ALBERT

Description: Introduction Historically, the predominant treatments for CLL and MCL have included intravenously (IV) administered chemotherapeutic regimens. However, there has been a rapid growth recently in new CLL/MCL treatment options, including orally administered products. Moreover, the therapeutic profiles of these newer agents are generally improving, particularly for patients with relapsed or refractory disease. There is currently a paucity of research evaluating patients’ experiences with current and emerging treatments for both CLL and MCL. The objective of this study was to explore patients’ experiences with, and preferences for, CLL/MCL therapies. Methods Data were collected from 27 May to 30 June 2014 via a self-administered, online, quantitative survey that was developed based on qualitative interviews with CLL and MCL patients. Patients with CLL or MCL were recruited from a market research panel or were referred by a physician or other patients. Patients were eligible for the survey if they had been diagnosed with CLL or MCL by a physician, had been treated for ≥ 2 weeks in the past 12 months, and were not a clinical trial participant. Quantitative data were collected regarding treatment history, factors influencing treatment selection, opinions of treatment, experiences with IV treatment, and patient-reported health and wellness. Results A total of 75 patients (52 with CLL, 23 with MCL) completed the survey. CLL and MCL patients provided similar responses to most questions. The majority of patients were white (72%), 〈 65 years of age (92%), and privately insured (81%); 51% were female. The mean EQ-5D self-reported score for health state (0 = worst imaginable to 100 = best imaginable) was 61. Almost half of both CLL and MCL patients had received one (44%) or two (40%) lines of treatment. A much smaller proportion of patients had received three or more lines of treatment (3rd line=4%, 4th line=8%, and 5th line or more=4%). For the following questions, patients were asked to check all reasons that applied to them. The most common reasons for changing/stopping past CLL/MCL treatments were: too many side effects (38%), medication did not work to treat the disease (36%), symptoms were not relieved (33%), and work productivity declined because of side effects (26%). When asked about reasons for dissatisfaction with CLL/MCL treatments, the most commonly reported reasons were safety concerns (33%) and side effects (32%); 37% said none applied. Common reasons for satisfaction with CLL/MCL treatment were: medication is covered by my insurance (49%), convenient dosing schedule (39%), easy to use (33%), works most of the time (32%), works all of the time (31%), works better than other drugs I have tried (28%), and is affordable (28%). 65% of patients visited their doctor together with a spouse, family member, friend, or paid helper. Frequency of IV treatment was every 1-2 weeks for 67% of patients and required an average of 3 hours for infusion and 4 hours overall, including travel and waiting time. Mean satisfaction with treatment (1 = extremely dissatisfied to 7 = extremely satisfied) was 5.3. Longer duration of effect was the most important treatment feature for CLL/MCL patients. Conclusions The results of this survey show that the greatest source of patients’ dissatisfaction with their current or most recent treatment for CLL/MCL was the treatment’s safety and tolerability. Many patients receive IV treatment for CLL/MCL every 1-2 weeks, and each IV treatment requires several hours of time not only for the patient, but in nearly two-thirds of cases, also for a family member or friend who accompanies the patient. These survey results suggest that substantial unmet needs remain for the care of patients with CLL and MCL. Disclosures Schenkel: Janssen Scientific Affairs, LLC: Employment, Stock ownership Other. Naim:Janssen Scientific Affairs, LLC: Employee of Janssen Scientific Affairs, LLC at the time of the study Other. Roland:Janssen Scientific Affairs, LLC: Consultancy. Wyant:Janssen Scientific Affairs, LLC: Consultancy.

Description: Purpose: Shared decision-making (SDM) incorporates patients' individual preferences and values into treatment decisions in collaboration with their healthcare providers (HCPs). Patients with previously treated mantle cell lymphoma (MCL) have multiple available treatment options and are candidates for SDM. The objective of this project was to develop an informational, patient-centered decision aid that will enable patients, in collaboration with their HCP, to weigh available evidence along with patients' individual preferences and values. Methods: The evidence-based decision aid is designed to be accessed online in the physician's office or at home. The decision aid discusses and compares evidence about the risks and benefits of different treatment options available to previously treated MCL patients. To help patients understand what is important to them as they consider available treatment options, the decision aid includes simple questions that assess patients' values and preferences. The development and design process follows the International Patient Decision Aid Standards (IPDAS) model, including: 1) identification and description of the treatment decision for patients with previously treated MCL; 2) formation of a multidisciplinary advisory committee with four HCPs and one patient with MCL to advise on the development, evaluation, and implementation of the decision aid; 3) assessment of decisional needs through literature review and needs assessment interviews with five patients and five practicing HCPs to elicit their views on patients' information and decision support needs in previously treated MCL; 4) determination of online format designed for integration into clinical practice; 5) review and synthesis of clinical evidence relevant to the treatment decision and options for previously treated MCL; 6) development of the draft decision aid with five iterative cycles of feedback from HCPs and patients; 7) alpha testing with direct feedback from patients and HCPs; and, 8) beta testing in real life conditions, using patients and HCPs external to the development process, evaluating the usability of the decision aid, and assessing patient knowledge, expectations, values, treatment choice, decisional conflict and confidence in one's ability to make decisions. Results: Needs assessment interviews with patients showed that patients understand that their disease will relapse and apply previous treatment experiences to later treatment decisions. Through our interviews we found that patients look for information online, and feel that most information online about MCL is incorrect and/or outdated. In order of importance, patients identify efficacy, adverse effects, cost, and impact on daily life as their primary decision determinants. Patients like an online format and want to be involved in decision-making. In the HCPs' needs assessment interviews, HCPs stated that some patients may require significant education on treatment options due to the rapidly changing treatment landscape and long remission periods. In order of importance, HCPs feel patients choose treatment based on cost, efficacy, and impact on daily life. HCPs believe an online decision aid would work for this patient population and that patients want to be involved in treatment decision-making. Conclusion: A patient-friendly online decision aid with graphics and audio was developed for patients with previously treated MCL. Feedback from patients and HCPs has been integrated into the decision aid. Guided by a well-documented and systematic development process, this SDM tool can complement other methodologies in decision-making and has the potential to improve patient-physician communication, ensuring patients' preferences and values are incorporated at the point of care. Disclosures LeBlanc: Flatiron: Consultancy; Epi-Q: Consultancy; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees; Helsinn Therapeutics: Honoraria, Research Funding. Wolf:Janssen Scientific Affairs, LLC: Consultancy. Neylon:Seattle Genetics: Speakers Bureau; Celgene: Speakers Bureau; Genentech: Speakers Bureau; Gilead: Speakers Bureau. Caroselli:Janssen Scientific Affairs, LLC: Research Funding. Deering:Janssen Scientific Affairs, LLC: Research Funding. Schenkel:Janssen Scientific Affairs, LLC: Employment.

Description: Background: Understanding the predictors of increased healthcare resource utilization is essential for better management of patients with MCL, especially as new agents enter the market. This study evaluated predictors for ER visits and hospitalizations in patients with newly diagnosed and relapsed MCL treated with chemotherapy. Methods: Using claims data (MORE2 Registry®), patients treated with antineoplastics from August 2009-2013 for MCL were retrospectively identified by ICD-9 codes (200.4, 200.40 - 200.48). Patients with secondary malignancies, pregnancy, and age 1 indicates increase in chance of events. Results: A total of 449 patients with MCL were identified. Median age at diagnosis was 71 years, 70% were male, 61% had Medicare primary insurance, 32% were treated in the relapsed setting, 50% had ER visits, and 53% had hospitalizations throughout their treatment history. Significant increases in ER visits and hospitalizations were associated with the following factors (OR/p-value): chemotherapy duration (ER: 1.001/.046, hospitalization: 1.001/.01), supportive care (ER: 2.249/.014, hospitalization: 2.56/.004), number of MCL related adverse events (ER: 10.571/

Description: Objective: To assess the treatment patterns and hematologic outcomes associated with epoetin alfa (EPO) and darbepoetin alfa (DARB) for the treatment of anemic cancer patients in the community practice setting. Methods: A retrospective observational study design was used. De-identified data from patients receiving care in community oncology practice settings were obtained from an electronic medical record system. Eligible patients were 〉= 18 years of age, had a cancer diagnosis, and were treated with an erythropoiesis stimulating agent (ESA: EPO or DARB) during the period July 2002 – July 2004, with baseline anemia (Hb=2 g/dL by end of treatment episode) 41.4 34.7 = 2 g/dL or reaching 12 g/dL by end of treatment episode) 52.3 44.6

Description: Background: Acute care interventions negatively impact patients' quality of life and represent one of the major cost drivers in oncology care. Understanding the predictors for increased healthcare resource utilization is essential for better management of patients with CLL. This study evaluated predictors for ER visits and hospitalizations in patients with CLL treated with chemotherapy. Methods: Using claims data (MORE2 Registry®), patients receiving chemotherapy for CLL were retrospectively identified by ICD-9 codes (204.1X) during a 48-month period (August 2009-2013). Patients with secondary malignancies, pregnancy codes, and age 1 indicates increase in chance of event. Results: A total of 2,013 patients with CLL were identified. Median age at diagnosis was 72 years, 61% were male, 34% were treated in the relapsed setting, 42% had ER visits, and 39% were hospitalized throughout their treatment history. Significant increases in ER visits and hospitalizations were associated with the following variables (OR/p-value): age (ER: 1.015/.001, hospitalization: 1.001/.038), Charlson comorbidity index (ER: 1.253/.013, hospitalization: 1.038/.018), supportive care use (ER: 2.087/