- Email: [email protected]
Quality of Life and Taste Dysfunction in Head and Neck Cancer Treatment Survivors
A160
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
improvement on VAS after the second course. Stable patients (MD EQ-5D= 0.82; MD VAS= 80) and decliners (MD EQ-5D= 0.79; MD VAS= 80) started high; declining health state was evident at first course for VAS and second course for EQ-5D. A higher proportion of patients demonstrated stability on EQ-5D (34%) than VAS (17%) in 1L. Among 2L patients, there was less variability at baseline. Among improvers in 2L, EQ-5D and VAS scores initially exhibited a similar trend to 1L; however, many patients demonstrated some decline after their second cycle on both measures. Conclusions: Limited data exist regarding ED-SCLC patient reported outcomes across the treatment continuum. This cohort of ED-SCLC patients provides insight on the variability of health state at baseline and during therapy for patients undergoing 1L and 2L treatment. PCN145 Enhancing Interpretation of Patient-Reported Outcome Scores Through Intuitive Metrics: An Example from Prostate Cancer Naidoo S1, Paty J2, Fickley C2, Gwaltney C3, Hawryluk E2, Phung D4, Holmstrom S4 Medical Affairs Global, Chertsey, UK, 2Quintiles Advisory Services, New York, NY, USA, 3Quintiles Advisory Services, Cambridge, MA, USA, 4Astellas Pharma Inc., Leiden, The Netherlands 1Astellas
Objectives: Regulatory agencies have highlighted the value of patient-reported outcome (PRO) endpoints in understanding treatment benefit. However, interpreting statistically significant health-related quality of life (HRQoL) benefits of new treatments can be challenging. Although the original scoring approaches must be used in trials, it may also be useful to generate complementary, intuitive metrics for PRO instruments that are easier to interpret by non-experts. In metastatic castrateresistant prostate cancer, enzalutamide delays deterioration of various aspects of HRQoL versus placebo. Our objective was to develop a methodology for ‘translating’ quantitative PRO findings into simple metrics and language that describes the patient experience of disease and treatment impact thereon. Methods: We utilized data from four enzalutamide clinical trials in different prostate cancer populations. A 0–100% metric for total scores and domains was computed through a linear transformation of results, in order to facilitate interpretation across trials and instruments (FACT-P, BPI, EORTC-QLQ C30/PR25). The 0–100% metric indicates the responses’ position relative to maximum scale length (e.g. a score of 119 on a 0–156 scale would equal 76%). This linear transformation to a common metric facilitated comparisons across trials and instruments. We then worked to align the metric with simple language that maps onto the patient’s experience. We summarized our findings across trials, instruments, and patient populations to identify consistent effects. Results: Transformation of PRO data to another metric helps in understanding and interpreting previous findings. An example is the overall FACT-P, where patients entering one of the enzalutamide trials reported at baseline that they are functioning at 77%, suggesting a relatively high level of functioning with respect to their HRQoL. Conclusions: The changes over time captured in these trials, to be presented in detail, are more readily interpreted by non-PRO experts using this approach to scoring and the related, simple terminology. PCN146 Effect of Brain Metastasis on Patient-Reported Outcomes in Advanced Nsclc Treated In Real-World Community Oncology Settings Walker MS1, Wong W2, Ravelo A3, Miller PJ1, Schwartzberg L4 1Vector Oncology, Memphis, TN, USA, 2Genentech, Inc., South San Francisco, CA, USA, 3Genentech, Inc., South San Francisco, TN, USA, 4The West Clinic, Memphis, TN, USA
Objectives: Health-related quality of life (HRQOL) in advanced non-small cell lung cancer (NSCLC) may be affected by treatment and patient factors, but also by disease characteristics, including the presence of brain metastasis (BM). We report findings from a prospective observational study that examined HRQOL measured by patient reported outcomes (PROs) in patients (pts) newly diagnosed with advanced NSCLC, with or without baseline BM, through one year of follow-up. Methods: Pts starting first-line treatment of stage IIIB/IV NSCLC were prospectively enrolled and consented at 34 US-based community oncology settings. PROs were collected once per cycle during treatment, and at each visit after discontinuation. PROs included the EORTC QLQ-C30 and QLQ-LC13, the MDASI-LC, and the Rotterdam Activity Level Scale (RALS). Linear mixed models examined the impact of baseline BM, including differences in change over time. Results: Of 155 eligible pts enrolled, 145 provided follow-up data, including 1,100 PRO surveys. Pts were 58.6% male, 86.2% Caucasian. Pts with baseline BM were younger (61.3 vs. 65.8, p= 0.0396) with more concurrent radiotherapy (56.3% vs. 15%, P< 0.0001). Results showed essentially no group differences in baseline HRQOL, but significant differences emerged on 20 PRO measures during the one year follow-up. 18 of these 20 PRO measures showed significant deterioration over time for patients with baseline BM compared to those without. These 18 measures included all QLQ-C30 composite measures except Global Health Status, all MDASI-LC measures, and the RALS (all p< 0.05). For these measures, the average one-year deterioration relative to patients without baseline BM was 18.5% of the instrument range, where 5-10% change is the minimum important difference (Ringash, et al., 2007). The largest deterioration was 29.9% for interference with daily activities. Conclusions: Newly diagnosed advanced NSCLC pts with baseline BM experienced a significantly faster and clinically meaningful deterioration in PRObased HRQOL compared to those without baseline BM. PCN147 Impact of Disease Progression on Patient Reported Outcomes in Advanced Nsclc: Evidence from Patients Treated in Real World Community Oncology Settings Walker MS1, Wong W2, Ravelo A2, Hazard S2, Miller PJ1, Schwartzberg L3 Oncology, Memphis, TN, USA, 2Genentech, Inc., South San Francisco, TN, USA, 3The West Clinic, Memphis, TN, USA
1Vector
Objectives: Treatment of advanced non-small cell lung cancer (NSCLC) involves balancing the efficacy and tolerability of treatments, including the impact of disease
progression on health-related quality of life (HRQOL). We report findings from a prospective medical record registry that examined HRQOL as measured by patient reported outcomes (PROs) in patients (pts) newly diagnosed with advanced NSCLC through one year of follow-up. Methods: Pts starting first-line treatment of stage IIIB/IV nonsquamous NSCLC were prospectively enrolled and consented at 34 US-based community oncology settings. PROs were collected once per cycle during treatment, and at each visit if patients discontinued treatment. PROs included the EORTC QLQ-C30 and QLQ-LC13, the MDASI-LC, and the Rotterdam Activity Level Scale (RALS). Results: Of 155 eligible pts enrolled, 145 provided follow-up data, including 1,100 PRO surveys. Pts received standard, widely used chemotherapy regimens, and were 58.5% male, 86.4% Caucasian, with mean age 64.8 (±10.9) years. 13.6% had impaired performance status (ECOG 2+ or equivalent). PFS events occurred in 141 of 147 pts (95.9%) based on scan records and physician progress notes, with overall median PFS of 5.59 (4.83-6.25) months. Fifty-nine pts provided PRO data after disease progression. Linear mixed models showed that disease progression was associated with significant or near significant adverse impact on HRQOL in 18 of 32 PRO endpoints. Among the 12 significant effects, the average adverse effect of disease progression was 5.7% of the instrument range, where 5% - 10% change is the minimum important difference (Ringash, et al., 2007). The strongest effects were QLQ-LC13, Sore mouth (8.0%) and Dyspnea (7.3%), and QLQ-C30 constipation (7.6%). Effects on the QLQ-C30 Global Health Status and Physical Functioning measures were 4.7% and 5.3%, respectively (all p < 0.05). Conclusions: PROs showed significant and clinically meaningful worsening of symptoms at disease progression, as indicated by widely used HRQOL measures. PCN148 Quality of Life and Taste Dysfunction in Head and Neck Cancer Treatment Survivors McLaughlin LA1, Hinyard L2, Mahon S1 1Saint Louis University, St. Louis, MO, USA, 2Saint Louis University Center for Outcomes Research (SLUCOR), Saint Louis, MO, USA
Objectives: To test the effectiveness of interventions to mitigate taste dysfunction (IMTD) on improving nutrition and health related quality of life (HRQoL) in a group of head and neck cancer treatment survivors (HNCTS). Methods: In order to test the theory that IMTD will improve nutrition and HRQoL in HNCTS, a prospective randomized trial was conducted. The sample for this pilot study was drawn from a pool of HNCTS seen in a surgery follow up clinic at a Midwestern academic medical center. The sample of adult head and neck cancer treatment survivors (n = 23) who had completed all treatment at least 3 months prior to participation where recruited over a six month period and followed for up to three post treatment data collection time points. Results: Significant improvements in taste scores were observed in the treatment group (p= 0.01). No significant differences in the dependent variables were observed between the treatment and control group. Dry mouth and oral/throat pain were negatively associated with taste scores. Conclusions: Tailored intervention may help improve in taste perception in head and neck cancer survivors. Greater attention to treatment for complaints of dry mouth and oral pain may enhance taste function. It is feasible to measure taste and design tailored intervention to promote coping with taste deficits. Taste is an individual experience. In order to improve appetite, taste must be assessed to design specific interventions that are more likely to be effective. Ongoing assessment is critical to select optimal strategies to enhance the taste experience and improve nutrition, promote weigh maintenance, and improve quality of life. PCN149 Health-Related Quality of Life of Patients with Acute Myeloid Leukemia: A Systematic Literature Review van Nooten FE1, Korol E2, Levis M3, Ravandi-Kashani F4, Wang S2, Johnston K2 Pharma BV, Leiden, The Netherlands, 2ICON, Vancouver, BC, Canada, 3Johns Hopkins University, Baltimore, MD, USA, 4University of Texas – MD Anderson Cancer Center, Houston, TX, USA 1Astellas
Objectives: Patients with acute myeloid leukemia (AML), including those with relapsed or refractory AML (R/R AML), have poor clinical prognoses and outcomes. While assessment of health-related quality of life (HRQoL) has become increasingly important in oncology, HRQoL in hematology and in AML in particular has received relatively little attention. The purpose of this literature review was to identify and summarize estimates of HRQoL in patients with AML in the United States (US) and Europe, including those with R/R AML. Methods: A systematic literature review was performed. MEDLINE and EMBASE databases were searched for peer-reviewed literature published between 2004 and 2014 in the US and Europe, as were the abstracts from the proceedings of four relevant conferences between 2012 and 2014. Data from eligible studies were extracted, describing the HRQoL instruments used, domains assessed, and HRQoL scores reported. Results: A total of 14 peerreviewed studies met the eligibility criteria and were included in the review. Canceror leukemia-specific HRQoL measures (eg, European Organization for Research and Treatment of Cancer [EORTC]-QLQ-C30, EORTC-QLQ-Leu, Functional Assessment of Cancer Therapy) were used in 78.6% of the studies. Reported HRQoL declined shortly after diagnosis or treatment initiation and recovered over time, and it was superior in AML survivors compared with patients on active treatment. Fatigue was identified as the most problematic symptom domain in patients, irrespective of their treatment status. Conclusions: The included studies identified a decrease in HRQoL after diagnosis or treatment initiation, and highlighted fatigue as a factor in HRQoL in this patient population. Limited HRQoL data from R/R AML patients were identified in this review. Further studies exploring HRQoL in the R/R AML patient population are needed to inform disease management and treatment decisions. PCN150 Impact of Depression on Health-Related Quality of Life among Survivors of Skin Cancer Bhattacharya K1, Noori W2, Khanna R3
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
improvement on VAS after the second course. Stable patients (MD EQ-5D= 0.82; MD VAS= 80) and decliners (MD EQ-5D= 0.79; MD VAS= 80) started high; declining health state was evident at first course for VAS and second course for EQ-5D. A higher proportion of patients demonstrated stability on EQ-5D (34%) than VAS (17%) in 1L. Among 2L patients, there was less variability at baseline. Among improvers in 2L, EQ-5D and VAS scores initially exhibited a similar trend to 1L; however, many patients demonstrated some decline after their second cycle on both measures. Conclusions: Limited data exist regarding ED-SCLC patient reported outcomes across the treatment continuum. This cohort of ED-SCLC patients provides insight on the variability of health state at baseline and during therapy for patients undergoing 1L and 2L treatment. PCN145 Enhancing Interpretation of Patient-Reported Outcome Scores Through Intuitive Metrics: An Example from Prostate Cancer Naidoo S1, Paty J2, Fickley C2, Gwaltney C3, Hawryluk E2, Phung D4, Holmstrom S4 Medical Affairs Global, Chertsey, UK, 2Quintiles Advisory Services, New York, NY, USA, 3Quintiles Advisory Services, Cambridge, MA, USA, 4Astellas Pharma Inc., Leiden, The Netherlands 1Astellas
Objectives: Regulatory agencies have highlighted the value of patient-reported outcome (PRO) endpoints in understanding treatment benefit. However, interpreting statistically significant health-related quality of life (HRQoL) benefits of new treatments can be challenging. Although the original scoring approaches must be used in trials, it may also be useful to generate complementary, intuitive metrics for PRO instruments that are easier to interpret by non-experts. In metastatic castrateresistant prostate cancer, enzalutamide delays deterioration of various aspects of HRQoL versus placebo. Our objective was to develop a methodology for ‘translating’ quantitative PRO findings into simple metrics and language that describes the patient experience of disease and treatment impact thereon. Methods: We utilized data from four enzalutamide clinical trials in different prostate cancer populations. A 0–100% metric for total scores and domains was computed through a linear transformation of results, in order to facilitate interpretation across trials and instruments (FACT-P, BPI, EORTC-QLQ C30/PR25). The 0–100% metric indicates the responses’ position relative to maximum scale length (e.g. a score of 119 on a 0–156 scale would equal 76%). This linear transformation to a common metric facilitated comparisons across trials and instruments. We then worked to align the metric with simple language that maps onto the patient’s experience. We summarized our findings across trials, instruments, and patient populations to identify consistent effects. Results: Transformation of PRO data to another metric helps in understanding and interpreting previous findings. An example is the overall FACT-P, where patients entering one of the enzalutamide trials reported at baseline that they are functioning at 77%, suggesting a relatively high level of functioning with respect to their HRQoL. Conclusions: The changes over time captured in these trials, to be presented in detail, are more readily interpreted by non-PRO experts using this approach to scoring and the related, simple terminology. PCN146 Effect of Brain Metastasis on Patient-Reported Outcomes in Advanced Nsclc Treated In Real-World Community Oncology Settings Walker MS1, Wong W2, Ravelo A3, Miller PJ1, Schwartzberg L4 1Vector Oncology, Memphis, TN, USA, 2Genentech, Inc., South San Francisco, CA, USA, 3Genentech, Inc., South San Francisco, TN, USA, 4The West Clinic, Memphis, TN, USA
Objectives: Health-related quality of life (HRQOL) in advanced non-small cell lung cancer (NSCLC) may be affected by treatment and patient factors, but also by disease characteristics, including the presence of brain metastasis (BM). We report findings from a prospective observational study that examined HRQOL measured by patient reported outcomes (PROs) in patients (pts) newly diagnosed with advanced NSCLC, with or without baseline BM, through one year of follow-up. Methods: Pts starting first-line treatment of stage IIIB/IV NSCLC were prospectively enrolled and consented at 34 US-based community oncology settings. PROs were collected once per cycle during treatment, and at each visit after discontinuation. PROs included the EORTC QLQ-C30 and QLQ-LC13, the MDASI-LC, and the Rotterdam Activity Level Scale (RALS). Linear mixed models examined the impact of baseline BM, including differences in change over time. Results: Of 155 eligible pts enrolled, 145 provided follow-up data, including 1,100 PRO surveys. Pts were 58.6% male, 86.2% Caucasian. Pts with baseline BM were younger (61.3 vs. 65.8, p= 0.0396) with more concurrent radiotherapy (56.3% vs. 15%, P< 0.0001). Results showed essentially no group differences in baseline HRQOL, but significant differences emerged on 20 PRO measures during the one year follow-up. 18 of these 20 PRO measures showed significant deterioration over time for patients with baseline BM compared to those without. These 18 measures included all QLQ-C30 composite measures except Global Health Status, all MDASI-LC measures, and the RALS (all p< 0.05). For these measures, the average one-year deterioration relative to patients without baseline BM was 18.5% of the instrument range, where 5-10% change is the minimum important difference (Ringash, et al., 2007). The largest deterioration was 29.9% for interference with daily activities. Conclusions: Newly diagnosed advanced NSCLC pts with baseline BM experienced a significantly faster and clinically meaningful deterioration in PRObased HRQOL compared to those without baseline BM. PCN147 Impact of Disease Progression on Patient Reported Outcomes in Advanced Nsclc: Evidence from Patients Treated in Real World Community Oncology Settings Walker MS1, Wong W2, Ravelo A2, Hazard S2, Miller PJ1, Schwartzberg L3 Oncology, Memphis, TN, USA, 2Genentech, Inc., South San Francisco, TN, USA, 3The West Clinic, Memphis, TN, USA
1Vector
Objectives: Treatment of advanced non-small cell lung cancer (NSCLC) involves balancing the efficacy and tolerability of treatments, including the impact of disease
progression on health-related quality of life (HRQOL). We report findings from a prospective medical record registry that examined HRQOL as measured by patient reported outcomes (PROs) in patients (pts) newly diagnosed with advanced NSCLC through one year of follow-up. Methods: Pts starting first-line treatment of stage IIIB/IV nonsquamous NSCLC were prospectively enrolled and consented at 34 US-based community oncology settings. PROs were collected once per cycle during treatment, and at each visit if patients discontinued treatment. PROs included the EORTC QLQ-C30 and QLQ-LC13, the MDASI-LC, and the Rotterdam Activity Level Scale (RALS). Results: Of 155 eligible pts enrolled, 145 provided follow-up data, including 1,100 PRO surveys. Pts received standard, widely used chemotherapy regimens, and were 58.5% male, 86.4% Caucasian, with mean age 64.8 (±10.9) years. 13.6% had impaired performance status (ECOG 2+ or equivalent). PFS events occurred in 141 of 147 pts (95.9%) based on scan records and physician progress notes, with overall median PFS of 5.59 (4.83-6.25) months. Fifty-nine pts provided PRO data after disease progression. Linear mixed models showed that disease progression was associated with significant or near significant adverse impact on HRQOL in 18 of 32 PRO endpoints. Among the 12 significant effects, the average adverse effect of disease progression was 5.7% of the instrument range, where 5% - 10% change is the minimum important difference (Ringash, et al., 2007). The strongest effects were QLQ-LC13, Sore mouth (8.0%) and Dyspnea (7.3%), and QLQ-C30 constipation (7.6%). Effects on the QLQ-C30 Global Health Status and Physical Functioning measures were 4.7% and 5.3%, respectively (all p < 0.05). Conclusions: PROs showed significant and clinically meaningful worsening of symptoms at disease progression, as indicated by widely used HRQOL measures. PCN148 Quality of Life and Taste Dysfunction in Head and Neck Cancer Treatment Survivors McLaughlin LA1, Hinyard L2, Mahon S1 1Saint Louis University, St. Louis, MO, USA, 2Saint Louis University Center for Outcomes Research (SLUCOR), Saint Louis, MO, USA
Objectives: To test the effectiveness of interventions to mitigate taste dysfunction (IMTD) on improving nutrition and health related quality of life (HRQoL) in a group of head and neck cancer treatment survivors (HNCTS). Methods: In order to test the theory that IMTD will improve nutrition and HRQoL in HNCTS, a prospective randomized trial was conducted. The sample for this pilot study was drawn from a pool of HNCTS seen in a surgery follow up clinic at a Midwestern academic medical center. The sample of adult head and neck cancer treatment survivors (n = 23) who had completed all treatment at least 3 months prior to participation where recruited over a six month period and followed for up to three post treatment data collection time points. Results: Significant improvements in taste scores were observed in the treatment group (p= 0.01). No significant differences in the dependent variables were observed between the treatment and control group. Dry mouth and oral/throat pain were negatively associated with taste scores. Conclusions: Tailored intervention may help improve in taste perception in head and neck cancer survivors. Greater attention to treatment for complaints of dry mouth and oral pain may enhance taste function. It is feasible to measure taste and design tailored intervention to promote coping with taste deficits. Taste is an individual experience. In order to improve appetite, taste must be assessed to design specific interventions that are more likely to be effective. Ongoing assessment is critical to select optimal strategies to enhance the taste experience and improve nutrition, promote weigh maintenance, and improve quality of life. PCN149 Health-Related Quality of Life of Patients with Acute Myeloid Leukemia: A Systematic Literature Review van Nooten FE1, Korol E2, Levis M3, Ravandi-Kashani F4, Wang S2, Johnston K2 Pharma BV, Leiden, The Netherlands, 2ICON, Vancouver, BC, Canada, 3Johns Hopkins University, Baltimore, MD, USA, 4University of Texas – MD Anderson Cancer Center, Houston, TX, USA 1Astellas
Objectives: Patients with acute myeloid leukemia (AML), including those with relapsed or refractory AML (R/R AML), have poor clinical prognoses and outcomes. While assessment of health-related quality of life (HRQoL) has become increasingly important in oncology, HRQoL in hematology and in AML in particular has received relatively little attention. The purpose of this literature review was to identify and summarize estimates of HRQoL in patients with AML in the United States (US) and Europe, including those with R/R AML. Methods: A systematic literature review was performed. MEDLINE and EMBASE databases were searched for peer-reviewed literature published between 2004 and 2014 in the US and Europe, as were the abstracts from the proceedings of four relevant conferences between 2012 and 2014. Data from eligible studies were extracted, describing the HRQoL instruments used, domains assessed, and HRQoL scores reported. Results: A total of 14 peerreviewed studies met the eligibility criteria and were included in the review. Canceror leukemia-specific HRQoL measures (eg, European Organization for Research and Treatment of Cancer [EORTC]-QLQ-C30, EORTC-QLQ-Leu, Functional Assessment of Cancer Therapy) were used in 78.6% of the studies. Reported HRQoL declined shortly after diagnosis or treatment initiation and recovered over time, and it was superior in AML survivors compared with patients on active treatment. Fatigue was identified as the most problematic symptom domain in patients, irrespective of their treatment status. Conclusions: The included studies identified a decrease in HRQoL after diagnosis or treatment initiation, and highlighted fatigue as a factor in HRQoL in this patient population. Limited HRQoL data from R/R AML patients were identified in this review. Further studies exploring HRQoL in the R/R AML patient population are needed to inform disease management and treatment decisions. PCN150 Impact of Depression on Health-Related Quality of Life among Survivors of Skin Cancer Bhattacharya K1, Noori W2, Khanna R3