Citations

Abstract Complicated grief (CG) is characterized by lengthy, intense, and functionally impairing grief which disproportionately affects older adults. Accelerated Resolution Therapy (ART) is a brief, protocol driven, exposure/imagery rescripting therapy which uses lateral left-right eye movements. ART, unlike traditional psychotherapy, directs the person to perform two tasks simultaneously (e.g. re-experiencing the grief experience and performing eye movements), taxing limited working memory capacity. Importantly, this may force memory traces representing events, emotions, and sensations to compete for permanence, as well as reduce the vividness and emotional intensity of the original grief. Two CG case studies are presented (expected; unexpected death) with their response to ART. Stake’s instrumental case study methodology was used to identify and study cases which reflect a range of CG. Additionally, CG was measured by the Inventory of Complicated Grief (ICF). ICF’s range is 0-76 with scores > 24 indicating CG. Case 1 was a spousal caregiver with a single, expected death where helplessness, guilt, shame, and a life alone had resulted in CG (baseline ICF 33). Her ICF at 8 weeks post-ART was 10. Case 2 was an adult child caregiver with multiple (parent, sibling), unexpected deaths in quick succession where loss, guilt, anger, and helplessness had resulted in CG (baseline ICF 25). Her ICF at 8 weeks post-ART was 9. Both participants were able to process the distressing sensations that emerged during the imaginal exposure component facilitated with the use of eye movements. This suggests that ART may be a powerful new mind-body treatment for CG.

Background Implant-based breast reconstruction (IBR) accounts for 70% of postmastectomy reconstructions in the United States. Improving the quality of surgical care in IBR patients through accurate measurements of outcomes is necessary. The purpose of this study is to compare the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) data from our institution to our complete institutional health records database. Methods Data were collected and recorded for all patients undergoing IBR at our institution from 2015 to 2017. The data were completely identified and compared with our institutional NSQIP database for demographics and complications. Results The electronic health records data search identified 768 IBR patients in 3 years and NSQIP reported on 229 (30%) patients. Demographics were reported similarly among the 2 databases. Rates of tissue expander/implant infections (5.9% vs 1.8%; P = 0.003) and wound dehiscence (3.5% vs 0.4%; P = 0.003) were not reported similarly between our database and NSQIP. However, the rates of hematoma (2.7% vs 1.8%) and skin flap necrosis (2.5% vs 1.8%) were comparable between the two databases. In our database, 43% of all complications presented after 30 days of surgery, beyond NSQIP's capture period. Conclusions Databases built on partial sampling, such as the NSQIP, may be useful for demographic analyses, but fall short of providing data for complications after IBR, such as infections and wound dehiscence. These results highlight the utility and importance of complete databases. National comparisons of clinical outcomes for IBR should be interpreted with caution when using partial databases.

Objectives: To examine perceptions of nurses and physicians in regard to ethical decision-making climate in the ICU and to test the hypothesis that the worse the ethical decision-making climate, the greater the discordance between nurses’ and physicians’ rating of ethical decision-making climate with physicians hypothesized to rate the climate better than the nurses. Design: Prospective observational study. Setting: A total of 68 adult ICUs in 13 European countries and the United States. Subjects: ICU physicians and nurses. Interventions: None. Measurements and Main Results: Perceptions of ethical decision-making climate among clinicians were measured in April-May 2014, using a 35-items self-assessment questionnaire that evaluated seven factors (empowering leadership by physicians, interdisciplinary reflection, not avoiding end-of-life decisions, mutual respect within the interdisciplinary team, involvement of nurses in end-of-life care and decision-making, active decision-making by physicians, and ethical awareness). A total of 2,275 nurses and 717 physicians participated (response rate of 63%). Using cluster analysis, ICUs were categorized according to four ethical decision-making climates: good, average with nurses’ involvement at end-of-life, average without nurses’ involvement at end-of-life, and poor. Overall, physicians rated ethical decision-making climate more positively than nurses (p < 0.001 for all seven factors). Physicians had more positive perceptions of ethical decision-making climate than nurses in all 13 participating countries and in each individual participating ICU. Compared to ICUs with good or average ethical decision-making climates, ICUs with poor ethical decision-making climates had the greatest discordance between physicians and nurses. Although nurse/physician differences were found in all seven factors of ethical decision-making climate measurement, the factors with greatest discordance were regarding physician leadership, interdisciplinary reflection, and not avoiding end-of-life decisions. Conclusions: Physicians consistently perceived ICU ethical decision-making climate more positively than nurses. ICUs with poor ethical decision-making climates had the largest discrepancies.

Abstract Breast cancer survivorship guidelines recommend at least annual follow-up visits, yet the degree to which this occurs in clinical practice is uncertain. Claims data from a US commercial insurance database (OptumLabs) were used to identify women treated with curative intent surgery for newly diagnosed breast cancer between 2006 and 2014. In 25 035 women, median follow-up was 3 years. In the second year after surgery, 9.6% of the patients did not visit a primary care provider, an oncologist, or a surgeon (guideline-nonadherent). The guideline-nonadherent proportion increased from 7.8% in women diagnosed in 2006 to 12.2% in those diagnosed in 2014 (two-sided Wald P &lt; .001). During years 2–6, guideline-nonadherence was also associated with older age, nonwhite race, no radiation, no chemotherapy, no endocrine therapy, and increasing time after surgery. There is a substantial and increasing rate of inadequate follow-up among breast cancer survivors. This has the potential to impair outcomes.

Abstract Background Myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET) are myeloproliferative neoplasms (MPNs) whose associated disease burden includes a range of debilitating symptoms, thrombosis, hemorrhage, and shortened survival. To enhance patient care, it is important to understand the impact of MPNs in patients' lives; however, little is known regarding how these conditions affect patients' quality of life (QOL), activities of daily living, productivity, and emotional well-being. The US LANDMARK survey (Mesa et al. BMC Cancer 2016) captured data for US patients. Here, we present an interim analysis of results of another MPN LANDMARK survey conducted in the rest of the world. Methodology MPN LANDMARK survey is a cross-sectional survey of MPN patients across 6 countries (Australia, Canada, Germany, Japan, Italy, and UK). Patients completed an online questionnaire to measure MPN related symptoms experienced over the past 12 months and the impact of their condition on their QOL and ability to work. Additional questions related to employment productivity and activity impairment (including absenteeism and loss of productivity over the past 7 days). Patients included in this interim analysis had completed the survey by July 18, 2016, with enrollment continuing in all countries. Results Patients: Overall, 437 patients had completed the survey (98 MF, 121 PV, 218 ET). For MF and PV, the male to female gender split was relatively even (54% male for each), whereas an expected greater proportion of ET patients was female (70%). Patients with MF were significantly older than PV and ET patients (mean ages, 62, 59, and 55 years, respectively) and more had been diagnosed within 2 years of experiencing their symptoms (83% MF, 67% PV, 71% ET). MPN Symptoms (Table): Most patients (94%) experienced MPN-related symptoms in the past 12 months. The most commonly reported symptom among all subtypes was fatigue (69% MF, 62% PV, 73% ET), incidence of other common symptoms varied depending on disease subtype (MF: shortness of breath [38%], bruising [36%], night sweats [35%], early satiety [33%]; PV: night sweats [36%], trouble concentrating [36%], trouble sleeping [34%], dizziness [34%]; ET: trouble sleeping [37%], dizziness [37%], bruising [35%], night sweats [35%]). When asked which symptom patients would most like to have resolved, most patients preferred to have feeling of fatigue/tiredness improved across all disease subtypes (31% MF, 30% PV, 33% ET). Patients experienced an average of 6.4 symptoms at diagnosis but this progressed to an average of 7.6 symptoms since diagnosis after a median time of 6 years. QOL: A majority of patients indicated that they experienced a reduction in QOL due to MPN symptoms (87% MF, 71% PV, 73% ET) with 33% and 26% of MF and ET patients expressing that their condition has caused emotional hardship, and one-third of patients with PV reporting that they have felt worried or anxious about their disease (39%). MPN Impact on Activity/Employment: Patients reported a high impact on their ability to work, 12% reported voluntarily leaving their job, 10% had taken early retirement, 10% had moved onto disability living allowance, 8% moved to a lower paid job, and 2% experienced involuntary loss of work (Table). Of the patients who were in full-time or part-time employment at the time of the survey (MF [n=17]), PV [n=41], ET [n=98]), approximately, 40% had been absent from work within the past 7 days; this was the highest in MF patients (41% MF, 38% PV, 33% ET). On an average, over the past 7 days, MF patients had missed 3.1 hours from work, PV patients 2.3 hours and ET patients 2 hours. Across all subgroups, a substantial proportion of patients reported impairment in work (mean: 34% MF, 33% PV, 31% ET) and overall activity (mean: 46% MF, 42% PV, 39% ET). Conclusions This interim analysis from the MPN LANDMARK survey indicates that MPN patients experience a high burden of disease, including a high prevalence of symptoms, an increase in the number of symptoms from diagnosis and reduction of their emotional well-being, QOL, and ability to work. These results are consistent with those from the previous US LANDMARK survey with the addition of novel data on how MPNs impact work. When treating MPN patients, care should be taken in trying to manage a patient's disease burden, so as to minimize the impact on a patient's daily life. Further results from additional survey responses will be presented at the congress. Disclosures Harrison: Baxaltra: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Other: travel, accommodations, expenses, Research Funding, Speakers Bureau; Gilead: Honoraria, Speakers Bureau; Incyte Corporation: Honoraria, Speakers Bureau; Shire: Honoraria, Speakers Bureau. Koschmieder:Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Foltz:Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Koehler:Novartis Inc. (Germany): Consultancy, Other: Training. Komatsu:Shire: Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Boothroyd:Novartis: Employment, Equity Ownership. Spierer:Novartis: Employment. Ronco:Novartis: Employment. Taylor-Stokes:Adelphi Real World: Employment. Waller:Adelphi Real World: Employment. Mesa:Celgene: Research Funding; Galena: Consultancy; Novartis: Consultancy; CTI: Research Funding; Ariad: Consultancy; Incyte: Research Funding; Gilead: Research Funding; Promedior: Research Funding.

Abstract INTRODUCTION: PR-171 is a novel, irreversible proteasome inhibitor under investigation for the treatment of hematological malignancies. In preclinical studies, PR-171 was well tolerated in rats and monkeys when given daily × 5 (QDx5), every two weeks. Proteasome inhibition determined in blood and other tissues one hour after dosing at the maximum tolerated dose (MTD) was >80%. Despite the irreversible mechanism of action, the half-life of recovery of proteasome inhibition in tissues was approximately 24 hours. PR-171 was effective in suppression of tumor growth in xenograft studies in mice when administered QDx2 every week for three weeks. Two phase I dose-escalation studies have been initiated, aimed at determining the safety, tolerability, and clinical response to PR-171. METHODS: Two different dose-intensive schedules were employed in these phase I studies. In PX-171-001, PR-171 was administered on a two week cycle, QDx5 with nine days rest, while in PX-171-002, PR-171 was administered on a four week cycle, QDx2 weekly for three weeks with 12 days rest. The objective of these studies was to evaluate the safety and effectiveness of single-agent PR-171 administered according to a modified Fibonacci dose escalation scheme in cohorts of three. Patients with multiple myeloma (MM), non-Hodgkin Lymphoma (NHL), Hodgkin disease, or Waldenstrom’s Macroglobulinemia who received two or more prior treatments were eligible. RESULTS: Both studies were initiated with a dose of 1.2 mg/m2. Thus far, a total of 15 and 23 subjects have been enrolled in PX-171–001 and -002, respectively. PR-171 has been well tolerated at the highest doses thus far, 8.4 and 15 mg/m2, respectively. Proteasome inhibition in whole blood at the highest dose levels exceeded 75%, and in peripheral blood mononuclear cells inhibition exceeded 65%, one hour after the first dose. There have been no dose-limiting toxicities, no adverse events (AEs) considered probably related to study medication, no dose-related increases in the incidence or severity of AEs, and no incidence of painful peripheral neuropathy on either study. Although the MTD has not yet been identified on either study, preliminary evidence of efficacy has been observed with reduction in myeloma paraprotein levels and symptomatic improvement in patients on both protocols. Eleven subjects remain on study with stable disease (SD), which has been observed in MM and NHL patients on both studies, lasting up to eight months. CONCLUSION: PR-171 is well-tolerated in relapsed and refractory MM and NHL patients at proteasome inhibition levels of more than 75%. Several subjects have achieved long-lasting SD, reduction in paraprotein levels or symptomatic improvement. Further data from these ongoing trials will be discussed at the meeting.

Abstract Abstract 2917 Multiple myeloma (MM) is a cancer in the bone marrow (BM) characterized by the accumulation of transformed plasma cells (PCs). The pre-malignant form of the disease, monoclonal gammopathy of undetermined significance (MGUS), shares many of the genetic abnormalities found in MM, including chromosomal translocations, hyperdiploidy, and gene-specific mutations. Given this, we believe other factors within the tumor microenvironment must contribute to disease progression by influencing cell survival and/or proliferation. Eosinophils (Eos) are granulocytic leukocytes that are best known for their involvement in host immune defense and pathologic states such as allergy and asthma. Recently, they were also shown to play a role in the regulation of murine BM PC homeostasis via their secretion of IL-6 and APRIL. Murine BM PCs and Eos both express CXCR4 and are believed to home to CXCL12 expressing stromal cells (SCs) in the BM. The goal of this study, therefore, was to investigate whether Eos, or soluble mediators released by Eos, have biological activity on MM cells. Thus, it is possible that this type of innate immune cell may be present in the tumor microenvironment in MM patients to support disease progression. To our knowledge, a potential role for Eos in MM has not been previously studied. We began our studies by assessing whether Eos are co-localized with normal BM PCs and/or MM PCs. Immunofluorescence analysis of BM core biopsies from normal subjects revealed occasional colocalization of PCs with Eos. Similarly, MM biopsies showed regions of MM cell clusters with increased Eos density, suggesting possible biological interactions. However, we also observed regions of MM cell clusters that lack Eos, which could indicate the liberation of these transformed cells from the requirement of Eos for survival/proliferation. Next, using Eos isolated from human BM aspirates and a panel of disease-relevant human MM cell lines (HMCLs) extensively characterized in our laboratory, we aimed to verify that MM cells and Eos could both migrate toward the chemokine CXCL12. Our data showed that indeed the KAS-6/1, ANBL-6, DP-6, and KP-6 HMCLs and human BM Eos all migrated toward this chemokine. We then determined if Eos had biological activity towards MM cells as revealed by enhanced DNA synthesis. Consistent with our interpretation of the immunofluorescence stained sections, the proliferation of some, but not all, HMCLs was enhanced when cocultured with Eos isolated from either human BM or peripheral blood. To address whether contact between Eos and HMCLs was required for this phenomenon, we assessed HMCL proliferation upon treatment with Eos culture supernatant (SN). Our data suggest that the effect of Eos on the Eos-inducible HMCLs can be contact-independent as treatment of these HMCLs with Eos SN increased their proliferation. Similarly, proliferation of primary CD138+ MM cells was also enhanced when treated with Eos SN. Because BM PCs reside in niches that include support cells such as SCs and that proliferation of MM PCs is enhanced in the presence of SCs, we next questioned whether Eos can substitute for SCs in this niche or if Eos and SCs support PC survival/proliferation through different mechanisms. We observed that Eos and BM SCs together stimulated more HMCL proliferation than either cell type did alone, indicating the presence of non-redundant roles for the two cell types. Finally, we began to investigate the mechanism by which Eos enhance HMCL proliferation. In contrast to prior reports that murine Eos express IL-6, mRNA transcripts of IL-6, a known proliferation-inducing cytokine for MM cells, were not detected in human Eos. Moreover, analysis of the Eos SN showed an absence of IL-6. Neutralization of IL-6 in the HMCL-Eos coculture did not abolish the induced proliferation. Altogether, these data suggest that human Eos utilize a yet to be identified, IL-6-independent mechanism to support malignant PC proliferation. Taken together, our data show that Eos and MM cells can colocalize in the BM via their migration toward a common source of CXCL12, i.e. BM SCs, to create a niche that promotes tumor cell growth. Eos can enhance malignant PC proliferation via soluble products, although additional contact-dependent effects may exist as well and have not been explored. Additional studies are currently underway to further characterize the mechanism by which Eos may influence the biology of MM in the tumor microenvironment. Disclosures: No relevant conflicts of interest to declare.

Abstract Background CD19, a B cell-specific marker, is expressed in the majority of patients with B-lineage leukemia and non-Hodgkin lymphoma. SGN-CD19A is a novel antibody-drug conjugate (ADC) composed of a humanized anti-CD19 monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin F (MMAF) via a maleimidocaproyl linker. Methods This first-in-human, phase 1, open-label, dose-escalation study is investigating the safety, tolerability, pharmacokinetics, and antitumor activity of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-cell leukemia or highly aggressive lymphoma (NCT 01786096). Eligible patients must have B-cell acute lymphoblastic leukemia (B-ALL) or lymphoma (B-LBL), Burkitt leukemia or lymphoma, and be relapsed or refractory to at least 1 prior systemic regimen. A modified continual reassessment method is used for dose allocation and maximum tolerated dose (MTD) estimation for both pediatric and adult patients. The study is evaluating 2 schedules of IV SGN-CD19A administration: weekly (Days 1 and 8 of 21-day cycles; 0.3-4.5 mg/kg) or every 3weeks (q3week; 0.5-6 mg/kg). Results To date, 49 patients with relapsed or refractory leukemia (n=40) or lymphoma (n=9) have been treated. Median age of adult (n=38) and pediatric patients (n=11) was 37 and 11 years (range, 18-74 and 1-16), respectively. Patients received a median of 2 prior therapies (range 1-9); 14 patients (29%) previously received an allogeneic stem cell transplant. On the weekly schedule, 39 patients (28 adult, 11 pediatric) have been treated, and the median number of cycles is 2.5 (adults; range, 1-12) or 1 (pediatric; range, 1-4). On the q3week schedule, 10 adult patients have been treated, and the median number of cycles is 2.5 (range, 1-4) to date. Six patients remain on study treatment (3 on each schedule), and enrollment is ongoing. The toxicity profiles were similar across both dosing schedules (0.3-2.3 mg/kg weekly and 4-5 mg/kg q3week) and across adult and pediatric patients. The most frequently reported drug-related AEs included pyrexia, nausea, chills, vomiting, blurred vision, and dry eye. Frequent infusion-related reactions were observed early in the study, and recommendation for premedication was instituted. Ocular events were also observed and treated with ophthalmic steroids; steroid eye drop prophylaxis was instituted with each dose. Corneal findings consistent with superficial microcystic keratopathy were observed in 13 adult patients (34%) and in 1 pediatric patient (9%). Grade 3/4 corneal AEs have been observed in 4 adult patients; the majority of these events have resolved or improved to Grade 1 or 2. Steroid eye drop prophylaxis has reduced the incidence of Grade 3/4 events at this interim analysis. Three DLTs were observed: acidosis in a pediatric patient at 1 mg/kg weekly, cytokine release syndrome in an adult patient at 2 mg/kg weekly, and asymptomatic Grade 4 AST elevation in an adult patient at 5 mg/kg q3week. MTD has not yet been determined. SGN-CD19A ADC pharmacokinetic profiles indicate target-mediated drug disposition in patients with leukemia. Plasma ADC exposures generally increased with doses and were lower than those in patients with lymphoma. To date, no objective responses were observed in 9 efficacy-evaluable pediatric patients or in 3 adult patients with Burkitt lymphoma/leukemia. However, in efficacy-evaluable adult patients with B-ALL/B-LBL, objective responses were observed in 6 of 25 patients treated on the weekly schedule (3 CR, 2 CRp, 1 PR), and in 4 of 8 patients treated on the q3week schedule (2 CR, 2 CRp). Of 8 B-ALL patients with CR/CRp, 6 were MRD negative. Conclusions MTDs have not yet been identified, and dose escalation continues on weekly and q3week schedules. SGN-CD19A has been generally well tolerated. At this interim analysis, objective responses were observed in 30% (10 of 33) of heavily pretreated adult B-ALL/B-LBL patients dosed weekly or q3week. Evidence of activity in relapsed/refractory patients and lack of overlapping toxicities suggest opportunities for combination with conventional anti-leukemic therapies in lymphoblastic malignancies. Disclosures Fathi: Ariad: Consultancy; Exelixis: Research Funding; Takeda pharmaceuticals International Co.: Research Funding; Seattle Genetics, Inc.: Consultancy, Research Funding. Off Label Use: SGN-CD19A is an investigational agent being studied in patients with B-cell malignancies. SGN-CD19A is not approved for use. . Chen:Seattle Genetics, Inc.: Consultancy, Research Funding, Speakers Bureau, Travel expenses Other. Trippett:OSI Pharmaceuticals: Research Funding; Seattle Genetics, Inc.: Research Funding. O'Brien:Seattle Genetics, Inc.: Research Funding. DeAngelo:Seattle Genetics, Inc.: Research Funding. Shah:Pharmacyclics: Consultancy; SWOG: Consultancy; Celgene: Consultancy, Speakers Bureau; NCCN: Consultancy; Seattle Genetics, Inc.: Research Funding; Janssen: Consultancy. Cooper:Seattle Genetics, Inc.: Research Funding. Foran:Seattle Genetics, Inc.: Research Funding. Hale:Seattle Genetics, Inc.: Research Funding. Pressey:Seattle Genetics, Inc.: Research Funding. Silverman:Seattle Genetics, Inc.: Research Funding. Tibes:Seattle Genetics, Inc.: Research Funding. Kim:Bayer: Consultancy; Eli Lily: Consultancy; Seattle Genetics, Inc.: Consultancy, Research Funding. Albertson:Seattle Genetics, Inc.: Employment, Equity Ownership. Sandalic:Seattle Genetics, Inc.: Employment, Equity Ownership. Zhao:Seattle Genetics, Inc.: Employment, Equity Ownership. Borate:Genoptix: Consultancy; Seattle Genetics, Inc.: Research Funding.

Abstract Background: Limited data exist to describe the clinical features and outcomes for elderly pts with FL. The FLASH group performed a prospectively planned pooled analysis of IPD from first-line RCTs and examined associations between age (<= 70 vs. > 70 years), clinical characteristics and FL outcomes. Methods: We identified 18 randomized controlled multicenter clinical trials in the FLASH database which enrolled elderly pts (> 70 yrs). From these 18 studies, 5922 previously untreated FL pts were included for this analysis. Complete response (CR) at 24 and 30 months were defined as whether the pt achieved and remains in CR at 24 months and 30 months after initiation of induction treatment. PFS24 is defined as proportion of pts progression-free and alive at 24 months post-randomization. Time to progression (TTP) and overall survival (OS) were defined as time from randomization to the date of progression (censoring for death without progression) and date of death due to any cause, respectively. Progression-free survival (PFS) was defined as time from randomization to the date of progression or death, due to any cause, whichever comes first. Non-lymphoma death was defined as death without prior progression. Early disease outcomes, i.e. CR24, CR30, and PFS24 were primary outcomes; secondary outcomes were TTP, OS, and PFS. For time-to-event outcomes, Kaplan-Meier method and log-rank test were used for univariate estimation and comparison; stratified Cox proportional hazard modeling was used for multivariable analyses. Cumulative incidence methods were used to model PFS while treating disease progression as the primary event of interest and non-lymphoma death as a competing risk. For binary outcomes, multivariable logistic regression was used to estimate the association between age groups and outcomes. Variable adjusted in the regression models are FLIPI score without the age component, ECOG performance status (>= 2 vs < 2), and rituximab use. Results: Among 5922 previously untreated FL pts from 18 RCTs, 63% (n = 3728) were <= 60, 28% (n = 1652) 61-70, and 9% (n = 542) > 70 yrs. Pts age > 70 (vs. <= 70) more commonly had elevated LDH (42% vs 36%, p = 0.02), hemoglobin < 12 g/dL (27% vs 19%, p < 0.0001), ECOG PS >= 2 (8.8% vs 5.0%, p = 0.0004), and elevated β2-microglobulin (68% vs 49%, p < 0.001), less often had > 4 lymph nodes involved (54% vs 65%, p < 0.001), and had similar FLIPI scores without age component (p = 0.17). There were no significant differences between groups in: Ann Arbor stage (94% vs 95% stage III/IV) or rituximab use (62% vs 58%). Median survival follow-up was 5.6 yrs. Pts > 70 yrs did not differ from pts <= 70 in rates of CR24 (27% vs 30%, p=0.32), CR30 (29% vs 31%, p=0.55) or PFS24 (63% vs. 67%, p=0.10). Median TTP was 3.8 and 4.0 years for pts > 70 and <= 70, respectively (HR=1.08, 95% CI 0.96-1.23, p=0.20). With a median OS of 14.6 years for all pts, median OS was 7.4 and 15.7 years for pts > 70 and <= 70, respectively (HR=2.35, 95% CI=2.03-2.73, p<0.001). PFS was statistically significantly different but clinically similar at median 3.1 and 3.8 years for pts > 70 and <= 70, respectively (HR=1.26, 95% CI =1.12-1.41, p<0.001). Further investigation showed the difference in PFS was due to higher incidence of non-lymphoma death in pts > 70 with no difference in disease progression (Figure). In regression models, adjusting for rituximab use, ECOG PS >= 2, and FLIPI score without the age component, age > 70 was a significant predictor of OS and PFS (due to higher incidence of non-lymphoma death), but not PFS24, CR24 or CR30 (Table). Conclusions: FL pts > 70 yrs treated on trials have similar early disease outcomes to younger patients. There is no disease-specific outcome difference between age groups. Age alone should not disqualify patients from standard treatments or RCTs. Disclosures Flowers: Genentech: Consultancy, Research Funding; NIH: Research Funding; Mayo Clinic: Research Funding; TG Therapeutics: Research Funding; Millenium/Takeda: Research Funding; ECOG: Research Funding; Acerta: Research Funding; Pharmacyclics, LLC, an AbbVie Company: Research Funding; Roche: Consultancy, Research Funding; AbbVie: Research Funding; Infinity: Research Funding; Gilead: Consultancy, Research Funding. Ou:Mayo Clinic: Employment. Shi:Mayo Clinic: Employment. Hochster:Genentech: Consultancy, Other: Consultancy fees for advisory boards for GI cancer and bevacizumab with amounts within Yale University de minims guidelines. Brice:Roche: Honoraria; Takeda Pharmaceuticals International Co.: Honoraria, Research Funding; Bristol Myers-Squibb: Honoraria; Gilead: Honoraria; Seattle Genetics: Research Funding. Hiddemann:Roche: Other: Grants; Roche: Membership on an entity's Board of Directors or advisory committees; Genentech: Other: Grants. Marcus:Takeda: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau. Kimby:Abbvie: Consultancy, Honoraria; Jansen: Consultancy, Honoraria; Celgene: Honoraria; Baxalta: Consultancy; Gilead: Honoraria. Herold:Gilead: Other: Personal fees from member advisory board; Celgene: Honoraria; Genentech: Other: Grants; Roche: Honoraria, Other: Grants. De Bedout:Celgene: Employment. Nielsen:Hoffmann-La Roche: Employment. Morschhauser:Roche: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Servier: Consultancy, Honoraria; Gilead Sciences: Consultancy, Honoraria; Janssen: Honoraria. Rummel:Mundipharma GmbH: Other: Personal fees, Research Funding; Roche Pharma AG: Other: Personal fees, Research Funding. Vitolo:Gilead: Other: Honoraria for lectures; Takeda: Other: Honoraria for lectures; Roche: Membership on an entity's Board of Directors or advisory committees, Other: Honoraria for lectures; Janssen: Membership on an entity's Board of Directors or advisory committees, Other: Honoraria for lectures. Salles:Celgene: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Gilead: Honoraria, Research Funding; Janssen: Consultancy, Honoraria; Roche/Genentech: Consultancy, Honoraria, Research Funding; Mundipharma: Honoraria. Sargent:Celgene: Research Funding.

Background Male breast cancer (MBC) is a rare disease for which there is limited understanding of treatment patterns and prognostic factors. Methods Men with TNM stage I to stage III breast cancer diagnosed between 2004 and 2014 in the National Cancer Data Base were included. Trends in treatment modalities were described using the average annual percentage change (AAPC) and estimated using Joinpoint software for the analysis of trends. Kaplan‐Meier curves and the multivariate Cox proportional hazards regression model were used to compare survival between subgroups and to identify prognostic factors. Results A total of 10,873 MBC cases were included, with a median age at diagnosis of 64 years. Breast‐conserving surgery was performed in 24% of patients, and 70% of patients undergoing breast conservation received radiotherapy. Approximately 44% of patients received chemotherapy, and 62% of patients with estrogen receptor–positive disease received endocrine therapy. Oncotype DX was ordered in 35% of patients with lymph node–negative, estrogen receptor–positive/human epidermal growth factor receptor 2 (HER2)‐negative tumors. During the study period, there was a significant increase in the rates of total mastectomy, contralateral prophylactic mastectomy, radiotherapy after breast conservation, ordering of Oncotype DX, and the use of endocrine therapy ( P < .05). On multivariate analysis, factors found to be associated with worse overall survival were older age, black race, higher Charlson Comorbidity Index, high tumor grade and stage of disease, and undergoing total mastectomy. Residing in a higher income area; having progesterone receptor–positive tumors; and receipt of chemotherapy, radiotherapy, and endocrine therapy were associated with better overall survival. Conclusions Despite the lack of prospective randomized trials in patients with MBC, the results of the current study demonstrated that the treatment of this disease has evolved over the years. These findings further the understanding of the modern treatment and prognosis of MBC, and identify several areas for further research.