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e19542Background: Prognosis of diffuse large B cell lymphoma (DLBCL) patients depends on lymphoma and patient-related risk factors, best summarized in IPI (International Prognostic Index). The aim ...

Purpose A randomized trial of oblimersen plus fludarabine/cyclophosphamide (OBL-FC; n = 120) versus FC (n = 121) was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). The primary end point was met: the complete response (CR) rate, defined as complete or nodular partial response, was significantly greater with OBL-FC than with FC (17% v 7%; P = .025). Among patients with CR, response duration was significantly longer with OBL-FC than with FC (median not reached; > 36 months v 22 months; P = .03). Maximum benefit with OBL-FC, including a four-fold increase in CR rate and a survival benefit with 3 years of follow-up (hazard ratio, 0.53; P = .05), was observed in patients with fludarabine-sensitive disease. We evaluated long-term survival and poststudy CLL therapy among all randomly assigned patients. Methods Poststudy CLL treatment information was collected. Patients were observed for survival for up to 5 years from the date of random assignment. Results Poststudy CLL treatment was balanced between arms. Intent-to-treat analysis of 5-year survival showed no significant between-treatment difference (hazard ratio, 0.87; P = .34). Among the greater than 40% of patients with complete or partial remission, a significant 5-year survival benefit was observed with OBL-FC (hazard ratio, 0.60; P = .038). Among patients with fludarabine-sensitive disease who had previously demonstrated maximum benefit with OBL-FC, the previously observed survival benefit improved: a 50% reduction in the risk of death was observed (P = .004). Conclusion In relapsed/refractory CLL, OBL combined with FC offers patients who achieve complete or partial remission, as well as those who have fludarabine-sensitive disease, a significant survival benefit.

e19515 Background: Advances in anti-lymphoma therapy and subsequent prolongation of overall survival, make doxorubicin cardiotoxicity an important clinical issue. Methods: Doxorubicin cardiotoxicit...

e18532 Background: Cardiovascular (CVS) system disorders in Poland are responsible for 52% of all deaths and 18% loss of DALY (disability-adjusted life year), compared to 38% and 11% in US respecti...

e18520 Background: CNS relapse is a life threatening complication of 5-10% high risk aggressive NHL. Safety and efficacy of Liposomal Cytarabine as CNS relapse prophylaxis was assessed in a retrosp...

e18519 Background: Mantle cell lymphoma (MCL) is a rare subtype (3-9%) of non-Hodgkin lymphoma (NHL) with a relatively poor prognosis (5-year survival < 40%). Consolidation with autologous stem cel...

6588 Background: The phase of chronic myeloid leukemia (CML) at diagnosis (dx) remains significant prognostic factor for the outcome of therapy with tyrosine kinase inhibitors (TKI) therefore patie...

e19510 Background: In MCL, early intensification and consolidation of the first line therapy by ASCT is the treatment of choice. Elderly age and co-existing co-morbidities makes it however feasible for less than a third of patients. Methods: All MCL cases consulted in 8 PLRG centers within the last 5 years (n=140) were included in a retrospective analysis. Only 23% (n=32) were consolidated with ASCT, further 28% (n=40) by radioimmunotherapy (Ibritumomab), while in 49% (n=68) neither consolidation was performed. Rituximab was used in 36/72 patients subjected to consolidation and 25/68 treated without consolidation. There were no statistically significant differences in IPI, CS (clinical stage), frequency of extranodal manifestations and B symptoms between analyzed subgroups ( Table ) although patients subjected to ASCT were younger (median age 54 vs 62) and tend to have higher LDH (556 IU vs 473), while those who were not consolidated more frequently had a large tumor burden (defined as a mass > 7 cm, 24 vs 15%). Results: There was a clear impact of consolidation on overall and progression-free survival (OS,PFS): at 5 years OS 65 vs 20 % (p= 0.0003 in Gehan Wilcoxon test); and PFS 40 vs 0 % (p= 0.0003 in Gehan Wilcoxon test). Rituximab used in the first line therapy further increased it's efficiency in terms of PFS, prolonging median time to progression from 15 to 26 months, however the OS benefit was seen only in consolidated patients (at 5 years 75% OS in those with Rituximab including induction followed by consolidation). Conclusions: With all limitations of retrospective analysis, it strongly supports the necessity of post induction therapy in MCL patients. The role of ASCT is established in younger patients, radioimmunotherapy may prove to be a feasible approach for the elderly and unfit ones. [Table: see text] No significant financial relationships to disclose.

8541 Background: In Europe both ABVD and escalated BEACOPP regimens are considered as a “standard therapies”. In our previous analysis (ASCO 2007, Abstract No. 8063), patients with advanced disease...

8063 Background: HD patients with high risk have a relatively poor prognosis with less than 50% 5-year overall survival (OS) if treated with ABVD regimen. Methods: Therapy results of all 105 patients with advanced HL (CS IIBX -IV) treated from diagnosis at our Department in the last decade, are presented. The choice of initial 3 cycles between ABVD and escalated BEACOPP was done at the patients preferal and physician's adivice. Further 3 chemotherapy cycles depended on initial response assessment: poorly responding ABVD treated patients were offered therapy escalation. Patients with a good response (over 80% regression) after the first 3 cycles were later treated with ABVD. EFS and OS were primary endpoints of the study. Results: We divided patients into 2 treatment groups, depending on the first 3 cycles (escalated BEACOPP n = 57 or ABVD n = 48). Poor response resulting in therapy intensification was not considered as an event defined only as a relapse or progression during therapy. There was a statistically insignificant imbalance between the risk factor distribution with less favorable prognosis in patients treated with esc BEACOPP: 38 % of pts in IV th clinical stage (as compared to 31% in ABVD group), 3,08 EORTC risk factors (as compared to 2,64 in ABVD group) and 2,19 according to German Hodgkin Study Group (1.93 respectively). Increased toxicity of esc BEACOPP regimen was due to grade 3/4 cytopaenia (present in all patients) resulting in more infection episodes (according to WHO scale stage 3 - 16 pts , stage 4 - 8 pts; in ABVD group, 2 and 1 pt respectively). There were no treatment related mortalities. In esc BEACOPP projected 5 y OS was 96% and EFS 89% , which is comparable to GHSG results. 5 y OS and EFS in ABVD group are 87% and 66% respectively. The difference in EFS is statistically significant (p< 0.05). Conclusions: In our study we checked the feasibility of esc BEACOPP regimen in high risk HD pts. The results show the importance of the intensity of the first line approach. In the poor responders after the initial 3 cycles, even early treatment intensification, didn’t improve the outcome. De-escalation of therapy after the first 3 cycles, in good responders, didn’t make OS and EFS inferior to GHSG results in which they recommend 6 cycles of esc BEACOPP therapy. No significant financial relationships to disclose.

7035 Background: CAM307 is a phase III, open-label, randomized controlled trial comparing alemtuzumab (CAM) with chlorambucil (CHLO) for previously untreated B-CLL. Methods: The trial enrolled 297 previously untreated patients requiring therapy according to NCI-WG criteria. Patients were randomized 1:1 to CAM (n=149) vs CHLO (n=148) using standard dosing regimens. Diagnosis, Rai stage, response and disease progression were confirmed by an independent response review panel. In the overall study population, CAM demonstrated significantly higher overall response rates (ORR) than CHLO (83 % vs 55%) and a significant improvement in PFS (p= 0.0001) with manageable toxicities1. Outcomes according to Rai stage and cytogenetics have been previously reported.1,2 A pre-specified subgroup analysis of response rates (RR) and progression-free survival (PFS) by prognostic factors was performed. Results: Additional analyses revealed statistically significant PFS advantage in favor for CAM vs. CHLO for patients with β-2 microglobulin =3 mg/L (p No significant financial relationships to disclose. [Table: see text]

7533 Background: Radioimmunotherapy (RIT) has demonstrated high clinical efficacy in follicular lymphoma but varying results in mantle cell lymphoma (MCL). Methods: We performed a comparative analysis of two phase II studies with similar inclusion criteria to identify potential predictors of response. 32 patients with relapsed or refractory MCL, WHO performance status ≤2, appropriate hematopoesis (ANC > 1,500/mm3, platelets > 100,000/mm3) and adequate function of liver and kidneys were treated with RIT upfront (Arm A, n = 16) or as consolidation after initial cytoreduction (Arm B, n = 16). 28 patients (88%) had been previously treated with rituximab. Patients with >25% bone marrow involvement, known CNS lymphoma, HIV infection or other severe concurrent disease were excluded. Ibritumomab tiuxetan (Zevalin) was applied at a dose of 15 MBq 90Y/kg, whereas patients with reduced platelet counts (3) received 11 MBq 90Y/kg. Results: The median age was 66.9 years (range 58–72) in Arm A and 63.1 years (range 45–79) in Arm B. The median number of prior regimens was 4 (range 2–6) in Arm A and 1 (1–5) in Arm B. RIT treatment was generally well tolerated with the most common toxicities being hematologic. Thrombocytopenia grade 3 and 4 was observed in 69% of patients, one patient died of hemorrhagic stroke. Granulocytopenia grade 4 occurred in 34% of patients, one patient developed a grade 4 infectious complication. Currently 22 patients are evaluable for response rate and duration of remission (DR). In Arm A a partial response (PR) was observed in 2 of 6 evaluable patients (33.3%) with a median DR of 3.9 months only. In Arm B chemoinduction achieved 2 complete responses (CR) and 14 PR. Following RIT seven of 14 PR patients (50%) converted to CR. Currently, 13 of 16 patients (81%) are still in remission. As expected the most important adverse risk factor was bulky disease before RIT with no responses seen in this patient population. Patients with less prior therapeutic lines (< 2) had significantly higher response rates. Conclusions: In future trials, RIT should be applied earlier in the treatment algorithm of MCL after a debulking strategy with combined immuno-chemotherapy. [Table: see text]

6601 Background: CAM307, a phase III, open-label, randomized comparative trial, enrolled 297 Rai stage I-IV BCLL patients with previously untreated, progressive disease requiring treatment. Patients were randomized to treatment with CAM (n=149) vs. CHLO (n=148) using standard dosing regimens. Methods: Cytogenetic assessment was conducted prior to the start of protocol-specified therapy. Chromosomal aberrations were detected by fluorescence in situ hybridization (FISH) using specific probes. Molecular cytogenetic analyses by FISH included deletions (del) 6q21, 6q telomere, 11q22–23, 13q14–14.3 and 17p13; trisomy bands of 8q24 and 12p11.1-q11.1. Results: A total of 271 patients have been evaluated. Chromosomal aberrations were detected in 207 patients (76%) while 64 patients (24%) exhibited normal karyotype. Cytogenetic abnormalities were evaluated by response [overall response rate (ORR) and complete response (CR)] to each therapy based upon an independent response review. The comparisons of ORR and CR between treatment arms for each mutation type were calculated using the Exact method. Conclusions: Preliminarydata demonstrate a statistically significant superior response to CAM in patients with del 13q (ORR and CR) and del 11q (ORR) as well as a statistically significant superior CR to CAM in patients with normal cytogenetics. In addition, although the sample size is small, there is a trend towards a better ORR in patients with del 17p. Further exploration of CAM response rates relative to cytogenetic abnormality is warranted. [Table: see text] [Table: see text]

6563 Background: CAM307, a Phase III, open-label, international, randomized trial compares efficacy and safety of alemtuzumab (CAMPATH, MABCAMPATH® [CAM]) to chlorambucil (CHLO) in B-CLL. Methods: ...

6728 Background: Standard staging procedures in Hodgkin's disease (HD) include full physical examination and imaging studies: usually CT scan of the chest and abdomen. In case of low grade lymphoma...

6641 Background: According to current EBMT recommendations 2.0 x 106 CD34 positive cells /kg is regarded as adequate transplant material, capable to reconstitute hematopoiesis after high dose chemo...