ALBERT

Description: Abstract 2714 Background: The addition of immunotherapy–rituximab–to the treatment regimen of follicular lymphomas has led to a significant improvement in therapeutic efficacy. In the mid-2000's, immuno-chemotherapy was approved by European authorities as part of the induction treatment for untreated and relapsed follicular lymphomas followed by maintenance therapy. Data about efficacy and safety of rituximab maintenance following first-line induction with R-CVP or R-CHOP have not been available. Therefore the Hungarian National Working-Group initiated a trial: Hungarian Study of Maintenance after Rituximab Pretreatment. Methods: Between July 2005 and December 2008 126 newly diagnosed patients with follicular lymphoma who had achieved partial or complete remission after induction treatment with either R-CVP or R-CHOP were treated with two years of rituximab maintenance. In this open-label, single-arm study rituximab was administered in standard dose (375 mg/m2) every 8 weeks, 12 times in total. Results: 126 patients have been included. Data of 99 patients are available for this interim analysis. Average age of the 30 male (30%) and 69 female (70%) patients were 53.2 (29–80) years. Histological subtypes were grade-1 in 32% of patients, grade-2 in 49%, and grade-3a in 19%. Twenty-eight percent of patients had tumors with size over 7 cm. Sixty-four percent of patients were in the moderate risk group (FLIPI: 1–2) and 36% in the high risk group. Fifty-six percent of patients received R-CVP and 44% R-CHOP induction treatment. After induction 61% achieved complete remission and 39% partial remission. With respect to induction treatment regimen, patients treated with R-CVP 52% showed CR and 48% PR. In patients treated with R-CHOP 75% had CR and 25% had PR. Fourteen patients (37%) in PR converted to CR during or after rituximab maintenance therapy. Three-year OS after initiation of maintenance was 94%, EFS was 84%, and PFS was 88%. With respect to FLIPI, OS rates were 97% and 89% for moderate and high risk groups respectively. Patients treated with R-CHOP achieved significantly better PFS (98% vs. 80%; p=0.0096) and EFS (93% vs. 76%; p=0.0332) than those treated with R-CVP. Patients achieving CR compared to PR showed significantly higher PFS (100% vs. 68 %; p

Description: Abstract 5050 Introduction: We aimed to investigate the effect of bortezomib-based induction therapy for the treatment of transplant-eligible multiple myeloma (MM) patients, as compared to non-bortezomib-based treatments, in daily clinical practice. Patients and methods: All 122 transplant eligible MM patients treated at our center between 2003 and 2011 were reviewed retrospectively without selection. Patients had received induction with or without a bortezomib-based regimen, followed by high dose therapy (single Mel200+APSCT). The group consistend of 64 males and 58 females, mean age: 55, 2±8, 7 year. 45, 9% of the patients had IgGκ (56), 18% IgGλ (22), 10, 6% IgAκ (13), 7, 3% IgAλ (9), 0, 8% IgMκ (1), 3, 2% κ (4), 10, 6% λ (13), and 3, 2% had non secretory (4) MM. Bone marrow FISH analysis revealed del-13q in 2 cases, monosomy 13 in 14, t4:14 in 1, monosomy 13 + del 17p in 1. Plasma cell leukemia (primary and secondary) was found in 2 cases. Induction therapy was applied either in our center, or patients were referred to us to perform high dose therapy after induction therapy given in other regional hematology departments. Due to regulatory reasons, patients mainly received non-bortezomib containing induction (VAD, thal-dex 78%, bortezomib-based 22%) until 2008. Later predominantly bortezomib-based therapy was used (69%, mainly VTD or PAD), the remaining (mainly those referred to our center) cases had thal-dex, or CTD induction. Results: Patients without bortezomib in induction: The mean followup of the 22 patients who did not receive bortezomib as part of induction was 53. 2+21. 9 month, 14 of them died (66, 7%) during followup. Median survival reached at 38 month following induction, or if calculated after completion of high dose therapy median survival was 52 month. Patients with bortezomib based induction. The mean follow-up time of this 100 patients time was 44, 5+ 27, 6 months. 25 pts died (25%) and survival probability at 50 month from the initation of induction was 69. 8 % in these patients compared to the 40. 7% estimated survival for the patients without bortezomib (p

Description: Abstract 4889 Background: Considering the especially poor outcome of mantle cell lymphoma with traditional induction chemotherapies, the Hungarian working group initiated a Hungarian Mantle Cell Lymphoma Study (REMENY) using rituximab (MabThera) based immunochemotherapy. The structure of the trial: National, multicenter, open label trial rituximab based immunochemotherapy induction in mantle cell lymphoma. Two therapies were available according to investigators' choice: R-CHOP-21 (8x) or R-HyperC-VAD/R-MA according to the MD Anderson protocol. High dose therapy + autologous stem cell support (ASCT) was allowed, according to the investigators decision. Diagnosis was based upon standard histology. Initial staging included the standard protocols, imaging techniques, bone marrow evaluation and gastrointestinal endoscopy (not compulsory at initial staging). Recruitment period was planned to be 3 years, the follow-up 2 years. Remission was evaluated according to Cheson (IWC) criteria,CR was qualified only after completion of gastroscopy and colonoscopy, which did not reveal any mantle cell related abnormality. In some cases FDG PET-CT was allowed to substitute for endoscopy. Primary endpoints: OS and PFS, safety Results: Recruitment started in June 2007 and completed unexpectedly early (Nov 2008). 48 patients were included, per protocol Patients were 31 (64.58%), follow-up (24 months) was completed for 15 (31.25%) patients. Ann Arbor III-IV B 43 (89.58%) was dominant. Median PFS for all patients was 30.4 months (SD 5.839, 95% CI: 19–41.9). PFS median for those patients who reached a CR has not been reached while it was 23.7 months in PR (p=0.031). Safety: One hundred-thirteen adverse events occurred in 31 (64.58%) patients; 53 serious adverse events in 15 (31.25%) patients: 17 cytopenia, including fever with neutropenia 7, transient bronchospasm during rituximab (MabThera) infusion 1, hyperglycemia 1 which may be treatment related. There were 20 death cases, 13 of them due to progression of disease, two due to septic complication, three heart failures and one second malignancy (breast cancer). Significantly more patients on the R-HyperC-VAD/R-MA arm experienced adverse events (11/12 patients, 91.6%) compared to R-CHOP (20/36, 55.5%, p=0.035). Conclusion: This trial further confirmed the value of adding rituximab to standard induction therapies in mantle cell lymphoma. The results are conforming to data published in literature. Higher percentage of patients completed R-CHOP regimen. R-HyperC-VAD/R-MA was more effective in inducing CR, but could be completed only in one third of patients. However, in those patients who adhered to R-HyperC-VAD/R-MA therapy, it resulted in 80% CR, vs. 42.3% in the R-CHOP group. This difference is not statistically significant (p=0.172) possibly due to low case numbers. Those patients who reached CR had significantly longer PFS. PFS obtained in this trial is comparable to international data, and could be further improved by adding immunotherapy maintenance. Planned total number of patients (48) entered the trial during the first 12 months. This was surprising, as the expected number of mantle cell lymphoma based on the international incidence data is cca. 30–35 yearly. The unexpectedly high patient numbers need further explanation. Disclosures: Off Label Use: Rituximab is not authorized for Mantle Cell Lymphoma in Hungary.