MD Anderson Symptom Inventory Scores Research Articles

Quality of life and symptom distress after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/ HIPEC) for peritoneal surface malignancy can effectively control the disease, however it is also associated with adverse effects which may affect quality of life (QoL). To investigate early perioperative QoL after CRS/HIPEC, which has not been discussed in Taiwan. This single institution, observational cohort study enrolled patients who received CRS/HIPEC. We assessed QoL using the Taiwanese version of the MD Anderson Symptom Inventory (MDASI-T) and European Organization Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Participants completed the questionnaires before CRS/HIPEC (S1), at the first outpatient follow-up (S2), and 3 mo after CRS/HIPEC (S3). Fifty-eight patients were analyzed. There was no significant perioperative difference in global health status. Significant changes in physical and role functioning scores decreased at S2, and fatigue and pain scores increased at S2 but returned to baseline at S3. Multiple regression analysis showed that age and performance status were significantly correlated with QoL. In the MDASI-T questionnaire, distress/feeling upset and lack of appetite had the highest scores at S1, compared to fatigue and distress/feeling upset at S2, and fatigue and lack of appetite at S3. The leading interference items were working at S1 and S2 and activity at S3. MDASI-T scores were significantly negatively correlated with the EORTC QLQ-C30 results. QoL and symptom severity improved or returned to baseline in most categories within 3 mo after CRS/HIPEC. Our findings can help with preoperative consultation and perioperative care.

Baseline MD Anderson Symptom Inventory Score is Strongly Associated With Patient-reported Acute and Late Toxicity Following (Chemo) Radiotherapy for Head and Neck Cancers

AimsPatient-reported outcomes measures (PROMs) are an increasingly recognised end point of radiotherapy studies. We hypothesised that the baseline PROMs score is the strongest predictor for acute and late scores after treatment. We assessed the strength of association of baseline MD Anderson Symptom Inventory (MDASI) scores, alongside other known factors for patient- or clinician-reported toxicity, with acute (6-week) and late (12-month) scores in head and neck cancer (HNC) patients following (chemo)radiotherapy. Materials and methodsThis was a retrospective analysis of longitudinal MDASI scores for 247 patients receiving (chemo)radiotherapy for HNC via multivariable linear regression. The factors investigated were: baseline symptom score, age, sex, concurrent chemotherapy, disease stage, radiotherapy fractionation, prior definitive surgery and performance status. Patients with a baseline score >4 in any item were defined as symptomatic in that category. ResultsPatients rated symptomatic for an MDASI item pre-treatment on average reported statistically (P < 0.0005) and clinically (>–1.5) significant reductions in scores 6 weeks and 12 months after (chemo)radiotherapy for all considered sub-items except taste, dryness of mouth and problems with teeth. Conversely patients asymptomatic at baseline reported a worsening of scores at both time points. Other investigated factors showed little association with changes in MDASI scores following treatment. ConclusionsOur data show that baseline MDASI scores are strongly associated with patient-reported toxicity 6 weeks and 12 months after (chemo)radiotherapy for HNC. Patients who are symptomatic at baseline can experience an early and durable benefit from treatment. This finding can inform discussions with patients before therapy and has implications for use of PROMs scores for the assessment of toxicity in randomised trials.

Health-related quality of life in patients with resectable undifferentiated pleomorphic sarcoma treated with neoadjuvant checkpoint blockade in a single institution randomized phase II clinical trial.

11544 Background: In SARC028, patients with undifferentiated pleomorphic sarcoma (UPS) had a 40% overall response rate to pembrolizumab. Based on this, we conducted a randomized, phase II, non-comparative trial of combination nivolumab (nivo/RT) and ipilimumab (ipi/nivo/RT) and demonstrated an 89% major pathologic response. Here, we report the health-related quality of life (HRQoL) metrics. Methods: In this study (NCT03307616), patients with resectable UPS were randomized (1:1) to receive one dose of nivo (3mg/kg) or one dose of combination nivo (3 mg/kg) and ipi (1 mg/kg), followed by combination of nivo (3 doses, 3mg/kg every 2 weeks) plus 50 Gy in 25 fractions (both arms). HRQoL was assessed using the MD Anderson Symptom Inventory (MDASI), European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30, and the Functional Assessment of Cancer Therapy – General (FACT-G) questionnaires. Questionnaire completion rates were calculated using the number of patients with at least one baseline and post-baseline assessment. Analyses included mean change from baseline scores to week 11 (preoperative) and week 54 (postoperative). Results: Ten patients were randomized from October 2017 to February 2020. HRQoL were collected at baseline (n = 10) and at week 11 for five (83%) nivo/RT and three (60%) ipi/nivo/RT patients. Three (60%) nivo/RT and three (100%) ipi/nivo/RT patients had week 54 assessments. MDASI scores indicative of symptom severity and interference of daily life both decreased for patients undergoing ipi/nivo/RT (0.8→0.67 and 0.9→0.46, respectively) while both increased in the nivo/RT group (1.6→2.22 and 1.9→3.33, respectively). Both arms had similar increases at 54 weeks. Patients undergoing ipi/nivo/RT experienced a greater decline in EORTC-QLC global health status at 54 weeks than those undergoing single agent therapy (-22.92 vs -8.33). The mean change in total FACT-G score did not differ between the two arms at 11 weeks (-4.0 vs -4.5), however, there was a significant decline for patients undergoing ipi/nivo/RT at 54 weeks (-20.3 vs -5.7). Conclusions: For patients with resectable UPS, combination immune checkpoint blockade with ipi/nivo/RT is associated with an improvement in short term HRQoL compared to single-agent nivo/RT. This finding warrants further study with more patients, controlling for baseline symptom scores. Combination therapy was associated with a slower recovery to baseline function, with ongoing decline in HRQoL at 54 weeks post treatment. Our study demonstrates the feasibility of collecting HRQoL metrics, which can be key factors in guiding patient management decisions. Clinical trial information: NCT03307616.

Unilateral vs. Bilateral Radiotherapy for Oropharyngeal Carcinoma: Impact on Long Term Symptom Burden

<h3>Purpose/Objective(s)</h3> Bilateral neck radiotherapy (RT) is often required for oropharyngeal carcinoma (OPC) patients while unilateral neck RT is only used for selected small well-lateralized primary tonsillar tumors with no/minimal ipsilateral nodal disease. Our purpose is to compare long-term symptom burden following unilateral vs bilateral RT in patients with oropharyngeal carcinoma (OPC). <h3>Materials/Methods</h3> A retrospective review was conducted for patients with T1-3 N0-2b (AJCC 7th edition) tonsillar cancer treated with IMRT from 2011 to 2017. Patient-reported symptom burden was collected in routine practice using the MD Anderson Symptom Inventory (MDASI) at baseline, RT-end (3 weeks pre or post final RT fraction), 3 weeks – 3 months, 3 – 6 months, 6 – 12 months, 12 - 24 months, and 24 - 36 months post RT. Within each period, the latest record was chosen if there were multiple records available for one patient. MDASI symptom scores (ranging from 0 = "not present" to 10 = "as bad as you can imagine") were compared between unilateral vs bilateral RT groups at each time point using Wilcoxon Rank-Sum tests and linear mixed effect model. <h3>Results</h3> A total of 256 patients were eligible, of whom MDASI scores were available in 125 including 22 (18%) with unilateral and 103 (82%) with bilateral neck RT. Median age was 59 years, and 95 (76%) were male. The differences in "Dry Mouth" scores from baseline to 6 months and from baseline to 36 months were significantly better (lower) in the unilateral RT group on mixed effect model analysis [mean 2.11 (95% CI: 1.056 – 3.17) vs 3.72 (95% CI: 3.15 – 4.29), p = 0.004] and [mean 1.43 (95% CI: 0.44 - 2.42) vs 2.62 (95% CI: 2.1 - 3.13), p = 0.04] respectively; these differences meet a conventional threshold for clinical importance. MDASI change scores in other domains were similar between the two groups (all p > 0.05). Mean MDASI raw scores were highest at RT-end for all domains with improvement by 2 years for most symptoms. The unilateral RT group had significantly better (lower) raw MDASI scores in "Dry Mouth" at baseline (mean 0.3 vs 1.4, p = 0.045) and 6 months post RT (mean 2.6 vs 5.4, p <0.001). "Swallowing" raw scores were also statistically and clinically significantly better (lower) in the unilateral RT group at 6 months post-RT (mean 2.1 vs 3.5, p = 0.047). <h3>Conclusion</h3> Patients receiving unilateral RT fare better with "Dry mouth" by 6-month and 36-month and possibly with "Swallowing" by 6-month post RT compared to patients receiving bilateral RT.

Longitudinal health utility and symptom-toxicity trajectories in patients with head and neck cancers.

This study examined long-term health utility and symptom-toxicity trajectories among patients with head and neck cancer (HNC). For patients diagnosed with HNC (2014-2019), Health Utility Index 3 (HUI-3), Edmonton Symptom Assessment Scale (ESAS), and MD Anderson Symptom Inventory (MDASI) surveys (including both the core and head and neck cancer modules) were prospectively collected at multiple time points (at the baseline, after surgery, during radiotherapy, and 3, 6, 12, and 24 months after treatment). Locally estimated scatterplot smoothing plots were generated to describe HUI-3, ESAS, and MDASI trajectories over time by clinicodemographic factors, treatment modality, and tumor subsite. Contributions of clinical factors were assessed with univariable and multivariable analyses. In 800 patients, the treatment modality and the tumor subsite produced unique HUI-3, ESAS, and MDASI trajectories. Patients treated with surgery alone experienced rapid improvements in HUI-3, ESAS, and MDASI scores postoperatively. Among patients treated with chemoradiotherapy, patients with nasopharyngeal carcinoma had greater declines in HUI-3 during treatment in comparison with patients with oropharyngeal carcinoma, but they had similar ESAS/MDASI scores. Among patients treated with radiotherapy, patients with laryngeal carcinoma had better HUI-3/ESAS/MDASI scores than those with oropharyngeal carcinoma during treatment, but they slowly converged after treatment. Female sex, an age > 75 years, a household income < $40,000, a Charlson comorbidity score > 1, an Eastern Cooperative Oncology Group performance status > 0 (at the baseline), and current smoking were independently associated with worse HUI-3 trajectories. HUI-3 had mild to moderate correlations (ρ = 0.2-0.5) with individual symptom-toxicity trajectories. Long-term HUI-3 trajectories are associated with tumor subsite, clinicodemographic, and treatment factors, and this may be partly explained by relationships with symptoms/toxicities. Separate evaluations by subsite and treatment should occur in health utility and symptom-toxicity studies of HNC. This study indicates that the long-term health utility and symptoms/toxicities of patients with the most common head and neck cancers (ie, squamous cell carcinomas and nasopharyngeal carcinomas) differ over time with a variety of factors, including the tumor anatomic site, treatment volume, clinicodemographic characteristics (eg, age, human papillomavirus status, tumor stage, gender, smoking status, alcohol status, education, and comorbidities), and treatment modalities. Generalizations across all head and neck cancers should be strongly discouraged. Future studies should evaluate health utility, symptoms and toxicities, and patient need assessments separately for each anatomic site and treatment modality.

Health‐related quality of life with fixed‐duration venetoclax‐obinutuzumab for previously untreated chronic lymphocytic leukemia: Results from the randomized, phase 3 CLL14 trial

Chronic lymphocytic leukemia (CLL)-related symptoms impair the well-being of patients, making improvement of health-related quality of life (QoL) a goal of treatment. The CLL14 trial demonstrated higher efficacy of fixed-duration venetoclax-obinutuzumab (Ven-Obi) compared to chlorambucil-obinutuzumab (Clb-Obi) in patients with previously untreated CLL. To assess patients' QoL, the following patient-reported outcomes (PRO) measures were assessed: the M.D. Anderson Symptom Inventory (MDASI) core instrument and CLL module and the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). At treatment start, physical functioning (mean 75.9 [standard deviation (SD) ± 20.1] in the Clb-Obi arm and 76.9 [±19.4] in the Ven-Obi arm), role functioning (73.6 [±27.86] and 72.6 [±26.9]) and GHS/QoL (63.6 [±21.0] and 60.3 [±20.5]) were comparable between treatment arms per EORTC QLQ-C30 scale scores. Baseline levels of physical and role functioning were maintained throughout treatment and follow-up, with no relevant improvement or deterioration. On average, patients treated with Ven-Obi showed a meaningful improvement of GHS/QoL during treatment and follow-up by at least eight points at cycle three, whereas improvement was delayed until cycle eight with Clb-Obi. According to MDASI scores, CLL symptoms (1.5 [±1.2] and 1.6 [±1.3]), core cancer symptoms (1.5 [±1.4] and 1.8 [±1.7]) and symptom interference (2.1 [±2.3] and 2.3 [±2.3]) were generally low and comparable between treatment arms at baseline and were maintained throughout treatment and follow-up. This analysis demonstrates that the higher efficacy of Ven-Obi is not associated with QoL impairment and that Ven-Obi achieves early relief of CLL-related symptoms in elderly unfit patients.

Abstract PS9-21: Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program

Abstract Background: With breast cancer (BC) treatment primarily managed in the ambulatory setting opportunities exist to provide support services to individuals that enhance their ability to manage side effects of treatment and their overall health outcomes. The aim of this randomized control trial was to evaluate the effect of a digital health coaching program on patient reported outcomes (PROs) and experience of women with BC undergoing chemotherapy treatment in the ambulatory setting. Methods: Women newly diagnosed with BC were randomized to receive either a 3-month digital health coaching intervention or standard of care support services provided by the treating hospital. PROs were captured at baseline and monthly for 3 months. The primary objective compared Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale scores between arms at the 3-month assessment. Secondary objectives evaluated the PROMIS physical and mental subscales, and the MD Anderson Symptom Inventory (MDASI) for differences between arms and over time. Summary statistics were used to describe demographic and baseline clinical characteristics by arm. Linear mixed effects models were used to assess PROMIS and MDASI over time. Statistical analysis were performed using Stata/MP v15.0. Results: A total of 210 subjects were randomized to the control arm and 208 to the digital health coaching intervention. A significant time (Table 1) but not intervention effect was observed. The mean (SD) of the PROMIS physical health t-score for the control arm was 43.9 (4.7) and 44.1 (4.3) for the intervention arm (p = 0.699). The mean (SD) of the PROMIS mental health t-score for the control arm was 45.3 (5.4) and 45.1 (5.0) for the intervention arm (p = 0.742). The mean (SD) of MDASI severity score for the control arm was 2.4 (1.6) and was 2.5 (1.8) for the intervention arm (p = 0.715). The mean (SD) of the MDASI interference for the control arm was 2.6 (2.3) and was 2.8 (2.3) for the intervention arm (p = 0.633). Of 208 individuals randomized to the intervention, the majority (n=195; 94%) preferred engagement by phone, email and text. Participants averaged 9.17 calls with a mean duration of 13.04 minutes per call, 12.3 outbound texts to and 3.8 inbound texts from the participant, and a 47% email open rate over the course of 12-weeks. Conclusions: Study results suggest that while digital health coaching did not produce a statistically significant improvement in PRO over the course of the first 3 months of treatment, it did result in engagement that could be leveraged during and potentially beyond primary treatment for women with BC. PRO scores reflected minimal symptom burden and high global health at baseline before the start of treatment, which predictably declined over the course of treatment. Results informed the development of a currently enrolling expansion trial for individuals with diverse treatment types to evaluate which population receives the greatest benefit. Given the need for increasing engagement using telehealth solutions, the optimization of digital health coaching for individuals with BC is timely and increasingly relevant to promote optimal health self-efficacy and PROs. Table 1. Linear Mixed Models of PROMIS and MDASI Scores Over TimePROMISEffectBeta95% LB95% UBp-valuePhysicalTime&amp;lt;0.00130-0.88-1.50-0.260.00660-0.74-1.390.090.02690-1.88-2.53-1.22&amp;lt;0.001Intervention0.12-0.730.980.980MentalTime&amp;lt;0.00130-3.53-4.22-2.85&amp;lt;0.00160-3.94-4.66-3.22&amp;lt;0.00190-4.64-5.36-3.92&amp;lt;0.001Intervention-0.25-1.130.630.583MDASIEffectBeta95% LB95% UBp-valueSeverityTime&amp;lt;0.001301.170.991.35&amp;lt;0.001600.990.811.18&amp;lt;0.001901.261.061.45&amp;lt;0.001Intervention-0.08-0.330.160.499InterferenceTime&amp;lt;0.001301.321.081.58&amp;lt;0.001601.190.921.46&amp;lt;0.001901.561.291.83&amp;lt;0.001Intervention-0.09-0.420.240.587 Citation Format: Kelly J Brassil, Bryan Fellman, Brett Wisse, Diana Urbauer, Valerie Shelton, Carolyn Harty, Mazi Rasulnia. Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-21.

A Randomized, Placebo-Controlled, Double-Blind Study of Minocycline for Reducing the Symptom Burden Experienced by Patients With Advanced Pancreatic Cancer

ContextAlthough it is well known that patients with advanced pancreatic cancer (PC) experience significant symptom burden, few strategies for effective symptom intervention are available for them. ObjectivesTo investigate the efficacy of minocycline, an anti-inflammatory agent, for symptom reduction in patients with advanced PC. MethodsWe conducted Phase II, randomized, and placebo-controlled trial to obtain preliminary estimates of the effects on symptom reduction with 100 mg of minocycline or placebo given twice a day. Eligible patients had diagnosed advanced PC and were scheduled for standard chemotherapy. Patient-reported symptoms were measured weekly during the eight-week trial using the MD Anderson Symptom Inventory (MDASI) module in patients with gastrointestinal cancer. The primary outcome measure was the area under the curve values of the five most severe symptoms in the two arms. ResultsOf the 44 patients recruited, 31 (71%) were evaluable for the primary efficacy analysis, with 18 received minocycline and 13 placebo. Fatigue, pain, disturbed sleep, lack of appetite, and drowsiness were the most severe symptoms reported by both groups. No significant differences in area under the curve values over time between the study arms were found for the composite MDASI score or single-item scores of the five most severe MDASI items. No treatment-related deaths were reported, and no Grade 3–4 toxicities were observed. ConclusionMinocycline is safe for use in patients receiving treatment for PC. There is no observed symptom reduction with minocycline on the major symptom burden associated with advanced PC compared with placebo. Attrition because of rapid disease progression impacted the study significantly.

Rapid Improvement of Patient-Reported Outcomes with Venetoclax Plus Obinutuzumab in Patients with Previously Untreated CLL and Coexisting Conditions: A Prospective Analysis from the CLL14 Trial

Rapid Improvement of Patient-Reported Outcomes with Venetoclax Plus Obinutuzumab in Patients with Previously Untreated CLL and Coexisting Conditions: A Prospective Analysis from the CLL14 Trial

Patient-reported outcomes of symptom burden in patients receiving surgical or nonsurgical treatment for low-intermediate risk oropharyngeal squamous cell carcinoma: A comparative analysis of a prospective registry

PurposeTo explore treatment-related changes in symptom burden and quality of life (QOL) in oropharyngeal squamous cell cancer (OPSCC) patients treated surgically and non-surgically. Patients and MethodsEighty-six patients with human papillomavirus–associated OPSCC treated at the Head and Neck Center at The University of Texas MD Anderson Cancer Center were recruited to a prospective registry study between 2014 and 2016 and completed the core, head and neck-specific, and symptom interference sections of the MD Anderson symptom inventory (MDASI) multi-symptom questionnaire and the EQ-5D health status assessment as a measure of QOL at four time points. ResultsLongitudinal improvements from post-treatment nadir were observed across all groups. For patients treated with single modality, symptom interference, but not core and head and neck specific, MDASI scores were significantly better at 6 months in patients treated with surgery than radiation (P = 0.04). For patients treated with multiple modalities, scores for each of the three domains (i.e., core, head and neck -specific, and interference MDASI) were significantly better in the surgical group than the nonsurgical group at treatment completion (P = 0.0003, P = 0.0006 and P = 0.02) and 6 weeks (P = 0.001, P = 0.05 and P = 0.04), but not 6 months (P = 0.11, P = 0.16 and P = 0.040). No significant differences in EQ5D health status were observed between groups at any time point, reflecting similar overall QOL in all groups. ConclusionSymptom burden and QOL improves after treatment in OPSCC survivors over time regardless of whether primary surgical or nonsurgical treatment is used, although acute symptom profiles may differ.

Taste Disturbance Evaluation Is Feasible and Higher Melphalan Pharmacokinetics Are Associated with Poorer Nutrition and Symptom Burden after Autologous HCT for Multiple Myeloma

Introduction Dysgeusia commonly influences nutritional intake and quality of life after HCT, yet its pathobiology is poorly understood and methods to study it are not established. We report interim results of a prospective feasibility study of chemical gustometry (CG) to measure dysgeusia in pts with multiple myeloma (MM) undergoing high-dose melphalan and autologous HCT (mel-AHCT). We evaluated associations between dysgeusia and symptoms, nutrition, mel pharmacokinetics (PK), and oral microbiota composition. We hypothesized that mel penetration into saliva contributes to dysgeusia. Methods CG was performed by the Henkin method pre-AHCT and on days (d) -1, +7, +14, +30 testing 5 flavors (sweet, sour, salty, bitter, umami) to calculate a total taste score (max value 30). CG was considered feasible if > 60% of pts could complete > 60% of all evaluations. Caloric intake (kcal) was calculated with 24-hr recall using the USDA 5-Step Multiple-Pass Method, and pt-reported symptoms were assessed using the MD Anderson Symptom Inventory (MDASI) at the above times and on d +3 and +10. Salivary microbiome diversity was assessed longitudinally by 16S sequencing and the inverse Simpson index. 6-point serum mel concentrations were used to calculate an area under the curve (AUC) and peak salivary mel was obtained 75 min post-infusion. Spearman rank-sum correlation was used to assess associations. Results 22 mel-AHCT MM pts have follow-up through d +30. 18 pts (82%) completed > 60% of all assessments. Median age was 62 (range 41-75). 11 pts (50%) were male. Mel 200 mg/m2 and 140 mg/m2 was given in 19 (86%) and 3 (14%) pts, respectively. Median serum mel AUC was 12.6 mg*h/L (range 5.8-17.5); median salivary mel was 119 ng/ml (range 25-662). Higher serum mel AUC correlated with higher salivary mel levels, p=0.004, and associated with poorer caloric intake from pre-ASCT to d +30, p=0.04. Higher serum mel AUC associated with higher MDASI scores (worse symptom burden) from pre-AHCT to d +30, p=0.005, but not with taste scores. Higher salivary mel associated with poorer caloric intake from pre-AHCT to d +30, p=0.02. MDASI scores peaked d +10, coincident with nadirs in taste scores and caloric intake on d +7 and +10, respectively. Taste scores partially recovered by d +30, but often did not return to baseline (Fig 1A-C). Oral microbiota diversity was stable early after AHCT but increased by d+100. D+7 diversity did not correlate with serum mel AUC, p=0.4, or salivary mel, p=0.84 (Fig 2A-C). Conclusion CG is a feasible method to evaluate dysgeusia after AHCT. Dysgeusia peaked by d +7 and often persisted through d +30. Oral microbiota diversity was stable early after AHCT. Higher serum and salivary mel levels did not correlate with microbiota diversity but were associated with poorer caloric intake and higher MDASI scores suggesting that using targeted mel PK dosing may improve caloric intake and limit symptom burden after AHCT.

Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study.

To assess the impact of chronomodulated irinotecan fluorouracil-leucovorin and oxaliplatin (chronoIFLO4) delivered at home on the daily life of patients with cancer in real time using a home-based e-Health multifunction and multiuser platform. This involved multidimensional telemonitoring of circadian rest-activity rhythm (CircAct), sleep, patient-reported outcome measures, and body weight changes (BWCs). Patients received chronoIFLO4 fortnightly at home. Patients completed the 19-item MD Anderson Symptom Inventory on an interactive electronic screen, weighed themselves on a dedicated scale, and continuously wore a wrist accelerometer for CircAct and sleep monitoring. Daily data were securely teletransmitted to a specific server accessible by the hospital team. The clinically relevant CircAct parameter dichotomy index I < O and sleep efficiency (SE) were calculated. The dynamic patterns over time of patient-reported outcome measures, BWC, I < O, and SE informed the oncology team on tolerance in real time. The platform was installed in the home of 11 patients (48 to 72 years of age; 45% men; 27% with performance status = 0), who were instructed on its use on site. They received 26 cycles and provided 5,891 data points of 8,736 expected (67.4%). The most severe MD Anderson Symptom Inventory scores were: interference with work (mean: 5.1 of 10) or general activity (4.9), fatigue (4.9), distress (4.2), and appetite loss (3.6). Mean BWC was -0.9%, and mean SE remained > 82%. CircAct disruption (I < O ≤ 97.5%) was observed in four (15%) cycles before chronoIFLO4 start and in five (19%) cycles at day 14. The patient-centered multidimensional telemonitoring solution implemented here was well accepted by patients receiving multidrug chemotherapy at home. Moreover, it demonstrated that chronoIFLO4 was a safe therapeutic option. Such integrated technology allows the design of innovative management approaches, ultimately improving patients' experience with chemotherapy, wellbeing, and outcomes.

Utility of a patient-reported outcome in measuring functional impairment during autologous stem cell transplant in patients with multiple myeloma.

We aimed to determine the utility of a patient-reported outcome (PRO) as it relates to patient performed testing (PPT) for measuring functional status in multiple myeloma patients after autologous hematopoietic stem cell transplantation (auto-HCT). Symptom interference on walking (a PRO) was measured by the MD Anderson Symptom Inventory (MDASI). PPT was assessed via 6-min walk test (6MWT). Mixed effects modeling was used to examine (1) the longitudinal relationship between the MDASI score and 6MWT distance and (2) the MDASI scores between patients who did or did not complete the 6WMT. Receiver operating characteristic (ROC) curve analysis was performed to quantify the construct validity of the PRO by differentiating performance status. Seventy-nine patients were included. Mean 6MWT distance significantly correlated with MDASI-walking interference score (PRO) over the first month of auto-HCT (est = 6.09, p = 0.006). There was a significantly higher completion rate for MDASI versus 6MWT at each time point (p < 0.01). Patients who completed the 6MWT reported less interference on walking during the study period (est = 1.61, p < 0.0001). Finally, the PRO demonstrated significant construct validity for measuring functioning status with MDASI-walking against ECOG-PS as the anchor (AUC = 0.77, 95% CI 0.60-0.94, p = 0.003). The PRO of MDASI-walking interference is a valid physical functioning measure, correlating with an objective functional measure (6MWT) in MM patients undergoing auto-HCT. As patients with poorer functional status during therapy are less likely to complete PPT, this PRO may offer a more practical quantitative measure of functioning in patients.

1559P - Multidimensional telemonitoring of cancer patients (pts) receiving chronomodulated (chrono) Irinotecan (I), 5-fluorouracil (F), leucovorin (L) and oxaliplatin (O; chronoIFLO4) combination at home

Background: FOLFIRINOX is an active yet toxic regimen against intestinal cancers. Improving its tolerability could widen its use in routine clinical practice. Circadian-based chrono administration of this triplet can be performed using a multichannel programmable-in-time pump. Here, we show the safety of chronoIFLO4 at home, through real-time multidimensional telemonitoring of circadian rest-activity rhythm (CircAct), sleep, patient-reported outcome measures (PROM) and body weight changes (BWC) using 1st generation e-Health platform inCASA. Methods: Pts received Day (D)1 chrono I (180 mg/m2, over 6-h; peak rate at 5:00), and D 2-4 chrono O (25 mg/m2/d, over 11.5-h; peak rate at 16:00) and F-L (800 mg/m2/d and 400 mg/m2/d, respectively, over 11.5-h; peak rate at 04:00), q2 weeks at home. Pts completed the 19-item MD Anderson Symptom Inventory (MDASI) on an interactive electronic screen, weighed themselves on a dedicated scale, and continuously wore a watch-sized wrist-accelerometer for CircAct and sleep monitoring. Daily data were securely teletransmitted via Internet to a specific server accessible by the hospital team. The validated and clinically-relevant CircAct parameter I<O and sleep efficiency (SE) were calculated. The dynamic patterns over time of PROMs, BWC, I<O and SE inform the oncology team on tolerance in real time. Results: Eleven patients (48-72 years; 45% males; 27% PS = 0) received 26 cycles (cy) of chronoIFLO4, and provided 5,891 data points/8,736 expected (67.4%). No grade 3-4 clinical toxicity occurred. The most severe MDASI scores remained low: interference with work (mean: 5.1/10) or general activity (4.9); fatigue (4.9); distress (4.2) and appetite loss (3.6). Mean BWC was -0.9% and mean SE remained above 82%. CircAct disruption (I<O ≤97.5%) was observed in 4 (15%) cys before chronoIFLO4 start and in 5 (19%) cys at D14. Conclusions: ChronoIFLO4 represents a safe therapeutic option at home, and the pt-centered multidimentional telemonitoring solution allows the design of innovative management approaches, ultimately improving pt experience with chemotherapy, safety and outcomes. Legal entity responsible for the study: INSERM and European Commission Funding: None Disclosure: All authors have declared no conflicts of interest.

Safety and efficacy of trabectedin when administered in the inpatient vs. outpatient setting in a subset analysis of a phase III randomized clinical trial.

e22516 Background: Trabectedin (T) has been shown to improve progression free survival (PFS) (4.2 vs 1.5 months, HR 0.55, p &lt; 0.0001) in comparison to dacarbazine (D) in patients (pts) with advanced leiomyosarcoma or liposarcoma following failure of prior chemotherapy. Pts randomized to T in this phase III trial (ET743-SAR 3007) received T as a 24 hr IV infusion in either an inpatient (InP) or outpatient (OP) setting, based upon site preference. Here we report the safety, efficacy, and patient reported outcomes (PROs) of pts based on first infusion site of care. Methods: Pts were randomized 2:1 to receive T (1.5 mg/m2) or D (1 g/m2 over 20-120 min). Site of T infusion was based on institutional preference/standard of care. The site of T administration (InP vs OP) was collected for the first infusion with the assumption that site of care was unchanged for subsequent doses. Results: Of 378 pts treated with T, 100 (27%) and 277 (73%) pts received T as InP or OP, respectively. No differences were observed in PFS or overall survival (OS) by site of care (InP vs OP): Median PFS of 4.1 vs 4.2 months; HR 0.90, p = 0.49 and median OS of 14.3 vs 13.7 months; HR 0.89, p = 0.40. No difference in other efficacy endpoints between InP vs OP were observed: disease control rate (CR+PR+(SD≥18wks)) (38% vs 33%; Odds Ratio [OR] 1.22; p = 0.44) and Overall Response Rate (14% vs 8%; OR 1.76; p = 0.15)). Grade 3-4 adverse events (AEs) occurred in 87% InP vs 79% OP pts and grade 3-4 SAEs occurred in 43% InP vs 33% OP. The most common grade 3-4 AEs in both groups were increased ALT/AST, hematologic toxicity, nausea and fatigue. The incidence of grade 3-4 febrile neutropenia was similar in both groups at 5.0% InP vs 4.7% OP, as was increased blood creatine phosphokinase at 5.0% InP vs 6.1% OP, and catheter related complications of any grade at 16% InP vs 15% OP. No clinically meaningful differences were observed in PROs measured by MD Anderson Symptom Inventory scores. Conclusions: The majority of patients randomized to the trabectedin arm of the ET743-SAR-3007 Phase III study received trabectedin in the OP setting. Treatment outcomes with trabectedin suggest equivalent efficacy and safety when administered in the InP or OP setting. Clinical trial information: NCT01343277.

Ruxolitinib for symptom control in patients with chronic lymphocytic leukaemia: a single-group, phase 2 trial

SummaryBackgroundDisease-related symptoms impair the quality of life of countless patients with chronic lymphocytic leukemia (CLL) who do not require systemic therapy. Currently available therapies are not specifically aimed at symptom control. Because stimulation of the B-cell receptor activates Janus kinase (JAK)-2 in CLL cells and the JAK2 inhibitor ruxolitinib improves symptoms of patients with myelofibrosis, we hypothesized that ruxolitinib would improve disease-related symptoms in CLL patients.MethodsRuxolitinib (10 mg twice daily) was administered to symptomatic CLL patients who did not require systemic therapy for CLL. Scores on the brief fatigue inventory (BFI), CLL module of the MD Anderson symptom inventory (MDASI) and symptom-associated interference in daily activities (interference score; IS), were assessed prior to treatment and after 3 months of treatment. Plasma cytokine/chemokine levels were measured at baseline and at 3 months.FindingsForty-one CLL patients (25 untreated and 16 previously treated) were enrolled. Thirty-two (78%) of the participants experienced ≥20% reduction in the average BFI score or in the average MDASI score. 59% of the participants had ≥2 units reduction in worst fatigue score in 24 hours as assessed by the BFI. The mean percentage reductions in BFI, MDASI, and IS scores were >42% (p<0.0001). Improvements in the three symptom scores correlated with reductions in levels of IL-6, C-reactive protein, CXCL10, osteopontin, TNF-α, ICAM-1/CD54, VCAM-1/CD106, and beta-2 microglobulin. Furthermore, treatment with ruxolitinib increased and then decreased lymphocyte counts to baseline levels or lower. Grade 3/4 cytopenias were recorded in three patients.InterpretationIn CLL patients, ruxolitinib significantly improved disease-related symptoms, reduced cytokine and chemokine levels, and increased and then decreased lymphocyte counts, likely through mobilization followed by apoptosis of CLL cells. Further studies aimed at testing the therapeutic efficacy of ruxolitinib in CLL are warranted.FundingSupported by the Incyte Corp., MD Anderson Cancer Center Support Grant CA016672 and Award Number P01 CA049639 from the National Cancer Institute.

Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: a single-blind, randomized, controlled trial

BackgroundChemotherapy-induced nausea and vomiting adversely affects the quality of life of patients who receive chemotherapy via intravenous infusion or transcatheter arterial chemoembolization (TACE). This study aimed to investigate the clinical effects of transcutaneous electrical acupoint stimulation (TEAS) on nausea and vomiting after TACE.MethodsA total of 142 patients who received TACE with cisplatin for primary or metastatic liver cancer were assigned to the active-acupuncture (n = 72) or placebo-acupuncture (n = 70) groups using a covariate-adaptive randomization at a ratio of 1:1. The acupoints Hegu (LI4), Neiguan (P6), and Zusanli (ST36) were stimulated twice daily for 6 days. The effects of TEAS on nausea and vomiting were assessed by using occurrence rate and severity of these symptoms. Anorexia scale and M. D. Anderson Symptom Inventory (MDASI) scores were secondary endpoints and were used to assess the effect of TEAS on patient appetite and quality of life. The safety of the treatments was also monitored.ResultsBetween the two groups, the differences in occurrence rates and severities of nausea and vomiting after TACE were not significant (all P > 0.05). From the second day after TACE, anorexia scores were significantly lower in the active-acupuncture group than in the placebo-acupuncture group and continued to decrease over time with treatment (all P values less than 0.01). On days 0, 1, and 2, the mean MDASI scores for the active-acupuncture group were slightly lower than those for the placebo-acupuncture group, but the differences were not statistically significant (all P > 0.05). No significant differences were found between the two groups in the occurrence rate of any adverse event (P > 0.05).ConclusionTEAS appears to be a safe and effective therapy to relieve patients’ gastrointestinal discomfort after chemotherapy.Trial registration NCT01895010. Registered 21 June 2013

Clinical Relevance of the First Domomedicine Platform Securing Multidrug Chronotherapy Delivery in Metastatic Cancer Patients at Home: The inCASA European Project.

BackgroundTelehealth solutions can improve the safety of ambulatory chemotherapy, contributing to the maintenance of patients at their home, hence improving their well-being, all the while reducing health care costs. There is, however, need for a practicable multilevel monitoring solution, encompassing relevant outputs involved in the pathophysiology of chemotherapy-induced toxicity. Domomedicine embraces the delivery of complex care and medical procedures at the patient’s home based on modern technologies, and thus it offers an integrated approach for increasing the safety of cancer patients on chemotherapy.ObjectiveThe objective was to evaluate patient compliance and clinical relevance of a novel integrated multiparametric telemonitoring domomedicine platform in cancer patients receiving multidrug chemotherapy at home.MethodsSelf-measured body weight, self-rated symptoms using the 19-item MD Anderson Symptom Inventory (MDASI), and circadian rest-activity rhythm recording with a wrist accelerometer (actigraph) were transmitted daily by patients to a server via the Internet, using a dedicated platform installed at home. Daily body weight changes, individual MDASI scores, and relative percentage of activity in-bed versus out-of-bed (I<O) were computed. Chemotherapy was administered according to the patient medical condition. Compliance was evaluated according to the proportions of (1) patient-days with all data available (full) and (2) patient-days with at least one parameter available (minimal). Acceptability was assessed using the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire. Linear discriminant analysis was used to identify the combination of parameters associated with subsequent unplanned hospitalization.ResultsA total of 31 patients (males: 55% [17/31]; World Health Organization Performance Status=0: 29% (9/31); age range: 35-91 years) participated for a median of 58 days (38-313). They received a total of 102 chemotherapy courses (64.7% as outpatients). Overall full compliance was 59.7% (522/874), with at least one data available for 830/874 patient-days (95.0%), during the 30-day per-protocol span. Missing data rates were similar for each parameter. Patients were altogether satisfied with the use of the platform. Ten toxicity-related hospitalizations occurred in 6 patients. The combination of weighted circadian function (actigraphy parameter I<O), body weight change, and MDASI scores predicted for ensuing emergency hospitalization within 3 days, with an accuracy of 94%.ConclusionsMultidimensional daily telemonitoring of body weight, circadian rest-activity rhythm, and patient-reported symptoms was feasible, satisfactory, and clinically relevant in patients on chemotherapy. This domomedicine platform constitutes a unique tool for the further development of safe home-based chemotherapy administration.

The prevalence and nature of supportive care needs in lung cancer patients.

In the present work, we set out to comprehensively describe the unmet supportive care and information needs of lung cancer patients. This cross-sectional study used the Supportive Care Needs Survey Short Form 34 (34 items) and an informational needs survey (8 items). Patients with primary lung cancer in any phase of survivorship were included. Demographic data and treatment details were collected from the medical charts of participants. The unmet needs were determined overall and by domain. Univariable and multivariable regression analyses were performed to determine factors associated with greater unmet needs. From August 2013 to February 2014, 89 patients [44 (49%) men; median age: 71 years (range: 44-89 years)] were recruited. The mean number of unmet needs was 8 (range: 0-34), and 69 patients (78%) reported at least 1 unmet need. The need proportions by domain were 52% health system and information, 66% psychological, 58% physical, 24% patient care, and 20% sexuality. The top 2 unmet needs were "fears of the cancer spreading" [n = 44 of 84 (52%)] and "lack of energy/tiredness" [n = 42 of 88 (48%)]. On multivariable analysis, more advanced disease and higher MD Anderson Symptom Inventory scores were associated with increased unmet needs. Patients reported that the most desired information needs were those for information on managing symptoms such as fatigue (78%), shortness of breath (77%), and cough (63%). Unmet supportive care needs are common in lung cancer patients, with some patients experiencing a very high number of unmet needs. Further work is needed to develop resources to address those needs.

Randomized, placebo-controlled trial of K1 acupoint acustimulation to prevent cisplatin-induced or oxaliplatin-induced nausea.

Greater than 70% of patients with cancer experience chemotherapy-induced nausea and vomiting. In the current study, the authors examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot because it is believed to have the potential to control chemotherapy-induced nausea and vomiting. In this trial, 103 patients diagnosed with primary or metastatic liver cancer were recruited before transcatheter arterial infusion (TAI) of cisplatin or oxaliplatin and randomized to either group A (51 patients who were treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes approximately 1 to 2 hours before TAI on the first day and then daily for the subsequent 5 days) or group B (52 patients who were treated with tropisetron and electrostimulation at a placebo point on the heel). The rate, intensity, and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI. Quality of life was assessed daily using the MD Anderson Symptom Inventory and the EuroQoL scale. No differences were found between groups A and B with regard to the incidence and degree of nausea or vomiting on day 1 or the following 5 days. Patients in group A had better EuroQoL scores compared with patients in group B (72.83 in group A vs 65.94 in group B; P =.04) on day 4 but not on the other days. No group differences were noted at any time point for MD Anderson Symptom Inventory scores. Electrostimulation of K1 combined with antiemetics did not result in initial prevention of cisplatin-induced or oxaliplatin-induced nausea or vomiting.