The Symptom Burden of Chronic Myelogenous Leukemia (CML)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2408-2408
Author(s):  
Loretta A Williams ◽  
Patricia Ault ◽  
Xin Shelley Wang ◽  
Charles S. Cleeland ◽  
Tito R. Mendoza ◽  
...  
Keyword(s):  
Tyrosine Kinase ◽  
Symptom Severity ◽  
Performance Status ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Dry Mouth ◽  
Patient Treatment ◽  
Ecog Performance Status ◽  
Treatment Characteristics ◽  
Patient Reported

Abstract Symptom burden is the combined impact of all disease-related and therapy-related symptoms on one’s ability to function as one did before onset of disease or therapy. Lack of understanding of symptoms may result in failure to address symptoms and return patients to optimum functioning. This is critical for patients with chronic diseases who are receiving continuing therapy, such as patients with chronic myeloid leukemia (CML). Additionally patient-reported outcome measures are becoming primary endpoints in clinical trials to test results such as reduction in symptom burden that establish treatment benefits from the patient’s perspective. No patient-reported outcome measure for CML currently exists, and there is little understanding or knowledge of the symptom burden of CML and its treatment. The purpose of this study was to initially explore the symptom burden of CML. Methods: Retrospective analysis of 29 patients with CML who participated in two larger cross-sectional studies exploring cancer-related symptoms. Patients used the M. D. Anderson Symptom Inventory (MDASI) to rate the severity of their symptoms (13 items) and the degree to which their symptoms interfered with daily living (6 items) on a 0–10 scale. Results: Patient/treatment characteristics are summarized in Table 1. Table 1: Patient/Treatment Characteristics N=29 Mean SD Age 53.9 14.6 Highest Grade Completed 14.45 2.08 n % Sex–Male 17 58.6% Race–White, non-Hispanic 27 93.1% Employment Status–Employed or Homemaker 13 44.8% ECOG Performance Status–< 2 21 72.4% Treatment Type Interferon-Based Therapy 9 31.0% Tyrosine Kinase Inhibitor 10 34.5% Mean global symptom severity was 1.86 (SD 1.76) and mean global interference was 1.79 (SD 2.05). Cronbach alpha for the symptom scores was 0.916 and for the interference scores was 0.922, indicating that the MDASI is reliable in this sample. The 6 most severe symptoms (mean severity score > 2.5) were fatigue, drowsiness, lack of appetite, disturbed sleep, difficulty remembering things, and dry mouth. Symptoms interfered most with work and general activities. Mean symptom severity scores and standard deviations for the top most severe symptoms and most bothersome interference items are reported in Table 2. Table 2: Symptom and Interference Means and SD There was no significant difference in mean symptom severity or interference between patients receiving interferon-based therapies and patients receiving tyrosine kinase inhibitors. There were significant differences in mean symptom severity (p = .001) and interference (p < .001) scores between patients with good (0 or 1) and poor (≥ 2) ECOG performance status. Preliminary analysis has encouraged us to investigate further relationships among the 13 symptom items, the 6 interference items, and demographic, disease, and treatment related factors. This further, more-detailed analysis will be presented. n Minimum Maximum Mean SD Symptom Item Fatigue 29 0 9 4.62 2.691 Drowsiness 29 0 10 3.00 3.151 Lack of Appetite 29 0 8 2.83 2.916 Sleep disturbance 29 0 10 2.66 2.595 Difficulty Remembering 29 0 7 2.62 2.162 Dry mouth 29 0 10 2.52 2.681 Interference Item Work 28 0 9 3.14 3.003 Activity 28 0 10 3.11 2.897 Conclusion: Methods for patients with CML to report symptom burden to clinicians and researchers are needed. Based on preliminary results, the MDASI is a reliable instrument that captures many symptoms of CML and differentiates between levels of severity of illness. Further work is ongoing to identify and add symptom items to the MDASI that will capture CML-specific and treatment-specific symptoms.

Understanding the symptom experience of breast cancer outpatients: The validity and utility of the M.D. Anderson Symptom Inventory (MDASI).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9106-9106
Author(s):  
Tito R. Mendoza ◽  
Fengmin Zhao ◽  
Charles S. Cleeland ◽  
Lynne I. Wagner ◽  
Linda J. Patrick-Miller ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Assessment Method ◽  
Patient Reported Outcome ◽  
Symptom Experience ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Patient Reported

9106 Background: Breast cancer and its treatments can produce multiple symptoms that cause distress and impair function. The MDASI, a patient-reported outcome measure of symptoms (sxs) and functional interference has been validated in general oncology and has the potential to inform symptom experience and guide treatment specific to breast cancer patients (pts). Methods: The Eastern Cooperative Oncology Group (ECOG) conducted the Symptom Outcomes and Practice Patterns (SOAPP) study at academic and community medical oncology clinics and included pts with breast cancer of all stages and phases of care. At baseline and 4 weeks, pts completed the MDASI. Symptom experiences and psychometric properties of the MDASI in breast cancer pts (n = 1544) were analyzed. Results: The median age was 58 years, and the race/ethnicity included 11% black and 8% hispanic. 5% had ECOG performance status (PS) ≥2. The 5 most prevalent moderate/severe sxs reported at baseline were fatigue (31%), disturbed sleep (27%), drowsiness (21%), hair loss (22%) and dry mouth (19%); moderate/severe skin rash (6%) and vomiting (4%) were the least prevalent. At follow-up, about 1/3 of patients had moderate/severe fatigue and 19% had moderate/severe pain and distress. Internal consistency and test-retest reliability were good, with Cronbach alphas of ≥0.85 and intraclass correlations of ≥0.76 for all subscales. Among those whose PS was stable or improving, the change scores in sx severity improved most for sleep disturbance, numbness/tingling, and difficulty remembering things. Significantly higher scores and moderately large effects for the severity scale were reported by pts with poorer PS (ES=.61) and those with local/regional/metastatic disease (ES=.67). Results were similar for the interference scale. Pts whose quality of life (QOL) declined showed greater increase in severity (1.1 vs .07, p<.001) from baseline to follow-up than pts whose QOL was unchanged, demonstrating sensitivity to change. Conclusions: Breast cancer pts have significant sx burden despite well-preserved PS. The MDASI is a valid, reliable, and sensitive sx assessment method for research and patient care in breast cancer outpatients.

A new symptom measure in gastrointestinal stomal tumors.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17508-e17508 ◽  
Author(s):  
Loretta A. Williams ◽  
Dejka M. Araujo ◽  
Tito R. Mendoza ◽  
Mary L Sailors ◽  
Nazim N Ali ◽  
...  
Keyword(s):  
Symptom Severity ◽  
Clinical Care ◽  
Reliability And Validity ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Response To Therapy ◽  
Major Barrier ◽  
Specific Symptom ◽  
Disease Information ◽  
Patient Reported

e17508 Background: Symptom burden is the combined impact of disease- and treatment-related symptoms on daily functioning. A major barrier to effective symptom management in gastrointestinal stromal tumors (GIST) is inadequate assessment. Our aim was to develop a short, valid, reliable patient-reported outcome measure of GIST symptoms for research and practice. Methods: After giving IRB-approved informed consent, 110 patients with GIST completed the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 9 GIST-specific symptom items generated from patient and expert input. Items were measured on a 0-10 scale (0 = none, 10 = worst imaginable). 65 patients completed the same items 1 day later. Patients also answered a single overall quality-of-life (QOL) question. Demographic and disease information was collected on all patients. Psychometric procedures determined reliability and validity of the MDASI-GIST. Results: Mean subject age was 59.2 years (standard deviation [sd] = 11.9). 54% of the subjects were female, 85% were white, 47% were employed, 55% were on imatinib, and 30% had no evidence of disease. Mean overall QOL rating was 8.1 (best = 10, sd = 2.0). Symptoms reported as most severe were fatigue (mean [M] = 2.65, sd = 2.66), drowsiness (M = 2.36, sd = 2.55), disturbed sleep (M = 2.18, sd = 2.55), and muscle soreness/cramping (M = 2.18, sd = 2.67). Two items (abdominal swelling and malaise) were eliminated for redundancy. Internal consistency (Cronbach α) and test-retest reliability of the 20 symptom items were 0.94 and 0.93, respectively, and of the 6 interference items were 0.94 and 0.87, respectively. The mean severity of the 20 symptom items was significantly correlated with QOL rating (correlation = -0.7, P < 0.001). Mean GIST-specific symptom severity and symptom interference discriminated between patients who were employed and patients who were disabled (P = 0.05 and 0.03, respectively). Conclusions: We have validated an analytic tool, the MDASI-GIST, to quantify GIST symptom burden, assess side effects in treatment trials, and monitor symptoms in clinical care. Additional research on the longitudinal symptom burden of GIST, including differences based on type of therapy and response to therapy, is ongoing.

Implementation of a novel patient-reported outcomes measure for patients with cancer and COVID-19 infection.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 153-153
Author(s):  
Ishwaria Mohan Subbiah ◽  
Tito R. Mendoza ◽  
Xuetao Lu ◽  
Yanhong Zhou ◽  
J. Jack Lee ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Sleep Disturbance ◽  
Symptom Severity ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Validity And Reliability ◽  
Specific Patient ◽  
Patient Reported ◽  
Health Rating

153 Background: The long-term symptoms from COVID-19 (C19) infection in pts with cancer is not fully known. To monitor the evolution of this symptom burden over time, we designed and implemented a C19-specific patient-reported outcome (PRO) measure that integrated with a known measure of cancer symptom burden. Methods: Within the institutional initiative on C19 and cancer named Data-Driven Determinants for C19 Oncology Discovery Effort (D3CODE), pts with cancer & PCR-pos C19 are invited to participate in this longitudinal study. Pts complete the EQ-5D-5L, the 13 symptom severity & 6 interference items of the core MD Anderson Symptom Inventory (MDASI)+14 COVID-specific items, all scored on a 0-10 scale, 0 = none, 10 = worst imaginable. Pts complete the survey daily x 14 days from positive test date, then weekly x 3months, then monthly x 2yrs. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: Between 5/15/20 – 02/14/21, 2154 pts w PCR-confirmed C19 were invited to participate in the longitudinal study. 1282 (60%) pts provided consent and began the longitudinal completion of PRO surveys. Pts were 54.5% Female and 45.5% Male, median age 59 years (range 15 – 92). 1021 (80%) are White/Caucasian, 206 (16%) Hispanic, 113 (9%) African American, and 39 (3%) Asian. The validation analysis of MDASI-COVID instrument included the 1st 600 pts where the mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). showed internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between pts who required hospitalization (symptom M 2.32, SD 2.09; interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85; interference M 2.20, SD 2.64) (symptom P 0.007; interference P 0.004). Conclusions: We successfully deployed a PRO-based long-term symptom monitoring platform for pts with C19 and cancer. The validation analysis of this novel C19 specific PRO, the MDASI-COVID, aids in the quantification of the global symptom burden in pts with both cancer and COVID-19 infection. Deployment of this measure in the ongoing longitudinal observational cohort allows for in-depth understanding of the long-term symptoms related to C19 and cancer.

Patient-reported symptom burden and functioning in patients with advanced esophageal, gastroesophageal junction (GEJ), and gastric cancer undergoing chemotherapy.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 183-183
Author(s):  
Xin Shelley Wang ◽  
Lisa M. Hess ◽  
Fang-Yu Lin ◽  
Tsun Hsuan Chen ◽  
Elizabeth Gonzalez ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Performance Status ◽  
Gastroesophageal Junction ◽  
Symptom Burden ◽  
General Activity ◽  
Ecog Performance Status ◽  
Disturbed Sleep ◽  
Patient Reported ◽  
Line Of Therapy ◽  
Over Time

183 Background: For advanced upper gastrointestinal (GI) cancers, patient-reported symptoms are driven by both disease and treatment toxicities. This real-world longitudinal study was designed to evaluate patient-reported outcomes (PROs) of symptom burden and functioning among patients (pts) treated with anti-cancer therapy. Methods: Adult pts with advanced esophageal, gastroesophageal junction (GEJ), or gastric cancer were invited to participate in a prospective, longitudinal study. PRO assessment included pre-treatment and weekly completion of the M.D. Anderson Symptom Inventory GI module (MDASI-GI) as pts initiated a new line of therapy. Clinical and disease characteristics and treatment details were obtained from electronic health records. Up to 12 weeks longitudinal PRO data were analyzed using mixed-effect modeling with random intercept. Pts were classified into high or low symptom groups by group-based trajectory modeling. Time to deterioration in functioning (defined as a ≥2-point increase from baseline on 0-10 scale) was examined with Kaplan-Meier method. Results: At the interim analysis, 76 pts had enrolled: 33 (43%) were chemotherapy naïve for advanced disease, 18 (24%) had received 1 line of therapy, 14 (18%) had received > 1 line of therapy, and 11 (14%) were excluded from this analysis due to study discontinuation without follow-up assessment. Among the 65 eligible pts in this analysis, 46 (70.8%) were male, most were white (n = 56, 86.2%), and 44 (67.7%) had an ECOG performance status score of 0-1. Pain, fatigue, disturbed sleep, lack of appetite and inability to eat were the most common severe symptoms reported prior to and during therapy. Pts who had received one line of therapy reported worsening symptoms of pain, fatigue, lack of appetite, difficulty swallowing, and reduced general activity, work, and enjoyment of life over time (group and time interaction P<.05). Pts with > 1 line of prior therapy had increased neuropathy symptoms (numbness/tingling) than those who were treatment-naïve ( P= 0.022). The median time to functioning deterioration of ≥2 points from baseline on the MDASI-“General activity” was 7 weeks. Up to 57% of pts were classified into high symptom trajectory group of pain, fatigue, disturbed sleep, and drowsiness with moderate to severe symptoms (≥4 points out of possible 10) over time; group membership was related to moderate to severe symptoms at baseline, after adjusting for age, sex, ECOG performance status, cancer site and prior therapies. Conclusions: This real-world observational study suggests that pts with advanced stage upper GI cancer undergoing standard therapy report high symptom burden. These preliminary findings support the use of a targeted symptom monitoring using well-defined PROs during active therapy, thereby adding the knowledge obtained from PROs to improve routine patient care.

Clinician Report of Oral Oncolytic Symptoms and Adherence Obtained via a Patient-Reported Outcome Measure (PROM)

2019 ◽  
pp. 1-6
Author(s):  
Victoria R. Nachar ◽  
Karen Farris ◽  
Katie Beekman ◽  
Jennifer Griggs ◽  
Shannon Hough ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Medical Record ◽  
Symptom Severity ◽  
Positive Impact ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Self Report ◽  
Oncolytic Therapy ◽  
Patient Reported ◽  
Oral Oncolytics

PURPOSE Patient-reported outcome measures (PROMs) for symptom monitoring during cancer therapy have been shown to have a positive impact on outcomes. These findings have primarily been shown for patients receiving intravenous chemotherapy. In addition, there is known discordance between physician reporting of symptoms and patient self-report. This initiative sought to describe patient-reported symptom burden and medication adherence and to indicate the degree of PROM results being discussed with the provider as indicated by documentation in the medical record for patients taking oral oncolytic therapy. METHODS The Michigan Oncology Quality Consortium (MOQC) PROM, which included symptom ratings, medication adherence, and patient confidence in self-management, was completed during outpatient visits and compared with corresponding data documented in the electronic medical record (EMR). RESULTS There were 82 completed PROMs. Approximately half included at least one symptom rated as severe (46%). Sixty-five percent of reported severe symptoms were documented in the EMR. Patient-reported moderate-to-severe pain was most likely to be documented in the EMR (100%), whereas patient-reported moderate-to-severe depression and anxiety were least likely to be documented (21%). Of the total symptoms documented, grading of symptom severity matched that of the patients’ own report for 11% of severe symptoms. Adherence to oral oncolytics was excellent for 63% of patients, and patient adherence was documented in 7% of provider notes. CONCLUSION Patients frequently reported moderate-to-severe symptoms, and approximately 40% of patients reported nonadherence. Clinician report (documented in the EMR) of the patient symptom burden, symptom severity, and adherence to oral oncolytic therapy was not consistent with the patients’ self-report. Use of a PROM for patients taking oral oncolytics has the opportunity to improve symptom management and medication adherence.

scholarly journals Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038223
Author(s):  
Lili Tang ◽  
Ying Pang ◽  
Yi He ◽  
Qiuling Shi ◽  
Xinkun Han ◽  
...  
Keyword(s):  
Study Protocol ◽  
Symptom Management ◽  
Depression Scale ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Critical Parameters ◽  
Advanced Lung Cancer ◽  
Optimal Time ◽  
Patient Reported

IntroductionAn electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.Methods and analysisThe study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cancer or breast cancer. The primary outcome is the change of symptom burden. MD Anderson Symptom Inventory, and other PRO instruments (Insomnia Severity Index, Hospital Anxiety and Depression Scale, 9-item Patient Health Questionnaire and EuroQol-5 dimensions-5 levels version) were used. The secondary outcomes include feasibility of using ePRO, symptom-related quality of life, reasons for no improvement of symptoms, defining frequency of PRO assessments and cut-points, items for screening and management of comorbidity and satisfaction with ePRO platform in patients and health providers. After initial outpatient visit for baseline assessment, ePRO system will automatically send follow-up notification seven times over 4 weeks to patients. The characteristics and changing trajectory of symptoms of patients will be described. Parameters for using PROs, such as optimal time points for follow-up and cut-off point for alert will be determined. The feasibility of ePRO platform to track the changes of target symptoms in outpatients will be evaluated.Ethics and disseminationThe study protocol and related documents were approved by the Institutional Research Board (IRB) of Peking University Cancer Hospital on 13 February 2019 (2019YJZ07). The results of this study will be disseminated through academic workshops, peer-reviewed publications and conferences.Trial registration numberChiCTR1900023560.

NCOG-16. RELEVANCE OF GERIATRIC ASSESSMENT FOR PRIMARY BRAIN TUMOR PATIENTS: IMPLICATIONS FOR RESEARCH AND CARE

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi155-vi155
Author(s):  
Heather Leeper ◽  
Anna Choi ◽  
Elizabeth Vera ◽  
Alvina Acquaye ◽  
Nicole Briceno ◽  
...  
Keyword(s):  
Geriatric Assessment ◽  
Older Patients ◽  
Performance Status ◽  
Age Groups ◽  
Symptom Burden ◽  
Tumor Grade ◽  
Primary Brain Tumor ◽  
Functional Impairments ◽  
Who Grade ◽  
Patient Reported

Abstract BACKGROUND The utility of geriatric assessment (GA) has been evaluated in older adults diagnosed with solid tumors other than primary brain tumors (PBT). We assessed several key GA domains in adults with PBT receiving tumor-directed treatment. METHODS Patient and disease characteristics and key GA domains within patient-reported outcomes (PROs) including symptom burden (MDASI-BT), Anxiety/ Depression (PROMIS-short forms) and general health status (EQ-5D-3L) were systematically and prospectively collected between 9/2016–8/2019 from adults diagnosed with PBT. Descriptive statistics and regression analyses were used to assess PROs. RESULTS Of 581 participants, 92 were 65 – 85 years old (median age = 70 years; “older”) and 489 were ≤ 64 years (median age = 46 years; “younger”). Tumor grade distribution in the older group was 74% WHO grade III/IV, 26% WHO grade I/II; tumor types included gliomas and meningiomas with no tissue diagnosis in 3 patients. Older patients were 49% less likely to receive chemotherapy and twice as likely to have KPS ≤ 80 (p=0.003, OR=0.51, OR=1.98). More older patients reported problems with mobility (57% vs 44%), self-care (38% vs 26%), and usual activities (64% vs 51%) than younger patients. Charlson Comorbidity Index mean scores were significantly higher in older patients (3.5 vs 0.6, p&lt; 0.001). The top 3 most frequently reported moderate-to-severe symptoms were similar in older vs younger groups: fatigue (44% vs 41%), feeling drowsy (29% vs 30%) and difficulty remembering (28% vs 29%). Feeling distressed was the only symptom whose frequency differed between the age groups (11% older vs 27% younger, p=0.001). CONCLUSION Older PBT patients had lower performance status, more co-morbidities and increased functional impairments, affirming that GA is relevant. Symptom burden was similarly high in both age groups. These findings support conducting GA concurrently in future symptom intervention and therapeutic clinical trials for adults with PBT receiving tumor-directed treatment.

scholarly journals Symptom Burden of Busulfan and Melphalan Versus Melphalan Alone for Multiple Myeloma

Blood ◽  
2017 ◽  
Vol 130 (Suppl_1) ◽  
pp. 681-681
Author(s):  
Loretta A. Williams ◽  
Muzaffar H. Qazilbash ◽  
Qiuling Shi ◽  
Qaiser Bashir ◽  
Huei K. Lin ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Muscle Weakness ◽  
Symptom Severity ◽  
Conditioning Regimen ◽  
Symptom Burden ◽  
Phase Iii ◽  
Dry Mouth ◽  
Fixed Dose ◽  
High Dose ◽  
Hematopoietic Stem

Abstract Background: High-dose melphalan 200 mg/m2 (Mel) is the standard for autologous hematopoietic stem cell transplantation (autoHSCT) for multiple myeloma. Retrospective analyses suggested that a combination of busulfan and melphalan (Bu-Mel) may be associated with a longer progression-free survival (PFS). A secondary aim of a randomized, phase III trial that compared the safety and efficacy of Bu-Mel vs Mel was to compare the symptom burden of the two regimens. Symptom burden is the combined impact of disease- and therapy-related symptoms on patient functional ability. Methods: Patients were randomized to Bu-Mel (Bu 130 mg/m2 daily for 4 days, either as a fixed dose or to target an average daily area under the curve of 5000 μmol-min, followed by 2 daily doses of Mel 70 mg/m)2or Mel (Mel 100 mg/m2 daily for 2 days). A subset of patients completed the 20 symptom severity and 6 interference items of MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) prior to the start of the treatment regimen and weekly for 4 weeks post autoHSCT. Symptoms and interference are rated on 0-10 scales (0 = none or no interference, 10 = worst imaginable or complete interference). Differences in individual symptom severity and interference between the two arms were assessed by t-tests and mixed modeling. Results: As previously reported, 204 (Bu-Mel: 104, Mel: 100) were enrolled between October 2011 and March 2017. At last evaluation, 52 (51%) and 49 (49%) patients achieved a CR (p=0.88), and 69 (68%) and 67 (67%) patients achieved a CR+nCR (p=0.88) in Bu-Mel and Mel arms, respectively. Median PFS was 64.7 months and 34.4 months (p=0.013) in Bu-Mel and Mel arms, respectively. There was no difference in OS between the two arms. One hundred sixty-five of the patients (Bu-Mel: 81, Mel: 84) completed at least one MDASI-MM assessment. Median ages at autoHSCT were 57.2 and 57.0 years in Bu-Mel and Mel groups, respectively (p=0.86). At baseline, t-tests showed significantly higher mean severity of constipation (1.80, standard deviation [SD] = 2.87 vs 0.98, SD = 1.94; p=0.036), muscle weakness (2.38, SD=2.49 vs 1.44, SD=1.87; p=0.034), diarrhea (1.45, SD=2.43 vs 0.60, SD=1.10; p=0.005), and global symptom interference (2.96, SD=2.81 vs 1.77, SD=2.00; p=0.003) in the Bu-Mel arm than the Mel arm. The Bu-Mel patients had a significantly higher mean severity of pain (5.67, SD=2.65 vs 3.17, SD=3.07; p=0.0043) and mouth sores (7.35, SD=2.41 vs 1.25, SD=2.22; p &lt;0.0001) than the Mel patients 7 days post autoHSCT. Longitudinal analysis using mixed modeling showed that the Bu-Mel arm had a significantly higher mean severity of pain (ED = 1.102, p=0.003), drowsiness (ED = 0.674, p=0.040), dry mouth (ED = 0.904, p=0.009), constipation (ED = 0.695, p=0.006), muscle weakness (ED = 0.815, p=0.006), mouth sores (ED = 1.683, p &lt;0.0001), rash (ED = 0.362, p=0.019), and interference with physical functions (general activity: ED = 1.015, p=0.010; working: ED=1.229, p=0.006; walking: ED=0.920, p=0.009) than the Mel arm during the 4 weeks following autoHSCT. Conclusions: Patients receiving Bu-Mel vs Mel prior to autoHSCT report some differences in symptom severity, with Bu-Mel patients experiencing more severe sore mouth, pain, and symptom interference with daily functioning. The greater intensity of the double-alkylating agent conditioning regimen of Bu-Mel likely led to these differences. The increased severity of drowsiness, dry mouth, constipation, and muscle weakness may be due to an increased need for opioids to control severe pain and mouth sores. The effect of significant differences in symptom severity and interference at baseline between these two groups, despite randomization, is not clear. However, the longer time to progression of myeloma with the Bu-Mel regimen may offset the greater symptom burden early post autoHSCT. Systematic measurement of symptom burden during clinical trials can provide useful information for clinicians and patients in evaluating the full impact of different treatment regimens and enhance treatment decision making and discussion between clinicians and patients. Disclosures No relevant conflicts of interest to declare.

Predictors of early hospice or death in patients with inoperable lung cancer treated with curative intent.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20525-e20525
Author(s):  
Anna Mary Brown Laucis ◽  
Kimberly A. Hochstedler ◽  
Thomas Pence Boike ◽  
Benjamin Movsas ◽  
Craig William Stevens ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Logistic Regression ◽  
Predictive Model ◽  
Performance Status ◽  
Ecog Performance Status ◽  
Curative Intent ◽  
Heart Dose ◽  
Patient Reported ◽  
Mean Heart Dose ◽  
Nsclc Patients

e20525 Background: Treatment for inoperable stage II-III non-small cell lung cancer (NSCLC) involves aggressive chemo-radiotherapy (CRT). While outcomes have improved with immunotherapy, some patients transition to hospice or die early in their treatment course. To help identify these patients, we developed a predictive model for early poor outcomes in NSCLC patients treated with curative intent. Methods: In a statewide consortium involving 27 sites, information was collected prospectively on stage II-III NSCLC patients who received curative CRT from April 2012 to November 2019. We defined an early poor outcome as termination of treatment due to hospice enrollment or death within 5 months of initiating radiation therapy. Potential predictors included clinical characteristics and patient reported outcomes (PROs) from validated questionnaires. Logistic regression models were used to assess potential predictors and build predictive models. Multiple imputation was used to handle missing data. We used Lasso regularized logistic regression to build a predictive model with multiple predictor variables. Results: Of the total of 2267 included patients, 128 patients discontinued treatment early due to hospice enrollment or death. The mean age of the 128 patients was 71 years old (range 48-91) and 59% received concurrent chemotherapy. Significant uni-variable predictors of early hospice or death were advanced age, worse ECOG performance status, high PTV volume, short distance to normal tissue critical structures, high mean heart dose, uninsured status, lower scores on the Functional and Physical Well-Being scale and the Lung Cancer Symptoms sub-scale of the FACT-L quality of life instrument, as well as higher levels of patient-reported lack of energy, cough, and shortness of breath. The best predictive model included age, ECOG performance status, PTV volume, mean heart dose, patient insurance status, and patient-reported lack of energy and cough. The pooled estimate of area under the curve (AUC) for this multivariable model was 0.71, with a negative predictive value of 95%, specificity of 97%, positive predictive value of 23%, and sensitivity of 16% at a predicted risk threshold of 20%. Conclusions: Our models identified a combination of clinical variables and PROs that may help identify individuals with inoperable NSCLC undergoing curative intent chemo-radiotherapy who are at a high risk of early hospice enrollment or death. These preliminary results are encouraging and warrant further evaluation in a larger cohort of patients.

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