 (2.2-6.94) years vs. 3.1 (2.48-8.6) years also with no statistical significance. Conclusion Our results show, that rituximab maintenance given every 2 or every 3 months for two years in first line treatment brings similar benefit to the FL patients in terms of remission duration and overall survival. Despite the fact, that presented data are retrospective observation, this is the first report comparing two different rituximab maintenance regimens in FL. Further prospective study and longer follow up are needed to confirm our preliminary data. This work was supported by grant NT/12193-5 and MHCZ-DRO (FNBr 65269705) Disclosures: Mayer: Roche: Consultancy, Research Funding; Glaxo: Consultancy, Research Funding. Trneny:Roche: Honoraria, Research Funding.

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.

First Line Treatment of Advanced Stage Hodgkin Lymphoma with Six Cycles of BEACOPPescalated Results in Superior Overall Survival Compared to ABVD: Results of a Network Meta-Analysis Including 10,011 Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 551-551
Author(s):  
Peter Borchmann ◽  
Sven Trelle ◽  
Michaela Rancea ◽  
Heinz Haverkamp ◽  
Volker Diehl ◽  
...  
Keyword(s):  
Overall Survival ◽  
Initial Treatment ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Advanced Stage ◽  
Secondary Malignancies ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Abstract Abstract 551 Background: The best treatment strategy for advanced stage Hodgkin lymphoma (HL) is still a matter of debate. The German Hodgkin Study Group (GHSG) advocates aggressive treatment with BEACOPPescalated (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) to cure as many patients as possible with first-line therapy. However, BEACOPPescalated may expose patients to excessive toxicity. Treatment with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) is supposed to be better tolerable. Proponents of primary ABVD therapy acknowledge a lower progression-free survival (PFS) compared to BEACOPPescalated. However, they argue that relapsing patients can subsequently be cured by high-dose chemotherapy resulting in comparable overall survival (OS). All trials evaluating these two strategies directly were either very small or included patient subgroups only. Although they congruently showed a significant PFS advantage for BEACOPPescalated, they were not powered to detect differences in OS, which obviously is the most important endpoint. Purpose: To assess the benefits and risks of different initial treatment strategies for adult patients with advanced stage HL and to provide patients and physicians with a high-level evidence for treatment decisions. Methods: Data Sources: We developed sensitive search strategies for CENTRAL, MEDLINE, and conference proceedings (searched from 01/1980 to 03/2012). Missing data was obtained from investigators. Study selection: Randomized trials that compared at least two out of twelve pre-defined chemotherapy regimens in adults with advanced stage HL. Two authors independently assessed studies for eligibility. Data extraction: We extracted data and assessed quality of trials in duplicate. The primary outcome was OS. Secondary outcomes included freedom-from-treatment failure (FFTF) and secondary malignancies. Data relates to four or five years of follow-up depending on the status of the trial. Data synthesis: We pooled data using network meta-analysis. Direct comparisons within trials were combined with indirect evidence from other trials by using a Bayesian random-effects model. Results are reported relative to ABVD with a hazard ratio (HR) >1 indicating superiority of ABVD. Results: 1,984 references were identified, of which 77 publications, reporting 14 trials, evaluating 11 different regimens were included. A total of 10,011 patients with 59,000 patient-years of follow-up were evaluable for the analyses of survival outcomes. Six cycles of BEACOPPescalated and 8 cycles of BEACOPP-14 were associated with the lowest risk for death of any cause (HR 0.38, 95%-CrI 0.20 to 0.75 and HR 0.43, 95%-CrI 0.22 to 0.86, respectively). Assuming a five-year survival rate of 89% for ABVD this would result in a 5-year survival benefit of 7% and 6% for 6 cycles of BEACOPPescalated and 8 cycles of BEACOPP-14, respectively (95%-CrI 3% to 9% and 2% to 9%, respectively). Eight cycles of BEACOPPescalated were also statistically significantly better as compared to ABVD but the effect was less pronounced. All other treatment strategies showed no statistically significant difference to ABVD. Similar results were obtained for FFTF. Between-trial heterogeneity was negligible in both analyses (tau-square 0.01 and 0.05, respectively). Overall, 327 secondary malignancy and 109 leukemia events accumulated over 57,529 patient-years of follow-up. Given the low number of events we were not able to accurately quantify the risk associated with each regimen; however, Stanford V might be associated with the lowest risk and C(M)OPP/EBV/CAD with the highest risk for secondary leukemias. Limitations: Some of the regimens were only evaluated in one trial. The number of secondary malignancies, especially leukemias, was low. Conclusions: The comparison of different first-line treatment strategies for advanced stage HL in this network meta-analysis shows a significant and relevant OS benefit for both, 6 cycles of BEACOPPescalated and 8 cycles of BEACOPP-14 over standard ABVD treatment. This analysis provides the currently best available evidence on OS of different initial treatment strategies for advanced stage HL patients and therefore adds valid and important information for both, patients and physicians. Disclosures: No relevant conflicts of interest to declare.

Cost-effectiveness of rituximab plus CVP for first-line treatment of advanced indolent lymphoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6583-6583
Author(s):  
J. Hornberger ◽  
C. Reyes ◽  
E. Verhulst ◽  
D. Lubeck ◽  
N. Valente
Keyword(s):  
Overall Survival ◽  
Cost Effectiveness ◽  
Follicular Lymphoma ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Line Treatment ◽  
First Line ◽  
Economic Implications ◽  
The Cost ◽  
First Line Treatment

6583 Background: The addition of rituximab (RTX) to CVP (cyclophosphamide, vincristine, prednisone) in the treatment of advanced follicular lymphoma increases median time to progression by 17 months (15 month v 32 months; p < 0.0001) (Marcus et al, Blood 2005). A societal cost-effectiveness analysis was performed to estimate projected lifetime clinical and economic implications of this treatment. Methods: The cost-effectiveness (CE) of RTX + CVP versus CVP was estimated for a 50 yr old patient. Kaplan-Meier estimates of progression-free and overall survival, up to 4 years, were obtained from the M39021 trial. After 4 years, transition rates from initiation of treatment to progression or death were assumed to be the same in both arms. The clinical and economic implications of relapse and its treatment were included in the model. Incremental costs associated with addition of RTX were estimated using Medicare reimbursement rates and published retail price data. Costs included drug and administration costs, adverse events, treatment of relapses, and end-of-life costs. Utility estimates were derived from the literature and a 3% discount rate was employed. Results: Projected mean overall survival is 1.5 yrs longer for patients assigned to RTX+ CVP versus only CVP (13.7 v 12.2 yrs). The addition of RTX to CVP is estimated to cost an additional $26,439 on average, with an expected gain of 0.85 year of quality-adjusted survival. Over a lifetime, the cost per QALY gained is $31,329. Sensitivity analyses revealed that the variables that most influenced cost-effectiveness were the time horizon (range: $18,800- $31,240) and the unit drug cost of RTX (range: $24,000-$38,000). Conclusion: The model estimates a cost-to-QALY gained ratio that is below that of many treatments used for oncology patients. The use of RTX + CVP for first-line treatment of advanced follicular lymphoma is projected to be cost-effective compared to CVP alone under a range of sensitivity analyses. No significant financial relationships to disclose.

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.

Retrospective Analysis of 41 Consecutive Patients with Non Gastrointestinal (GI) Extranodal Marginal Zone B-Cell Lymphoma (EMZL): Correlation of Clinical Characteristics and Outcome with Disease Localization.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4785-4785
Author(s):  
Christina Kalpadakis ◽  
Marina P. Siakantaris ◽  
Marie-Christine Kyrtsonis ◽  
Theodoros P. Vassilakopoulos ◽  
Tatiana Tzenou ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Characteristics ◽  
Marginal Zone ◽  
Advanced Stage ◽  
Line Treatment ◽  
First Line ◽  
Extranodal Site ◽  
Stage Disease ◽  
First Line Treatment

Abstract Extranodal marginal zone B-cell lymphomas of mucosa associated lymphoid tissue (MALT) are indolent lymphomas with specific clinical and pathologic features. MALT lymphomas can arise from any extranodal site. Non-gastrointestinal (non-GI) MALT lymphomas are rarer (<1% of NHL) and have been described in various sites (salivary glands, orbit, lung, skin etc). We retrospectively studied 41 patients with an initial diagnosis of EMZL according to the REAL/WHO classification criteria and presenting with a clinically dominant non-GI site of localization in order to evaluate the clinical characteristics of patients and to correlate disease localization with clinical behaviour, treatment and patient outcome. The studied population included 20 men and 21 women with a median age of 50 years (23–87). The most commonly affected sites were skin (13,32%), salivary glands (11%), followed by lung (7%), orbit (5%), oral cavity non salivary (4%), upper airway (1%) and thyroid (1%). The majority of patients (69%) presented in stage I. Advanced stage disease was due to bone marrow (12%) or/and lymph node involvement (12%), while in 4 patients there was more than one extranodal site involved. Autoimmune disorders were noticed in 7 patients, while monoclonal gamopathy in 5 (12%). Two patients presented B-symptoms (both with BALT ). Patiens with extranodal skin lymphoma (SALT) received treatment with interferon-α (54%), Mabthera iv or intralesionally (31%) or resection alone with a 100% CR rate. With a median follow up of 42 months no disease related death was noticed. Among 11 patients with salivary gland EMZL 5 had stage IV disease at presentation (45%). First line treatment was chlorombucil +/− Mabthera with a 90% CR rate. With a median follow up of 80 months two relapses in another MALT site (stomach) and one disease related death due to disease transformation were noticed. Patients with BALT lymphomas presented some specific clinical characteristics: There was a long time interval between onset of symptoms and diagnosis, B-symptoms were presented in 2 of 7 patients while most of them had symptoms from the respiratory system (cough, dyspnea, expectoration). 3 patients had advanced stage disease. First line treatment was chlorambucil +/− Mabthera +/− surgical excision with response rates of 70%. With a median follow up of 51 months two disease related death were noticed (one due to disease transformation). 4 of 5 patients with orbital MALT lymphoma received chlorambucil while one patient received radiotherapy alone. With a median follow up of 52 months one relapse to another extranodal site was noticed and no disease related death. In conclusion our data confirms the indolent behaviour of MALT lymphomas with a 5- and 10-year overall survival 82±8% and 65±13% respectively. The 5-year overall survival was 90% or more for each non-lung presentation vs 70% for BALT NHL. The optimal management of MALT lymphomas with regard to surgery, chemotherapy, immunotherapy and radiation therapy alone or in combination as well as abstention from therapy is not well defined. Additionally MALT lymphomas of various anatomic sites seem to present a clinical heterogeneity that may reflect heterogeneity at a molecular level.

Long Term Follow-up of the GELF86 French and Belgian Trials: Complete Remission after First Line Treatment with Conventional Chemotherapy in Newly Diagnosed Follicular Lymphoma Patients Correlates with Prolonged Overall Survival Compared with Partial Remission

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2590-2590 ◽  
Author(s):  
E. Bachy ◽  
P. Brice ◽  
M. Fournier ◽  
H. Tilly ◽  
C. Haioun ◽  
...  
Keyword(s):  
Overall Survival ◽  
Complete Remission ◽  
Follicular Lymphoma ◽  
Tumor Burden ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
First Line ◽  
Long Term Follow Up ◽  
First Line Treatment

Abstract Purpose . Frontline treatment for newly diagnosed follicular lymphoma (FL) patients, ranging from watch and wait policy to high-dose therapy, still remains debated, even in the rituximab-based combination therapy era. Few studies have addressed the question whether complete remission (CR) translates into better survival compared to partial remission (PR). The aim of this study was to assess the potential correlation between response quality to first line treatment and overall survival in light of a long-term follow-up. Patients and methods. Data from 536 FL patients, 435 enrolled in the French and Belgian GELF86 trials and 101 additional patients treated with the same chemotherapy regimen (CHVP-IFN or CHVP regimen after the accrual stopping date with prospectively collected data), were analysed in the study. Data from the GELF86 trials have been previously reported: 193 patients had low tumor burden (LTB) (Brice et al., JCO, 1997) and 242 and the aforementioned 101 additional patients had high tumor burden (HTB) at diagnosis (Solal-Céligny et al., NEJM 1993). All patients with at least one criteria for HTB were treated as frontline therapy with an anthracycline based CHVP regimen: cyclophosphamide, doxorubicin, teniposide, and prednisone monthly for 6 months and then every 2 months for 1 more year. Patients were randomly assigned to the CHVP arm (n=153) or the CHVP-IFN arm (n=190) when they also received α-interferon three times weekly for 18 months. Patients with LTB FL were randomly assigned to one of the three arms: arm 1, no initial treatment (n=66); arm 2, prednimustine for 5 days per month for 18 months (n=64); or arm 3, IFN three times per week for 15 months (n=63). Results. Median follow-up was 14.3 years and median overall survival (OS) was 9.8 years for the whole cohort. As expected, the Follicular Lymphoma International Prognostic Index (FLIPI) was a strong prognostic factor as well as bone marrow involvement, erythrocyte sedimentation rate (ESR), and B symptoms in univariate analysis or the FLIPI, lymphocytes count, ESR and male sex in multivariate analysis, respectively. Furthermore, treated patients who achieved a CR (n=170, 40%) had a significant longer OS than those only reaching a PR (n=162, 38%) throughout treatment (10-year OS was 64% (95% CI, 57–71%) for CR patients and 46% (95% CI, 38–54%) for PR patients, logrank p=0.0002). In a subgroup analysis by tumour burden, CR remained highly predictive of a better outcome for HTB patients (logrank p=0.001) but not for LTB patients. No difference was observed between patients who went into early complete remission (≤ 6 months) versus late complete remission (&gt; 6 months). Finally, when only HTB patients receiving CHVP-IFN were compared with those receiving the same treatment in the FL2000 trial (Salles et al., Blood, in press), Cox analysis adjusted for the FLIPI indicated a better outcome for FL2000 patients (HR=0.66, 95% CI 0.44–0.99, p=0.047). Conclusion. These data provide a long follow-up of these patients’ cohorts, and indicate strong evidence that better response to first line treatment translates into a favorable outcome for patients with newly diagnosed FL, especially for HTB patients.

Rituximab Plus Chlorambucil Compared with Chlorambucil and Prednisone In Patients with Untreated Follicular Lymphoma

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3956-3956
Author(s):  
Simona Bassi ◽  
Simona Sammassimo ◽  
Federica Gigli ◽  
Giancarlo Pruneri ◽  
Paola Bertazzoni ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Conflicts Of Interest ◽  
Maintenance Phase ◽  
Observation Time ◽  
Induction Phase ◽  
Line Treatment ◽  
First Line ◽  
Term Outcome ◽  
Long Term Outcome ◽  
First Line Treatment

Abstract Abstract 3956 Background: Recently in large randomized studies, the addition of Rituximab to standard chemotherapy in the first-line treatment of follicular lymphoma (FL) demonstrated improvements in long-term outcome in FL. Methods: We compared the outcome of 111 naive FL patients (pts) treated at our institution from 1995 to 2009 with a single alkylating agent in combination or not with Rituximab: 58 pts received Chlorambucil plus Rituximab (R-Chl) and 53 pts Chlorambucil and prednisone (Chl+PDN). The 2 schedules included an induction phase, where Chlorambucil was given at 6mg/mq for 6 consecutive weeks in both groups and the Rituximab in 4 weekly administrations. The maintenance phase was longer in the Chl+PDN group: Chlorambucil was administered 6mg/mq daily 14 days each month for a total of 12-months of treatment versus 14 days with monthly-Rituximab for 4 consecutive months in the R-Chl group. Results: The demographic and prognostic factors are reported in Table 1. At the end of treatment the ORR was 98% in the R-Chl pts and 77% in the Chl+PDN group, with a percentage of complete response of 79% and 55% respectively. No significant incidence of adverse events were reported and only one HBsAg positive patient in R-Chl group discontinued the therapy. One case of myelodysplastic syndrome was described in a Chl+PDN relapsed patient. With a median follow up of 34 months, the OS and the EFS in R-Chl pts is 95% and 76% respectively. Otherwise, with a median observation time of 82 months in the Chl+PDN group 73% are alive and only 28% of pts maintained the response. The median time to subsequent therapy (TTST) is 21 and 15 months respectively in the 2 groups. Conclusions: The addition of Rituximab to alkylating in first-line treatment in previously untreated FL pts improves significantly the EFS and prolongs the time to next antilymphoma therapy compared with alkylating alone. Because of its low toxicity profile, our combination with Rituximab and Chlorambucil could be considered a first-line therapy, especially in FL patients not eligible for aggressive chemotherapy regimens. Disclosures: No relevant conflicts of interest to declare.

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