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Comprehensive clinical characteristics of Australian patients with classical Hodgkin Lymphoma (cHL) have not previously been systematically collected and described. We report real-world data of 498 eligible patients from the first five years of the Lymphoma and Related Diseases Registry (LaRDR), including baseline characteristics, histologic subtype and treatment patterns in first-line therapy. Patient demographics and distribution of histopathological subtypes of cHL are similar to reported international cohorts. Doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) was the most common therapy for both early and advanced-stage disease, and 48% of patients with early-stage disease received radiotherapy. Treatment patterns are consistent with international guidelines. In comorbid patients ≥ 60 years of age with advanced-stage disease, there is greater variation in treatment. In patients with a recorded response, the objective response rate (ORR) was 96% in early-stage disease, and 88% in advanced-stage disease. Early progression-free survival data suggest Australian patients with cHL have good outcomes, similar to other international studies.

BACKGROUND: Studies comparing mortality following massive transfusion (MT) with fresher versus longer-stored red blood cells (RBCs) have focused on trauma patients. The Australian and New Zealand Massive Transfusion Registry collects data on all adult MT cases (≥5 RBCs within 4 hours, any bleeding context, ≥18 years) at participating hospitals. METHODS: Years 2007 to 2018 data from 29 hospitals were analyzed to quantify the association between mortality and RBC storage time in adult MT cases. We ran three logistic regression models separately on each of seven bleeding contexts, with in-hospital mortality as the outcome and, in turn, (1) mean storage time (STmean) quartiles, (2) proportion of RBCs ≥30 days old (propOLD), and (3) scalar age of blood index as predictors. RESULTS: A total of 8,685 adult MT cases involving transfusion of 126,622 RBCs were analyzed with Australian and New Zealand data analyzed separately. Mean storage times for these cases were (by quartile in ascending order) as follows: Australia, 12.5 days (range, 3.1-15.5 days), 17.7 (15.5-19.9), 22.3 (19.9-24.9), and 29.8 (24.9-41.7); New Zealand, 11.3 days (3.6-13.7), 15.3 (13.7-16.8), 18.7 (16.8-20.7), and 24.5 (20.7-35.6). The odds ratios comparing in-hospital mortality for each quartile with that of the control first quartile (freshest blood), proportion of longer-stored (≥30 days) RBCs, and scalar age of blood index were not statistically significant across all bleeding contexts. CONCLUSION: We find no correlation between in-hospital mortality and storage time of transfused RBCs in a large cohort of adult MT patients representing all bleeding contexts. These results are consistent with those of recent large multicenter trials. LEVEL OF EVIDENCE: Epidemiologic, level III; Therapeutic, level IV.

BACKGROUND: Real-world multiple myeloma (MM) data are scarce, with most data originating from clinical trials. The Myeloma and Related Diseases Registry (MRDR) is a prospective clinical-quality registry of newly diagnosed cases of plasma cell disorders established in 2012 and operating at 44 sites in Australia and New Zealand as of April 2020. METHODS: We reviewed all patients enrolled onto the MRDR between June 2012 and April 2020. Baseline characteristics, treatment, and outcome data were reviewed for MM patients with comparisons made by chi-square tests (categorical variables) and rank sum tests (continuous variables). Kaplan-Meier analysis was used to estimate progression-free survival and overall survival (OS). RESULTS: As of April 2020, a total of 2405 MM patients were enrolled (median age, 67 years, with 40% aged > 70 years). High-risk features were present in 13% to 31% of patients: fluorescence in-situ hybridization (FISH) ≥ 1 of t(4;14), t(14;16), or del(17p) 18%, International Staging System (ISS)-3 31%, and Revised ISS (R-ISS)-3 13%. Cytogenetic/FISH analyses were performed in 50% and 68% of patients, respectively, with an abnormal karyotype result in 34%. Bortezomib-containing therapy was the most common first-line therapy (79.3%, n = 1706). Patients not receiving bortezomib were older (median age, 76 vs 65 years, P < .001) with inferior performance status (Eastern Cooperative Oncology Group performance status ≥ 2, 41% vs 18%, P < .001). Median progression-free survival and OS were 30.8 and 65.8 months, respectively. Younger patients had superior OS (76.3 vs 46.7 months, P < .001, < 70 and ≥ 70 years, respectively). R-ISS score was available in 50.7% (n = 1220) of patients, and higher R-ISS was associated with inferior OS (R-ISS-1 vs R-ISS-2 vs R-ISS-3: not reached vs 68.1 months vs 33.2 months, respectively, P < .001). CONCLUSION: Clinical registries provide a more complete picture of MM diagnosis and treatment, and highlight the challenges of adhering to best practices in a real-world context.

Supported by clinical trial proven survival benefit, clinical guidelines recommend upfront autologous stem cell transplantation (ASCT) for eligible MM patients. However, reported real-world utilisation is lower than expected (40–60%). We reviewed ASCT utilisation, demographics and outcomes for MM patients (≤70 years, ≥12-month follow-up) enroled onto the Australian/New Zealand MRDR from June 2012 to May 2020. In 982 patients (

The frequency and causes of early mortality in patients with newly diagnosed multiple myeloma (NDMM) have not been well described in the era of novel agents. We investigated early mortality in a prospective cohort study of all patients with NDMM registered on the Australian and New Zealand Myeloma and Related Diseases Registry (MRDR) at 36 institutions between July 2011 and March 2020. Early mortality was defined as death from any cause within the first 12 months after diagnosis. A total of 2377 patients with NDMM were included in the analysis, with a median (interquartile range) age of 67.4 (58.9-74.60 years, and 60% were male. Overall, 216 (9.1%) patients died within 12 months, with 119 (4.5%) having died within 6 months. Variables that were independent predictors of early mortality after adjustment in multivariable regression included age (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.05-1.08; p 0.001), Eastern Cooperative Oncology Group performance status (OR 1.50, 95% CI 1.26-1.79; p 0.001), serum albumin (OR 0.95, 95% CI 0.93-0.98; p 0.001), cardiac disease (OR 1.96, 95% CI 1.35-2.86; p 0.001) and International Staging System (OR 1.40, 95% CI 1.07-1.82; p = 0.01). For those with a primary cause of death available, it was reported as disease-related in 151 (78%), infection 13 (7%), other 29 (15%). Infection was listed as a contributing factor for death in 38% of patients.

In the context of critical bleeding and massive transfusion (CB/MT), little is known about the development of new red blood cell (RBC) alloantibodies. We performed a retrospective, observational study to examine the frequency of RBC alloantibodies (pre-existent, anamnestic, or new) in patients with CB/MT, defined as transfusion of five or more RBC units in any 4-hour period, for any cause of CB.Data on 2,585 New Zealand patients (date/time of MT initiation, demographic data, blood group, clinical context, and transfused RBCs) were obtained from the Australian and New Zealand Massive Transfusion Registry. RBC alloantibody screening/identification data were extracted from the New Zealand Blood Service database. We calculated summary statistics, compared proportions between different independent groups using the Chi-squared test, and performed logistic regression analysis to examine the effects of variables on alloantibody presence or formation. We also determined the immunogenicities of selected RBC antigens in the context of CB/MT.Of 1,234 assessable patients, 1,166 (94.5%) showed no evidence of any alloantibody. Pre-existent, anamnestic, and new alloantibodies were found, respectively, in 4.3%, 0.4%, and 7.2% of assessable patients. By multivariable regression analysis, transfusion of D-positive RBC to D-negative patients was independently associated with new alloantibody formation. Neither the quantum of RBC transfused nor trauma as clinical context were so associated although the latter trended towards a predisposition. "Antibodies of undetermined specificity" were the commonest pre-existent and new alloantibodies. The immunogenicity of JkRBC alloantibodies of any type were rare in this CB/MT population. Patients undergoing CB/MT appear to have low risks of re-stimulating anamnestic alloantibodies, or of developing new RBC alloantibodies.

Background Lymphoma is a malignancy of lymphocytes and lymphoid tissues comprising a heterogeneous group of diseases, with up to 80 entities now described. Lymphoma is the 6th most common cancer in Australia, affecting patients of all ages, with rising incidence rates. With the proliferation of efficacious novel agents, therapeutic strategies are increasingly diverse and survival is improving. There is a clear need for contemporary robust and detailed data on diagnostic, investigational and management strategies for this disease in Australia, New Zealand and worldwide, to inform and benchmark local and international standards of care. Clinical quality registries can provide these data, and support development of strategies to address variations in management, including serving as platforms for clinical trials and research. The Lymphoma and Related Diseases Registry (LaRDR) was developed to capture details of patient demographics, disease characteristics, and management throughout their disease course and therapy and to develop outcome benchmarks nationally and internationally for lymphoma. This report describes the aims, development and implementation of the LaRDR, as well as challenges addressed in the process.Methods The LaRDR was established in 2016 as a multicentre, collaborative project at sites across Australia with a secure online database which collects prospective data on patients with a new diagnosis of lymphoma or chronic lymphocytic leukaemia (CLL). LaRDR development required multidisciplinary participation including specialist haematology, information technology, and biostatistical support, as well as secure funding. Here we describe the database development, data entry, ethics approval process, registry governance and support for participating sites and the coordinating centre.Results To date more than 4,700 patients have been enrolled from 27 sites. Multiple challenges arose during the development, which we describe, along with approaches used to overcome them. Several confirmed international collaborations are now in place, and the registry is providing valuable data for clinicians, researchers, industry and government, including through presentations of results at major national and international conferences.Conclusion Challenges in establishing the LaRDR have been successfully overcome and the registry is now a valuable resource for lymphoma clinicians, researchers, health economists and others in Australia and globally.

We read with interest the study from Rampotas et al (1) where they evaluated 158 transplant-non-eligible newly diagnosed myeloma patients treated with bortezomib (Velcade), cyclophosphamide and dexamethasone (VCD) chemotherapy. They showed that fixed duration VCD led to an overall response rate (ORR) of 72% and was 'reasonably well tolerated'. They concluded that the comparatively poor event free survival (EFS) may be improved "with the use of higher cumulative bortezomib" doses.

Māori and Pacific peoples (MPP) in New Zealand (NZ) have poorer health outcomes than other ethnicities. However, this has not been clinically investigated in multiple myeloma (MM). Using data from the Australian and NZ Myeloma and Related Diseases Registry for all participating centers in NZ, we compared MPP demographics, clinical characteristics, diagnostics, treatment, and outcomes to non-MPP.MPP were defined as having ≥1 grandparent of this heritage. We tested ethnicity as a predictor of overall survival (OS) with multivariable Cox regression.Of 568 NZ patients with MM (September 2012 to April 2021) and ethnicity data, 138 were MPP. They were diagnosed younger than non-MPP (median age 63 [IQR: 57-72] vs. 70y [62-77], P.001). Obesity (53 vs. 27%, P.001), diabetes (24 vs. 8%, P.001), renal insufficiency (28 vs. 17%, P = .005), pulmonary disease (10 vs. 5%, P = .02) and FISH abnormalities (54 vs. 42%, P = .04) were more common in MPP, and a lower proportion received first-line drug therapy (88 vs. 94%, P = .03) and autologous stem cell transplant (ASCT) (age70y: 56 vs. 70%, P = .03). OS for MPP was shorter than non-MPP even after adjusting for age, comorbidities, disease stage, performance status, FISH abnormalities and treatment (HR 1.58 [1.04-2.39], P = .03).MPP with MM in NZ were younger, a greater proportion had comorbidities and FISH abnormalities at diagnosis, fewer received first-line treatment and/or ASCT, and they had poorer OS than non-MPP. Investigation of modifiable factors to improve outcomes and discern why MM occurs at a younger age in MPP is needed.

Background Renal impairment (RI) is a common complication of multiple myeloma (MM) and remains a poor prognostic factor despite improved survival with newer therapies. Patients and Methods We evaluated baseline characteristics, treatment, and outcomes of newly diagnosed MM patients with RI at diagnosis in the Australia and New Zealand Myeloma and Related Diseases Registry over 5 years to April 2018; we compared patients with RI (estimated glomerular filtration rate [eGFR] Results Overall, 36% of patients with newly diagnosed MM had RI; they were older, had more advanced disease and comorbidities, and worse performance status. Bortezomib-based induction therapy was most commonly used, although administered to fewer RI patients, despite similar response rates. Patients with RI were less likely to receive ASCT; however, recipients had longer progression-free survival (PFS) and overall survival (OS). Patients with RI had shorter OS and PFS after adjusting for age. In ASCT recipients with RI versus no RI, there was no difference in PFS and OS. Conclusion Our findings in “real world” MM patients with RI confirm that patient-, disease-, and treatment-related factors (such as suboptimal bortezomib and ASCT use), and delays in commencing therapy, might contribute to poorer outcomes, and support the use of ASCT in patients with RI.

Background Graft-versus-myeloma (GvM) effect from allogeneic-SCT potentially affords long-term disease control in multiple myeloma (MM). A salvage program incorporating chemotherapy followed by tandem autologous + non-myeloablative allogeneic-SCT (TAA-SCT) may offer a survival advantage over chemotherapy alone (ChA) Method Consecutive patients with relapsed MM (R-MM) salvaged with chemotherapy followed by TAA-SCT at the Alfred between Jan-08 and Dec-19 were identified. A 2:1 comparator cohort salvaged with ChA (iMiD agent/PI available) matched for age/sex/ISS-stage, was extracted from the Myeloma and Related Diseases Registry (MRDR). All patients received autologous-SCT as part of their upfront treatment. Survival was assessed by Kaplan-Meier method and compared using log-rank test. Prognostic variables were adjusted using Cox-regression. Results 48 patients received TAA-SCT following salvage chemotherapy during the study period; 35% met criteria for high-risk myeloma at diagnosis (ISS-III and/or adverse CG/FISH) with a median age at salvage of 57 [range: 32-68] and 2 prior therapy lines [range: 1-7]. Preceding TAA-SCT, salvage chemotherapy yielded ≥ PR in ~95% of cases; iMiD® and/or PI were used in ~85%. 87 matched patients were identified from the MRDR as the ChA cohort. Baseline characteristics were comparable, except that the TAA-SCT cohort was more heavily pre-treated (p Conclusion In the iMiD® and PI era, TAA-SCT following chemotherapy remains an effective salvage strategy in selected patients with R-MM, providing an immunological platform for a GvM effect with OS and PFS advantage over chemotherapy alone.

Introduction Multiple myeloma (MM) is an incurable blood cancer with a high disease burden. Early assessment of health-related quality of life (HRQOL) can help to guide therapy planning. EQ-5D-5L (EQ5D) scores are collected in the Australian and New Zealand Myeloma and Related Diseases Registry (MRDR) at diagnosis and follow-up as a non-mandatory item. We describe the use of EQ5D utility scores to assess patients’ HRQOL at diagnosis. Methods Utility scores are a measure of HRQOL, from ‘0’ (equal to death) to ‘1’ (full health). Scores were calculated for Australian patients with EQ5D data at diagnosis on the MRDR (Feb 2013 - Mar 2021) using a scoring algorithm developed for Australia1. Kaplan-Meier methods were used for survival analysis. Results Of 2239 Australian patients with MM on the MRDR, 483 had baseline EQ5D within 6m of diagnosis, with data for all 5 dimensions. Median age was 68y (59-76), 63% were male, and median overall survival was 63.0m (54.1-NR). In self-care, 66% of pts reported no problems at diagnosis, while only 22% were pain-free. Problems with mobility were reported in 55%, anxiety/depression in 56%, and problems with usual activities in 67% of patients at diagnosis. Patient characteristics were compared between EQ5D utility score groups (Q1: Conclusion Pain/discomfort was the most frequently reported health issue in MM, and self-care related problems the least, compared to the other health dimensions. EQ5D utility scores in Australian MRDR patients with MM were independent of age, gender and disease stage (ISS=3), but high scores were associated with higher EQ VAS score, improved ECOG, less cardiac disease, and better overall survival. HRQOL of MM patients at diagnosis has prognostic potential with better EQ5D utility scores associated with longer overall survival

Supported by clinical trial proven survival benefit, clinical guidelines recommend upfront autologous stem cell transplantation (ASCT) for eligible MM patients. However, reported real-world utilisation is lower than expected (40-60%). We reviewed ASCT utilisation, demographics and outcomes for MM patients (≤70 years, ≥12-month follow-up) enroled onto the Australian/New Zealand MRDR from June 2012 to May 2020. In 982 patients (65 years: 684, 65-70 years: 298), ASCT utilisation was 76% overall (65 years: 83%, 65-70 years: 61%, front-line therapy: 67%). Non-ASCT recipients were older (median age: 65 years vs 60 years, p 0.001), had more comorbidities (cardiac disease: 16.9% vs 5.4%, p 0.001; diabetes: 19.1% vs 7.0%, p 0.001; renal dysfunction: median eGFR(ml/min): 68 vs 80, p 0.001), inferior performance status (ECOG ≥ 2: 26% vs 13%, p 0.001) and higher-risk MM (ISS-3: 37% vs 26%, p = 0.009, R-ISS-3 18.6% vs 11.8%, p = 0.051) than ASCT recipients. ASCT survival benefit (median progression-free survival (PFS): 45.3 months vs 35.2 months, p 0.001; overall survival (OS): NR vs 64.0 months, p 0.001) was maintained irrespective of age (65 years: median PFS: 45.3 months vs 37.7 months, p = 0.04, OS: NR vs 68.2 months, p = 0.002; 65-70 years: median PFS: 46.7 months vs 29.2 months, p 0.001, OS: 76.9 months vs 55.6 months, p = 0.005). This large, real-world cohort reaffirms ASCT survival benefit, including in 'older' patients necessitating well-designed studies evaluating ASCT in 'older' MM to inform evidence-based patient selection.

Introduction Serious infection is common in patients with multiple myeloma (MM), and associated with major morbidity and mortality. Immunoglobulin (Ig) replacement is frequently used to reduce frequency and severity of infections, however evidence is based on small trials conducted >20 years ago. Ig utilisation and associated costs in this patient cohort are rising worldwide. In Australia (Aus), Ig for secondary hypogammaglobulinaemia is funded if total IgG is below lower limit of reference range with a history of recurrent or severe bacterial infection, or in severe hypogammaglobulinaemia (IgG < 4 g/L excluding paraprotein). In New Zealand (NZ), patients generally require a history of recurrent infections and trial of oral antibiotics before commencing Ig. This study aims to outline Ig use in the "real-world" MM setting, identify variation in and predictors of use, and describe association of Ig with survival outcomes. Methods Retrospective review of patients registered on the MRDR, a prospective registry established in 2012, currently open at >60 sites across Aus/NZ. Patients with a diagnosis of MM or plasma cell leukaemia with verifiable data regarding Ig use were included in this analysis. Ig use was confirmed using medical/laboratory records, national Aus Ig dispensing tool or the NZ Blood Service portal. Quality of survival outcomes and cause of death data was augmented via linkage with national death registries. Baseline patient/disease characteristics, therapy and survival outcomes were compared between patients who received any Ig within 24 months of MM diagnosis and non-recipients using chi-square tests for categorical variables and rank sum tests for continuous variables. Variation in Ig use across sites were compared. Kaplan-Meier survival analysis was used to estimate time to Ig and duration of use. A time-dependent Cox analysis was used to compare survival for patients whilst on and off Ig therapy. All statistical analysis was completed on STATA/IC statistical software v16.1 (College Station, TX, USA). Results As of July 2021, >4600 patients with plasma cell dyscrasias are registered on the MRDR. Of these, 2025 patients from 13 sites (12 Aus across five states/territories and one NZ) with verifiable data on Ig were included. 242 (12.0%) received Ig during follow-up, with a median time from MM diagnosis to Ig use of 14.2 months, median duration of Ig use of 54.9 months, and median patient follow-up time of 23 months (Figure 1). At 24 months following MM diagnosis, 14.9% (160 of 1075 patients reaching 24-month follow up) received Ig, and a further 7.6% (82 patients) received Ig later, after 24 months. Administration of Ig within 24 months post-MM diagnosis varied widely across Aus states and territories (2.7%-29.6%), and was 2.0% from one NZ site. Patients administered Ig within 24 months post-MM diagnosis had lower baseline IgG (3.7 vs. 5.6 g/L, p Ig use was not associated with an overall survival benefit (HR=0.79, 0.50-1.24, p=0.3). At time of last follow-up, there were 577 deaths (28.5%). Available data on cause of death was available for 175 deaths (30.3%). Of these, 65 deaths (37.1%) had infection listed as primary/secondary cause of death (COD). 64 of 65 infection-related deaths occurred in non-Ig recipients. In patients who received Ig (at any time), 12.5% had infection as primary/secondary COD, compared to 38.5% in non-recipients (p=0.14). Conclusion This Aus/NZ analysis found that 14.9% of MM patients received Ig by 24 months post-MM diagnosis with wide variation in practice. Ig use was associated with lower baseline Ig levels (all subtypes), abnormal FISH and first-line IMiD/anti-CD38 therapy. In this "real-world" cohort, Ig use was not associated with survival, highlighting the need for well-designed contemporary studies to inform evidence-based patient selection, especially with increasing use of Ig and targeted anti-myeloma therapies, and a high burden of infection-related mortality. Figure 1 Figure 1. Disclosures Hamad: Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Harrison: Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche/Genentech: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene/ Juno/ BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Eusa: Consultancy, Honoraria, Speakers Bureau; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; GSK: 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; Terumo BCT: Consultancy, Honoraria. Mollee: Janssen, Pfizer: Research Funding; Amgen, BMS, Janssen, Caelum, EUSA, Pfizer, SkylineDx, Takeda: Membership on an entity's Board of Directors or advisory committees, Other: No personal fees received. Quach: GlaxoSmithKline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Antengene: Consultancy, Membership on an entity's Board of Directors or advisory committees; CSL: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen/Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Spencer: Celgene: Honoraria, Research Funding, Speakers Bureau; Janssen: Honoraria, Research Funding, Speakers Bureau; Amgen: Honoraria, Research Funding; Bristol Myers Squibb: Research Funding; Takeda: Honoraria, Research Funding, Speakers Bureau; STA: Honoraria. Wood: Amgen, Celgene, Gilead, Janssen, Novartis, Sanofi, Takeda: Research Funding; Abbvie, Amgen, Antengene, Bristol-Myers Squibb, Celgene, Gilead, GSK, Janssen, Novartis, Sanofi, and Takeda.: Other: The Australian and New Zealand Myeloma and Related Diseases Registry (MRDR) has received funding from Abbvie, Amgen, Antengene, Bristol-Myers Squibb, Celgene, Gilead, GSK, Janssen, Novartis, Sanofi, and Takeda. . McQuilten: Amgen, Celgene, Gilead, Janssen, Novartis, Sanofi, Takeda: Research Funding; Abbvie, Amgen, Antengene, Bristol-Myers Squibb, Celgene, Gilead, GSK, Janssen, Novartis, Sanofi, and Takeda.: Other: The Australian and New Zealand Myeloma and Related Diseases Registry (MRDR) has received funding from Abbvie, Amgen, Antengene, Bristol-Myers Squibb, Celgene, Gilead, GSK, Janssen, Novartis, Sanofi, and Takeda. .

Background In addition to 4 CRAB criteria, 3 biomarkers were adopted as myeloma-defining events: clonal marrow plasma cell (PC) percentage ≥60%, serum free light chain ratio (SFLCR) ≥100 and >1 MRI focal lesion, known as SLiM (SixtyLightchainMRI), but there has been no analysis of their clinical impact. Methods We compared the characteristics, treatment & outcomes of 1686 pts diagnosed by CRAB and 132 pts by SLiM enrolled in the MRDR from 2013 - 2018, to assess the impact of these criteria on clinical practice and treatment outcomes. Results Patient & Disease characteristics. In 132 SLiM pts, 48 had SFLCR≥100, 58 BMPC>60% and 26 were known to have both, nil had MRI lesions (limited by MRI availability). CRAB pts included a higher proportion with advanced stage ISS-3 (35.6% v 10.7%, p Outcomes OS was longer in SLiM than CRAB (median 76.3 v 65.2 m, p=0.02, HR 1.75), with no difference in PFS (30.8 v 30.2 m, p=0.30, HR 1.17). However PFS2 was superior for SLiM of 48.7 m v 38.2 m for CRAB (HR 1.38, p=0.06). No difference in best response rates (≥PR & ≥VGPR) was seen in SLiM v CRAB. Within SLiM, comparing 3 groups: those who satisfied the criteria of SFLCR>100 only (SFLC group, n=28), PC≥60% only (PC group, n=34) or both (n=20), pts with Discussion We found differences in characteristics between SLiM and CRAB pts – higher BM PC infiltration and SFLCR in SLiM, and a trend for higher incidence of FISH anomalies in CRAB. SLiM pts had a median OS 11.1 m longer than CRAB, but no difference in PFS1 or response rates. The OS difference of -1 yr could reflect the earlier initiation of therapy in SLiM. However the trend for a longer PFS2 for SLiM indicates improved treatment outcome to therapy at first relapse, suggesting the shorter PFS2 of CRAB pts may result from residual or re-emerging drug-resistant clones. Conclusions In a real-life population our findings support the benefit of earlier initiation of therapy by SLiM criteria, with an improved OS and a trend towards improved outcome at first relapse (PFS2). Patients with PC criteria in the SLiM cohort have an increased risk for suboptimal response compared to those who satisfy SFLC criteria alone.

Background and Aims: The Asia-Pacific (APAC) Myeloma and Related Diseases Registry (MRDR) collects data on epidemiology, treatment and outcome trends for patients with multiple myeloma (MM) in participating regional countries. Prevalence of MM is expected to continue to increase with ageing populations and improvements in survival. Although some MM data are available for Asia, very few exist at regional level. Generation of 'real world evidence' on practice and outcomes is important to complement data from clinical trials. In the APAC MRDR, regional clinical experts provide local clinical context and registry oversight, and participating hospitals obtain local ethics approval and manage patient recruitment and data collection. Methods: The APAC MRDR prospectively collects observational data on patient characteristics, diagnosis, medical history, treatment (including supportive therapies), and outcomes (overall and progression-free survival, and quality of life using the EQ-5D-5L) on newly diagnosed MM (NDMM), plasma cell leukaemia, plasmacytoma, and MGUS patients via a secure, country-specific, web-based database. Participants are reviewed 4-monthly for a minimum of 2 years. Preliminary data from October 2018 to June 2020 were analysed. Results: 20 hospitals have ethics approval to participate and patient recruitment has commenced at 14 hospitals in Korea, Singapore, and Malaysia. Sites in Taiwan will also start recruitment in 2020, and sites in China have been identified. To date, a total of 469 patients (419 NDMM) have been enrolled, of which, data from 348 (83%) NDMM participants from Korea, Singapore, and Malaysia were available for analysis. Results are presented in Table 1. Summary and Conclusions: The APAC MRDR is now successfully established and expanding. As data mature, these will provide important new information on the epidemiology and treatment of MM across the APAC region, and provide opportunities for regional benchmarking and collaborative research. Disclosures Spencer: Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding; Secura Bio: Consultancy, Honoraria; Pharmamar: Research Funding; Roche: Honoraria; Servier: Consultancy, Honoraria, Research Funding; HaemaLogiX: Consultancy, Honoraria, Research Funding.

BACKGROUND For many years active myeloma (MM) was defined by 4 CRAB criteria: hyperCalcemia, Renal impairment, Anaemia, Bone lesions. In 2014, 3 additional biomarkers that were associated with ≥70% chance of activation to symptomatic myeloma (CRAB) within 2 years were adopted as myeloma defining events: clonal bone marrow (BM) plasma cell (PC) percentage ≥60%, involved: uninvolved serum free light chain ratio (SFLCR) ≥100, and >1 focal lesion on MRI - the SLiM criteria (SixtyLightchainMRI). We assessed the application of these criteria in a real-life population to determine their impact on clinical practice and treatment outcomes. METHODS AND AIMS We evaluated clinical characteristics, treatment & outcomes of pts registered in the Australian & New Zealand Myeloma Registry (MRDR) from 2013 to 2018, comparing pts diagnosed with active MM by CRAB (n=1686) vs SLiM (n=132) criteria. RESULTS Patient & Disease characteristics: In 132 SLiM pts, 58 had BMPC≥60%, 48 SFLCR≥100 and 26 were known to have both, nil had MRI lesions. CRAB pts included a higher proportion with advanced stage ISS-3 (35.6% vs 10.7%, p Outcomes: There was no difference in therapy between SLiM and CRAB. Median OS of SLiM pts was longer than CRAB (76.3 vs 65.2 m, p=0.02, HR 1.75 Fig 1a), with no difference in PFS (30.8 vs 30.2 m, p=0.30, HR 1.17, Fig 1b). However PFS2 was superior for SLiM of 48.7 m vs 38.2 m for CRAB (HR 1.38, p=0.06, Fig 1c). No difference in best response rates (≥PR & ≥VGPR) was seen in SLiM vs CRAB. Within SLiM, comparing 2 groups who only satisfied the criteria of SFLCR≥100 (SFLC group, n=28) or PC≥60% (PC group, n=34) alone and with treatment responses, there was a difference in the distribution. CR was lower in SFLC group (7 v 20%), but VGPR +PR was higher (89% vs 61%). More pts in PC group had only minimal response (MR) or stable disease (SD) as best clinical response (17.6%) compared to SFLC group (3.6%). The rate of pts with DISCUSSION Apart from the expected differences distinguishing SLiM and CRAB pts eg. renal impairment, we found additional differences in pt & disease characteristics between the 2 groups - higher BM PC infiltration and SFLCR in SLiM, and a higher incidence of FISH anomalies in CRAB. Not surprisingly a higher proportion of CRAB pts had advanced stage and poor performance status. SLiM pts had a median OS 11.1 m longer than the CRAB group, but no difference in PFS1 nor response rates. The OS difference of ~1 yr could reflect the earlier initiation of therapy in SLiM (with OS calculated from time of first therapy, corresponding to the SLiM criteria derived from ≥70% chance of transformation to CRAB within 2 yrs if untreated). However the trend for a longer PFS2 for SLiM indicates an improved treatment outcome to therapy for first relapse, suggesting that the shorter PFS2 of CRAB pts may result from residual and re-emerging clones that are more drug resistant at relapse. Within the SLiM cohort, while PFS & OS did not differ between pts treated by SFLCR, PC criteria or both, supporting their equal impact on disease behavior, a higher proportion of pts with PC criteria (alone, or with SFLCR) had a suboptimal response ( CONCLUSIONS Our findings support the benefit of earlier initiation of therapy by SLiM criteria in a real-life population, indicating an improved OS and a trend towards improved salvageability at first relapse (PFS2). Patients with PC criteria in the SLiM cohort are associated with an increased risk for suboptimal response compared to those who satisfy SFLC criteria alone. Disclosures Quach: GlaxoSmithKline: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Glaxo Kline Smith: Consultancy, Research Funding; Karyopharm: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Research Funding; Janssen Cilag: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding. Harrison:Janssen: Honoraria; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Honoraria, Patents & Royalties: wrt panobinostat; BMS: Consultancy, Honoraria; CRISPR Therapeutics: Consultancy, Honoraria; Haemalogix: Consultancy; F. Hoffmann-La Roche: Consultancy, Honoraria. Mollee:Pfizer: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Caelum: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS/Celgene: Membership on an entity's Board of Directors or advisory committees. Spencer:Celgene, Janssen and Takeda: Speakers Bureau; AbbVie, Amgen, Celgene, Haemalogix, Janssen, Sanofi, SecuraBio, Specialised Therapeutics Australia, Servier and Takeda: Honoraria; Amgen, Celgene, Haemalogix, Janssen, Servier and Takeda: Research Funding; AbbVie, Celgene, Haemalogix, Janssen, Sanofi, SecuraBio, Specialised Therapeutics Australia, Servier and Takeda: Consultancy.

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 (p70y OR 1.59 (95% CI 1.11-2.28; p=0.01) and B-based 1L OR 0.47 (95% CI 0.29-0.75; p=0.001). Median overall (OS) survival for SOR was similar to that of responders (R): 57.8m (95%CI, 36.7 - NR) vs 59.3m (95%CI, 55.4 - NR), for SOR vs R, respectively, but with an excess of early deaths from the time of diagnosis in a sub-set of SOR patients: survival at 12m 85% vs 96%, 24m 73% vs 88% and 36m 61% vs 79%, for SOR vs R, respectively, (HR 1.6, 95% CI 1.2 - 2.3; p=0.001) (Figure A). Conversely, EP was associated with a range of indicators of higher-disease burden: higher ISS (p Conclusions: These real-world data demonstrate that 40% of patients with SOR will die within 3y of diagnosis. More strikingly, EP is associated with high disease burden at diagnosis and high likelihood of refractoriness at 1R, with median OS of only 20.2m. While recent data demonstrate that 1L triplets or quadruplets containing the monoclonal antibody daratumumab may mitigate against both SOR and EP, these approaches remain financially implausible in most jurisdictions. A more affordable approach could be informed by response-adaptive trials in functional HR MM in an attempt to address the ongoing unmet therapeutic need in these patient groups. Figure Disclosures Spencer: Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Specialised Therapeutics Australia: Consultancy, Honoraria; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Mollee:Janssen: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. Blacklock:Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Harrison:AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: investigator on studies, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Quach:Karyopharm: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Membership on an entity's Board of Directors or advisory committees; Sanofi: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Ho:Celgene: Other: investigator meeting travel costs; Janssen: Other: investigator meeting travel costs; Novartis: Other: investigator meeting travel costs; La Jolla: Other: investigator meeting travel costs. Spearing:Celgene: Consultancy, Honoraria, Other: Travel costs; Roche: Other: Travel costs. Prince:Amgen: Consultancy, Honoraria; Celgene: Honoraria; Takeda: Consultancy, Honoraria; Allergan: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria. Moore:Gilead: Research Funding; Takeda: Research Funding. McQuilten:Takeda Pharmaceuticals: Research Funding; AbbVie: Research Funding; Janssen-Cilag: Research Funding; Celgene: Research Funding; Gilead Sciences: Research Funding; CSL Biotherapies: Research Funding. Wood:Roche: Research Funding; Gilead: Research Funding; Takeda: Research Funding; Amgen: Research Funding; Abbvie: Research Funding; Janssen-Cilag: Research Funding; Novartis: Research Funding; Sanofi: Research Funding; Bristol-Myers Squibb: Research Funding; Alexion: Research Funding; Celgene: Research Funding; CSL Behring: Research Funding.

Introduction: Recent studies suggest that incidence of multiple myeloma (MM) is increasing in Asian countries. Prevalence is also expected to rise due to ageing populations and advances in treatment. Therapeutic options continue to expand as new, targeted agents enter the market. However, despite advances in therapy and supportive care, MM remains incurable. Most patients receive care outside the setting of clinical trials. Therefore, the generation of Real-World Evidence (RWE) on practice, including long-term monitoring and evaluation of current and future treatment strategies, is important in informing optimal therapies for MM and enable benchmarking to improve outcomes, quality of life (QoL), and cost-effectiveness of care for patients. Some country-specific data are available in Asia, but few at regional level. We established the Asia-Pacific (APAC) Myeloma and Related Diseases Registry (MRDR) in 2018, as a regional collaboration and sister registry to the Australian and New Zealand MRDR (ACTRN12618000659202). The aims are collection of a standardised APAC dataset for analysis and benchmarking. Key opinion leaders from the participating countries were invited to form the steering committee to provide local clinical context and oversight of the registry. Early in the process, ethics committees and legal counsel were consulted to assist with challenges presented by the diversity in data privacy and ethical regulations across the APAC region. Participating hospitals are responsible for obtaining local ethics approval, patient recruitment, and data collection. Participants provide written informed consent before data collection. Methods: The APAC MRDR prospectively collects observational data on patient characteristics, diagnosis, medical history, treatment (including supportive therapies), and outcomes (overall and progression-free survival, and QoL using the EQ-5D-5L) on newly diagnosed MM (NDMM), plasma cell leukaemia, plasmacytoma, and MGUS patients via a secure, country-specific web-based database. Whilst the core dataset is standardised across countries to ensure comparability, regional differences such as units of measurements and local privacy laws were accommodated in the design of each country's database. Participants are reviewed 4-monthly for a minimum of 2 years. Longer-term outcomes will be collected through linkage with local cancer and death registries. Six-monthly hospital reports, providing de-identified, risk-adjusted outcome data at hospital- and country-level, will be provided to contributing hospitals. Preliminary APAC MRDR data from October 2018 to June 2019 were analysed. Results: Eleven hospitals now have Institutional Review Board approval to participate and patient recruitment has commenced at 6 hospitals in Korea and Singapore. Sites in Taiwan, Hong Kong, China, and Malaysia are in progress. To date, 182 patients have been enrolled and data collection on these patients is in progress. At the time of analysis, 85% (96/113) were NDMM. Median age was 66 years (IQR: 59-73) and 54% were male. Median EQ5D VAS Health State score at diagnosis was 70 (IQR: 50-80; self-report: 100=best health imaginable, 0=the worst). Comorbidities were present in 47%. Proportion of patients with main paraprotein type IgG: 64%, IgA: 17%, light chain only Kappa: 13%, light chain only Lambda: 6%. Median number of days from diagnosis to chemotherapy was 9.5 (IQR: 3-15). The top two most frequently used first-line regimens for NDMM patients in Korea and Singapore were: Korea: 1. bortezomib/thalidomide/dexamethasone (VTd: 39%), 2. lenalidomide/dexamethasone (Rd: 27%), and Singapore: 1. VTd: 41%, 2. bortezomib/cyclophosphamide/dexamethasone (VCD): 25%. Overall response rate to first-line chemotherapy (≥PR) was 86% (44/51). Conclusion: The APAC MRDR database is expanding and, as data mature and feedback is provided to participating sites, will provide RWE that will contribute to our understanding on current myeloma treatment strategies and patient outcomes in the Asia-Pacific region. Future plans include expansion to additional sites and countries, and linkage with local cancer and death registries. The registry can also serve as a regional resource by providing infrastructure and identifying eligible participants for clinical trials and other research. Disclosures Aoki: Janssen Asia-Pacific: Research Funding. Moore:Takeda: Research Funding; Gilead: Research Funding. Wood:Bristol-Myers Squibb: Research Funding; Novartis: Research Funding; Alexion: Research Funding; Roche: Research Funding; Takeda: Research Funding; Gilead: Research Funding; Janssen-Cilag: Research Funding; Amgen: Research Funding; CSL Behring: Research Funding; Sanofi: Research Funding; Celgene: Research Funding; Abbvie: Research Funding. McQuilten:Gilead Sciences: Research Funding; CSL Biotherapies: Research Funding; Celgene: Research Funding; AbbVie: Research Funding; Takeda Pharmaceuticals: Research Funding; Janssen-Cilag: Research Funding. Spencer:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Specialised Therapeutics Australia: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.

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.