ALBERT

Description: Background: The paradigm for treatment selection in newly diagnosed (ND) multiple myeloma (MM) is largely predicated on establishment of suitability for front-line autologous stem cell transplantation. In this context, real-world evidence from multiple jurisdictions demonstrates that the most widely employed front-line (1L) therapies are bortezomib (B)-based triplets in transplant-eligible patients, and in transplant-ineligible patients, B-based triplets (or doublets) or the combination of lenalidomide and dexamethasone. While a sound hypothetical rationale for treatment stratification at diagnosis is recognised, viz alternative treatments for high-risk (HR) versus standard-risk disease, this is rarely employed in either everyday practice or clinical trials. A significant impediment to such an approach is the lack of a uniformly recognised risk stratification model that not only recognises truly HR disease (e.g. median survival from diagnosis 〈 24 months [m]) but is also accessible and affordable. Against this background we evaluated data from the Australian and New Zealand Myeloma and Related Diseases Registry (MRDR) to define characteristics of 'functional' HR disease that could inform response-adaptive strategies, thus enabling the appropriate therapeutic targeting of HR patients. Methods: NDMM patients enrolled on to the MRDR since February 2013 with available data were evaluated. Patients were defined as either sub-optimal responders (SOR) to 1L if their best response was minimal response or stable disease (but not progressive disease [PD]), or early progressors (EP) if they demonstrated PD within 12m of commencing 1L therapy, irrespective of whether this occurred on or after the completion of 1L therapy. For categorical variables p-values were determined using a Pearson's chi-squared test, for continuous variables p-values were calculated using a Wilcoxon rank-sum test. Survival analysis was performed using the Kaplan-Meier method and p-values determined with the log-rank test. Results: 1320 NDMM patients were included with a median follow-up of 23m (12-37 IQR, 0-83 range). Of these, 152 were SOR (11.5%) and 118 were EP (8.9%). At diagnosis only 2 factors associated with SOR were identified: age 〉70y (p

Description: Careful planning is critical to ensure blood availability during times of reduced supply and/or increased demand, such as infectious pandemic, act of terrorism or natural disaster. Possible strategies include triaging of supply to prioritize support where transfusion cannot be deferred. However, few data concerning urgency of transfusion are available to inform planning. We designed a random sample survey to assess urgency of clinical need, and hence potential utility of triaging red cells (RC) in an emergency through restricting use only to urgent indications, for a regional population of approximately 5 million. An audit based on random sampling of units at point of distribution was used to assess state-wide RC use over time, and capture data in proportion to actual usage over both rural and metropolitan centers. Randomly selected RC units were tagged with a case-report form during production. Tagged units were distributed to hospital laboratories with routine supply. At time of issue for transfusion, the institutional laboratory completed and returned case report forms from the tagged units. Information regarding recipient demographics, indication for transfusion, urgency of supply, and (where issued to support surgery) urgency of surgery were obtained. Following an initial pilot study to refine the model, approximately 1000 tagged RC units (46% group O, 36% A, 13% B, and 4% AB; RhD positive 85% / negative 15%) of a planned 5000 total have been introduced to the state inventory. Three percent of units were not transfused. Major clinical categories of use included hematology (17% of overall use), gastroenterology (11%), orthopedic surgery (9%), non-hematological oncology (6%), gastrointestinal surgery (6%), cardiothoracic surgery (5%), obstetrics/gynecology (5%), urology (3%), trauma (3%) and pediatrics (2%); miscellaneous indications and anemia not otherwise specified constituted 10% and 22% of transfusions respectively. 18% of units were used in acute transfusion episodes (needed within 1h), 43% for urgent indications (1–24h), 33% semi-urgent (24h - 1 week) and 4% non-urgent. Of the 34% units allocated to support perioperative bleeding; only a quarter of procedures were elective. In 15% of cases the urgency of surgery was not stated. Thus, reporting institutions indicated that only 38% transfused units could have been deferred for more than 24h, and only 9% of total RCs were allocated to support potentially deferrable elective surgery. These early results suggest that triaging of RC supply in an acute shortage would only have a very short term impact on actual RC use, as the majority of RC use is already relatively urgent. Additional strategies for emergency blood contingency planning are required to meet priority clinical needs.

Description: Introduction: Major obstetric hemorrhage (MOH) can develop rapidly and, due to the unique characteristics of maternity patients, early recognition and management can be challenging. Use of blood components in MOH can be life-saving however there is uncertainty about optimal use of these products and the role of adjunctive therapies. The ANZ-MTR generates observational data on current transfusion management and outcomes in critically bleeding patients receiving massive transfusion (MT) across all clinical settings. This study aimed to describe the transfusion strategies used in the MOH population and report their outcomes. Methods: Patients who had a MOH and received a MT (≥5 units of red blood cells [RBC] in 4h) between April 2011 and December 2013 at 15 Australian & NZ hospitals were identified. Data on the type and volume of blood products transfused as well as selected laboratory results and clinical outcomes were reviewed. Results: A total of 154 cases were identified and reviewed, representing 6% of the total ANZ-MTR cohort. Median age was 34 [IQR29-37] years and 99% of women had a Charlson Comorbidity Index score ≤ 1. Table 1 presents the blood products transfused. The median [IQR] fresh frozen plasma (FFP) to RBC ratio and platelets to RBC ratio was 0.6 [0.3-0.8] and 0.1 [0-0.2], respectively. FFP, platelets and cryoprecipitate were transfused in 87%, 66% and 49% of patients. Prothrombinex-HT was administered to 1 patient and 3 patients received rFVIIa. Table 2 presents the laboratory results taken prior to MT onset as well as the lowest and highest result reported within 24hours after the MT onset. Fibrinogen levels following MT onset was available for 121 (79%) patients. Of these, 46% women had a fibrinogen level

Description: Abstract 2056 Introduction: Iron deficiency remains the commonest blood disorder worldwide. Hepcidin is a key regulator of iron homeostasis. In iron depletion, decreased hepcidin facilitates increased iron absorption and recycling. Hepcidin is detectable in whole blood, serum & urine, and although assays have been developed, the utility and clinically appropriate cutoffs for diagnosis of iron deficiency remain to be established. Blood donors are at particular risk of iron deficiency, yet early diagnosis remains challenging in this setting; thus donors are an ideal population in which to evaluate a new diagnostic test of iron deficiency. We evaluated hepcidin as a diagnostic test of iron deficiency in female blood donors. Methods: Subjects: Premenopausal, non-anemic females accepted for whole blood donation by the Australian Red Cross Blood Service, not taking iron supplements and with no history of hemochromatosis. Iron status assessment: Serum ferritin (chemiluminescence), soluble transferrin receptor (sTfR) (immunoturbidometry) and serum hepcidin (competitive ELISA). Analysis: Diagnostic utility of hepcidin, compared with ‘gold standards’ ferritin, sTfR and sTfR/log(ferritin) index, was evaluated by Area under Receiver Operating Characteristic curves (AUCROC). Potential hepcidin cutoffs were identified, and their sensitivities and specificities evaluated. Results: We recruited 261 donors: 22.6% had ferritin4.4mg/mL, and 20.3% had sTfR/log(ferritin) index〉3.2. The 95% range of hepcidin values was

Description: Abstract 3158 Poster Board III-95 Background Previous studies have demonstrated significant variation in red cell transfusion in cardiac surgery. Allogeneic red cell transfusion has been reported as associated with adverse post-operative outcomes in this setting, whilst there is conflicting evidence on potential adverse effects of platelets. We investigated the variation in transfusion practice (including red cell, platelets and plasma transfusion) across six large cardiac surgery centres and whether peri-operative transfusion was independently associated with clinical outcomes. Methods Data were prospectively collected on 9363 cardiac surgery patients at six major Australian hospitals from January 2005 to December 2008 through the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) Cardiac Surgery Database. The independent association of transfusion (including red cells, platelets and plasma) with clinical outcomes was determined by stepwise logistic regression analysis. Patient factors (including co-morbidities and medication use such as anticoagulants and anti-platelet agents) and surgical factors (including type of procedure, previous cardiothoracic intervention, urgency of surgery, cardiopulmonary bypass time, cross-clamp time, return to theatre and other peri-operative complications) were included in the analysis. Results Procedure types were: coronary artery bypass graft (CABG) surgery in 60%, valve surgery in 14%, CABG and valve in 10% and other procedure in 16%. There was significant variation in transfusion of all blood components between the six hospitals, which was not accounted for by patient or surgery related factors. The adjusted odds ratio (OR) for the risk of receiving a transfusion of red cells varied between the hospitals from 0.22 to 1.98, for platelets from 0.39 to 3.3 and for plasma from 0.27 to 2.0. Transfusion of red cells, platelets and plasma were each associated with all outcome measures. In multiple logistic regression analysis, red cell transfusion was independently associated with multi-system failure (OR, 2.97; 95% confidence interval [CI], 1.41 - 6.28; p = 0.004), peri-operative myocardial infarction (OR, 2.63; 95% CI, 1.45 - 4.77; p = 0.001), stroke (OR, 1.76; 95% CI, 1.13 - 2.72; p = 0.012), prolonged ventilation (OR, 2.6; 95% CI, 2.19 - 3.06; p 〈 0.001), pulmonary embolism (OR, 4.29; 95% CI, 1.4 - 13.16; p = 0.011), pneumonia (OR, 2.12; 95% CI, 1.8 - 2.72, p 〈 0.001) and septicaemia (OR, 2.29; 95% CI, 1.31 - 4.0; p = 0.004). Platelet transfusion was independently associated with multi-system failure (OR, 2.17; 95% CI, 1.3 - 3.63; p = 0.003) and pneumonia (OR, 1.25; 95% CI, 1.02 - 1.52; p = 0.03). Plasma transfusion was independently associated with in-hospital (OR, 2.46; 95% CI, 1.82 - 3.32; p 〈 0.001) and 30 day mortality (OR, 2.2; 95% CI, 1.61 - 2.99; p 〈 0.001), multi-system failure (OR, 1.97; 95% CI, 1.18-3.31; p = 0.010), prolonged ventilation (OR, 1.81; 95% CI, 1.55 - 2.13; p 〈 0.001) and septicaemia (OR, 1.83; 95% CI, 1.17 -2.85; p = 0.008). Conclusion There was significant variation in transfusion practice for red cells, platelets and plasma across these six major hospitals that was not accounted for by patient or surgery related factors. Peri-operative transfusions of red cells, platelets and plasma, after adjusting for established clinical risk factors, were each independently associated with an increased risk of adverse events. These findings from a large cohort of patients are in keeping with previous reports of adverse events associated with red cell transfusion in cardiac surgery and support the need for further research into the effects of transfusion on patient outcomes. An improved understanding of factors contributing to the significant variation in transfusion practice is also required as this may have important implications for patient outcomes. Disclosures No relevant conflicts of interest to declare.

Description: Background Meeting clinical requirements for platelets and plasma requires an understanding of usage, in order to plan for evolving demand and ensure supply in emergencies. Current strategies to ensure availability during increased demand or blood shortages include triaging by restricting supply to clinically urgent cases or deferring elective surgery. However, few data regarding urgency of need for different clinical indications are available. We developed a novel approach to clinical profiling of platelets and plasma to inform supply and contingency planning. Methods We conducted a random sample survey of platelet and plasma units in the Australian state of Victoria (population 5.3 million). The Australian Red Cross Blood Service produces and distributes all platelets and plasma for the state at a single site. Randomly selected units were tagged with a case report form (CRF) during production and distributed as usual. Institutional blood bank scientists completed the CRF when tagged units were issued for transfusion, reporting recipient demographics, clinical indication for transfusion, and transfusion urgency. Units were tagged over 12 months to minimize seasonal fluctuations. Results 1252 platelet units were tagged: 752 pooled (60%) and 500 apheresis units (39.9%). This represented 7.6% of issues during the study period (7.4% of pooled and 8.0% of all apheresis platelets). The fate of 1243 platelet units was determined (99.3%). Of these, 94 (7.6%) were discarded during production before issue and were excluded from analysis. 1885 plasma units were tagged, representing 9.6% of units issued. The fate of 1808 units was determined (95.9%). Transfusion rate for issued platelets was 72.2% (830 units); 71.2% of pooled and 73.7% of apheresis platelets were transfused. Common reasons for discard were expiry (300 units, 26.1%); recall (5, 0.4%), commonly for bacterial flags; and other (14, 1.2%). Transfusion rate for issued plasma was 87.8% (1587 units). Common reasons for discard were were expiry (48 units, 2.7%), recall (3, 0.2%) and other reasons including breakage and unit thawed but not used (170, 9.4%). Median age of platelets recipients was 58 years (range 0–99); 60.6% were male; for plasma recipients median age was 51 (0-98); 64.1% were male. For platelets, the clinical urgency of transfusion was reported to be acute (required within one hour) in 126 cases (15.2%); urgent (required within 24h) 527 (63.5%); semi-urgent (required within one week) 130 (15.7%); non-urgent 2 (0.2%); unreported 45 (5.4%). The most common indications for platelet transfusion were hematological and oncological, together 64% of cases (530 units), comprising acute leukemias 260 (31.3%); lymphoma 59 (7.1%); myeloma 35 (4.2%); non-hematologic malignancies 68 (8.2%). Surgical conditions followed: 25.1% (208) of cases, comprising cardiothoracic 91 (11.0%); urological 30 (3.6%); gastrointestinal 18 (2.2%) and solid organ transplantation 16 (1.9%). Clinical condition was not reported in 40 (4.8%). Only 66 platelet units (7.9%) were transfused to support elective surgery. For plasma, urgency was reported as acute in 566 (35.7%), urgent in 857 (54.0%); semi-urgent in 84 (5.3%) and non-urgent in 13 (0.8%) and unreported in 67 (4.2%). The most common indications for plasma transfusion were surgical: cardiothoracic 249 cases (15.7%); vascular 87 (5.5%); gastrointestinal 58 (3.7%); orthopedic 29 (1.8%). Others included hematology (234 cases, 14.7%), mainly to support TTP patients (139, 8.8% of total); gastroenterology (227, 14.3%), mainly to support chronic liver disease patients (114, 7.2% of total) and trauma (104, 6.6%). Across all areas, 168 plasma units (18.9%) were transfused to support elective surgery and 179 (11%) to reverse warfarin. Conclusions The high levels of urgent transfusion and low proportion of platelets and plasma used in elective surgery seen here suggest that in a shortage conventional triage strategies would have little impact on demand. Clinical platelet and plasma usage is highly concentrated in specialized areas, predominantly to support patients with hematologic and malignant disorders, those undergoing major non-elective surgery, and the critically ill. Changes in demand or clinical practice in these areas may have substantial effects on requirements. Additional strategies are required to ensure continued adequacy of supply during blood shortages or demand fluctuations. Disclosures: No relevant conflicts of interest to declare.

Description: Background There are conflicting data on the impact of monosomal karyotype (MK) on overall survival (OS) in patients with myelodysplastic syndrome (MDS) and in particular whether MK is an independent predictor of survival in the subset of MDS patients with a complex karyotype (CK). We aimed to determine whether MK was associated with inferior survival independent of number of cytogenetic abnormalities. Methods Patients and data sources: A retrospective cohort study was performed using three population-based datasets from the Australian state of Victoria (population approximately 5.3 million). All incident cases of MDS notified to the Victorian Cancer Registry (VCR) from 2000 to 2010 were included. VCR data was linked with cytogenetic testing results performed by The Victorian Cancer Cytogenetic Service, the single provider of cytogenetic services for hematological malignancies in Victoria, and with hospital admission records held within the Victorian Admission Episode Database (VAED), a database of all hospital admissions within the state of Victoria. Cytogenetics: Metaphase cytogenetic analysis was performed according to standard techniques and karyotypes were described using the International System for Cytogenetic Nomenclature (ISCN). Statistical analysis: MK was defined as the presence of 2 or more autosomal monosomies or one monosomy with at least one additional structural abnormality. CK was defined as 3 or more cytogenetic abnormalities (CA). Overall survival (OS) was defined from date of diagnosis until death, censoring surviving patients at study end. OS was estimated using Kaplan-Meier curves, with survival between groups compared with the log rank test. Multivariable analysis was performed using the Cox proportional regression method, including all those variables associated with OS with a p-value less than 0.2 on univariate analysis. Results 1476 incident MDS cases notified to the VCR had cytogenetic testing performed. Metaphase cytogenetic testing was successful in 1407 cases (95%). The median age at diagnosis was 77 (interquartile range [IQR] 69-83) and 866 (62%) were male. The most common MDS subtypes were refractory anemia (RA) with multi-lineage dysplasia (n=482; 34%), RA with excess blasts (RAEB, n=243, 17%), RA (n=136, 9%), RA with ring sideroblasts (n=127, 9%) and not specified in 334 (24%). Hospital admission records were available for 1197 (85%), of whom 676 (56%) had one or more co-morbidity and 150 (12%) were red cell transfusion dependent (RC-TD) at diagnosis. 908 (65%) had a normal karyotype and 499 (34%) had at least one cytogenetic abnormality. CK was present in 129 (9%) and more than 5 CA in 96 (7%). MK was present in 90 (6%), of whom 82 (91%) also had CK and 74 (82%) also had 5 or more CA. Patients with a MK had worse overall survival compared to patients who did not have a MK (non-MK) (median OS 7 months vs. 41 months, Figure 1, p

Description: Background The recent UK/Australia TOPPS trial of prophylactic platelet transfusions (PltTx) recruited 600 patients with hematologic malignancies and reported that for all patients prophylaxis led to lower rates of World Health Organization (WHO) grade 2-4 bleeding. However, between 43 and 50% of all patients in the trial had some grade 2-4 bleeding, and there was evidence that the effect of PltTx varied by patient subgroup. Given the limited effectiveness of prophylactic PltTx to reduce bleeding risk, the issue remains whether other patient factors or clinical characteristics are more important prognostic factors for bleeding. Methods Statistical models were developed to explore risk factors for bleeding in all patients and in the large subgroup of autologous HSCT patients in the TOPPS dataset. Models were developed for baseline characteristics at presentation and for recurrent analysis of bleeding to assess the risks of grade 2-4 bleeding on any given day, accounting for previous bleeds in the 30 day time period. Additional analyses were undertaken to explore the severity and burden of thrombocytopenia, and importance of fever as a risk factor for bleeding. Results Baseline characteristic data were complete for 592 patients and 560 of these had complete follow-up data for the 30 days of the study. 256 (46%) of the 560 patients had at least one grade 2-4 bleed in the 30 days. Figure 1 shows the results of the main multivariate modeling of baseline characteristics associated with number of cumulative days bleeding. Treatment plan (alloHSCT/chemo), female sex and treatment arm (no-prophylaxis) were all found to be significantly associated with increased number of days of bleeding. Relevance of a low plt count over the previous 3 days was investigated for study days 4 to 30 (6712 bleeding records, 588 patients). There was evidence of a significant association between bleeding and a plt count

Description: Background and Aims The detection of sequence variants and copy number changes can improve diagnosis, inform prognosis and guide treatment in patients with bone marrow failure syndromes (BMFS). We aimed to establish and prospectively assess the impact of comprehensive genomic evaluation on diagnostic categorisation and clinical outcomes in patients with genomically uncharacterised BMFS. Methods Eligible patients were recruited from four participating institutions across Victoria, Australia. Inclusion criteria were (i) age 〉3 months (ii) clinicopathological diagnosis or suspicion of either acquired aplastic anaemia (AA), inherited BMFS, hypoplastic myelodysplastic syndrome (hMDS) or a BMFS with marrow hypoplasia/aplasia not able to be definitively categorised. Patients initially underwent 90-gene targeted sequencing (Peter MacCallum Cancer Centre PanHaem and Myeloid Amplicon next generation sequencing [NGS] panels) for rapid turnaround of accredited results for clinical decision-making. In addition, whole exome sequencing (WES), whole genome copy number analysis, NGS T-cell receptor β (TRB) repertoire assessment and longitudinal monitoring of selected mutations by digital droplet PCR (ddPCR) were performed. All patients received pre-test counselling and assessment. Genomic results were reviewed in centralised multidisciplinary case conferences including the treating clinician, molecular haematopathologists, medical scientists, clinical geneticists and genetic counsellors. Results 100 patients were enrolled. Median age was 25 years (range 3 months - 80 years); 39% were under 18 years. Detection of sequence variants or copy number abnormalities led to or confirmed a diagnosis of either an inherited or acquired BMFS in 36 patients. In 17 patients a diagnosis of an inherited BMFS was positively made by detection of pathogenic sequence variants or copy number changes in FANCA(1 patient [pt]), FANCM(1 pt), FANCI(1 pt), RAD51C(1 pt), HAX1(1 pt), SBDS(1 pt), DNAJC21(1 pt), RPS19(5 pts), RPL35A(1 pt), TERT(1 pt), TINF2(1 pt) and SAMD9L(1 pt). In five patients the clinical BMFS was considered undifferentiated without a clear candidate gene suspected on phenotypic features prior to genomic evaluation. Importantly, an established diagnosis of AA was altered to an inherited BMFS by genomic characterisation in two patients (SAMD9L, FANCA). In 19 patients pathogenic sequence variants or copy number changes were detected either leading to or confirming a diagnosis of an acquired BMFS (paroxysmal nocturnal haemoglobinuria, hMDS or AA). Pathogenic sequence variants were detected in TET2(n=5), RUNX1(n=4), ASXL1(n=3), PIGA(n=3), DNMT3A(n=3),CBL(n=2), and BCOR/IDH2/SF3B1/SRSF2/TP53/U2AF1(n=1 each). Sequencing-detected copy number abnormalities included loss of chromosome 7 (n=6), losses on chromosome 5q (n=2) and copy number loss of ETV6(n=2). Longitudinal monitoring of an acquired truncating RUNX1 mutation by ddPCR resulted in one patient undergoing allogeneic bone marrow transplant for a progressively rising allelic burden. There was a trend towards more restricted TRB diversity in patients with genomically-defined acquired BMFS versus inherited BMFS (normalised Shannon index ≤0.85, 36.4% vs 0%, p=0.09). Conclusion We have established and evaluated a model of comprehensive multimodal genomic characterisation and multidisciplinary care for 100 patients with BMFS. Our results demonstrate a significant contribution to diagnostic categorisation and patient care in this area of clinical need. Disclosures Lieschke: CSL Behring Australia: Consultancy. Tam:Janssen: Honoraria, Research Funding; Gilead: Honoraria; AbbVie: Honoraria, Research Funding; Pharmacyclics: Honoraria, Travel funding; Pharmacyclics: Honoraria; Beigene: Honoraria, Other: Travel funding; Roche: Honoraria; Beigene: Honoraria, Other: Travel funding; Gilead: Honoraria; Roche: Honoraria; AbbVie: Honoraria, Research Funding.

Description: Background The time to treatment initiation is determined by tumour burden in patients with follicular lymphoma (FL). The Groupe d'Etude des Lymphomes Folliculaires ('GELF') criteria, defined in the pre-rituximab era, are commonly used to assess tumour burden.2 Patients must meet ≥1 of the following criteria to be considered "high" tumour burden according to GELF: any tumour mass 〉7 cm; ≥ 3 nodal sites (each 〉3 cm); B symptoms; splenomegaly; compression syndrome; pleural/peritoneal effusion; leukemic phase or cytopenias. Low tumour burden FL is often excluded from clinical trials, based on data from initial retrospective studies and later randomised trials, demonstrating no survival advantage with chemotherapy compared with observation alone. 1-3 Conversely, it is recommended those with high burden disease receive immediate therapy. The use of GELF in therapeutic decision-making outside of clinical trials is not well described. Methods Cases of newly diagnosed Grade 1-3a FL were retrospectively identified from the Australian Lymphoma and Related Diseases Registry (LaRDR), and 2 additional institutional databases from 2002-2019. Additional data was obtained from electronic hospital records. The primary aim of the study was to determine the utilisation of GELF criteria in guiding therapeutic decisions in FL. The secondary aims were to document frequency of GELF according to stage and treatment and to determine the impact of the number of GELF criteria on PFS. Survival analysis was calculated according to the Kaplan-Meier method. Results 385 cases were identified. Patient characteristics are in table 1. The median follow-up was 2 years (range 0.1-18) with 2-year PFS and OS of 89% (95% CI 85-92%) and 96% (95% CI 92-98%) respectively. 94 (24%) patients underwent a 'watch and wait' approach (W&W), 54 (14%) received radiotherapy alone and 237 (62%) received chemotherapy +/- radiotherapy. 118 (31%) patients had stage I/II disease at diagnosis, of these 36 (30%) underwent a W&W approach, 41 (35%) had radiotherapy alone and 41 (35%) received chemotherapy +/- radiotherapy (with only 3 patients in the latter group being enrolled on clinical trial). 260 (69%) had advanced stage disease, of these 56 (22%) underwent a W&W approach, 13 (5%) had radiotherapy alone and 191(73%) received chemotherapy +/- radiotherapy. In the W&W group, 23% of patients had ≥1 GELF criteria, of these, 38% had limited stage disease. Of the patients who received chemotherapy +/-radiotherapy and radiation therapy, 36% and 57% respectively had no GELF criteria identified with 25% and 80% having limited stage disease respectively (table 2) Where available the reasons for commencing chemotherapy +/- radiotherapy in GELF negative patients were examined and included pain associated with lymph nodes, concerns regarding high-grade transformation (secondary to high SUVmax, size of nodal mass or trajectory of growth), cosmesis, nausea and fatigue. In both the W&W and treated cohorts, the number of GELF criteria did not predict outcome (Figure 1A & B). In a subgroup analysis by treatment modality, patients with no GELF criteria versus those with ≥1 GELF criteria, no statistically significant difference in PFS in the W&W group (PFS: HR 0.69 95% CI 0.14-3.27, P=0.63), the chemotherapy +/- radiotherapy group (PFS: HR 1.66 95% CI 0.79-3.52, P=0.18) and the radiotherapy alone group (PFS: HR 4.53 95% CI 0.51-40.71, P=0.13) was demonstrated. Conclusion One fifth of W&W FL patients had ≥ 1 GELF criteria and 36% of those receiving chemotherapy +/-radiotherapy had no GELF criteria at baseline, suggesting clinicians are using other measures to make therapeutic decisions. By restricting eligibility for clinical trials to those with high tumour burden, using GELF, a significant proportion of patients being treated in the 'real world' are not represented. In our cohort of both treated and untreated patients with FL, the presence of ≥1 GELF criteria did not influence prognosis. References 1. Young RC, et al. The treatment of indolent lymphomas: watchful waiting v aggressive combined modality treatment. Semin Hematol 1988. 2. Brice P, et al. Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the GELF. J Clin Oncol 1997. 3. Ardeshna KM, et al; Long-term effect of a W & W policy versus immediate systemic treatment for asymptomatic advanced-stage NHL. Lancet 2003. Disclosures Cheah: Roche: Other: Travel expenses; Celgene, Roche, Abbvie: Research Funding; Roche, Janssen, MSD, Gilead, Loxo Oncology, Acerta, BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Keane:Roche: Consultancy, Other: Travel Grant; Celgene: Consultancy; MSD: Consultancy; Gilead: Consultancy; BMS: Research Funding. Johnston:Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen, Roche: Membership on an entity's Board of Directors or advisory committees. Dickinson:Merck Sharpe and Dohme: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; GlaxoSmithKline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Opat:Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Epizyme: Research Funding; CSL: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Research Funding; Mundipharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Beigene: Research Funding; Pharmacyclics LLC, an AbbVie Company: Research Funding; Amgen: Research Funding; Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Novartis: Consultancy. McQuilten:CSL Biotherapies: Research Funding; Celgene: Research Funding; Gilead Sciences: Research Funding; Takeda Pharmaceuticals: Research Funding; AbbVie: Research Funding; Janssen-Cilag: Research Funding. Wood:Abbvie, Alexion, Amgen, Bristol-Myers Squibb, Celgene, CSL Behring, Gilead, Janssen, Novartis, Roche,, Sanofi, Takeda: Research Funding. Hawkes:Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche/Genentech: Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses, Speakers Bureau; Merck KgA: Research Funding; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Research Funding; Takeda: Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Research Funding, Speakers Bureau; Mundi pharma: Research Funding; Astra Zeneca: Research Funding; Merck Sharp & Dohme: Membership on an entity's Board of Directors or advisory committees.