A Qualitative Interview Study to Explore the Patient Experience of Locally Advanced or Metastatic Pancreatic Cancer and Explore the Content of Patient-Reported Outcome Measures

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Objectives: Major amputation may be required when limb-sparing surgery is not possible for musculoskeletal tumors, or has failed. The authors aimed to assess the function and health-related quality of life (HRQoL) after major lower extremity amputation due to musculoskeletal tumors.  Methods: Thirteen non-consecutive adult patients (two men and 11 women; mean age 66 years) who had been fitted with a prosthesis after having undergone major lower extremity amputation due to a tumor. Participants completed a general health survey on a 0-100mm (bestworst) visual analog scale, the Locomotor Capabilities Index 5, and the 15D HRQoL instrument at a median of five years after amputation. Twenty-four major lower extremity trauma patients who had their amputated limb fitted with a prosthesis served as HRQoL controls.  Results: The mean (SD) general health was 23/100 (13), 15D Mobility dimension was 2.2/5 (0.6) and locomotor capability was 44/100 (13). The mean 15D index was 0.85 (0.11) and that of the control group 0.87 (0.11). Both scores were somewhat lower than those usually observed in similar aged general population (around 0.90).  Conclusions: Function after major lower extremity amputation due to musculoskeletal tumors is good among patients who had undergone succesful prosthetic fitting, and the HRQoL is slightly lower than similar aged general population but comparable to that of major lower extremity trauma amputees. PCN232 A Qualitative Interview Study to Explore the Patient Experience of Locally Advanced or Metastatic Pancreatic Cancer and Explore the Content of Patient-Reported Outcome Measures Degboe A1, Kitchen H2, Aldhouse NV2, Trigg A2, Herman JM3, Narang A3, Hodgin M3, Johnson C4, Halling K5 1AstraZeneca, Gaithersburg, MD, USA, 2DRG Abacus, Manchester, UK, 3Johns Hopkins University, Baltimore, MD, USA, 4University of Southampton, Southampton, UK, 5AstraZeneca, Molndal, Sweden

Objectives: This study aimed to a) understand the lived experiences of patients with locally advanced or metastatic pancreatic cancer and b) develop a conceptual model to guide future outcomes measurement. Patient-reported outcome (PRO) instruments (EORTC QLQ-C30 & PAN26; FACT-Hep) were assessed for their suitability in this population.  Methods: Patients with locally advanced or metastatic pancreatic cancer who had received treatment in the past 12 months participated in an interview. A semi-structured interview guide was developed, based on published literature and medical expert interviews (n= 6). Interviews were thematically analyzed in ATLAS.ti.v7; quotes were coded to identify concepts. Concepts arising from interviews were grouped into domains to form a conceptual model. Framework analysis was applied to identity PRO conceptual relevance, comprehension, and interpretation.  Results: Twenty-four patients were interviewed (62.5% female, aged 35-84). Before diagnosis, patients experienced pain (n= 21) including in the abdomen (n= 9) or back (n= 6) and jaundice-associated symptoms e.g., yellow skin/eyes (n= 8). Treatment included Whipple surgery, chemotherapy and radiation regimens. Surgery was associated with acute pain and gastrointestinal symptoms; chemotherapy/chemo radiation with cyclical side effects including fatigue/tiredness (n= 21), appetite loss (n= 15), bowel problems (n= 15), nausea and vomiting (n= 15). Radiation was also associated with skin problems at the radiation site. Patients experienced significant impairment to physical function and daily activities (e.g. tiredness, difficulty walking), sleep, socializing, work, and wellbeing. Patients generally found the QLQ-C30 & PAN26 and FACT-Hep to be understandable and conceptually relevant.  Conclusions: Pancreatic cancer and its treatment are associated with significant symptoms, side effects, and impact on patient lives. PRO instruments included in clinical trials should assess the effect of therapies on pain, gastrointestinal symptoms and fatigue. The QLQ-C30 & PAN26 and FACT-Hep appeared relevant and suitable to capture symptoms and impacts in clinical trials but FACT-Hep assesses additional distal impacts. Items in both PRO instruments could be amended/added to ensure conceptual comprehensiveness. PCN233 Treatment Satisfaction and Burden of Illness With Oral Vs Injectable Multiple Myeloma Therapy in Patients with Newly Diagnosed Disease (NDMM) Romanus D1, DasMahapatra P2, Hoole M2, Lowe M2, Lawler E2, Curran C2, Campbell S1, Bell J3 1Takeda Pharmaceuticals International Co, Cambridge, MA, USA, 2PatientsLikeMe, Cambridge, MA, USA, 3Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA

Objectives: We compared patient-reported satisfaction, productivity, and burden of illness with oral vs injectable therapy in NDMM.  Methods: Patients were recruited from PatientsLikeMe, MyelomaCrowd, and Facebook. Eligible US patients were: ≥  18 years, on current treatment without any prior change in therapy due to progression, without amyloidosis, and without other cancers. The cross-sectional electronic survey included: Treatment Satisfaction Questionnaire for Medication (TSQM), Work Productivity and Activity Impairment - Specific Health Problem, and burden of illness questions. Outcomes of interest were compared between all-oral (oral users) or injectable therapy with or without oral medication (injectable users). Adjusted analyses were controlled for age, gender, race and frailty.  Results: Among 176 patients, mean age was 61 years, 38% were male, 86% were Caucasian, and 27% had ECOG-PS: 2+. Patients using oral vs injectable agents comprised 44% (78/176) and 56% (98/176), respectively. Baseline characteristics were balanced between the groups. Adjusted means were comparable for treatment effectiveness (72 vs 71, p= 0.72), and global satisfaction (54 vs 57, p= 0.18) of the TSQM, but a trend toward greater convenience of treatment among patients using oral vs injectable agents was observed (81 vs. 76, p= 0.06). Patient activity impairment was lower among patients using oral vs injectable agents (33% vs. 43%, p < 0.05). Lower adjusted mean number of monthly clinic visits (1.2 vs 3.4, p< 0.001), adjusted mean monthly travel and clinic visit time (minutes; patient: 185 vs 458, p< 0.01; and caregiver: 58 vs 326, p< 0.05) and estimated monthly per patient cost (sum of patient/caregiver travel and clinic visit value of time, and visit copay/parking) $150 vs $322 (p< 0.01) were reported among patients

using oral vs injectable agents.  Conclusions: In NDMM, an all-oral regimen is associated with lower economic burden of illness and less activity impairment than an injectable regimen, and a trend towards greater treatment convenience. PCN234 Work Productivity in HER2 Positive Breast Cancer: A Comparison of Patients Across Stages of Early and Metastatic Disease Verrill M1, Schmid P2, Retzler J3, Smith AB3, Bottomley CJ4, Dando S5, Tran I5, Leslie I5, Wardley A6 1Northern Centre for Cancer Care, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK, 2Barts Cancer Institute, Queen Mary University of London, London, UK, 3York Health Economics Consortium Ltd, York, UK, 4pH Associates (an Open Health company), Marlow, UK, 5Roche Products Limited, Welwyn Garden City, UK, 6The Christie NHS Foundation Trust, Manchester, UK

Objectives: While the clinical impact of HER2+ breast cancer (HER2+BC) is well described, data on the societal impact are lacking. This study compared work productivity in three HER2+ patient groups: early (E)BC during adjuvant treatment, EBC post-treatment, and metastatic (M)BC.  Methods: A cross-sectional, observational study of 299 consenting female patients recruited from 14 secondary care centres. Group1 (n= 89): receiving targeted HER2 therapy±chemotherapy for EBC; Group2 (n= 108): in follow-up post-targeted treatment for EBC; Group3 (n= 102): MBC on treatment. Patients completed questionnaires including the Work Productivity and Activity Impairment (WPAI) measure and EQ-5D-5L; clinical staff collected patient and disease characteristics from medical records. Associations and inter-group differences were assessed using correlational analysis and univariate analysis of variance (ANOVA). [NCT03099200].  Results: Fewer Group3 patients were employed (n= 28) compared to Group1 (n= 45) and Group2 (n= 55) (p< 0.003), with more reporting an inability to work (Group3: n= 27, Group1: n= 7, Group2: n= 5) (p< 0.003). Of employed patients, Group2 reported lower mean (SD) levels of work absenteeism (9% [24%]) and overall work impairment (26% [31%]), compared to Group1 (38% [44%]; p< 0.001 and 49% [40%]; p= 0.015, respectively), and marginally lower mean (SD) levels of absenteeism than Group3 (31% [44%]; p= 0.068). Across all patients (including unemployed), mean (SD) activity impairment in Group1 (34% [28%]) and Group2 (28% [26%]) was lower than in Group3 (48% [31%]; p< 0.005). Across groups, higher work and activity impairments were associated with lower EQ-5D-5L health utility: r= -.3950; p< 0.001, and r= -0.6670; p< 0.001, respectively.  Conclusions: The relatively low levels of absenteeism and work impairment reported by employed patients suggest that those who were able to work remained productive. However, a higher proportion of MBC patients were unable to work, and reported significantly higher levels of overall activity impairment compared to those with EBC. Impairment was related to health utility, reflecting the overall impact of advanced disease. PCN235 The Humanistic Burden of Microsatellite Instability-High (MSI-H) Colorectal Cancer (CRC) and Metastatic CRC (MCRC) Patients Treated with Subsequent Line Therapy: A Systematic Review Kohn CG1, Nguyen E2, Miller JD2, Nwokeji E3, Laurie M3, Kamble S3, Khan T3, Masood A4, Korytowsky B3 1University of Connecticut/Hartford Hospital Evidence-Based Practice Center, Hartford, CT, USA, 2Truven Health Analytics, Cambridge, MA, USA, 3Bristol-Myers Squibb, Princeton, NJ, USA, 4Saint Lukes Cancer Institute, University of Missouri Kansas City, Kansas City, MO, USA

Objectives: To summarize the impact of subsequent line pharmacotherapy on the humanistic burden of patients with MSI-H CRC and mCRC.  Methods: A systematic literature review was conducted, searching MEDLINE form January 2007 through April 2017; manual backward-citation tracking was also employed. Searches used disease-specific terms for MSI-H CRC and mCRC combined with terms for “humanistic burden.” Humanistic burden encompassed health state utilities, quality of life (QoL), and other patient-reported outcomes (PROs). English-language studies of patients with MSI-H CRC or mCRC who received subsequent line pharmacotherapy and provided data on humanistic burden were included.  Results: The search yielded 621 non-duplicate citations. Following title/abstract and full-text screening, no MSI-H CRC studies met inclusion criteria. Fifteen mCRC studies were included; 7 reported on both utilities and QoL/PROs while 8 studies reported outcomes individually. All utility studies used EQ-5D and 9 QoL studies used QLQ-C30. Reported utilities ranged from 0.68-0.84; most utility studies reported no differences between treatments or lacked statistical analyses. Improved QoL was seen with cetuximab when compared to best supportive care (BSC) or added to irinotecan. Similar QoL improvements were also observed when panitumumab was compared to BSC or added to irinotecan. However, a randomized controlled trial (RCT) comparing cetuximab to panitumumab revealed no significant differences between these treatments. RCT-data evaluating ramucirumab+FOLFIRI vs. placebo+FOLFIRI and regorafenib+BSC vs. placebo+BSC showed similar results between cohorts.  Conclusions: While published research assessing QoL or PROs in MSI-H CRC patients receiving subsequent line pharmacotherapy is limited, patients with mCRC reportedly experience significant humanistic burden. With the emergence of immunotherapies for MSI-H CRC, there is a need to better understand the humanistic burden associated with this population, including the association between humanistic and clinical outcomes. PCN236 Health-Related Quality of Life (HRQOL) and Disease Symptoms in Patients with Unresectable Hepatocellular Carcinoma (HCC) Treated with Lenvatinib (LEN) or Sorafenib (SOR) Vogel A1, Qin S2, Kudo M3, Hudgens S4, Yamashita T5, Yoon J6, Fartoux L7, Simon K8, Lopez C9, Sung M10, Dutcus C11, Kraljevic S12, Tamai T11, Grunow N4, Meier G11, Breder V13 1Hannover Medical School, Hannover, Germany, 2Nanjing Bayi Hospital, Nanjing, China, 3Kindai University Faculty of Medicine, Osaka, Japan, 4Clinical Outcomes Solutions, Tucson, AZ, USA, 5Kanazawa University Hospital, Kanazawa, Japan, 6Seoul National University Hospital, Seoul, Korea, Republic of (South), 7Hôpital Saint-Antoine, Paris, France, 8NZOZ Centrum, Badan Klinicznych, Wroclaw, Poland, 9Hospital Universitario Marques de Valdecilla, Santander, Spain,