Introduction Patients (pts) with newly diagnosed, advanced-stage cHL are at risk for poor health-related quality of life (HRQoL) due to their underlying disease and its treatment. We assessed PROs in S1826, a trial showing that nivolumab plus doxorubicin, vinblastine, and dacarbazine (N+AVD) resulted in longer progression-free survival compared to brentuximab vedotin plus AVD (BV+AVD). Methods S1826 was a phase 3 multicenter, cross-network trial for pts >12 years old with stage III or IV newly diagnosed cHL. PROs assessment was required for pts able to complete questionnaires in English, Spanish, or French, and was obtained before registration (“baseline”) and at cycle 3, at 4-8 weeks after the end of treatment (EOT), and at 1 and 3 years (yrs) after randomization. The PROMIS-Fatigue 7a (or Ped PROMIS-Fatigue 10a), the FACT-GOG-Ntx, and the PROMIS-Global Health (Adult and Pediatric) scales were collected at each assessment. Two primary endpoints for fatigue (at EOT and 1 year) and two for neuropathy (at 1 and 3 yrs) were pre-specified, each tested using a two-sided alpha=.0125 test. Linear regression was used, adjusting for the baseline PRO score, age at randomization (12-17 vs 18-60 vs >60 yrs), the International Prognostic Score (IPS; 0-3 vs 4-7), and intent to use radiation (yes vs no). An effect size of 0.3 for both fatigue and neuropathy endpoints was targeted, corresponding to minimal clinically meaningful differences (MCID) of 3.6 points and 3.0 points, respectively. MCID, established separately for each questionnaire, characterizes the level at which a treatment tangibly affects a patient's daily life in terms of their well-being and HRQoL. We previously reported worse fatigue at cycle 3 and EOT for pts on the N+AVD arm, and worse neuropathy in the BV-AVD arm at the EOT and Year 1. In this update, we examine whether fatigue and neuropathy results differed by age group, using interaction tests, for mature data through 1 year (yr). We also report on the PROMIS-Global Health findings by arm and age group. Results The N=970 eligible pts included 236 (24.3%) aged 12-17 yrs, 639 (65.9%) aged 18-60 yrs, and 95 (9.8%) aged >60 yrs. Pts were predominantly male (56.1%); 11.8% identified as Black, and 32.0% had an IPS score of 4-7. PRO completion rates ranged from 98% at baseline to 70% at 1 yr post registration. For pre-specified primary endpoints, the adjusted PROMIS-Fatigue score was 1.7 (95% CI, -3.1 to -0.4, p=.01) points lower (i.e., more fatigue) for the N+AVD arm at EOT, although the difference did not exceed the MCID. At 1 year, there was no significant difference in fatigue from baseline (p=.83). While fatigue scores did not meaningfully differ by study arm (interaction p>.70 for all assessments), they did vary by participant age, with younger pts (12-17 yrs) and older pts (>60 yrs) reporting worse fatigue on treatment. In contrast, neuropathy scores at 1 yr were better for pts on the N+AVD arm, exceeding the MCID (3.0 points, 95% CI, 2.0-3.9, p<.001), and, secondarily, at EOT (5.6 points, 95% CI, 4.4-6.3, p<.001). However, the MCID in neuropathy at EOT and Yr 1 were only observed for pts aged 18-60 and >60 but not for pts 12-17 yrs (age interaction p<.05). Global health (HRQoL) scores were better for patients on the N+AVD arm among adults in both age groups (18-60 and >60 yrs through EOT; this pattern of improvement was not seen among adolescents, aged 12-17 yrs in the between-arm comparison. Conclusions Worse fatigue was found at the EOT, and less neuropathy was reported by yr 1, for pts on the N+AVD arm, results that were consistent across age groups. Worse neuropathy was found in the BV-AVD arm over time, specifically among pts aged 18 yrs and over. Global HRQoL was better for adult pts on the N+AVD arm through EOT, but did not differ by arm for adolescents. Trial results support the feasibility of serial collection of PROs, as indicated by high response rates, despite participants' advanced stage disease and broad institutional participation. Future analyses will address the planned 3-year outcomes as well as formal evaluation of missing data.

Background Incorporating brentuximab vedotin into the treatment of advanced-stage classic Hodgkin's lymphoma improves outcomes in adult and pediatric patients. However, brentuximab vedotin increases the toxic effects of treatment in adults, more than half of pediatric patients who receive the drug undergo consolidative radiation, and relapse remains a challenge. Programmed death 1 blockade is effective in Hodgkin's lymphoma, including in preliminary studies involving previously untreated patients.Methods We conducted a phase 3, multicenter, open-label, randomized trial involving patients at least 12 years of age with stage III or IV newly diagnosed Hodgkin's lymphoma. Patients were randomly assigned to receive brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (BV+AVD) or nivolumab with doxorubicin, vinblastine, and dacarbazine (N+AVD). Prespecified patients could receive radiation therapy directed to residual metabolically active lesions. The primary end point was progression-free survival, defined as the time from randomization to the first observation of progressive disease or death from any cause.Results Of 994 patients who underwent randomization, 970 were included in the intention-to-treat population for efficacy analyses. At the second planned interim analysis, with a median follow-up of 12.1 months, the threshold for efficacy was crossed, indicating that N+AVD significantly improved progression-free survival as compared with BV+AVD (hazard ratio for disease progression or death, 0.48; 99% confidence interval [CI], 0.27 to 0.87; two-sided P=0.001). Owing to the short follow-up time, we repeated the analysis with longer follow-up; with a median follow-up of 2.1 years (range, 0 to 4.2 years), the 2-year progression-free survival was 92% (95% CI, 89 to 94) with N+AVD, as compared with 83% (95% CI, 79 to 86) with BV+AVD (hazard ratio for disease progression or death, 0.45; 95% CI, 0.30 to 0.65). Overall, 7 patients received radiation therapy. Immune-related adverse events were infrequent with nivolumab; brentuximab vedotin was associated with more treatment discontinuation.Conclusions N+AVD resulted in longer progression-free survival than BV+AVD in adolescents and adults with stage III or IV advanced-stage classic Hodgkin's lymphoma and had a better side-effect profile. (Funded by the National Cancer Institute of the National Institutes of Health and others; S1826 ClinicalTrials.gov number, NCT03907488.) In patients with advanced-stage Hodgkin's lymphoma, nivolumab added to chemotherapy resulted in greater 2-year progression-free survival than the addition of brentuximab vedotin to chemotherapy.

Diffuse large B cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy; however, cure is highly dependent on the ability to deliver intensive, anthracycline-based chemoimmunotherapy. Nearly one third of cases of DLBCL occur in patients over age 75 years, and advanced age is an important adverse feature in prognostic models. Despite this incidence in older patients, there is no clear accepted standard of care due to under-representation of this group in large randomized clinical trials. Furthermore, insufficient assessments of baseline frailty and prediction of toxicity hamper clinical decision-making. Here, we present an ongoing randomized study of R-miniCHOP chemoimmunotherapy with or without oral azacitidine (CC-486, Onureg) for patients age 75 and older with newly diagnosed DLBCL and associated aggressive lymphomas. The incorporation of an oral hypomethylating agent is based on increased tumor methylation as a biologic feature of older patients with DLBCL and a desire to minimize the injection burden for this population. This is the first randomized study in this population conducted in North America by the National Clinical Trials Network (NCTN) and will enroll up to 422 patients including 40 patients in a safety run-in phase. This study incorporates an objective assessment of baseline frailty (the FIL Tool) and a serial comprehensive geriatric assessment (CGA). Key correlative tests will include circulating tumor DNA (ctDNA) assays at pre-specified timepoints to explore if ctDNA quantity and methylation patterns correlate with response. S1918 has the potential to impact future trial design and to change the standard of care for patients 75 years and older with aggressive lymphoma given its randomized design, prospective incorporation of geriatric assessments, and exploration of ctDNA correlatives. Trial registration: The trial is registered with ClinicalTrial.gov Identifier NCT04799275 (c) 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

The 2018 Accelerating Anticancer Agent Development ( AAADV) Workshop assembled a panel of experts for an in-depth discussion session to present "Challenges with Novel Clinical Trial Designs." This panel offered assessments of the challenges faced by industry, the FDA, investigators, institutional review boards, and patients. The panel focused on master protocols, which include umbrella trials, platform trials, and basket trials. Umbrella trials and platform trials share many commonalities, whereas basket trials are more distinct. Umbrella and platform trials are generally designed with multiple arms where patients of the same histology or other unifying characteristics are enrolled into different arms and multiple investigational agents are evaluated in a single protocol. In contrast, basket studies generally enroll patients with different tumor types based on the presence of a specific mutation or biomarker regardless of histology; these trials may include expansion cohorts. These novel designs offer the promise of expedited drug assessment and approval, but they also place new challenges on all the stakeholders involved in the drug development process. Only by identifying the challenges of these complex, innovative clinical trial designs and highlighting challenges from each perspective can we begin to address these challenges. The 2018 AAADV Workshop convened a panel of experts from relevant disciplines to highlight the challenges that are created by master protocols, and, where appropriate, offer strategies to address these challenges

Background: Individuals with acute myeloid leukemia (AML) are at risk for significant physical and psychological burden related to their illness. While overall survival rates are improving, treatments may be associated with lengthy hospitalizations, and the risk of relapse remains substantial. This study explores cancer-related distress and concerns among AML survivors, as well as supportive care received from their healthcare team. Methods: 58 AML patients and survivors enrolled in the Cancer Support Community's online Cancer Experience Registry; 38 completed CancerSupportSource® (CSS) questions, a 25-item distress screening tool in which they rated their level of concern (0=Not at all; 4=Very seriously) about emotional well-being, symptom burden and impact, body image and healthy lifestyle, healthcare team communication, and relationships and intimacy. CSS includes validated subscales that identify individuals at risk for clinically significant depression and anxiety. Participants also completed questions about their unmet needs and desired help. Pearson's correlation coefficients were used to explore bivariate associations between socio-demographic variables and clinical history with overall distress (sum of CSS ratings) in AML respondents. Results: Mean (SD) age was 50 (14) years (range: 18-77); mean time since diagnosis was 5.6 years. Participants were 87% White and 64% female. 33% were receiving treatment at the time of taking the survey; 23% had ever experienced a recurrence of their cancer. Participants' greatest concerns (% rated Moderately to Very seriously) included: eating and nutrition (61%); exercising (57%); fatigue (53%); worry about the future and what lies ahead (51%); feeling irritable (51%); health insurance or money worries (49%); sleep problems (47%); changes or disruptions in work, school, or home life (46%); and feeling sad or depressed (45%). Based on responses to CSS risk screening subscales, more than half of participants (54%) were at risk for clinically significant level of anxiety; 42% were at risk for clinically significant levels of depression. Over half of respondents indicated their healthcare team asked about emotional concerns (58%); half said they were asked about lifestyle concerns such as diet and exercise (50%) and about financial concerns (e.g., out-of-pocket costs) (50%); roughly two-out-of-five had a health professional talk to them about employment concerns (40%) or family (42%). A majority of participants wished they had received more help with managing emotions related to cancer (67%), managing short-term (50%) and long-term (61%) side effects and symptoms, changing lifestyle behaviors (53%), and financial advice/assistance (47%). In bivariate analysis, greater overall distress was associated with younger age (r=-.49; p<.01), less education (r=-.44; p<.01), and lower annual household income (r=-.74; p<.001). Conclusions: This exploratory study demonstrates that substantial proportions of AML survivors express concerns about emotional distress, symptom burden and impact, and practical matters including finances. Yet, many report they are not counseled about these concerns, and the majority wish for more help to address these needs. Efforts are needed to enhance social and emotional support and improve access to integrated supportive care for individuals with AML, to reduce the potential impact of illness burden and distress on quality of life, treatment adherence, and other illness outcomes. Future research will examine multivariate predictors of distress and unmet needs. Disclosures Zaleta: Pfizer: Research Funding; Gilead: Research Funding; Athenex: Research Funding. Albrecht:Cancer Support Community: Membership on an entity's Board of Directors or advisory committees; Oncology Nursing Society: Honoraria; Carevive: Research Funding. LeBlanc:Medtronic: Membership on an entity's Board of Directors or advisory committees; NINR/NIH: Research Funding; Astra Zeneca: Consultancy, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; CareVive: Consultancy; Celgene: Honoraria; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Helsinn: Consultancy; Heron: Membership on an entity's Board of Directors or advisory committees; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Research Funding; American Cancer Society: Research Funding; Duke University: Research Funding; Jazz Pharmaceuticals: Research Funding; Flatiron: Consultancy; AbbVie: Membership on an entity's Board of Directors or advisory committees; Pfizer Inc: Consultancy. Liesveld:Abbvie: Membership on an entity's Board of Directors or advisory committees; Onconova: Other: Data safety monitoring board. Rogers:Teva: Speakers Bureau; Takeda: Honoraria; Genentech: Speakers Bureau; Seattle Genetics: Speakers Bureau; Abbvie: Speakers Bureau; Cardinal Health: Honoraria; Genentech: Honoraria; Mylan: Honoraria; Coherus: Speakers Bureau.

BACKGROUND:Because follicular lymphoma (FL) patients have heterogeneous outcomes, the FL international prognostic index (FLIPI) was developed to risk-stratify patients and to predict survival. However, limited data exist regarding the role of FLIPI in the era of routine first-line rituximab (R) and R-chemotherapy regimens and in the setting of community oncology practices.PATIENTS AND METHODS:We evaluated the outcome data from the National LymphoCare Study (NLCS), a prospective, observational cohort study, which collects data on patients with FL in the United States (US) community practices.RESULTS:Among 1068 male and 1124 female patients with FLIPI data, most were treated in US community practices (79%); 35% were FLIPI good risk, 30% intermediate risk, and 35% poor risk. FLIPI risk groups were significant predictors of overall survival (OS) and progression-free survival (PFS) for patients who undergo watchful waiting (WW), and those who receive non-R-containing regimens, R-alone, and R-chemotherapy combinations.CONCLUSIONS:In the setting of contemporary practice with routine R use, stratifying patients into good, intermediate, and poor FLIPI risk groups predicts distinct outcomes in terms of OS and PFS. FLIPI remains an important prognostic index in the R era and should be used in clinical practices to support discussions about prognosis.

This study extends a risk information seeking and processing model to explore the relative effect of cognitive processing strategies, positive and negative emotions, and normative beliefs on individuals' decision making about potential health risks. Most previous research based on this theoretical framework has examined environmental risks. Applying this risk communication model to study health decision making presents an opportunity to explore theoretical boundaries of the model, while also bringing this research to bear on a pressing medical issue: low enrollment in clinical trials. Comparative analysis of data gathered from 2 telephone surveys of a representative national sample (n = 500) and a random sample of cancer patients (n = 411) indicated that emotions played a more substantive role in cancer patients' decisions to enroll in a potential trial, whereas cognitive processing strategies and normative beliefs had greater influences on the decisions of respondents from the national sample.

Clinical research published since the first evidence-based review on the role of hematopoietic stem cell transplantation (SCT) in the treatment of pediatric acute lymphoblastic leukemia (ALL) is presented and critically evaluated in this update. Treatment recommendations are provided by an expert panel. Allogeneic SCT is recommended for children who: are in second complete remission (CR2) after experiencing an early marrow relapse for precursor-B ALL; experienced primary induction failure, but subsequently achieved a CRI; have T-lineage ALL in CR2; or have ALL in third or greater remission. Although the 2005 pediatric ALL evidence-based review (EBR) recommended allogeneic SCT for children with Philadelphia chromosome positive (Ph+) ALL in CRI, preliminary tyrosine kinase inhibitor (TKI) data demonstrate that early outcomes are comparable for allogeneic SCT and chemotherapy + imatinib. Based on the evidence, autologous SCT is not recommended for ALL in CRI. Allogeneic SCT is not recommended for: T-lineage ALL in CRI; mixed-lineage leukemia (MLL)+ ALL when it is the sole adverse risk factor; isolated central nervous system (CNS) relapse in precursor-B ALL. Based on expert opinion, allogeneic SCT may be considered for hypodiploid ALL and persistent matched related donor (MRD) positivity in ALL in CRI or greater, although these are areas that need further study. Treatment recommendations pertaining to various transplantation techniques are also provided, as are areas of needed future research. Biol Blood Marrow Transplant 18: 505-522 (2012) (C) 2012 American Society for Blood and Marrow Transplantation

8036 Background: FLIPI uses five prognostic factors to define 3 risk groups. Limited data exists regarding the role of FLIPI in the era of rituximab (R) and R-chemo as initial therapy Methods: NLCS, a prospective, observational cohort study, collected demographic and clinical outcome data. Cox proportional hazards models were constructed to examine FLIPI strata as predictors for PFS, time to next therapy (TTNT) and OS. Results: Among the 1,069 male and 1,124 female patients (pts) with FL 52% were > 60 years, 69% stage III-IV, 22% had Hb <12 g/dL, 37% >4 nodal areas, and 22% LDH >ULN. Most pts were white (91%), treated in U.S. community practices (79%), had ECOG PS of 0/1 (67%/29%), and treated with single agent R (14%) or a R-containing regimen (54%). 771 pts (35%) were FLIPI low risk (LR), 666 (30%) intermediate (IR), and 756 (35%) high (HR). Statistically significant differences were seen between the 3 risk groups among pts receiving non-R containing regimens in OS, PFS and TTNT concordant with prior studies. FLIPI risk groups were significant predictors of PFS and OS for patients treated with R-alone, R-CHOP, and R-CVP. Conclusions: FLIPI remains a useful prognostic index in pts treated in US community practices with non-R and R-containing regimens. Stratifying pts into FLIPI risk groups, generally predicts better outcomes for the LR group > IR > HR in terms of PFS, TTNT and OS. TTNT PFS OS IR Haz (95% CI) HR Haz (95% CI) IR Haz (95% CI) HR Haz (95% CI) IR Haz (95% CI) HR Haz (95% CI) All (n=2,191) 1.4 (1.1, 1.6) 1.6 (1.4, 2.0) 1.6 (1.3, 1.9) 2.3 (2.0, 2.8) 2.5 (1.7, 3.7) 6.7 (4.8, 9.5) R or R-containing (n=1,480) 1.3 (1.0, 1.6) 1.7 (1.4, 2.1) 1.6 (1.3, 2.1) 3.0 (2.4, 3.7) 2.6 (1.5, 4.5) 8.4 (5.3, 13.6) R-CVP (n=263) 1.3 (0.6, 2.5) 2.2 (1.2, 3.9) 1.2 (0.6, 2.4) 3.4 (2.0, 6.0) 1.6 (0.4, 5.6) 6.8 (2.4, 19.0) R-alone (n=297) 1.0 (0.6, 1.6) 1.9 (1.3, 2.9) 1.7 (1.1, 2.7) 2.7 (1.8, 4.2) 6.1 (1.7, 21.1) 13.8 (4.3, 44.5) R-CHOP (n=584) 1.2 (0.8, 1.7) 1.4 (0.9, 1.9) 1.5 (1.0, 2.2) 2.3 (1.6, 3.4) 2.3 (0.9, 6.1) 6.8 (2.9, 15.8) Watchful waiting (n=374) 1.5 (1.1, 2.1) 1.4 (1.0, 2.1) 1.7 (1.3, 2.4) 1.8 (1.3, 2.6) 2.6 (1.2, 5.7) 4.6 (2.1, 9.7) Abbreviation: Haz, hazards ratio.

8049 Background: The National LymphoCare Study (NLCS) collects data on disease presentation, treatment patterns, and clinical outcomes for 2736 patients with with follicular lymphoma diagnosed 2004-2007 in the USA. Patterns of initial management (Rx1) in this cohort were reported previously (Friedberg, JCO 2009). The current report describes patterns of second-line therapy (Rx2). Methods: Data from pts enrolled in NLCS with a diagnosis of FL and active Rx1 were analyzed to establish patterns of Rx2. Therapy after initial period of observation is considered Rx1 for this analysis. Results: Of 2736 pts enrolled, 1841 remain in active follow-up after median 4.9 years and 991 had received Rx2 with median TTRx2 from Rx1 of 11.1 mos. 325 began Rx2 within six months of beginning Rx1, and 521 within a year. Thus far, 252 pts have begun Rx2 > 2 yrs following Rx1. 89% of Rx2 were for progressive disease, 10% toxicity, and 1% both. Seventy-one (7.3%) of the 991 received XRT monotherapy, 62 (6.3%) received therapy as part of a clinical trial and the rest received systemic therapy – most frequently rituximab plus chemotherapy (36.1%, median TTRx2 9.1mos) and rituximab monotherapy (32.4%, median TTRx2 14.1mos). 82 pts received chemotherapy alone, 33 received radioimmunotherapy, and 15 underwent BMT as part of Rx2. Among 461 pts receiving non-investigational chemotherapy, 154 received an anthracycline (median TTRx2 6.4 mos), 270 did not (median TTRx2 9.5mos) and 37 had incomplete data. After Rx2, 61% of pts remained anthracycline naive. Of pts who received investigational therapy as Rx2, 25.8% had received investigational therapy as Rx1, compared to 6.2% for the remaining Rx2 groups. Conclusions: Among the first half of NLCS pts who have received Rx2, a few notable patterns emerge: R-monotherapy is utilized more frequently as Rx2 than as Rx1; rituximab is again utilized frequently as part of Rx2, even when TTRX2 is short, presumably representing rituximab resistance by common definitions; and most pts remain anthracycline naïve. These data give some clarity to the characteristics of pts available for clinical research in the relapsed/refractory setting of FL, although patterns may change as pts who have longer interval to Rx2 are included over time.

Clinical research published since the first evidence-based review on the role of hematopoietic stem cell transplantation (SCT) in the treatment of acute lymphoblastic leukemia (ALL) in adults is presented and critically evaluated in this update. Treatment recommendations changed or modified based on new evidence include: (1) myeloablative allogeneic SCT is an appropriate treatment for adult (<35 years) ALL in first complete remission for all disease risk groups; and (2) reduced-intensity conditioning may produce similar outcomes to myeloablative regimens. Treatment recommendations unchanged or strengthened by new evidence include: (1) allogeneic SCT is recommended over chemotherapy for ALL in second complete remission or greater; (2) allogeneic is superior to autologous SCT; and (3) there are similar survival outcomes after related and unrelated allogeneic SCT. New treatment recommendations based on new evidence include: (1) in the absence of a suitable allogeneic donor, autologous SCT may be an appropriate therapy, but results in a high relapse rate; (2) it is appropriate to consider cord blood transplantation for patients with no HLA well-matched donor; and (3) imatinib therapy before and/or after SCT (for Ph+ ALL) yields significantly superior survival outcomes. Areas of needed research in the treatment of adult ALL with SCT were identified and presented in the review.

Abstract 1768 Background: Although advances in therapy have improved outcomes for patients (pts) with FL, no optimal patient management strategy for pts with FL grade 3 has been identified largely due to debate regarding the benefits of anthracyclines for this subtype. Methods: The NLCS is a multi-center, longitudinal, observational study that collects data on treatment and outcomes for pts with FL diagnosed at 265 community (80%) and academic practices in the United States from 2004–2007. Pts enrolled in NLCS with a diagnosis of FL grade 3 as recorded by the treating physicians were examined to compare patterns of presentation, treatment strategies, and outcomes. No central pathology review was required. Data from pts who received watchful waiting (WW), single agent rituximab (R), R with cyclophosphamide, adriamycin, vincristine, and prednisone (R-CHOP), or R with cyclophosphamide, vincristine, and prednisone (R-CVP) as initial therapy were summarized using median and range for continuous variables and frequencies for categorical variables. Univariate associations between demographic, baseline disease characteristics, treatment setting, and initial treatment strategy, were tested using a standard χ2 test where sample size allowed. Relationship and hazard ratios for progression free survival (PFS) were estimated using Cox regression models adjusted for FL International Prognostic Index (FLIPI). Results: Of 2736 pts enrolled in NLCS, 500 had grade 3 FL. FL grade 3 pts had a median age of 64 years (range 26–97 years), 53% were female, and 67% had stage 3/4 disease. Pts were evenly distributed across FLIPI categories (30% good, 33% intermediate and 37% poor risk). Initial therapies for pts with FL grade 3 were WW (n=48), R alone (n=41), R-CVP (n=30), R-CHOP (n=245), R with another anthracycline (n=26), R with other chemotherapy (n=28), radiation alone (n=14), combined modality therapy (n=26), and regimens without R (n=42). Pts with FL grade 3 who received R-CHOP were younger than those who received R-CVP but similar in other FLIPI factors (Table). Events, defined as death or disease progression, occurred for 58% of patients who watched and waited and 33% of those who received treatment. Treated patients had improved PFS (median not reached [NR] 95% CI 66 months-NR) versus WW (median 29 months; 95% CI 19–43 months). Pts who received R-CHOP had improved PFS compared with WW (hazard ratio [HR] 3.09 95% CI 1.97– 4.86) but not R-CVP (HR 1.06 95% CI 0.52–2.14; Figure) Conclusions: In this large observational dataset of FL grade 3 patients, R-CHOP was the most commonly used first-line regimen. These results suggest that R with chemotherapy provides meaningful PFS benefits over WW for this population. Prospective randomized trials in pathologically identified pts are needed to evaluate the benefit of R-CHOP versus non-anthracycline regimens. Disclosures: Flowers:Millenium: Research Funding; Prescription Solutions: Consultancy; Genentech: Consultancy; Biogen/Idec: Consultancy; Celgene: Consultancy. Taylor:Genentech: Consultancy; Roche: Stock Ownership. Byrtek:Genetech: Consultancy; Roche: Stock Ownership. Hirata:Genentech: Employment; Roche: Stock Ownership. Cerhan:Genentech: Consultancy, Honoraria, Research Funding. Hainsworth:Genentech: Consultancy, Research Funding. Link:Genentech: Consultancy, Research Funding; Biogen Idec: Consultancy, Research Funding; Millennium Pharm: Consultancy, Research Funding; GlaxoSmithKline: Research Funding. Friedberg:Genentech: Consultancy.

This study investigates whether perceived fairness of doctor-patient interactions relates to individuals' willingness to communicate with their doctors about clinical trial enrollment. It also explores how willingness to talk, the perceived fairness of interactions, and trust in doctors relate to intentions to participate in a future clinical trial. Results from a random digit dial (RDD) telephone survey of U.S. adults (N = 500) measured respondents' willingness to talk to their doctors about clinical trials and intentions to participate in future trials. Perceived fairness of interactions and trust in doctors were associated with willingness to talk about clinical trials. A negative relationship emerged between perceived fairness of interactions and intentions to participate when willingness to talk was introduced into the equation. This relationship suggested that when respondents were more willing to talk to their doctors and perceived these discussions as fair, they were also less likely to express intentions to enroll in future trials. In turn, perceiving these interactions as less fair was related to greater intention to enroll. Fairness of interactions and trust in doctors were less relevant to respondents who were less willing to talk to their doctors; however, these respondents also were more likely to express intentions to enroll in future clinical trials.

This study examines theoretical linkages between the Risk Information Seeking and Processing model (RISP) and the Theory of Planned Behavior (TPB) in a context of health decision making related to potential risks involved in clinical trials. A decade after the RISP model was proposed, abundant empirical evidence attesting to the model's robustness in depicting individuals' motivations for risk information seeking and processing deems that it is crucial to continue this exploration. Data from two telephone surveys showed that individuals who tended to process relevant risk information in a more systematic manner were more likely to report favorable attitudes toward clinical trials and express a willingness to enroll in a future trial. Those who reported greater trust in their doctors were also more likely to report favorable attitudes and willingness to enroll. In contrast, risk perceptions were negatively related to favorable attitudes toward clinical trials. Comparing several structural models specified to the data, individuals' tendency to rely on independent decisions seemed to moderate the relationship between subjective norm and behavioral intention. Using regression coefficients estimates to plot this interaction, among those who tended to rely on independent decisions, influence from their doctors might lead to less willingness to enroll in a future trial. Results from this study suggest that in an effort to pursue theory development within a unique research context, we could also identify important pathways to improve health communication practice related to patient accrual for clinical trials.

8100 Background: The benefits of R maintenance after R-based induction as front line therapy, and the patterns of R maintenance use for FL in the US remain undefined. Methods: The National LymphoCa...