Adelphi Values Research Articles

1709-P: Perceptions of Treatment Outcomes in People with Obesity and T2D—A Qualitative Study

Background: Treatments for obesity and T2D often combine lifestyle changes (diet, physical activity) and medication. Weight reduction is an expected outcome of obesity and some T2D treatments. Individuals’ perspectives on obesity treatments, attitudes towards reduced food intake via appetite changes, and treatment-related gastrointestinal adverse events (GI AEs) are not well characterized. The current study assessed individuals’ perceptions of obesity/T2D treatments that impact appetite, eating behaviors, and weight, and concerns about GI AEs. Methods: This cross-sectional study involved semi-structured interviews with 45 US adults (obesity, n=15; overweight, n=10; T2D, n=20). Two creative tasks explored participants’ perceptions of obesity/T2D treatment outcomes: 1) participants discussed perspectives on hypothetical obesity/T2D treatments that reduced appetite, hunger, and cravings; 2) participants indicated their choice from two hypothetical obesity/T2D treatments, which varied by degree of GI AEs, appetite changes, and weight reduction. Interviews were audio recorded and transcribed for analysis. Results: Most participants asked (28/35; 80%) perceived the hypothetical scenarios as a positive outcome of obesity/T2D treatment. Most (30/35; 86%) considered appetite reduction to be an important treatment benefit. Many also perceived fewer cravings (13/29; 45%) and lesser desire to eat (12/29; 41%) to be positive treatment outcomes. Participants associated treatment-related appetite changes with improvements in diet (10/33; 30%), emotional well-being (9/33; 27%), and daily activities (8/33; 24%). In the choice task, participants perceived appetite and weight reduction as positive treatment outcomes, irrespective of degree of GI AEs. Conclusions: Findings demonstrate that participants value appetite changes and/or weight reduction as treatment priorities, and are willing to accept potential GI AEs for these treatment outcomes. Disclosure J.Poon: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. L.O'hara: Other Relationship; Lilly. H.Kendal: Other Relationship; Eli Lilly and Company. K.Sully: None. M.Guy: Employee; Adelphi Values, Other Relationship; Eli Lilly and Company. H.Bradley: Other Relationship; Eli Lilly and Company. C.Tolley: None. B.Mason: None.

Clinical consensus regarding the importance of rapid reduction in depressive symptoms in major depressive disorder with acute suicidal ideation or behavior (MDSI)

IntroductionPatients with major depressive disorder (MDD) with acute suicidal ideation or behavior (MDSI) require immediate intervention. Though oral antidepressants can be effective at reducing depressive symptoms, they can take 4–6 weeks to reach full effect.ObjectivesThis study aimed to identify unmet needs in the treatment of patients with MDSI, specifically exploring the potential clinical benefits of rapid reduction of depressive symptoms.MethodsA Delphi panel consisting of practicing psychiatrists (n=12) from the US, Canada and EU was conducted between December 2020–June 2021. Panelists were screened to ensure they had sufficient experience with managing patients with MDD and MDSI. Panelists completed two survey rounds, and a virtual consensus meeting.ResultsThis research confirmed current unmet needs in the treatment of patients with MDSI.Hopelessness, functional impairment, worsening of MDD symptoms, recurrent hospitalization and higher risk of suicide attempt were considered as key consequences of the slow onset of action of oral antidepressants.Treatment with rapid acting antidepressant was anticipated by panelists to provide short-term benefit such as rapid reduction of core MDD symptoms which may contribute to shorter hospital stays and improved patient engagement/compliance, allowing for earlier interventions and improved patient outcomes. For long-term benefits, panelists agreed that improved daily functioning and increased trust/confidence in treatment options, constitute key benefits of rapid-acting treatmentsConclusionsThere is need for rapid-acting treatments which may help address key unmet needs and provide clinically meaningful benefits driven by the rapid relief of depressive symptoms particularly in patients with MDSI.DisclosureSB, ED, KJ, MO’H, QZ, MM, MH, SR, JA and DZ are employees of Janssen and hold stock in Johnson & Johnson Inc. AN is currently employed by Neurocrine Biosciences Inc. RP is an employee of Adelphi Values PROVE hired by Janssen.

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-Related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Final Data from the Phase 2 ELOQUENT-3 Trial

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-Related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Final Data from the Phase 2 ELOQUENT-3 Trial

Effect of Nivolumab on Patient-Reported Outcomes in Patients with Relapsed/Refractory Classical Hodgkin Lymphoma after Autologous Transplantation: Results from the Multicohort Phase 2 Checkmate 205 Study

Introduction:Nivolumab, an immune checkpoint inhibitor targeting the programmed death-1 (PD-1) receptor, is approved for treatment of pts with classical Hodgkin lymphoma (cHL) that has relapsed after autologous hematopoietic cell transplantation (auto-HCT) and brentuximab vedotin (BV) or ≥3 lines of therapy (LoTs) including auto-HCT. In CheckMate 205 (NCT02181738), a phase 2, multicohort, single-arm study of nivolumab monotherapy in pts with relapsed/refractory (R/R) cHL after failure of auto-HCT, frequent and durable responses with acceptable safety were observed in BV-naïve pts (Cohort A), pts treated with BV after auto-HCT (Cohort B), and pts who had received BV before and/or after auto-HCT (Cohort C) (Fanale M et al. ICML 2017). In addition to clinical safety and efficacy, it is important to consider pt-reported outcomes (PROs), particularly in the R/R setting where treatment options are limited and pts may have multiple prior LoTs. Here, we assess if the improvement in PROs observed in Cohort B (Younes A et al. Lancet Oncol 2016) can be extended to the broader spectrum of pts with cHL progressing after auto-HCT, in a pooled Cohort A+B+C analysis of CheckMate 205.Methods: General and cancer-specific PROs were assessed every 4 cycles (every 8 wk) using the 3-level EuroQoL 5 Dimensions Questionnaire (EQ-5D-3L) and the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30), respectively. All treated pts with baseline (BL) and ≥1 post-BL PRO assessment in Cohorts A, B, and C were included in this analysis. Least squares (LS) means were used to describe score changes from BL over time. EORTC QLQ-C30 scores range from 0 to 100 (for functioning/global health status [GHS], higher scores indicate better function/GHS; for symptom scales, higher scores indicate greater symptom burden). Subscale-specific thresholds for clinically meaningful change were prespecified (Cocks K et al. Eur J Cancer 2012); clinically meaningful improvements (CMIs) were reported if also statistically significant. EQ-5D visual analog scale (VAS) scores range from 0 to 100 and EQ-5D utility index scores range from −0.6 to 1.0 (higher scores indicate better health); a 7- and 0.08-point change represents a minimally important difference in VAS and utility index, respectively (Pickard A et al. Health Qual Life Outcomes 2007).Results:The analysis population included 219 pts (of 243 treated); 58 (26%) in Cohort A, 72 (33%) in Cohort B, and 89 (41%) in Cohort C. At Wk 93, 35/48 (73%) pts with an on-treatment study visit completed both questionnaires. At BL, pts had a median (range) age of 34 (18-72) y, 41% were female, 57% had BL ECOG performance status 0, and 58% had International Staging System stage IV disease. CMIs from BL in EORTC QLQ-C30 symptom scores of fatigue, pain, dyspnea, insomnia, appetite loss, and financial difficulties; functional domains of physical/role/emotional/social functioning; and GHS were reported as early as Wk 9 (7/15 EORTC QLQ-C30 subscales). Median (95% CI) time from randomization to first improvement was 26 (17-49) wk for EORTC QLQ-C30 GHS and 17 (16-24) wk for EQ-5D VAS. EORTC QLQ-C30 symptom scores of fatigue, pain, dyspnea, insomnia, appetite loss, and financial difficulties showed CMIs at ≥5 timepoints, and physical/role/emotional/social functioning at ≥3 timepoints; GHS at all timepoints. Clinically meaningful and statistically significant deterioration was observed only in the EORTC QLQ-C30 cognitive functioning score, and only at Wk 17 (without a clinically meaningful change at other timepoints). EQ-5D VAS showed a CMI at Wk 17-33, Wk 57, and Wk 93, and EQ-5D utility index showed a CMI at Wk 45 and Wk 81. At Wk 93, CMIs of 9.2 (standard error: 2.7) and 10.0 (4.6) were reported for EORTC QLQ-C30 GHS and EQ-5D VAS, respectively; EQ-5D utility index increased by 0.05 (0.02). Pts with an objective response to nivolumab had LS mean improvements > overall LS mean improvement from BL in EORTC QLQ-C30 GHS, all symptom scales except financial difficulties, EQ-5D VAS, and utility index at ≥1 timepoint.Conclusions: In addition to a high rate of durable responses across all 3 cohorts of pts with R/R cHL that had relapsed after auto-HCT in CheckMate 205, nivolumab treatment resulted in an early and sustained trend (Wk 9-93) towards improvement in general and cancer-specific PROs.Funding: Bristol-Myers Squibb (BMS). Medical writing: A Gill, Caudex, funded by BMS DisclosuresEngert:Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Affimed: Consultancy, Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding. Taylor:Adelphi Values: Employment. Bennett:Adelphi Values: Employment. Chen:Bristol-Myers Squibb: Employment. Cocks:Adelphi Values: Employment; Bristol-Myers Squibb: Consultancy; Amgen: Consultancy; Endomag Ltd: Consultancy; Orthox Ltd: Consultancy; Creo Medical Ltd: Consultancy. Cella:Pfizer: Consultancy; Novartis: Consultancy; Ipsen: Consultancy.

Systematic Literature Review of the Epidemiology of Advanced Prostate Cancer and Associated Homologous Recombination Repair Gene Alterations.

To characterize the global epidemiology of metastatic castration-sensitive prostate cancer (mCSPC), nonmetastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-resistant prostate cancer (mCRPC). Additionally, to assess the prevalence of homologous recombination repair gene alterations (HRRm) and their prognostic impact in advanced disease setting. A systematic literature review of real-world evidence published from January 2009 through May 2019 was conducted to assess global epidemiology and clinical practice trends for mCSPC, nmCRPC, mCRPC and HRRm; 4,732 papers were systematically screened for inclusion. Ten conference proceedings from 2014 through 2019 were reviewed. Of the screened articles 22 relevant publications were identified for this paper. Six publications reported global epidemiology of advanced prostate cancer. The prevalence of nmCRPC was estimated as 1.1% to 12.3% of prostate cancer cases and for mCRPC 1.2% to 2.1% of prostate cancer cases. No mCSPC prevalence was captured. Sixteen publications investigated HRRm prevalence in advanced prostate cancer with the majority conducted in mCRPC assessed using next-generation sequencing of tissue and germline samples. In mCRPC, the highest prevalence HRRm in both germline (3.3%-6.0%) and somatic (5.0%-15.1%) was BRCA2. Five publications reported the prognostic impact of HRRm in advanced prostate cancer. Published real-world evidence quantifying the prevalence of advanced prostate cancer and HRRm beyond mCRPC is sparse. Published data on HRRm, specifically BRCA2, are consistent with published clinical trial data for poly (ADP-ribose) polymerase inhibitors in mCRPC. In mCRPC, real-world evidence suggests that patients with HRRm have different clinical outcomes to noncarriers. More data are needed to better understand real-world patient segmentation and clinical outcomes for biomarkers given increasing interest in profiling.

Health State Utility Valuation in Patients with Triple-Class-Exposed Relapsed and Refractory Multiple Myeloma Treated with the Bcma-Directed CAR T Cell Therapy, Idecabtagene Vicleucel (ide-cel, bb2121): Results from the Karmma Trial

Health State Utility Valuation in Patients with Triple-Class-Exposed Relapsed and Refractory Multiple Myeloma Treated with the Bcma-Directed CAR T Cell Therapy, Idecabtagene Vicleucel (ide-cel, bb2121): Results from the Karmma Trial

Preliminary Exploration of Patient Perspectives on Tyrosine Kinase Inhibitors for the Treatment of Chronic-Phase Chronic Myeloid Leukemia

Introduction: Tyrosine kinase inhibitors (TKIs) represent the standard of care for patients with chronic-phase chronic myeloid leukemia (CP-CML). The emergence and availability of second-generation TKIs (dasatinib, nilotinib and bosutinib) has led to increased choice for patients and physicians, with data from randomized clinical trials indicating improved efficacy of such therapies compared to the first-generation TKI (imatinib). Differences in the efficacy of second-generation TKIs are negligible; however, all have distinct dosing instructions and safety profiles. Understanding the patient perspective is invaluable for optimizing healthcare decisions, with interest in information regarding patient preferences growing among a wide variety of stakeholders, including regulatory agencies, reimbursement bodies and prescribers. However, evidence is lacking regarding treatment preferences and priorities for patients with CP-CML. The aim of this study was to explore attributes of currently-licensed TKI therapies that are relevant and important to patients with CP-CML. This research represents the first step in the conduct of a discrete choice experiment (DCE), or conjoint analysis, to explore treatment preferences more broadly among CP-CML patients. Patient-guided design is crucial to ensuring attributes of investigation are meaningful. Hence the qualitative insights will advise and validate attribute and level selection for inclusion in the forthcoming DCE. Methods: In-depth qualitative interviews were conducted with 12 US-based patients with a clinician-confirmed diagnosis of CP-CML. The sample included 10 females and 2 males (median age 46 years) who were diagnosed 2 years (n=3), 4-7 years (n=5), 10-12 years (n=3) and 16.5 years (n=1) prior to interview. Ten patients had received a second-generation TKI. Current treatments were dasatinib (n=8), bosutinib (n=1) and imatinib (n=3). Previous treatments included imatinib (n=6), nilotinib (n=3) and dasatinib (n=1). The interviews utilized concept elicitation techniques to capture attributes of importance in both TKI treatment experience and TKI treatment selection. Transcripts were thematically analyzed using Atlas.ti. Results: Open-ended questioning elicited an array of attributes related to TKI treatments. It was important to all patients to ensure that a CP-CML treatment was effective. Treatment efficacy was conveyed with multiple descriptors; most commonly "BCR-ABL" (n=7) or major molecular response "MMR", polymerase chain reaction "PCR" and "remission" (each n=3). Eight patients discussed the importance of dose frequency, specifically the burden of scheduling self-administration of oral tablets (n=5). Seven patients conveyed the difficulty of taking a TKI with specific meal requirements, most notably when fasting is required prior to and post-administration (n=4). A multitude of important treatment side effects were elicited at investigation into the patient TKI treatment experience. Fatigue was reported by 11 patients (n=10 spontaneous) and considered by most patients (n=8/11) to be directly attributable to treatment versus the CML itself. Four patients considered fatigue an inevitable component of TKI treatment. Nausea was elicited by 7 patients (n=5 spontaneous) and some patients (n=5/9) considered it to be influential in treatment selection. Muscle pain was reported by 6 patients (n=4 spontaneous), while skin rash was reported by 5 patients and bone pain by 4 patients (all spontaneous). Diarrhea was reported by 4 patients (n=3 spontaneous). Additional symptoms reported by ≤2 patients are presented in Figure 1. Spontaneously elicited concepts were ranked by importance. All patients considered efficacy within the top three most important attributes. Six patients considered fatigue to be either of second or third most-importance. The rankings in Figure 2 serve to portray the varied perspectives and experiences of patients on TKI treatments. Conclusions: The TKI treatment experience for CP-CML patients is multifaceted. This type of study - the first that we know of - supplies valuable insight into the patient perspectives of TKI treatment to establish a foundation to better inform relevant decisions in the field. The qualitative findings will provide the input necessary to inform attribute and level selection to characterize treatment profiles ahead of an upcoming patient-preference DCE. Disclosures Mason: Adelphi Values: Employment; Pfizer: Consultancy. Mamolo:Pfizer: Employment, Equity Ownership. Johnson:Pfizer Inc: Consultancy; Adelphi Values Ltd: Employment. Viqueira:Pfizer Inc: Employment, Equity Ownership. Gater:Pfizer Inc: Consultancy; Adelphi Values Ltd: Employment. Russell-Smith:Pfizer: Employment, Equity Ownership. Tatlock:Adelphi Values: Employment. Shah:Pfizer: Employment, Equity Ownership. Cappelleri:Pfizer: Employment, Equity Ownership.

Treatment Decision Making in AML: Factors of Importance to Clinicians, AML Patients and Their Family

Treatment Decision Making in AML: Factors of Importance to Clinicians, AML Patients and Their Family

The Psychometric Properties of the ITP Life Quality Index Assessed in a Large Multinational “Real-World” Cohort of Immune Thrombocytopaenia Patients

Background Immune Thrombocytopenia (ITP) is an autoimmune disorder caused by immunologic destruction of otherwise normal platelets, most commonly occurring in response to an unknown stimulus. ITP is diagnosed after excluding other possible causes of disease, and symptoms can present across varying severities and treatments. The poor understanding of the symptoms and cause can result in both misdiagnosis and complex treatment patterns, which may significantly affect health related quality of life (HRQoL) in this patient population. There is currently no disease specific prospective tool in routine clinical practice to capture HRQoL in the adult ITP population. To help assess the impact of this condition on HRQOL, the ITP Life Quality Index (ILQI), a 10-item patient-reported outcome (PRO) measure was developed as a tool for clinical practice to aid discussions between patients and physicians about disease experience so to inform patient-centric treatment decisions. The ILQI was originally developed by clinical experts in the field of ITP and content validity was confirmed by conducting qualitative interviews with 15 adult patients with ITP. The ILQI was then cognitively debriefed patients with ITP and items refined following qualitative analysis and additional clinical input. The ILQI was included in the ITP World Impact Survey (I-WISh), a global observational study which collected data on the impact of ITP on patients' HRQoL. This large study provided an opportunity to assess the psychometric properties of the ILQI and confirm the scoring cut-offs. Methods The I-WISh survey resulted in data from 1,507 patients with ITP across 12 countries worldwide and was used to assess the structure, reliability and validity of the ILQI. The structure of the ILQI, how the items fit into total scores and subscales, was assessed by splitting the data into two datasets. One dataset was used for identifying the structure using exploratory factor analysis and one was used for checking the structure using confirmatory factor analysis. Validity, the ability of the ILQI to measure the correct construct, was assessed through known groups and convergent validity methods. Reliability, the consistency of the ILQI items and their ability to create reproducible scores, was assessed via internal consistency methods. To understand whether each ILQI item measured ITP in a similar way across countries, differential item functioning (DIF) was assessed using Cochran-Mantel-Haenszel test and Logistic regression. Finally, existing score cut-offs (20-"significantly impaired QoL"; 30 - "severely impaired QoL") were assessed using receiver operating characteristic (ROC) curves and a simulation study was conducted to develop rules for missing data. Results Results indicated that the ILQI has an essentially unidimensional structure, supporting the creation of a total score including all 10 items. The ILQI items work together to create a reproducible total score, usable for making judgements on an individual patient basis (Omega total and Cronbach's alpha coefficients ≥ 0.90). Known groups methods showed that ILQI monotonically increased with ITP severity (linear trends p's <0.001). Convergent validity methods confirmed hypothesized relationships between ILQI total/item scores and items which measure aspects of HRQOL, suggesting that the ILQI total score and its items measure the same concept of interest (i.e. HRQOL). DIF analyses showed that ILQI item responses were similar between the USA and Western countries. Some uniform DIF was discovered between the USA and other countries, and some non-uniform DIF was found between the USA and China for culturally relevant items as expected. The previous clinical cut-off of 20 for "significantly impaired QoL" was supported, but a cut-off 30 may be too conservative for assessing "severely impaired QoL". Missing data simulation suggests that a total score can be created even when some items are missing. Conclusion The ILQI is a valid and reliable, unidimensional measure to assess HRQoL of patients with ITP. Despite some variations in ILQI item responses between USA and China, adoption of the ILQI in routine care will improve consistency of patient-centric decision making and may lead to better outcomes for those patients whose HRQoL has been affected. The revised cut-off scores for the ILQI developed will also aid patient-centric decision making between patients and physician. Disclosures Griffiths: Adelphi Values Ltd: Employment; Novartis: Consultancy. Grant:Novartis: Consultancy; Adelphi Values Ltd: Employment. Bonner:Adelphi Values Ltd: Employment; Novartis: Consultancy. D'Alessio:Novartis: Employment, Equity Ownership. Hill:Apellis: Honoraria; Bioverativ, a Sanofi company: Honoraria; Novartis: Speakers Bureau; Alexion: Research Funding. Provan:Rigel ONO: Consultancy, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; UCB: Consultancy; MedImunne: Consultancy; ONO Pharmaceutical: Consultancy. Ghanima:Bayer: Honoraria, Research Funding; Amgen: Consultancy, Honoraria; Pfizer/BMS: Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Cooper:Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Rigel: Consultancy, Membership on an entity's Board of Directors or advisory committees; Principia: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Viana:Novartis: Employment, Equity Ownership.

Quality of Life Was Not Negatively Impacted By the Addition of Lenalidomide to R-CHOP Chemotherapy (R2-CHOP) Compared with Placebo Plus R-CHOP Chemotherapy in Patients with Previously Untreated Activated B-Cell (ABC)-Type Diffuse Large B-Cell Lymphoma (DLBCL): Health-Related Quality of Life (HRQoL) Analysis of the International Robust Study

Quality of Life Was Not Negatively Impacted By the Addition of Lenalidomide to R-CHOP Chemotherapy (R2-CHOP) Compared with Placebo Plus R-CHOP Chemotherapy in Patients with Previously Untreated Activated B-Cell (ABC)-Type Diffuse Large B-Cell Lymphoma (DLBCL): Health-Related Quality of Life (HRQoL) Analysis of the International Robust Study

Impact of Elotuzumab Plus Pomalidomide and Dexamethasone on Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Enrolled in the ELOQUENT-3 Study

Impact of Elotuzumab Plus Pomalidomide and Dexamethasone on Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Enrolled in the ELOQUENT-3 Study

Health-Related Quality-of-Life Outcomes in Patients with Classical Hodgkin Lymphoma: A Prospective, Observational Study in US Oncology Practices

Introduction: Classical Hodgkin lymphoma (cHL) is highly curable with front-line multi-agent chemotherapy with or without radiotherapy. The treatment landscape is rapidly evolving, with a continued focus on optimizing available therapies in order to improve outcomes and minimize toxicity. Randomized controlled trials provide valuable insights into new treatments and outcomes; however, real-world data describing treatment effectiveness, safety, and health-related quality of life (HRQoL) are limited. This analysis was conducted to understand patient-reported outcomes (PROs) in patients who were treated for newly diagnosed cHL across a range of academic and community settings. Methods: Study CA209655 is an ongoing, prospective, observational study (NCT02856646) at ~80 US oncology practices with a target enrollment of 500 patients and a planned follow-up of ≤ 5 years. Eligible patients are ≥ 18 years old with histologically confirmed cHL and are treatment naive or within ± 2 weeks of beginning any line of therapy at time of enrollment. HRQoL is a secondary endpoint and evaluated using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire. The FACT-Lym combines a generic cancer-related core consisting of the FACT-General (FACT-G; 27 items) that assesses physical (PWB; 7 items), social/family (SWB; 7 items), emotional (EWB; 6 items), and functional well-being (FWB; 7 items), and a 15-item disease-specific lymphoma subscale (LymS) that assesses lymphoma-specific symptoms. PROs were assessed using questionnaires at baseline (BL), every 3-6 months for ≤ 2 years, and annually thereafter. All patients with BL and ≥ 1 post-BL assessment were included in the PRO analysis. Completion rates and changes from BL scores were evaluated descriptively and analyzed based on published estimates for clinically important differences and individual responder definitions (Hlubocky et al. Lymphoma 2013; Carter et al. Blood 2008; Yost and Eton. Eval Health Prof 2005). High scores indicate better health/functioning for all scales/subscales. Results: Of 278 enrolled patients at data cutoff (Feb 2019), 226 (81%) were treatment naive; for those, the most common index therapy was chemotherapy (n = 210; 93%). The most common index chemotherapies were ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine; n = 187, 83%) and AAVD (adriamycin, brentuximab, vinblastine, dacarbazine; n = 10, 5%). Only patients receiving index chemotherapy were included in the full analysis set. In all, 89% (87/210) of patients had BL and ≥ 1 post-BL assessment and were included in the PRO analysis. PRO completion rate at BL was 97% (204/210) and remained > 70% up to 24 months for the expected population. Analysis of PROs was not feasible after 24 months owing to small patient numbers (≤ 10); therefore, PRO analyses were focused on the first 18 months. At BL, mean (SD) scores were: FACT-Lym total, 122 (24); FACT-G, 82 (15); PWB, 21 (6); SWB, 25 (3); EWB, 18 (4); FWB, 18 (6); and LymS, 40 (11). At 3 months there was a deterioration in mean scores from baseline in FACT-G (−3.8) and PWB (−3.0) (Figure A). Clinically meaningful improvement of mean scores was observed starting at 6 months in LymS (+4.4) and at 9 months in FACT-G (+7.1), PWB (+3.1), FWB (+2.8), and FACT-Lym total (+15.6). There were no clinically meaningful improvements in SWB and EWB. Based on individual responder definitions, ≥ 50% of patients had improvements in PWB (Figure B) and FACT-G from 12 months, and FACT-Lym total from 9 months. Conclusions: Initial data from this observational study suggest most patients receive multi-agent cytotoxic chemotherapy as first-line treatment of cHL. Patient-reported PWB initially declined with chemotherapy, but improved with time, and patients had a clinically meaningful improvement in HRQoL by 9 months. The timing of this improvement may be due to discontinuation of chemotherapy due to disease control. Future analyses will evaluate the relationship between improvements in HRQoL and other factors including response, use of immunotherapies versus chemotherapy, and the timing of treatment discontinuation. Study support: Bristol-Myers Squibb. Disclosures Svoboda: Seattle Genetics: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Merck: Research Funding; Incyte: Research Funding; Pharmacyclics: Consultancy, Research Funding; AstraZeneca: Consultancy; Celgene: Research Funding; Kyowa: Consultancy; Kite: Consultancy. Armand:Roche: Research Funding; Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Affimed: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Otsuka: Research Funding; Sigma Tau: Research Funding; Infinity: Consultancy; Genentech: Research Funding; Pfizer: Consultancy; ADC Therapeutics: Consultancy; Tensha: Research Funding. Taylor:Adelphi Values: Employment, Other: I am an employee of Adelphi Values, a consulting firm who has received payment from Bristol-Myers Squibb for statistical data analysis in Bristol-Myers Squibb's trials. Sun:Adelphi Values: Employment. Gajavelli:Bristol-Myers Squibb: Employment. Peterson:Bristol-Myers Squibb: Employment, Equity Ownership. Chen:Bristol-Myers Squibb: Employment.

A Mixed Methods Approach to Generate Meaningful Change Estimates for the EORTC QLQ-MY20

IntroductionIn addition to efficacy and safety, novel regimens for the treatment of multiple myeloma (MM) should be assessed in terms of disease-related symptoms, the adverse events patient's experience, and their effect on health-related quality of life (HRQOL). Patient-reported outcome (PRO) measures capture these experiences from the patient's perspective. However, an interpretative challenge of PROs is understanding the magnitude of change that can be considered clinically meaningful.The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, supplemented with the multiple myeloma-specific module (QLQ-MY20), are commonly used PRO measures in MM trials. However, the minimally important difference (MID) in QLQ-MY20 scores, between groups or for an individual who may be categorized as a responder, has not been established. Previously, estimates based on the statistical variability of scores, or a universal 10-point threshold, have been applied to approximate an MID or responder definition (RD).This study aims to provide empirical estimates of the MID and RD for the QLQ-MY20 in an adult newly diagnosed (ND) and relapsed/refractory (RR) MM population using clinical trial data and qualitative patient interviews.MethodsData were pooled from three completed Phase III clinical trials assessing the efficacy and safety of carfilzomib-containing regimens in patients with RRMM (ASPIRE [NCT01080391], ENDEAVOR [NCT01568866]) or NDMM (CLARION [NCT01818752]). A recommended MID or RD should come from triangulating estimates from several different techniques. MIDs were estimated quantitatively by evaluating the mean PRO score changes in patients grouped as ‘improved’, ‘stable’ or ‘deteriorated’ according to external anchors. The anchors were selected based on variables common to the source datasets expected to reflect changes in PRO scores, and assessed for suitability through correlations. Those included were based on a PRO measuring chemotherapy-induced neuropathy (FACT/GOG-Ntx), ECOG performance status, and matched CTCAE toxicity events. RDs for deteriorations and improvements in health were estimated using the same anchor measures through receiver operating characteristic (ROC) curves, supported by ‘distribution-based’ estimates incorporating the statistical variability of scores. Qualitative telephone interviews were conducted to obtain patient insights from patients with MM regarding what constitutes meaningful change, to further support RD estimates and triangulate quantitative findings. This directly utilizes patient input to define an important treatment benefit and translate HRQOL change scores into tangible and clinically relevant impacts of the treatment on a patient. Interview participants were independent to the clinical trial samples and recruited via patient associations and clinical sites in the US and UK. Ethical approval was obtained for the study.ResultsThe pooled sample from the clinical trials comprised 2,147 patients for analysis; 14 additional patients (to date) were interviewed. MID and RD estimates varied as a result of the different methods, anchors and time points used to derive them. Based on the clinical trial sample, the range of MID and RD estimates for the QLQ-MY20 subscales were calculated and are presented in Table 1. The qualitative interview findings to date suggest that patients consistently understood the subscale concepts, relevance and response options for each domain of the QLQ-MY20. Patients discussed the concept of meaningful change at the domain level and provided reliable meaningful change estimates. The quantitative and qualitative findings will be triangulated to derive weighted estimates recommended for use in future studies. A single global estimate may not be appropriate for all subscales, in which case a range may be recommended.ConclusionsUpdated data based on full triangulation of the qualitative and quantitative evidence will be presented at the annual meeting. Findings from the current study will inform the development of new recommended interpretation guidelines for QLQ-MY20. These values will facilitate power analysis when designing studies and enable consistent interpretation of treatment effect on patients' HRQOL by regulators, payers and clinicians. DisclosuresYucel:Amgen: Employment, Equity Ownership. Trigg:Adelphi Values: Employment; Amgen: Consultancy. Sully:Adelphi Values Ltd: Employment; Amgen: Consultancy. Harper:Adelphi Values: Employment; Amgen: Consultancy. Bonner:Amgen: Consultancy; Adelphi Values: Employment. Shah:Nkarta: Consultancy; Amgen: Consultancy; Sutro Biopharma: Research Funding; University of California San Francisco: Employment; Indapta Therapeutics: Consultancy; Bristol Myers Squibb: Consultancy; Bluebird: Research Funding; Janssen: Research Funding; Kite: Consultancy; Nekktar: Consultancy; Teneobio: Consultancy; Celgene: Research Funding; Indapta Therapeutics: Equity Ownership; Sanofi: Consultancy; Takeda: Consultancy. Panjabi:Amgen: Employment, Equity Ownership. Cocks:Amgen: Consultancy; Bristol-Myers Squibb: Consultancy; Celgene: Consultancy; Endomag Ltd.: Consultancy; Adelphi Values: Employment.

Quality-of-Life Outcomes in Patients with Relapsed/Refractory Multiple Myeloma Treated with Elotuzumab Plus Pomalidomide and Dexamethasone: Results from the Phase 2 Randomized Eloquent-3 Study

Quality-of-Life Outcomes in Patients with Relapsed/Refractory Multiple Myeloma Treated with Elotuzumab Plus Pomalidomide and Dexamethasone: Results from the Phase 2 Randomized Eloquent-3 Study

A Patient-Centred Approach to Understanding the Trade-Offs Associated with Treatment Decision Making in Hematological Cancers with Short Life Expectancy

INTRODUCTION: Patient experience data provides an opportunity to explore patient's perspectives on current and potential treatments. Gaining patient narratives on the expectation, tolerance and attitudes towards treatments can enhance clinical management and inform discussions with payers and regulatory agencies. Patient experience data is particularly beneficial in conditions where there is no clear, prescribed treatment pathway as it can contextualize joint treatment decisions made by patients and their treating physicians. Life expectancy among elderly patients with hematogical cancers such as acute myeloid leukemia (AML) is short. Patients with these conditions may be eligible for intensive chemotherapy (IC) or may face a decision between non-intensive chemotherapy (NIC) or palliative care. Further, eligible patients may not wish to undergo the taxing treatment regimens associated with IC. A targeted literature review was conducted to understand the trade-offs associated with treatment decision making and to gain patient perspectives on the value of extended overall survival (OS) in hematological cancers.METHODS: Searches of computerized bibliographic databases including PubMed (Medline), EMBASE and PsycINFO were conducted using the OVID platform. Searches were conducted using a combination of keywords and Medical Subject Headings (MeSH) terms. To be selected for review, articles must have contained keywords in the title and/or abstract and include information regarding patient experience or perspectives. Articles focussed on children (<18 years) and those not available in English were not included.RESULTS: A total of 26 articles were selected for full text review (12 AML-specific, 13 other hematological cancers and one article with findings relevant to both populations). Most articles selected for inclusion were qualitative research studies (n=23), providing rich detail regarding the patient perspective.AML patients discussed the lack of a clear, defined treatment pathway, unlike other cancers where there is a prescribed course of action. These patients described feeling trapped between two undesirable treatment options (IC versus palliative care) and described this treatment decision as “do or die”. Similarly, in other hematological cancers patients reported choosing IC to extend their life, while acknowledging that the treatment itself can be distressing. It appeared that the idea of living longer dominated this trade-off. Some patients expressed regret in choosing IC after experiencing the associated side effects. These findings suggest that patients may not fully understand the treatment options available to them, which highlights the importance of the patient-clinician relationship.Findings from studies also highlighted quality of life as an important consideration for patients in addition to the quantity or length of life. Specifically, patients emphasized their need to maintain a ‘normal life’ following their diagnosis and to be able to engage in their hobbies and daily activities. There is a paucity of research into important life milestones for AML patients. However, patients and caregivers with other hematological cancers described their desire to be alive for family occasions, such as births or weddings, as well as a sense of appreciation and gratitude for the time remaining with their loved one. This was particularly evident for those patients who were parents of younger children, who felt unprepared for the untimely passing of their kin.CONCLUSIONS: Heterogeneity in the presentation, functional status and presence of comorbidities among patients with AML and other hematological cancers presents unique challenges for treatment. Nevertheless, understanding of aetiology and epidemiology of these conditions continues to evolve. In response, medical product development/evaluation, policy and treatment decisions in clinical practice need to reflect patient perspectives of treatment in terms of expectations, goals, experiences and preferences to ensure selection of the most appropriate treatment for a given individual. Existing evidence provides some insight as to factors that are important to patients and may influence treatment decisions. However, further research to understand patient perspectives, particularly among those who may not be eligible or willing to receive IC, is required. DisclosuresJohnson:Adelphi Values Ltd: Consultancy. Bell:Pfizer: Employment, Equity Ownership. Sully:Adelphi Values Ltd: Employment; Amgen: Consultancy. Welch:Pfizer: Employment, Equity Ownership. Peloquin:Pfizer: Employment, Equity Ownership. Gater:Adelphi Values Ltd: Consultancy.

Evaluating Patient Preference for Haemophilia a Treatment

INTRODUCTION: FuseNGo is a dual-chamber syringe for administering coagulation factor concentrate that was developed to reduce the number of steps and components necessary to reconstitute the drug product. This study aimed to assess patients' perception and preference for Haemophilia A (HA) using a recently developed questionnaire (HaemoPREF). The study also aimed to build on existing evidence for the construct validity of the HaemoPREF by evaluating the relationship between patient perception and preference for HA treatment, as assessed by the HaemoPREF, and associated factors including treatment satisfaction, quality of life (QoL), adherence, work productivity and activity impairment.METHODS: A non-interventional, cross-sectional, questionnaire completion study was conducted in Spain (n=31), Germany (n=10) and Italy (n=48). Adult HA patients were required to have used ReFacto AF with FuseNGo for at least 40 infusions. Spanish and German patients completed a web-based survey; Italian patients' data was collected on paper as part of a nested sub-study in an ongoing real-world study. Patients completed: HaemoPREF; Treatment Satisfaction Questionnaire for Medication (TSQM); VeritasPRO; Hemophilia Well-being Index (HWBI) and Work Productivity and Activity Impairment: Haemophilia Specific (WPAI + CIQ: HS). Correlational analyses, univariate and multivariate regression analyses aimed to examine the relationship between HaemoPREF and these instruments.RESULTS: Higher scores on the HaemoPREF indicate greater satisfaction with, or importance of, a concept. Scores are provided as a fraction of the theoretical range. The subscales with the greatest mean scores are 'Ease of Using Clotting Factor Treatment' (27.9/40); and 'Burden of Clotting Factor Treatment' (13.7/20) indicating high levels of satisfaction. The subscale with the lowest mean score is 'Influence of Others on Treatment Choices' (8.6/20). Scores on the TSQM indicated overall satisfaction with treatment, in particular the 'Treatment Global Satisfaction' subscale was high on average (72.5/100). The mean VeritasPRO global score indicated that the sample was moderately adherent overall. The mean score on the HWBI was 22.9/24, indicating patients do not consider their QoL to be negatively affected. On the WPAI the 'Overall Work Impairment' mean score was 23.1% while the 'Activity Impairment' mean score was 29.4% indicating low levels of work and activity impairment (Table 1).Spearman’s correlations indicated the HaemoPREF global score had essentially a moderate relationship with the TSQM Treatment Global Satisfaction subscale (r=0.48), HWBI total score (r=0.41) and WPAI Activity Impairment score (r=0.39). Moderate correlations (≥0.40) were also noted between some of the HaemoPREF subscales. Some subscales on the TSQM, HWBI and WPAI. Correlations were low between the HaemoPREF and VeritasPRO (r=0.24) and the HaemoPREF and the WPAI Overall Work Impairment score (r=0.31) indicating the HaemoPREF is addressing something conceptually distinct to these measures.Multivariate regression on the pooled sample for the HaemoPREF global score (n=87) found the following variables were significant (p≤0.05) predictors of HaemoPREF global score: TSQM ’Treatment Convenience’ (regression coefficient estimate: 0.5), VeritasPRO ’Timing’ (regression coefficient estimate: 2.8), VeritasPRO ’Remembering’ (regression coefficient estimate: 3.1), HWBI Total Score (regression coefficient estimate: 1.0) and site (Germany/Spain vs Italy, regression coefficient estimate: 13.0).CONCLUSIONS: These findings suggest that patients using ReFacto AF with FuseNGo are satisfied with and adherent to their treatment, and do not consider their QoL to be negatively affected. There is a moderate association between patient perception and preference for HA treatment, treatment satisfaction, adherence and QoL. This suggests while the HaemoPREF is related to, and assesses these components, it also measures distinct and important concepts not assessed by the other questionnaires completed by patients in the study. Thus, the HaemoPREF appears to fill a gap in the tools currently available to assess patient treatment experience in HA. Additional research in larger samples across multiple sites could further evaluate the relationship between the factors of interest. [Display omitted] DisclosuresSchulz:Pfizer Inc: Employment. Gordo:Pfizer Inc: Employment. Tolley:Adelphi Values: Other: full-time employee of Adelphi Values, who worked on this study as paid contractors to Pfizer Inc.. Staunton:Adelphi Values: Other: full-time employee of Adelphi Values, who worked on this study as paid contractors to Pfizer Inc.. Brohan:Adelphi Values: Other: full-time employee of Adelphi Values, who worked on this study as paid contractors to Pfizer Inc.. Spurden:Pfizer Inc: Employment. Cicchetti:Pfizer Inc: Other: paid consultant through Execupharm Inc. by Pfizer Inc.. Cappelleri:Pfizer Inc: Employment, Equity Ownership.

361O Patient-reported outcomes (PROs) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab (Nivo) or Investigator's Choice (IC): CheckMate 141

Background Patients (pts) with platinum-refractory R/M SCCHN have median survival :::6 mo and suffer from their disease and its treatment. Accordingly, maintaining quality of life (QoL) is a key treatment goal. PRO data were collected as exploratory endpoints in CheckMate 141 (NCT02105636), a randomized, open-label, phase 3 trial comparing nivo to IC (methotrexate, docetaxel, or cetuximab) in 361 pts with platinum-refractory R/M SCCHN. We report the first comparative results for PRO for nivo and IC in R/M SCCHN. Methods The European Organisation for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ-C30), EORTC Head and Neck Cancer module (QLQ- H&N35), and EQ-5D were administered at baseline (BL), wk 9, and then at 6-wk intervals during treatment. A clinically relevant score change or difference was regarded as 10 points for the EORTC subscales. Analysis of covariance (ANCOVA) was applied to compare mean score changes between arms. Proportional hazards regression was used to evaluate time to clinically relevant score deterioration (TTD). Results BL questionnaire completion rates for nivo and IC were rv80% and rv75%, respectively. Low IC completion rates precluded analysis of mean differences after wk 15. Overall, 129 pts completed a PRO measure at BL and during follow up. Nivo significantly delayed TTD (P < 0.05, 2-tailed) vs IC for global health; physical, role, cognitive, and social functioning; fatigue; dyspnea; and insomnia (EORTC QLQ-C30) as well as pain; sensory problems; and mouth opening problems (QLQ-H&N35). ANCOVA revealed statistically significant, clinically relevant differences favoring nivo at wks 9 and 15 for role and social functioning, fatigue, dyspnea, and appetite loss (EORTC QLQ-C30) as well as pain and sensory problems (QLQ-H&N35). Differences in mean values were observed for other PROs at wk 15 only. Conclusions Pts treated with nivo had delayed worsening of functioning and symptoms with PRO differences between arms favoring nivo up to rv4 mo of follow up. These results, as assessed through wk 15, suggest that pts receiving nivo maintained functioning for longer and had less pain, fatigue, and dyspnea on treatment as compared with IC. Clinical trial indentification NCT02105636; Study start date, May 2014 Legal entity responsible for the study Bristol-Myers Squibb Funding Bristol-Myers Squibb Disclosure N. Kiyota: Grants from research funding, Ono Pharmaceutical Co. Ltd, Eisai Co. Ltd, and Nippon Boehringer Ingelheim Co. Ltd; personal fees (honorarium and research funding), Ono Pharmaceutical Co. Ltd; payment for seminar presentation, BMS, Merck Serono, and Bayer. K. Harrington: Fees paid to research institution by BMS; personal fees from and fees paid to research institution by Merck and Amgen; personal fees from AstraZeneca and Pfizer. R.L. Ferris: Personal fees and advisory board member, Merck and Celgene; grants, personal fees and advisory board member, AZ/Medimmune and BMS; and grants, VentiRx. J.W. Shaw: Employee and shareholder, Bristol-Myers Squibb. F. Taylor: Employee of Adelphi Values, a consulting company that is being paid by BMS to analyze clinical trial PRO data. D. Turner- Bowker: Employee of Adelphi Values, which received funding to conduct this research. L. Morrissey: Employee of Adelphi Values, which was paid for the statistical analyses. K. Cocks: Employee of Adelphi Values, which consults with BMS. M. Gillison: Consulting for BMS, Lilly and Merck Inc. J. Guigay: Grants and advisory board member, Merck; grants, GlaxoSmithKline; advisory board member, Bristol-Myers Squibb and Innate Pharma. All other authors have declared no conflicts of interest.

3012 Simultaneous integrated boost conformal radiotherapy in unresectable central non-small cell lung cancer: A prospective study

a statistically and clinically significant deterioration from BL but their EQ-5D index did not; at follow-up visit 2, their EQ-VAS and EQ-5D index scores were not statistically different from BL. Conclusions: In CheckMate 017, nivolumab patients’ health status improved from baseline during the first year of treatment, while docetaxel patients’ health status remained stable relative to baseline during their shorter time on treatment. These results show statistically and clinically significant improvements from baseline in health status for squamous advanced NSCLC patients treated with nivolumab. Conflict of interest: Ownership: N/A. Advisory Board: M. Reck has participated in advisory boards/been a consultant for Roche, Eli Lilly, Merck Sharpe & Dohme, Bristol-Myers Squibb, AstraZeneca, BoehringerIngelheim, Pfizer, and Novartis. Board of Directors: N/A. Corporatesponsored Research: N/A. Other Substantive Relationships: C. Coon, F. Taylor, and M. DeRosa are employees of Adelphi Values, which was paid by Bristol-Myers Squibb in connection with this study. J. Penrod, H. Dastani and L. Orsini are Bristol-Myers Squibb employees and stockholders. R. Gralla has been a consultant for Bristol-Myers Squibb.

3331 Quality of survival (QoS) concept framework to assess the quality of prolonged life in advanced melanoma (MEL): Principles and application related to treatment with nivolumab (NIVO)

s S675 may define QoS and vary in importance along the care continuum. During the interviews, we used the term “survival” as a generic term indicating the pt is alive, and could include the time during and post treatment. The QoS concept was viewed as simple, meaningful and relevant to discussing treatment decisions. Available data from the phase 3 CheckMate 066 trial comparing NIVO to dacarbazine in advanced MEL can be captured in some dimensions of the QoS concept map based on the demonstration of survival benefit, a manageable safety profile, symptom improvement and QoL maintenance. Data on the economic impact of NIVO are not yet available. Conclusion: The QoS concept map can be a unique and pt-centric means for examining elements contributing to the quality of long-term survival in cancer. Trial data for treatment of pts with advanced MEL with NIVO have the potential to inform domains of this QoS concept map. Preliminary results from trials with NIVO combined with ipilimumab in advanced MEL also suggest the same. Additional studies with economic, longer-term and real-world data are required to refine and validate the QoS map in treatment decision making, as well as to further explore the relationships between the domains forming the QoS framework and the derivation of a metric that factor them into one summary score to determine the value of cancer treatments. Conflict of interest: Advisory Board: E. Nadler has had an advisory board/ consulting role with Lilly and Genentech. Corporate-sponsored Research: A.P. Abernethy’s institution has received research funds from DARA Biosciences, GlaxoSmithKline, Celgene, Helsinn, Dendreon, Kanglaite, Bristol-Myers Squibb, and Pfizer. Other Substantive Relationships: L. Fallowfield has received consultancy payments from Bristol-Myers Squibb for work developing the QoS concept. E. Nadler has received honoraria from Genentech, Lilly, and Pfizer. has been on speakers’ bureau for Lilly, Genentech, and Pfizer. A.P. Abernethy is an employee of Flatiron Health, Inc. has leadership with Flatiron Health, Inc. and athenahealth, Inc. has stock ownership with athenahealth, Inc. has received honoraria from Bristol-Myers Squibb, Helsinn, and Merck. I. Gilloteau is a stockholder of Bristol-Myers Squibb. M. Greaney is an employee of Adelphi Values which provides consultancy services to Bristol-Myers Squibb. A. Gater is an employee of Adelphi Values, a health outcomes agency commissioned by Bristol-Myers Squibb to conduct and analyze findings from this research. L. Orsini and M. Subar are employed by Bristol-Myers Squibb. H. Dastani has employment and stock ownership from Bristol-Myers Squibb. G. Lyman has nothing to disclose.

Treatment Expectations and Drivers of Treatment Satisfaction Among Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome With Constipation (IBS-C) Patients

Introduction: To better understand, through qualitative research, treatment expectations and drivers of treatment satisfaction among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Methods: Semistructured, qualitative interviews were conducted with 40 adult patients in the United States (21 CIC, 19 IBS-C) following participation in a long-term safety study, which involved taking study treatment for CIC/IBS-C. Patients were asked to describe factors that influenced their treatment expectations, satisfaction with the study treatment, and the characteristics of an ideal CIC/IBS-C treatment. Qualitative analysis of verbatim transcripts was performed using ATLAS.ti software and thematic analysis methods. Following the interview, patients completed a survey in which they rated the treatment attributes they considered most important and the symptoms they most wanted to see improve with treatment. Results: The majority of CIC (86%) and IBS-C (74%) patients were satisfied with the study treatment. Primary drivers of treatment satisfaction for both CIC and IBS-C patients included passing bowel movements (BMs) daily, predictability of BM timing, and resolution of abdominal symptoms. Across both conditions, the symptoms patients reported as most important for an ideal treatment to treat included BM frequency (with the aim of achieving BMs that were frequent/daily and predictable in timing), abdominal pain/discomfort, and abdominal bloating. Some differences by condition were noted in patients’ descriptions of an ideal treatment. For example, a higher proportion of IBS-C patients (89%) highlighted desiring predictable BMs, compared with CIC patients (52%). Similarly, a larger proportion of IBS-C patients considered abdominal pain important to improve (IBS-C=68%; CIC=43%). The majority of CIC patients (62%) identified achieving a normal stool consistency as an ideal treatment characteristic, compared with only 11% of IBS-C patients. The treatment attributes patients rated most highly were low cost, daily administration, oral, solid formulation, effective in relieving symptoms, and no side effects apart from diarrhea. Conclusion: The findings provide evidence regarding drivers of treatment satisfaction and important attributes of an ideal treatment for CIC and IBS-C from the patient perspective. Generally, patients desire a treatment that improves both bowel and abdominal symptoms of CIC and IBS-C at a reasonable cost and is easy to take. As treatment satisfaction is an important driver of treatment adherence, it is critical that the above factors are considered when developing new CIC and IBS-C treatments. Disclosure - Rob Arbuckle is an employee of Adelphi Values, Ltd, which is a consultancy whose activities related to the project are funded by Forest Research Institute, and Ironwood Pharmaceuticals; Brooke. Witherspoon is a consultant to Ironwood Pharmaceuticals, Inc and Forest Research Institute; Robyn Carson is an employee of Forest Research Institute and owns stock and/or stock options in Forest. Laboratories, Inc. This research was supported by an industry grant from Forest Research Institute and Ironwood Pharmaceuticals.