ALBERT

Description: Introduction: High standardized uptake value (SUV) on FDG PET scan in follicular lymphoma (FL) suggests aggressive disease and possible transformation to diffuse large B-cell lymphoma. Schoder et al, J Clin Oncol, 2005, reported that SUV 〉10 predicted aggressive lymphoma with 〉80% certainty and SUV 〉13 with 〉90% certainty. However, it is unknown whether the maximum SUV (SUVmax) on FDG PET scan at baseline, suggesting the possibility of focal aggressive or transformed disease, has prognostic value in FL. Here, we determined the prognostic value of SUVmax on baseline FDG PET scan in patients with advanced stage FL treated uniformly with R-CHOP chemoimmunotherapy at initial diagnosis. Methods: We reviewed medical records of all patients with stage III or IV FL who had FDG PET scan at initial diagnosis and were treated with R-CHOP chemoimmunotherapy at MD Anderson Cancer Center between January 2001 and December 2012. Patients with histological diagnosis of concurrent diffuse large B-cell lymphoma were excluded. Results: For the 225 patients studied, the median age was 57 years (range, 20-82). 83 (37%) patients were 〉= age 60, 137 (61%) had grade 1 or 2 FL, and 88 (39%) had grade 3A (n=57, 25%) or 3B (n=31, 14%). The Ki-67 score was 40% for 56 (40%) patients. FLIPI risk groups were 54 patients (24%) low, 74 (33%) intermediate, and 97 (43%) high. GELF criteria were met in 133 (59%) patients. Tumor bulk of 〉= 6 cm was seen in 97 (43%) patients. The absolute lymphocyte count (ALC) was normal or high in 155 (69%) patients and low in 70 (31%). Sixty-nine (31%) patients received rituximab maintenance. There was no correlation between baseline SUVmax on FDG PET scan and Ki-67 score (Pearson correlation co-efficient of 0.168). The overall and complete response rates were 96% and 87%, respectively. The median follow-up time was 66 months. At 5 years, progression-free survival (PFS) was 85% and overall survival (OS) was 90%. Male gender, stage IV, high risk FLIPI, presence of GELF criteria, high beta-2 microglobulin, and low ALC were associated with significantly inferior PFS and OS (p= 60 was associated with inferior OS but not PFS. Rituximab maintenance was associated with improved PFS but not OS. On baseline FDG PET scan, median SUVmax was 13.7 and the SUVmax range was 1.5-42.1. 105 (47%) patients had SUVmax 13. Patient characteristics including age, gender, histological grade, Ki-67 score, and FLIPI risk groups were not significantly different between the two SUVmax populations (p〉0.05). The overall response rates were 94% and 96% for the SUVmax 13 groups, respectively. The complete response rate was 87% in both groups. At 5 years, the PFS and OS were not significantly different between the low and high SUVmax groups (61% vs 63% for PFS, p=0.98 and 90% vs 89% for OS, p=0.63). PFS and OS were not significantly different even when the patients were grouped into SUVmax 10 (p=0.9 and 0.61, respectively) or when other cut-offs were used. SUVmax was also not predictive of PFS and OS when only the patients meeting GELF criteria were analyzed. Conclusions: In this large cohort of advanced stage FL patients treated uniformly with R-CHOP chemoimmunotherapy, SUVmax on baseline FDG PET scan was not predictive of clinical outcome or correlated with other features. It is possible that the doxorubicin-based chemotherapy regimen may have benefited patients with high SUVmax who may have underlying aggressive or undiagnosed transformed disease. It remains to be determined whether SUVmax is predictive of clinical outcome in FL patients treated with other commonly used therapies such as rituximab monotherapy, rituximab and bendamustine, or R-CVP. Figure 1 Figure 1. Disclosures Wang: Pharmacyclics, Janssen: Honoraria, Research Funding. Westin:Novartis: Research Funding.

Description: Background: Primary mediastinal (PMBL), GCB and non-GCB B-cell lymphoma are three major subtypes of DLBCL with distinct clinical outcomes. PMBL and DLBCL of GCB immunophenotype have a higher chance of cure than patients with non-GCB DLBCL when treated with conventional chemotherapy. In the relapsed/refractory setting, there is paucity of data regarding the impact of histological classification of DLBCL on survival following alloSCT in patients who were not eligible for or who have failed a prior autologous SCT (ASCT). Herein, we compare outcomes of alloSCT in these patients. Methods and Patients: We identified 101 de novo DLBCL patients who were treated at our center from January 1, 1998 to December 31, 2011. Seventeen (17%) tumors were PMBL. We determined the cell-of-origin in the remaining patients, based upon the Visco/Young and Choi immunohistochemical algorithms, and classified 62 (61%) as GCB and 22 (22%) as non-GCB tumors. GCB patients were older than non-GCB [median (range): 54 (21-70) vs 48(24-58) years, p=0.003)] and PMBL [26(19-48), P

Description: Purpose: We assessed the survival outcome of patients with anaplastic large cell lymphoma (ALCL) who experienced disease progression or relapse after first line and subsequent therapy. We sought to evaluate the impact of brentuximab vedotin (BV), and survival outcome of patients with ALCL who experienced progression after BV. Patients and Methods: A total of 176 patients (74 ALK+, 102 ALK-) initially diagnosed between 1999 and 2014 were retrospectively analyzed. Progression-free survival (PFS) and overall survival (OS) after the progression/relapse following first-line chemotherapy (PFS1 and OS1), after first salvage therapy (PFS2 and OS2) and after second salvage therapy (PFS3 and OS3) were calculated. Outcome was separately analyzed according to the ALK status focusing on the use of BV. Results: The median age of the patients was 50 (range: 18-89). With a median follow up of 64 months, 111 patients (38 ALK+, 73 ALK-) experienced progression/relapse after the first-line therapy, of which 4 ALK- patients were post upfront stem cell transplant (SCT). Thirty and 15 patients eventually underwent autologous and allogeneic SCT after salvage chemotherapy, respectively. The median PFS1 and OS1 in patients with ALK+ALCL and ALK-ALCL were 8.4 and 28.5 months, and 13.1 and 47.7 months, respectively. In patients with ALK+ALCL, the median PFS1, PFS2 and PFS3 were 53.6, 5.2 and 2.3 months, respectively. The median OS1, OS2 and OS3 were not reached, 47.3 and 6.1 months, respectively. In patients with ALK-ALCL, the median PFS1, PFS2 and PFS3 were 12.9, 3.0 and 2.0 months, respectively. The median OS1, OS2 and OS3 were 54.3, 10.8 and 5.8 months, respectively. Interestingly, there were no significant difference in PFS2 between ALK+ALCL and ALK-ALCL. However, OS2 was significantly longer in patients with ALK+ALCL, suggesting possibly continued chemosensitivity of recurrent ALK+ALCL. A total of 30 patients received BV in 1st salvage (15 patients) and after 2nd salvage (15 patients).The use of BV at 1st salvage was associated with significantly longer PFS2 and OS2 both in patients with ALK-ALCL but not with ALK+ALCL likely due to small number of cases. Mutivariate analysis adjusting baseline PIT risk factors and the duration of the response to first line therapy revealed that use of BV (at any point in the salvage setting) is significantly associated with longer OS2 (HR: 0.43, 95%CI: 0.23-0.80). Overall, 12 patients experienced relapse/progression after BV treatment. The median OS after BV failure was 1.4 months (95%CI: 0.5-9.5 months) (Figure). Summary: Survival outcome for relapsed/refractory patients with ALK+ and ALK- patients is improved with BV. However, survival outcome after BV failure is very poor. A new treatment strategies to consolidate or maintain the response after BV and to develop more safe and better therapeutic options are needed. Figure 1. Figure 1. Disclosures Fanale: Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Honoraria, Research Funding; Infinity: Membership on an entity's Board of Directors or advisory committees; Spectrum: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Research Funding; Genentech: Research Funding; Medimmune: Research Funding; Novartis: Research Funding; Bayer: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Molecular Templates: Research Funding; ADC Therapeutics: Research Funding; Onyx: Research Funding; Gilead: Research Funding. Westin:Spectrum: Research Funding. Nastoupil:Celgene: Honoraria; Genentech: Honoraria; AbbVie: Research Funding; Janssen: Research Funding; TG Therapeutics: Research Funding. Wang:Celgene: Research Funding.

Description: Key Points BFR is an effective allogeneic conditioning for chronic lymphocytic leukemia/lymphoma. Remarkably, this BFR regimen resulted in a low incidence of myelosuppression and severe acute GVHD.

Description: Introduction: Mantle cell lymphoma (MCL) is a rare and incurable subtype of B-cell lymphoma. Intense chemo-immunotherapy with 8 cycles of Rituximab-HyperCVAD alternating with Rituximab-Methotrexate-Ara C is associated with an overall survival of 10.7 years but the 10-year cumulative incidence of therapy-related myeloid neoplasm was 6.2%. The ibrutinib-rituximab combination has produced durable responses in 88% of patients with relapsed and refractory MCL with acceptable toxicity. This gives rise to a "Window" of opportunity to use chemotherapy-free induction with ibrutinib plus rituximab followed by fewer cycles of chemo-immunotherapy consolidation in young and fit patients with newly-diagnosed, untreated MCL. Methods: Enrolment began in June 2015 for a Phase II single-center clinical trial consisting of an initial chemotherapy-free phase (window) of ibrutinib and rituximab combination treatment in Part 1 until best response, followed by a shortened course of intense chemo-immunotherapy in Part 2 among young newly diagnosed MCL patients of ≤65 years. The primary objective was to evaluate the response rate of ibrutinib plus rituximab. The secondary objectives were to evaluate the progression free survival (PFS) of ibrutinib plus rituximab after consolidation with a shortened number of cycles of intense chemo-immunotherapy, and to further evaluate the toxicity profile. Ibrutinib is dosed at 560 mg orally, daily, continuously. Rituximab is dosed at 375 mg/m2 IV weekly x 4 during cycle 1 (28 days cycle), then day 1 of cycles 3-12. Intense chemo-immunotherapy consists of rituximab plus cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD); alternating every 28 days with rituximab plus high-dose methotrexate-Ara C. If in complete remission (CR) after initial ibrutinib and rituximab treatment, a total of 4 additional treatments of intense chemo-immunotherapy are given. If the patient is in partial response or progression, and if responding to intensive chemo-immunotherapy, a total of 2 cycles of chemo-immunotherapy therapy are administered beyond achievement of CR. Results: As of August 2, 2016, we have completed the target enrolment by accruing 50 out 50 patients with newly-diagnosed untreated MCL. Forty one (n=41) patients have begun treatment and 36 are evaluable for response. Of the 36 evaluable patients, overall response rate (ORR) to Part 1 alone (Ibrutinib plus rituximab) is 100% (n=36) with PR in 28% (n=10) and CR in 72% (n=20). Nineteen 19 patients have completed both Part 1 (ibrutinib and rituximab) and Part 2 (chemo-immunotherapy). The ORR to both Part 1 and Part 2 (n=19) was 100% and was equal to the CR rate (100%, n=19), i.e. all have achieved a CR to Part 1 and Part 2. Toxicities are recorded as the number of patients experiencing a certain adverse event. Regardless of their relation to study drug in Part 1, the most common grade 1-2 non-haematological (non-heme) adverse effects (AEs) are fatigue (n=40), diarrhea (n=25), rash (n=24), myalgia (n=22), oral mucositis (n=17), peripheral neuropathy (n=15), nausea (n=14), blurred vision (n=14), edema (n=13), constipation (n=12), headache (n=11), dry eyes (n=9), dizziness (n=9) and watery eyes (n=6). Grade 3 non-heme AEs included fatigue (n=3), nausea (n=0), rash (n=1), pleural effusion (n=1), infection (n=2) and dyspnea (n=1). There was no grade 4 or grade 5 non-heme toxicities in Part 1. In part 2, common grade 1-2 hematological (heme) AEs was anemia (n=13). Grade 3-4 haematological AEs included neutropenia (n=2), ALT increase (n=1) and febrile neutropenia (n=1). In Part 2, there was no grade 5 hematologic toxicity. The toxicity after intensive immune-chemotherapy in shortened cycles are much improved compared to historical controls but longer follow-up is needed. Conclusions: Preliminary data indicate that the chemotherapy-free induction with ibrutinib and rituximab in newly diagnosed, young MCL patients was efficacious and well-tolerated. This unprecedented efficacy and safety may provide a window of opportunity for less chemo-immunotherapy needed for consolidation. Table Preliminary findings form the Window Study: a phase II clinical trial Table. Preliminary findings form the Window Study: a phase II clinical trial Disclosures Wang: Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Onyx: Research Funding; BeiGene: Research Funding; Pharmacyclics: Research Funding; Kite Pharma: Research Funding; Asana BioSciences: Research Funding; Juno Therapeutics: Research Funding; Acerta Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Research Funding. Fayad:Seattle Genetics: Consultancy, Research Funding.

Description: Abstract 1037 Poster Board I-59 Background: Voreloxin is a first-in-class anticancer quinolone derivative (AQD) that intercalates DNA and inhibits topoisomerase II, inducing apoptosis. Interim results of REVEAL-1, a Phase 2 (Ph 2) dose regimen optimization study of 3 schedules (sch) of single agent voreloxin in newly diagnosed elderly acute myeloid leukemia (AML) patients (pts), are reported. The initial dose regimen, voreloxin 72 mg/m2 qw x 3, was established in a Ph 1 dose-escalation study in relapsed/refractory leukemia pts (Lancet J et al., Proc ASH 2007). Overall remission rate (ORR = CR+CRp) was high (41%), but this regimen was less well tolerated in the frontline elderly population. The protocol explored 2 alternative voreloxin sch: 72 mg/m2 voreloxin qw x 2 and days 1 and 4 (d 1,4). A final cohort of pts is enrolling to the d 1,4 sch at 90 mg/m2. Dose escalation was based on safety data from the 72 mg/m2 cohort and from an ongoing Ph 1b/2 study of 90 mg/m2 voreloxin d 1,4 in combination with 1g/m2/d cytarabine x 5d (Lancet J, et al, ASCO 2009). Methods: Ph 2 study of 3 voreloxin sch (30 pts/sch): A 72 mg/m2 qw x 3 or B 72 mg/m2 qw x 2 or C 72 mg/m2 on d 1,4. C at 90 mg/m2 voreloxin is now enrolling to 20 pts. Eligibility: newly diagnosed AML (de novo or secondary AML), pts age ≥ 60 with ≥ 1 additional adverse risk factor (age ≥ 70, secondary AML, intermediate or unfavorable cytogenetics, or PS 2). PK were evaluated in a pt subset in cycle 1. Patient bone marrow aspirates (BMA) taken prior to dosing were tested ex vivo for extreme drug resistance (EDR®) to voreloxin. Results: To date, 105 pts have been treated. Preliminary safety and ORR are available for A, B and C at 72 mg/m2 voreloxin. Twelve pts in C at 90 mg/m2 are too early to evaluate (TETE). Overall incidence of infections and mucositis were reduced in B and C, sch with 2 voreloxin doses, relative to A which had 3 voreloxin doses. Voreloxin PK were similar to those in an earlier Ph 1 study in relapsed/refractory AML (Lancet J, et al., Proc ASH 2007). Pts whose BMA were inhibited 〈 48% by 1 μM voreloxin had a greater chance of treatment failure (p = 0.043) than those whose BMA were inhibited by ≥ 48%. Conclusions: In REVEAL-1, voreloxin demonstrates clinical activity with 3 dosing sch in previously untreated elderly (age ≥ 60) AML pts who are unlikely to benefit from standard chemotherapy. ORR across 3 sch was 35%; the majority (76%) were CR. Responses were seen in each risk factor category and with multiple risk factors. Of reinduced pts, 45% achieved CR(p). Durable remissions exceeding 6 months were observed in 50% (A) and 63% (B) thus far. C d 1,4 was selected for further development based on ORR (38%), 30 and 60 day all-cause mortality (7% and 14%, respectively) and an improved safety profile with lower rates of infection compared to previous schedules. Further accrual to C 90 mg/m2voreloxin d 1,4 is ongoing. Disclosures: Ravandi: Sunesis: sunesis study steering committee. Cripe:Sunesis: Research Funding. Chen:sunesis: Employment. Mahadocon:sunesis: Employment. Fox:Sunesis: Employment. Berman:Sunesis: Employment. Michelson:sunesis: Employment. Stuart:sunesis: sunesis study steering committee.

Description: Therapeutic options for chronic lymphocytic leukemia (CLL) at relapse are limited because of myelosuppressive toxicity. Denileukin diftitox (ONTAK®, Ligand Pharmaceuticals) is a genetically engineered fusion protein comprising the enzymatically active domain of diphtheria toxin and the full length sequence of interleukin-2 (IL-2) targeting malignancies expressing the medium and high affinity IL-2 receptors. We designed a phase II study to evaluate the efficacy of ONTAK® in patients with fludarabine-refractory CLL, which is a follow-up to the previously published study (Frankel, et al, Clin. Cancer Res.2003; 9:3555). Denileukin diftitox was administered at a dose of 18μg/kg IV daily for 5 days every 3 weeks, for a maximum of 8 cycles. Thirteen patients have been treated so far, with 10 patients being evaluable for response (completed ≥ 3 cycles). Median age was 59 years (range 44–84), and 62% (8/13) were Rai stage III-IV, with a median of 3 prior therapies (range 1–6). The overall response was 40%, with 1 CR (10%, duration of response 5+ months) and 3 PR (30%, duration of response 3+, 3+ and 4+ months). Two responding patients (both PR) are still on study, while two (1 CR, 1 PR) were removed from study because of toxicities after 7 and 5 cycles, respectively. Four patients (40%) had progressive disease after cycles 3, 4, 4, and 7, respectively. One patient has completed four cycles and restaging studies are pending. Of the 3 patients not evaluable for response, two are still on study (having not completed 3 cycles), while one refused further treatment after 4 doses of cycle one. The grade 3/4 toxicities encountered were: neutropenia 4/13, thrombocytopenia 4/13, vascular leak syndrome 3/13, left ventricular cardiac dysfunction 1/13, hypotension 2/13, tachyarrhythmia 3/13, elevated PT 1/13, fatigue 1/13, rash 1/13, SIADH 1/13, constipation 1/13, vomiting 2/13, petechiae 1/13, transient elevation of GGT 1/13, transient elevation of AST/ALT 7/13, hyperglycemia 4/13, electrolyte imbalance 8/13, infection and/or febrile neutropenia 4/13, insomnia 1/13, visual disturbance 1/13, dyspnea 2/13, hypoxia 2/13. We conclude that denileukin diftitox has activity in CLL, with toxicities that can be managed with adequate premedication and close monitoring.

Description: Background: Patients with advanced indolent non-Hodgkin lymphoma (iNHL) can develop chemoresistance and most relapse following standard therapy. Lenalidomide activates NK cells ± T cells and leads to in vivo expansion of immune effector cells in NHL models. In preclinical studies, we have shown the synergistic anti-tumor effect of combining lenalidomide with anti-CD20 molecules. (Wang 2007) The combination of rituximab and lenalidomide (R2) in relapsed and untreated iNHL is highly active. (Fowler 2014) We hypothesize these responses are related to augmentation of immune response and ADCC through alteration of immune cell subsets in tumor and peripheral blood. Obinutuzumab is a glycosylated type II anti-CD20 molecule with enhanced affinity for the FcγRIIIa receptors leading to improved ADCC. The primary objective of this study was to determine the safety and maximum tolerated dose of lenalidomide and obinutuzumab in patients with relapsed/refractory iNHL. Methods: Patients with relapsed SLL, marginal zone, and follicular lymphoma (gr 1-3a) were eligible. Patients enrolled in three predefined dose cohorts of lenalidomide (10mg,15mg, 20mg) given on days 2-22 of a 28 day cycle. Obinutuzumab was given at a fixed dose (1000mg) IV on days 1,8,15 and 22 of cycle 1 and day 1 of subsequent cycles. All patients received prophylactic steroids prior to obinutuzumab. In the absence of toxicity or progression, the combination was continued for up to 12 cycles. The standard '3+3' design was used with dose limiting toxicities (DLT) assessed during cycle 1. Patients attaining ≥partial response continued obinutuzumab every 2 months for up to 24 months. Prophylactic growth factors were not used. Adverse events were graded using CTCAE version 4.03. Results: 15 patients ( 9 during dose escalation, 6 during dose expansion at target dose) were enrolled; all were evaluated for safety and efficacy (all having had at least 1 post-baseline response assessment). The median age was 60 (36-82) years, and 7 (47%) were male. 21% of patients with follicular lymphoma had low, 29% intermediate, and 50% high FLIPI scores at study entry, 1 patient had SLL. No DLTs were observed during dose escalation. The most common grade 1-2 non-hematologic toxicities were fatigue 12/15 (80%), constipation 9/15 (60%), diarrhea 7/15 (47%), dyspnea 7/15 (47%), and myalgia 7/15 (47%). Grade ≥ 3 events included neutropenia (n=3, 20%), infection (n=2, 13%),thrombocytopenia (n=1, 6%), and two infusion related reactions (13%), both occurring during the first infusion of obinutuzumab. With a median follow up of 8.2 (4.1-14 mo), the overall response rate was 93% with 27% (4/15) achieving a complete response and 67% (10/15) with a partial response, all responding patients remain on active therapy. One patient progressed after 8 months and was withdrawn from study. Conclusion: The combination of 20 mg of lenalidomide and 1000mg obinatuzumab is safe and effective in patients with relapsed iNHL. Adverse events appeared similar to our prior experience with lenalidomide and rituximab. Overall response rates were high, with complete responses increasing with prolonged duration of therapy. Correlative efforts are ongoing to study the immunomodulatory potential of the combination and to identify biomarkers of response. The phase II portion of this study is currently enrolling with dose expansions in relapsed iNHL. Disclosures Off Label Use: Lenalidomide off label in low grade lymphoma Obinutuzumab off label in low grade lymphoma. Fanale:Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Honoraria, Research Funding; Infinity: Membership on an entity's Board of Directors or advisory committees; Spectrum: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Research Funding; Genentech: Research Funding; Medimmune: Research Funding; Novartis: Research Funding; Bayer: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Molecular Templates: Research Funding; ADC Therapeutics: Research Funding; Onyx: Research Funding; Gilead: Research Funding. Nastoupil:Celgene: Honoraria; Janssen: Research Funding; AbbVie: Research Funding; TG Therapeutics: Research Funding; Genentech: Honoraria.

Description: Abstract 3821 Introduction: The impact of socioeconomic status on patients with cancer has been previously reported. Health care funding improves access to care and thus outcome. There is little information on the impact of health care funding on hematological malignancies including multiple myeloma. Objectives: To analyze the effect of health care funding on the survival of patients with multiple myeloma (MM) and monoclonal gammopathy of uncertain significance (MGUS) in North Louisiana. A retrospective study of all patients diagnosed with multiple myeloma/MGUS and treated at Louisiana State University Health Science Center in Shreveport, LA between the years 1997 and 2010 was completed. Methods: Electronic medical records from our hospital and Social Security Death Index were used to identify patients and to define patient characteristics, demographic factors, medical funding source and date of death. Medical funding was defined as being funded (Medicaid, Medicare or private insurance) or non-funded (free care or self pay). Descriptive statistics, Product-Limit methods were used to estimate survival and Log rank test was used to compare the survival difference for each factor. Result: 257 patients were reviewed, of which 208 had multiple myeloma and 49 had MGUS. Median age of patients with MGUS and MM was 59 years and 60 years respectively (range 30–93).There were 92 (37%) Caucasians and 165 (63%) African Americans, 114 (44%) male and 143 (56%) female patients, and 177 (69%) were funded and 80 (31%) were non-funded. Of the patients with MM, 49 (23.5%) were stage 1, 23 (11%) were stage 2, 95 (45.6%) were stage 3A and 41 (19.7%) were stage 3B disease. The 5-year survival for MM was 60% and 42% for funded and non-funded patients respectively (p=0.03). The 5-year survival for MGUS was 95% and 62% for funded and non-funded patients respectively (p=0.012). Funded patients with MM had an overall survival of 6.2 years while it was 3.8 years for the non-funded (p=0.012). The survival difference relative to race and sex was not statistically significant. Conclusion: Our analysis demonstrates that patients with multiple myeloma and MGUS with funding have statistically significant increased overall survival compared to patients with no funding. Presumably patients with funding have better access to medical care, which would allow for earlier diagnosis, more effective therapy of smaller tumor burden and access to all therapeutic options. Lead time bias could contribute to some of the improved survival but is doubtful. To our knowledge, this is the first study to explore the impact of health funding on the survival of patients with multiple myeloma and MGUS, however validation with a larger prospective study is needed. Disclosures: No relevant conflicts of interest to declare.

Description: Background: Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma. As the incidence of DLBCL increases with age, the number of elderly patients with DLBCL in our aging society continues to increase. However, patients aged ≥ 80 years old are often frail and carry multiple comorbidities, and are generally underrepresented in prospective clinical trials. Patients and Methods: 207 patients, age ≥80 years of age at diagnosis of de novo DLBCL were identified between 2002 and 2014 at MD Anderson Cancer Center and included in this retrospective analysis. Failure-free survival (FFS) and overall survival (OS) were examined; baseline characteristics and frontline therapy were evaluated for the association with survival outcomes by hazard ratio (HR). Results: Median age was 83 years (range 80-96). Fifty-five percent of the patients were male, 66% had advanced stage and 37% had poor performance status (ECOG PS≥2). Forty-five percent of the patients were IPI high-intermediate or high risk. Eighty patients (39%) were GCB and 49 patients (24%) were non-GCB subtype, respectively, according to the Hans criteria, with 78 patients lacking data for classification. Thirty-two patients (15%) had ≥4 scores by Charlson comorbidity index (CCI, Charlson 1987). Treatment received included R-CHOP (n=144, 70%), R-EPOCH (n=12, 6%), and non-anthracycline based therapies including R-CEOP and R-CVP (n=20, 10%). Sixteen patients (8%) did not receive any treatment due to deteriorated condition or patient's decision. Fifteen patients received other treatment such as radiation and rituximab monotherapy. With a median follow up of 38.1 months, 88 patients (43%) experienced progression/relapse and 123 patients (59%) died. Sixty-two patients (50%) died of lymphoma, 32 patients (26%) died of other co-morbid conditions while in remission and 17 patients (14%) died as a result of treatment complication during frontline therapy. Thirteen patients died during R-CHOP, 2 patients each died during R-CEOP or R-CVP and R-EPOCH, respectively, most were the result of infection or multi-organ failure. The 3-year FFS and OS were 55% and 54%, respectively. After 3-years, almost all deaths were attributed to other diseases (Figure A). Patients who received R-CHOP or R-EPOCH had a significantly longer FFS than patients who received R-CEOP or R-CVP (Figure B). CCI ≥4 was not associated with inferior FFS but was significantly associated with inferior OS. Multivariate analysis for OS adjusted by IPI and frontline treatment revealed that being female was associated with significantly longer OS (HR: 0.50, 95% CI, 0.33-0.75, p2.0mg/l had significantly inferior OS (HR: 7.21, 95% CI, 1.67-31.1, p=0.01). Conclusion: Patients with DLBCL aged ≥80 years who received anthracycline-based regimens such as R-CHOP or R-EPOCH had outcomes similar to younger patients with de novo DLBCL. Although they carry higher risks of therapy-related mortality, anthracycline-based regimens are moderately well tolerated, and their use should not be minimized based solely on age. Inclusion of very elderly patients in prospective clinical trials is warranted to identify the most effective management strategy for this population. Figure 1. Figure 1. Disclosures Westin: Spectrum: Research Funding. Fanale:Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Honoraria, Research Funding; Infinity: Membership on an entity's Board of Directors or advisory committees; Spectrum: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Research Funding; Genentech: Research Funding; Medimmune: Research Funding; Novartis: Research Funding; Bayer: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Molecular Templates: Research Funding; ADC Therapeutics: Research Funding; Onyx: Research Funding; Gilead: Research Funding. Rodriguez:Orthobiotech: Research Funding. Wang:Celgene: Research Funding. Nastoupil:AbbVie: Research Funding; TG Therapeutics: Research Funding; Genentech: Honoraria; Celgene: Honoraria; Janssen: Research Funding.