Treatment-related Symptom Burden Research Articles

Psychosocial consequences of head and neck cancer symptom burden after chemoradiation: a mixed-method study.

Patients with head and neck cancer (HNC) experience significant symptom burden from combination chemotherapy and radiation (chemoradiation) that affects acute and long-term health-related quality of life (HRQOL). However, psychosocial impacts of HNC symptom burden are not well understood. This study examined psychosocial consequences of treatment-related symptom burden from the perspectives of survivors of HNC and HNC healthcare providers. This was a cross-sectional, mixed-method study conducted at an NCI-designated comprehensive cancer center. Participants (N = 33) were survivors of HNC who completed a full course of chemoradiation (n = 20) and HNC healthcare providers (n = 13). Participants completed electronic surveys and semi-structured interviews. Survivors were M = 61years old (SD = 9) and predominantly male (75%), White (90%), non-Hispanic (100%), and diagnosed with oropharynx cancer (70%). Providers were mostly female (62%), White (46%) or Asian (31%), and non-Hispanic (85%) and included physicians, registered nurses, an advanced practice nurse practitioner, a registered dietician, and a speech-language pathologist. Three qualitative themes emerged: (1) shock, shame, and self-consciousness, (2) diminished relationship satisfaction, and (3) lack of confidence at work. A subset of survivors (20%) reported clinically low social wellbeing, and more than one-third of survivors (35%) reported clinically significant fatigue, depression, anxiety, and cognitive dysfunction. Survivors of HNC and HNC providers described how treatment-related symptom burden impacts psychosocial identity processes related to body image, patient-caregiver relationships, and professional work. Results can inform the development of supportive interventions to assist survivors and caregivers with navigating the psychosocial challenges of HNC treatment and survivorship.

Symptom burden and functioning status in patients with advanced upper gastrointestinal cancers.

311 Background: Providing accurate symptom profiles is essential to facilitate integration of patient-reported outcome measures (PROs) into routine oncologic care. This study described the symptom trajectories and functioning status in patients with advanced esophageal, gastroesophageal junction (GEJ), or gastric cancers. Methods: The study included adult patients with advanced upper gastrointestinal (UGI) cancers who were initiating a new line of therapy at time of enrollment. Multiple symptoms were assessed weekly for 12 weeks, then every two weeks until Week 36 using the electronically administered M.D. Anderson Symptom Inventory GI module (MDASI-GI). Patients also completed the EORTC QLQ-C30 every six weeks. Longitudinal PRO data were analyzed using mixed-effect models. Time to deterioration was estimated using Kaplan-Meier method. Multivariable regression models evaluated the association of PROs with tumor response. Patients were classified in a high symptom burden group if their MDASI-GI symptoms were scored > 4 (scale of 0-10) for trajectory analysis. Results: Of the 111 enrolled patients, primary tumor site was available for 108 patients: esophageal (33%), GEJ (26%), gastric (41%). The mean age was 60.2 years; 70% were male. Nineteen patients who dropped within one week after baseline reported more severe vomiting and inability to eat than those who provided more post-baseline data (n=92). For the 92 patients, the top 6 most severe items at baseline were fatigue, lack of appetite, disturbed sleep, pain, drowsiness, and inability to eat. At baseline, patients who were treatment-naïve (n=43) reported more severe symptom burden and financial difficulty than patients who had received prior therapy (n=49). Those who were treatment-naïve reported faster general activity deterioration during the first 12 weeks than those who had received prior treatment (hazard ratio=2.183, 95% CI: 1.018, 4.673). More severe shortness of breath at baseline was significantly associated with better tumor response by Week 12 (odds ratio=1.35, 95% CI: 1.05, 1.74) for all patients with tumor response data. Trajectory analysis showed high symptom burden for pain (35% of patients), fatigue (60%), disturbed sleep (32%), lack of appetite (60%), drowsiness (54%), difficulty swallowing (37%), and inability to eat (50%) during the initial 12 weeks. High symptom burden continued for pain (41% of patients), fatigue (55%), lack of appetite (59%), drowsiness (48%), and numbness (29%) for Weeks 12-36. Conclusions: This longitudinal study documented high prevalence of disease- and treatment-related symptom burden and functioning deterioration among patients with advanced UGI cancers. These data support the implementation of PRO assessment in the routine patient care of this cohort of patients with significant physical and psychosocial challenges.

Patients’ perspective on the quality of prostate cancer follow-up care.

175 Background: Information about prostate cancer patients’ perspective on the quality of their follow-up care in the hospital is important to optimize survivorship care. This study assessed the quality of prostate cancer follow-up care as experienced by cancer patients and its association with patients’ sociodemographic and clinical characteristics, and treatment-related symptom burden. Methods: We surveyed 385 (response rate, 100%) patients with localized prostate cancer participating in a randomized controlled trial comparing the (cost)effectiveness of specialist- versus primary care-based prostate cancer follow-up. For this study, we used baseline data that were collected during patients’ first follow-up visit at the hospital (2-34 weeks) after primary treatment (radical prostatectomy or radiotherapy) prior to randomization. We assessed patients’ ratings of the quality of follow-up care using the Assessment of Patient Experiences of Cancer Care survey. This survey consists of thirteen scales: getting needed care, timeliness of care, waiting time in physician’s office, information exchange, physician’s affective behavior, physicians’ knowledge about patients’ life, interaction with nurses, interaction with office staff, symptom management, symptom information provision, health promotion, coordination of care, and overall rating of care. Logistic regression analysis was used to identify factors associated with perceived quality of follow-up care. Results: Patients reported positive experiences with follow-up care for 10 of 13 scales, with mean scores ranging from 72 to 97 (on a 0-100 response scale). The three scales where patients reported suboptimal follow-up care were symptom management (mean score of 43), health promotion (mean score of 45), and physicians’ knowledge about patients’ life (mean score of 66). Overall, patients’ report of suboptimal quality of follow-up care was associated significantly with being more highly educated, not having a partner, being older, having multiple comorbidities, and experiencing symptoms (urinary, bowel, and hormonal symptoms). Conclusions: Prostate cancer patients were generally positive about their initial, hospital-based follow-up care after primary surgery or radiation. However, physicians’ knowledge about patients’ lives, symptom management, and health promotion was rated as suboptimal. The findings point to areas where prostate cancer survivorship care can be improved.

Patient-reported treatment-related symptom burden for patients with advanced melanoma in Canada

BackgroundLittle is known on the impact of emerging treatments for advanced melanoma (stages III and IV) on patients’ functioning and well-being. The objective of this study was to describe the patient-reported treatment-related symptom (TRS) burden in advanced melanoma.MethodTwenty-nine in-depth, qualitative interviews were conducted among adult patients with advanced melanoma in Canada using a semi-structured interview method. Interviews were transcribed verbatim, and key concepts were identified using a grounded theory analytic approach.ResultsThe 29 patients reported 13 unique treatment journeys involving the following drug therapy categories: cytotoxic chemotherapies, CTLA-4 inhibitors, BRAF or MEK inhibitors, and PD-1 inhibitors. Patients typically underwent multiple treatment episodes over time. Common TRSs included nausea, fatigue, diarrhea or constipation, and skin rashes. Patients described these as impacting their physical functioning, ability to perform activities of daily living, social functioning, and overall quality of life.ConclusionOur findings provide a description of the patient’s experience with treatment for advanced melanoma. Our sample included patients typically diagnosed in mid-life, facing an urgent sequence of medical procedures and a pharmacological treatment journey that was burdensome. There is a need for less toxic and more efficacious treatments earlier in the patient journey to alleviate the impact of advanced melanoma treatment on patients’ health-related quality of life.

Racial differences in symptom management experiences during breast cancer treatment.

Racial disparities in cancer treatment-related symptom burden are well documented and linked to worse treatment outcomes. Yet, little is known about racial differences in patients' treatment-related symptom management experiences. Such understanding can help identify modifiable drivers of symptom burden inequities. As part of the Cancer Health Accountability for Managing Pain and Symptoms (CHAMPS) study, we examined racial differences in symptom management experiences among Black and White breast cancer survivors (BCS). We conducted six focus groups (n=3 Black BCS groups; n=3 White BCS groups) with 22 stages I-IV BCS at two cancer centers. Focus groups were audio-recorded and transcribed verbatim. Based on key community-based participatory research principles, our community/academic/medical partner team facilitated focus groups and conducted qualitative analyses. All BCS described positive symptom management experiences, including clinician attentiveness to symptom concerns and clinician recommendations for pre-emptively managing symptoms. Black BCS commonly reported having to advocate for themselves to get information about treatment-related symptoms, and indicated dissatisfaction regarding clinicians' failure to disclose potential treatment-related symptoms or provide medications to address symptoms. White BCS often described dissatisfaction regarding inadequate information on symptom origins and clinicians' failure to offer reassurance. This study elucidates opportunities for future research aimed at improving equity for cancer treatment-related symptom management. For Black women, warnings about anticipated symptoms and treatment for ongoing symptoms were particular areas of concern. Routine symptom assessment for all women, as well as clinicians' management of symptoms for racially diverse cancer patients, need to be more thoroughly studied and addressed.

A Patient-Reported Outcome Measure for Symptoms and Symptom Burden of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Background: Patient report of disease- and treatment-related symptom burden in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) is scarce. Symptom burden is the combined impact of disease and treatment symptoms on daily functioning. Lack of recognition and monitoring of symptoms and symptom burden can lead to inadequate management and possible treatment non-adherence.Aims: Our aim is to develop a short, valid, reliable patient-reported outcome measure of symptoms and symptom burden experienced by AML and MDS patients and to determine the validity of a single measure for research and practice.Methods: After obtaining IRB approval, patients with AML (N=152) and MDS (N=97) were recruited to this cross-sectional study. Patients rated the 13 core symptom items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, trouble remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness and tingling), 6 proposed AML/MDS symptom items (muscle weakness, malaise, fever, headache, diarrhea, skin problems), and 6 interference items (general activities, mood, work, relations with others, walking, and enjoyment of life) of the MD Anderson Symptom Inventory (MDASI) on 0-to-10 scales (0 = not present or no interference; 10 = as bad as can be imagined or complete interference) twice 1-2 days apart. Clinical and demographic information was collected from medical records and analyzed using descriptive statistics. Means of the symptom and interference ratings for the AML and MDS patients were compared using T-tests. Standard psychometric techniques were used to determine the reliability, stability, and validity of the instrument in patients with AML and MDS.Results: All MDS patients were outpatients while 75 of the AML patients were inpatients and 77 were outpatients. The AML and MDS patients had been diagnosed a mean of 13.8 months (standard deviation [SD]=23.9) and 30.5 months (SD=32.4) respectively. The mean (Mn) symptom and interference ratings respectively for the AML inpatients (Mn=2.8, SD=1.6; Mn=4.0, SD=2.4) were significantly higher than for the AML outpatients (Mn=1.8, SD=1.4, p<0.01; Mn=2.7, SD=2.3, p<0.01) or MDS patients (Mn=1.9, SD=1.5, p<0.01; Mn=2.7, SD=2.5, p<0.01). The mean ratings for the 5 most severe symptom means for AML and MDS patients respectively were: fatigue (Mn=4.0, SD=2.8; Mn=4.0, SD=2.5; p =0.97), disturbed sleep (Mn=3.3, SD=3.2; Mn=2.7, SD=3.3; P =0.19), drowsiness (Mn=3.0, SD=2.8; Mn=2.8, SD=3.1; P =0.70), muscle weakness (Mn=2.9, SD=2.8; Mn=2.9, SD=3.0; P =0.91), dry mouth for AML patients (Mn=3.4, SD=3.2; Mn=2.2,SD=2.8; p<0.01), and shortness of breath for MDS patients (Mn=2.7, SD=2.8; 1.9, SD=2.3; P =0.02). Two of the 6 AML/MDS symptom items (fever and headache) were dropped because so few patients said they experienced the symptoms at more than a mild (0-4 rating) level (12% and 11% respectively). Both groups of patients endorsed similar symptoms, and none of the means of the 4 final AML/MDS symptoms were significantly different between the groups. Cronbach's reliability for all symptom items for AML and MDS respectively were 0.88 and 0.91 and for all interference items were 0.86 and 0.92. The test-retest reliability intra-class correlations were 0.85 for the core symptoms, 0.77 for AML/MDS symptoms, and 0.84 for the interference items. The MDASI-AML/MDS can be completed by patients in less than 5 minutes.Conclusion/Summary: Lack of recognition of symptoms experienced by patients with AML and MDS can lead to inadequate management of symptoms, interfere with the ability of patients to function and enjoy life, and impact the tolerability of and adherence to treatment regimens. While the symptoms experienced by the two groups had some variation in severity, a similar group of symptoms were the most common and relevant for both groups of patients, and the same measure was appropriate for both groups. The MDASI-AML/MDS is a brief, easily-completed, and validated measure of symptom burden for patients with AML and MDS that can be used for accurate and consistent monitoring of symptoms by clinicians and researchers. DisclosuresWilliams:Amgen: Consultancy; Novartis: Research Funding. Cortes:Pfizer: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; BerGenBio AS: Research Funding; Teva: Research Funding; Ariad: Consultancy, Research Funding; Astellas: Consultancy, Research Funding; Ambit: Consultancy, Research Funding; Arog: Research Funding; Celator: Research Funding; Jenssen: Consultancy. Mendoza:Amgen Inc.: Consultancy. Shi:Amgen Inc.: Consultancy. Cleeland:Amgen Inc.: Consultancy.

MP27-17 DOMAIN-SPECIFIC SYMPTOM BURDEN AND INFORMATION NEEDS IN PROSTATE CANCER SURVIVORS: A CASE FOR TAILORED LONG-TERM SURVIVORSHIP CARE

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Quality of Life1 Apr 2015MP27-17 DOMAIN-SPECIFIC SYMPTOM BURDEN AND INFORMATION NEEDS IN PROSTATE CANCER SURVIVORS: A CASE FOR TAILORED LONG-TERM SURVIVORSHIP CARE Jennifer Bernat, Daniela Wittmann, Sarah Hawley, David Haggstrom, May Darwish-Yassine, and Ted Skolarus Jennifer BernatJennifer Bernat More articles by this author , Daniela WittmannDaniela Wittmann More articles by this author , Sarah HawleySarah Hawley More articles by this author , David HaggstromDavid Haggstrom More articles by this author , May Darwish-YassineMay Darwish-Yassine More articles by this author , and Ted SkolarusTed Skolarus More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1179AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Many of the nearly 3 million US prostate cancer (PCa) survivors live with long-term symptoms across several quality of life (QOL) domains (urinary, sexual, bowel, vitality and emotional). Whether supportive information (info) should be tailored to a PCa survivor's long-term symptom burden is unknown. For these reasons, we explored relationships between survivors' domain-specific symptom burden and their info-needs up to 15 years post-diagnosis. METHODS We used data from the Michigan Prostate Cancer Survivor Study, which examined long-term survivor outcomes (N=2499, response rate = 38%). Participants reported levels of symptom burden across the EPIC-26 domains (urinary, sexual, bowel, vitality) and an emotional domain. We separated domain-specific burden into low/high groups and used McNemar tests to assess group differences in info-needs. Additionally, we conducted multivariable logistic regression to examine the association between symptom burden and three survivorship-related info-needs (recurrence, relational effects and long-term effects). RESULTS Respondents were a median of 9 years from diagnosis (<5 years 11.1%, 5-9 years 40.9%, 10-14 years 28.8%, and >15 years 19.3%) with a median age of 76. Of those with active treatment, the majority underwent prostatectomy alone (55.1%). High symptom burden was reported across all domains (urinary 14.4%, sexual 44.4%, bowel 8.4%, vitality 12.7% and emotional 7.6%). When stratifying by symptom burden level and domain, those with high symptom burden searched for info more frequently regardless of the specific domain (p <.001; Figure). After adjustment, high sexual burden was associated with a greater need for relational info (OR=2.05; 95% CI 1.54-2.72) and long-term effects info (OR=1.60; 95% CI 1.23-2.07). High bowel burden was associated with a greater need for long-term effects info (OR=2.28; 95% CI 1.43-3.63). CONCLUSIONS Symptom burden is a lasting problem among long-term PCa survivors. Our data suggest that survivors suffering from high symptom burden need more supportive info long term. Health care providers should remain vigilant and assess treatment-related symptom burden in long-term survivors to help them navigate towards resources to improve QOL. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e309-e310 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jennifer Bernat More articles by this author Daniela Wittmann More articles by this author Sarah Hawley More articles by this author David Haggstrom More articles by this author May Darwish-Yassine More articles by this author Ted Skolarus More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

Using group-based trajectory modeling to examine heterogeneity of symptom burden in patients with head and neck cancer undergoing aggressive non-surgical therapy

Treatment-related symptom burden varies significantly among patients undergoing radiotherapy or chemoradiotherapy, yet such variation is typically not reflected in the results from single-group studies. We applied group-based trajectory modeling (GBTM) to describe the heterogeneity of symptom burden among patients with head and neck cancer and to identify subgroups with distinct symptom-development trajectories. Patients (n=130) were recruited pretherapy and rated multiple symptoms weekly for 10weeks via the M. D. Anderson Symptom Inventory. With the mean of five most severe symptoms over time as an outcome measure, GBTM was used to identify patient subgroups with distinct symptom trajectories. Linear mixed-effects modeling (LMM) was applied to compare with GBTM's ability to describe the longitudinal symptom data. The five most severe symptoms were problems with taste, difficulty swallowing or chewing, problems with mucus, fatigue, and dry mouth. A two-group GBTM model identified 68% of patients as having high symptom burden, associated with older age, worse baseline performance status, and chemoradiotherapy treatment. A four-group GBTM model generated one stable group (4% of patients) and three groups varying in symptom severity with both linear and quadratic functions over time. LMM revealed symptom-change patterns similar to that produced by GBTM but was inferior in identifying risk factors for high symptom burden. For cancer patients undergoing aggressive therapy, GBTM is capable of identifying various symptom-burden trajectories and provides severity groupings that will aid research and may be of clinical utility. These results may be generalizable to other cancer types and treatments.

Levels of Symptom Burden During Chemotherapy for Advanced Lung Cancer: Differences Between Public Hospitals and a Tertiary Cancer Center

We compared risk factors for high disease- and treatment-related symptom burden over 15 weeks of therapy in medically underserved patients with advanced non-small-cell lung cancer and in patients treated at a tertiary cancer center. We monitored symptom severity weekly during chemotherapy. Patients were recruited from a tertiary cancer center (n=101) and three public hospitals treating the medically underserved (n=80). We used a composite symptom-severity score and group-based trajectory analysis to form two groups: one with consistently more severe symptoms and another with less severe symptoms. We examined predictors of group membership. Seventy percent of the sample (n=126) reported low symptom-severity levels that decreased during therapy; 30% (n=55) had consistently severe symptoms throughout the study. In multivariate analysis, patients with good performance status being treated in public hospitals were significantly more likely than patients treated at the tertiary cancer center to be in the high-symptom group (odds ratio, 5.6; 95% CI, 2.1 to 14.6; P = .001) and to report significantly higher symptom interference (P = .001). Other univariate predictors of high-symptom group membership included variables associated with being medically underserved (eg, having less education, being single, and being nonwhite). No group differences by ethnicity were observed in the public hospitals. Medically underserved patients were less likely to receive adequate pain management. Patients with advanced lung cancer and good performance status treated at public hospitals were more likely than those treated at a tertiary cancer center to experience substantial symptoms during chemotherapy.

Prevalence and trajectory of disease- and treatment-related symptom burden in patients with multiple myeloma undergoing induction therapy.

e19627 Background: Patients with multiple myeloma (MM) undergoing induction therapy experience both disease- and therapy-related symptoms. This study selectively focused on the trajectory of pain, fatigue, numbness and bone aches from patient-reported outcome. Methods: MM patients (N=62) repeatedly rated symptoms via the M. D. Anderson Symptom Inventory (MDASI) (twice a week for 12 weeks, then weekly for 6 weeks). Ordinal regression analysis was used to describe symptom trajectories across time. Group-based trajectory modeling was used 1) to estimate the proportion of MM patients belonging to high, medium or low group by symptom severity; and 2) to examine the patterns of each group derived for each symptom. Results: During induction period, fatigue was persistently the most severe symptom, while therapy-induced neuropathy (MDASI numbness item) increased significantly from baseline (P=.0008). Group-based trajectory modeling resulted in 3 groups as the best model fit for 4 symptoms. The proportions of patients categorized as having high, medium or low symptom severity, respectively, were: for pain, 27%, 41% and 32%; for bone ache, 22%, 43% and 35%; for numbness, 22%, 48% and 30%; for fatigue, 28%, 58% and 14%. For pain, we observed a significant linear increased trend in the medium group (P<.001). For fatigue, bone ache and numbness, the medium and low groups exhibited only a slight change in slope, while the high symptom group showed a significant initial increase followed by a decrease trend (all quadratic trends, P<.001). Other than baseline performance status (P<.01), no clinical or patient factor was related to group membership. Conclusions: The majority of patients reported moderate or greater fatigue, pain and bone aches throughout the induction treatment, with little evidence of reduction, while numbness/tingling dramatically increased over time. We also observed that some MM patients persistently reported low symptom burden compared to others, despite similar disease burden and therapy. These results warrant further translational studies to identify biomarker(s) related to high symptom burden, so as to guide personalized patient care during standard induction therapy.

Vanderbilt Head and Neck Symptom Survey Version 2.0 (VHNSS 2.0): A tool for the study of long-term oral health consequences of therapy for head and neck cancer (HNC).

9055 Background: HNC therapy causes adverse late oral health outcomes (LOHO), the prevalence, severity, and functional implications of which are largely unknown. VHNSS 1.0 was developed to measure treatment-related symptom burden, but common LOHO were not included. We report the development of a LOHO subscale. Methods: Questions were developed by an expert panel and review of oral health measures for the general population. Final tool included 50 items which scored symptoms or functional manifestations from 0 (none) to 10 (severe). It was administered to 70 subjects who completed radiation ± chemotherapy. Results: Completion time <10 minutes. To focus on late effects, we report on 48 participants ≥ 6 months post-treatment. 60% reported moderate/severe (M/S) xerostomia which impacted chewing/swallowing (54%), speaking (39%), and sleeping (30%). 44% reported M/S thick mucous resulting in choking/gagging (22%), difficulty swallowing (22%), and altered sleep (15%). 28% reported M/S voice changes with hoarsene...

Inflammatory cytokines are associated with the development of symptom burden in patients with NSCLC undergoing concurrent chemoradiation therapy

Elevations in cancer treatment-induced circulating inflammatory cytokines may be partially responsible for the development of significant symptom burden (e.g., pain, fatigue, distress, disturbed sleep) during concurrent chemoradiation therapy (CXRT). Sixty-two patients undergoing CXRT for locally advanced non-small cell lung cancer (NSCLC) reported symptoms weekly for 15weeks via the M. D. Anderson Symptom Inventory (MDASI). Serum inflammatory cytokines were assessed weekly during therapy via enzyme-linked immunosorbent assay. Dynamic changes in cytokines and associated symptom profiles were estimated using mixed-effect models. MDASI symptom severity increased gradually as CXRT dose accumulated and peaked at week 8. Serum concentrations of interleukin (IL)-6, IL-10, and serum soluble receptor 1 for tumor necrosis factor (sTNF-R1) increased significantly by week 8 (all p<.05). During CXRT, controlled for age, sex, race, body mass index, cancer recurrence, previous treatment status, total radiotherapy dose, and CXRT delivery technique, an increase in sTNF-R1 was significantly related to an increase in the mean score for all 15 MDASI symptoms (estimate, 1.74; SE, 0.69; p<.05) and to a larger radiation dose to normal lung volume (estimate, 1.77; SE, 0.71; p<.01); an increase in serum IL-6 was significantly related to increased mean severity for the five most severe symptoms (pain, fatigue, disturbed sleep, lack of appetite, sore throat) (estimate, 0.32; SE, 0.16; p<.05). These results suggest a role for over-expressed pro-inflammatory cytokines in significant worsening of symptoms in NSCLC patients undergoing CXRT, and warrant further study to identify biological targets for ameliorating treatment-related symptom burden.

Measuring the symptom burden of head and neck cancer patients undergoing concurrent chemotherapy and radiation therapy using area under the curve

6067 Background: Patients with head and neck cancer (HNC) experience a significant treatment-related symptom burden during therapy that presents management challenges for both patients and treatment staff. Typical symptom measurement approaches have failed to capture the extent of this symptom burden over the course of therapy. We evaluated frequent symptom measurement summarized as area under the curve (AUC) as a way of portraying treatment related symptom burden in HNC patients, and explored this method for comparing symptoms produced by treatments that were expected to produce different levels of symptom impact. Methods: The M. D. Anderson Symptom Inventory - Head and Neck module - was administered at baseline and weekly for 10 weeks following the start of treatment to patients undergoing radiation therapy (XRT) as a single modality therapy (N = 49) and a second group receiving chemoradiotherapy CXRT (N = 53). We expected that treatment-related symptom burden would be greater for those patients receiving CXRT. A single value (AUC) was calculated based on the core symptoms reported by both groups of patients. Results: AUC comparisons for mean symptom severity for core symptom items demonstrated the expected greater symptom burden associated with CXRT (170.6 vs 120.9, p &lt; 0.008). The AUC for symptom interference, as measured by the MDASI-HN, was also greater for the CXRT group (p &lt; 0.002). AUCs for individual symptoms, such as fatigue (p &lt; 0.002), sleep disturbance (p &lt; 0.05) and lack of appetite (p &lt; 0.02), were also significantly larger for the CXRT group. Conclusions: The AUC of individual and combined symptoms during cancer therapy present a useful summary of treatment related symptoms that can be used to compare treatment-related symptom burden between different treatment strategies used for the same disease. No significant financial relationships to disclose.

Evaluation of symptom burden in patients receiving concurrent biochemotherapy for metastatic malignant melanoma (MMM)

6143 Background: Combination of cytotoxic chemotherapy and immunoregulators (biochemotherapy) is commonly used to treat patients with MMM. Response rates reported with this regimen vary between 18% and 60%. This treatment course is limited by acute toxicity and the resulting substantial symptom burden. Methods: Using the M. D. Anderson Symptom Inventory (MDASI) and ECOG performance status (PS), we evaluated the symptom burden in 12 patients receiving 1–5 cycles of concurrent biochemotherapy for MMM. Patients received Dacarbazine 800mg/m2 D1, Cisplatin 20 mg/m2 D1–4, Vinblastine 1.5 mg/m2 D1–4, Interleukin-2 9 MU/m2 IVCI D1–4, and Interferon-alpha-2b 5 MU/m2 SC D1–4. The MDASI was administered at baseline and daily for 21days. ECOG PS was evaluated at baseline and day 5. Data was collected by personal interview during hospitalization and by daily mail after discharge. Results: Most significant symptoms included fatigue, nausea, sleep disturbance, depressed appetite, drowsiness, dry mouth, and itching. Symptom intensity was graphed over time to develop a symptom curve. Consistently, the symptoms peaked at day 4 to 5 and returned almost to baseline levels at day 21. ECOG PS decreased from day 0 to day 5 and returned to baseline prior to the next treatment cycle. The table below shows the 7 highest reported symptoms rated on a 0–10 scale. Conclusions: Concurrent biochemotherapy induces substantial toxicity during the first 5–7 days of therapy. Acute toxicity seems tightly related to drug administration. Short-term symptom burden is more severe than seen with most treatment modalities. If substantial tumor response is not evident after 2 courses of therapy, the treatment-related symptom burden further limits its overall clinical benefit. Future studies will assess correlations with serum release of various cytokines and compare with high-dose Interleukin-2. No significant financial relationships to disclose.

Evaluation of symptom burden in patients receiving concurrent biochemotherapy for metastatic malignant melanoma (MMM)

6143 Background: Combination of cytotoxic chemotherapy and immunoregulators (biochemotherapy) is commonly used to treat patients with MMM. Response rates reported with this regimen vary between 18% and 60%. This treatment course is limited by acute toxicity and the resulting substantial symptom burden. Methods: Using the M. D. Anderson Symptom Inventory (MDASI) and ECOG performance status (PS), we evaluated the symptom burden in 12 patients receiving 1–5 cycles of concurrent biochemotherapy for MMM. Patients received Dacarbazine 800mg/m2 D1, Cisplatin 20 mg/m2 D1–4, Vinblastine 1.5 mg/m2 D1–4, Interleukin-2 9 MU/m2 IVCI D1–4, and Interferon-alpha-2b 5 MU/m2 SC D1–4. The MDASI was administered at baseline and daily for 21days. ECOG PS was evaluated at baseline and day 5. Data was collected by personal interview during hospitalization and by daily mail after discharge. Results: Most significant symptoms included fatigue, nausea, sleep disturbance, depressed appetite, drowsiness, dry mouth, and itching. Symptom intensity was graphed over time to develop a symptom curve. Consistently, the symptoms peaked at day 4 to 5 and returned almost to baseline levels at day 21. ECOG PS decreased from day 0 to day 5 and returned to baseline prior to the next treatment cycle. The table below shows the 7 highest reported symptoms rated on a 0–10 scale. Conclusions: Concurrent biochemotherapy induces substantial toxicity during the first 5–7 days of therapy. Acute toxicity seems tightly related to drug administration. Short-term symptom burden is more severe than seen with most treatment modalities. If substantial tumor response is not evident after 2 courses of therapy, the treatment-related symptom burden further limits its overall clinical benefit. Future studies will assess correlations with serum release of various cytokines and compare with high-dose Interleukin-2. No significant financial relationships to disclose.