Gradient Boosted Tree Approaches for Mapping European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Onto 5-Level Version of EQ-5D Index for Patients With Cancer.

OBJECTIVES: This study aimed to develop direct and response mapping algorithms from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 onto the 5-level version of EQ-5D index based on the gradient boosted tree (GBT), a promising modern machine learning method. METHODS: We used the Quality of Life Mapping Algorithm for Cancer study data (903 observations from 903 patients) for training GBTs and testing their predictive performance. In the Quality of Life Mapping Algorithm for Cancer study, patients with advanced solid tumor were enrolled, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and 5-level version of EQ-5D were simultaneously evaluated. The Japanese value set was used for direct mapping, whereas the Japanese and US value sets were used for response mapping. We trained the GBTs in the training data set (80%) with cross-validation and tested the predictive performance measured by the root mean squared error (RMSE), mean absolute error (MAE), and mean error in the test data set (20%). RESULTS: The RMSE and MAE in the test data set were larger in the GBT approaches than in the previously developed regression-based approaches. The mean error in the test data set tended to be smaller in the GBT approaches than in the previously developed regression-based approaches. CONCLUSIONS: The predictive performances in the RMSE and MAE did not improve by the GBT approaches compared with regression approaches. The flexibility of the GBT approaches had the potential to reduce overprediction and underprediction in poor and good health, respectively. Further research is needed to establish the role of machine learning methods in mapping a nonpreference-based measure onto health utility.

Floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 Physical Functioning subscale is a widely used patient-reported outcome measure that quantifies cancer patients' physical functioning. Strong floor/ceiling effects can affect a scale's sensitivity to change. The aim of this study was to characterize floor/ceiling effects of the physical functioning domain in patients with advanced/metastatic breast cancer enrolled in commercial clinical trials and a community-based trial. METHODS: The clinical trial cohort comprised patients from 5 registrational trials submitted to the Food and Drug Administration for review (2010-2017). The community cohort comprised a subgroup of patients from the Alliance Patient Reported Outcomes to Enhance Cancer Treatment (PRO-TECT) trial. The distribution of patient responses to Physical Functioning items and the summed score were assessed at the baseline and 3-month follow-up for both cohorts. Descriptive statistics were used to determine floor/ceiling effects at the item and scale levels. RESULTS: The clinical trial cohort and the community cohort consisted of 2407 and 178 patients, respectively. Twenty-four percent or more of the respondents reported "not at all" for having trouble/needing help with each Physical Functioning item across both cohorts and measurement time points. Fourteen to twenty percent of the patients scored perfectly (100 of 100) on the Physical Functioning subscale summary measure (where higher scores indicated better physical functioning) across both cohorts and time points. CONCLUSIONS: Minor floor effects and notable ceiling effects were found at the item and scale levels of the Physical Functioning subscale, regardless of cohort, and this creates some uncertainty about its ability to detect changes in physical functioning among high-functioning patients. Investigators may consider adding additional high-functioning items from the EORTC's item library to more accurately describe the impact of anticancer treatment on patients' physical functioning.

Prognosis-Related Nutritional Score for Cancer Patients (PRNS): a clinical nutritional score derived from a retrospective cohort study.

BACKGROUND: Nutritional assessment and quality of life (QOL) have become important indices for therapeutic efficacy in patients with malignancies. We aim to develop and validate an easy-to-use questionnaire with prognostic value to assess nutritional status in hospitalized cancer patients. METHODS: A comprehensive survey focused on patient-generated subjective global assessment (PG-SGA) and 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 Chinese version) was performed in a cohort of 22,776 patients derived from the INSCOC study. Among them, 1948 patients were followed for 3 years after admission. An observational, retrospective, cross-sectional cohort study was conducted in accordance with TRIPOD statement. Breiman's random forest model was applied to calculate variable importance (VIMP) for items in PG-SGA and EORTC QLQ-C30 (Chinese version) for nutritional recommendation. Cox regression model was employed to construct Prognosis-Related Nutritional Score for Cancer Patients (PRNS). Kaplan-Meier Survival curve, ROC and DCA were calculated to evaluate prognostic value of nutritional status categorized by PRNS, and compared with PG-SGA. RESULTS: Nutritional status was classified into 4 levels by PRNS scores: well nourished (≤ 4.5 points), mild malnourished (5-7.5 points), moderate malnourished (8-14.5 points), and severe malnourished (≥ 15 points). Significant median overall survival differences were found among nutritional status groups stratified by the PRNS (all Ps < 0.05). Compared with PG-SGA, PRNS had better prognostic value for survival stratified by nutritional status. The external, internal validity, test-retest reliability and rater reliability were satisfactory. CONCLUSIONS: We systematically developed and validated PRNS as a nutrition screening tool for cancer patients. Compared with PG-SGA, PRNS has better prognostic value and simpler operation. TRIAL REGISTRATION: Investigation on Nutrition Status and its Clinical Outcome of Common Cancers, ChiCTR1800020329. Registered 24 December 2018-Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=31813.

Analysis of factors associated with patient-reported physical functioning scores at discharge of allogeneic hematopoietic stem cell transplantation patients: a cross-sectional study.

PURPOSE: The purpose of this study was to clarify the independent factors related to patient-reported physical functioning (PF) scores at discharge of patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). METHODS: A total of 103 patients who underwent allo-HSCT were included in this cross-sectional study. As a screening method, a single regression analysis was conducted with the PF domain in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at discharge as the dependent variable, and body mass index, adverse events related to HSCT, and objective physical functions as independent variables. Multiple regression analysis was performed with PF as the dependent variable and variables that passed the screening by single regression analysis and confounders as independent variables. RESULTS: The mean PF score at discharge of the patients was 76.5 (standard deviation: 15.2). Based on the results of screening by the single regression analysis, length of stay, infections (+ / -), acute graft-versus-host disease grade, brief fatigue inventory score (BFI), knee extensor strength, and 6-min walk distance (6MWD) were included in the multiple regression analysis. BFI (B = - 11.94, p < 0.001) and 6MWD (per 10 m) (B = 0.56, p = 0.001) were extracted as significant independent variables governing the PF at discharge in the multiple regression model (adjusted R2 = 0.59). CONCLUSION: Higher exercise tolerance and lower fatigue in patients who underwent allo-HSCT were associated independently with patient-reported better PF scores at discharge.

Validation of the QLQ-EN24 instrument for the assessment of health-related quality of life for women with endometrial cancer in México.

PURPOSE: The impact of disease activity or treatments on health-related quality of life (HRQL) is crucial in Oncology, but adequate instruments for this assessment are scarce. Our aim is to validate the Mexican-Spanish version of the QLQ-EN24 questionnaire to evaluate HRQL in women with endometrial cancer (EC). METHODS: This is a prospective study of Mexican women with EC, attending a single cancer centre, who responded the QLQ-C30 and QLQ-EN24 instruments; usual psychometric analysis were performed as well as the association of HRQL scales and relevant clinical data. Correlation analysis was performed with the Spearman's method, reliability analysis with the Cronbach's alpha, known-group comparisons with the Kruskal-Wallis test, and survival analysis with the Kaplan-Meier method and Log-rank test. RESULTS: One hundred and eighty-nine women with EC were assessed. Most functional scales reported high values, and most symptom scales, low. Questionnaire compliance rates were high and internal consistency tests demonstrated adequate convergent and divergent validity. Cronbach's α coefficients of the five multi-item scales the QLQ-EN24 instruments were from 0.659 to 0.887. Scales of the QLQ-C30 and QLQ-EN24 instruments distinguished among clinically distinct groups of patients, particularly based on serum albumin levels. The Urological symptoms, Gastrointestinal symptoms, Body image, Pelvic pain and Taste change scales were significantly associated with OS. CONCLUSION: The Mexican-Spanish version of the QLQ-EN24 questionnaire is reliable and valid for the assessment of HRQL in patients with EC and can be broadly used in multi-national clinical trials. However, conclusions derived from scales evaluating sexual function should be handled carefully.

Validation study of the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 for patients with testicular cancer.

OBJECTIVE: To validate the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 in Japanese-speaking testicular cancer survivors. METHODS: A total of 200 testicular cancer survivors were recruited at eight high-volume institutions in Japan. The participants completed the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and the International Index of Erectile Function 15 questionnaires. A total of 40 participants completed a retest of the questionnaires 2 weeks after the first response. The psychometric properties of the Japanese version including test-retest reliability, internal consistency and concurrent validity were evaluated. RESULTS: The mean age at response was 43 years (range 22-74 years), and the mean period after treatment was 77 months (range 0-416 months). The response rate for each item, except sexual function, was high, and the percentage of missing values was less than 3.5%. For test-retest reliability, seven of 12 scales met the criteria (intraclass correlation 0.70-0.86). For internal consistency, four of seven scales met the criteria (Cronbach's alpha 0.62-0.91). For concurrent validity, treatment side effects of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 were related to some domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. The sex-related subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 were moderately correlated with some International Index of Erectile Function 15 domains. CONCLUSIONS: The psychometric properties of the Japanese version are equivalent to the properties of the original European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26. The Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 questionnaire is a useful tool to assess the health-related quality of life of testicular cancer patients.

Quality of Life of Head and Neck Cancer Patients: Psychosocial Perspective using Mixed Method Approach.

OBJECTIVES: Head and neck cancers are one of the most visible cancers permanently damaging appearances and affecting some of the very basic life functions of the patients. With advances in medical care and multidisciplinary team interventions, such changes can be managed and patient's quality of life (QOL) be improved. Thus, it is important to understand the QOL concerns of the patients. The objective of the study was to examine QOL concerns of the patients with head and neck cancer. MATERIALS AND METHODS: A sample of 100 adult cancer patients was selected from NCT of Delhi using non-probability sampling design. Data were collected through European Organization for Research and Treatment of Cancer QOL Questionnaires 30 (EORTC QLQ30) and EORTC QLQ Head and Neck specific 35 inventories which was supplemented with qualitative data obtained through semi-structured interviews. Interdependence of the variables and their impact on QOL of patients was studied using co-relational analyses. RESULTS: Patients with head and neck cancer experienced major changes in their speech, appearances, eating pattern, daily routine, and work efficiency. Emotional functioning of the patients was poorest, followed by social functioning, role functioning, physical functioning, and cognitive functioning. Education had significant positive correlation with global QOL (0.382**, P < 0.01). CONCLUSION: QOL of head and neck cancer patients was poor. Emotional functioning of the patients was worst affected as patients had high emotional concerns. The study recommends psycho-educational intervention programs to help patients cope up better with the disease and improve their QOL. Patients' support group and peer counseling would give emotional strength to the patients as few patients derived positive experience out of the disease episode.

A single-institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer.

BACKGROUND: The objective of the current study was to compare the safety and efficacy between 2 analgesic regimens for patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT). METHODS: The current study was a prospective, single-institution, 2-arm, randomized pilot study. Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT were randomized to either arm 1, which entailed high-dose gabapentin (2700 mg daily) with the institutional standard of care (hydrocodone and/or acetaminophen progressing to fentanyl as needed), or arm 2, which comprised low-dose gabapentin (900 mg daily) with methadone. The primary endpoints were safety and toxicity. Secondary endpoints were pain, opioid requirement, and quality of life (QOL). Differences between the treatment arms at multiple time points were compared using a generalized linear mixed regression model with Sidak correction. RESULTS: A total of 60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017. There was no difference between the treatment arms with regard to adverse events or serious adverse events. Pain was not found to be different between the treatment arms. More patients in arm 1 did not require an opioid during treatment (42% vs 7%; P = .002). Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01). CONCLUSIONS: High-dose prophylactic gabapentin increased the percentage of patients who required no opioid during treatment. Methadone may improve QOL compared with a regimen of short-acting opioids and fentanyl. However, pain was found to significantly worsen throughout treatment regardless of treatment arm, necessitating further studies to identify a more optimal regimen.

Desmoid tumors: To treat or not to treat, That is the question.

Desmoid tumors (DTs) are a rare disease of intermediate malignancy characterized histologically by a locally aggressive, monoclonal, fibroblastic proliferation and clinically by a variable and often unpredictable course. For decades, surgical resection has been the standard initial treatment approach; however, more recently, a paradigm shift toward a more conservative treatment strategy has been introduced. More than 5 years ago, The Desmoid Tumor Working Group started a consensus initiative in Europe with the aim of harmonizing the strategy among clinicians and setting up treatment recommendations for patients with DTs. This review summarizes the latest joint, global, evidence-based guideline approach to DT management. Moreover, a number of gray areas in the treatment recommendations are discussed, and possible future perspectives on the treatment armamentarium for patients with DTs are presented.

Chemotherapy-Induced Peripheral Neuropathy and its Impact on Health-Related Quality of Life among Multiple Myeloma Patients: A Single-Center Experience.

AIM: Chemotherapy-induced peripheral neuropathy (CIPN) is a long-term neurological health issue in patients diagnosed with multiple myeloma (MM). The aim of this study was to assess CIPN symptoms and health-related quality of life (HRQOL) among MM patients. METHODS: A cross-sectional survey was conducted among patients diagnosed with MM in a tertiary care hospital using a self-reported Arabic questionnaire, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire for CIPN scale (QLQ-CIPN20). The HRQOL was assessed using EORTC multiple myeloma module (QLQ-MY20). Categorical variables were reported in frequency tables and percentages. Age and duration of MM diagnosis were reported as mean and standard deviation. Survey responses were presented using descriptive statistics. RESULTS: In total, 62 patients had participated. Males were 60%. The average age was 58.74 ± 11.49 years. On sensory scale, 20% reported "quite a bit"/"very much" tingling in fingers/hands, 23% in toes/feet, 39% numbness in fingers/hands, 37% in toes/feet, and 43% reported trouble standing or walking. On motor scale, 40% reported trouble walking and 60% had difficulty in climbing stairs/standing up from chair. On autonomic scale, 27% reported orthostatic hypotension and only 13/37 (46%) males reported erectile dysfunction. For HRQOL, 50% reported bone aches/pain, 42% reported back pain, 57% reported feeling ill, 33% reported lost hair, 35% had been thinking about their illness, whereas 28% were worried about future health and 22% had reported being worried about dying. CONCLUSION: MM patients encounter CIPN symptoms with impaired HRQOL. Capturing CIPN as a patient-reported outcome needs to be considered in routine clinical practice.

Emotional functioning to screen for psychological distress in breast and colorectal cancer patients prior to adjuvant treatment initiation.

INTRODUCTION: The objective was to analyze the usefulness of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) EF subscale to detect emotional problems in patients with breast (BC) and colorectal cancer (CRC). METHODS: A prospective, observational, cross-sectional study was conducted. Participants completed the Brief Symptom Inventory (BSI) and EORTC-QLQ-C30. The following psychometric properties were calculated: accuracy, sensitivity, positive predictive value, specificity and negative predictive value. RESULTS: The sample analyzed included 445 patients: 202 with BC and 243 with CRC. In total, 129 BC patients (64%) and 104 CRC patients (43%) suffered psychological distress according to the BSI. The accuracy of EORTC-QLQ-C30 EF in detecting psychological distress was 77% and 82% in BC and CRC respectively. Specificity rates for BC and CRC were 81% and 82%, and sensitivity was 75% and 82% respectively. Positive predictive value was 87% and 77%, and negative predictive value was 65% and 86% in BC and CRC respectively. The mean AUC for BC was 0.83 and 0.88 for CRC. CONCLUSIONS: The EORTC-QLQ-C30 EF is useful for rapid screening. The systematic application of this scale would allow patients with cancer and emotional problems to be easily identified in clinical practice.

Factors related to the quality of life in liver cancer patients during treatment phase: A follow-up study.

OBJECTIVE: This study aims to explore the predictive value of demographic and clinical factors in changes in quality of life (QoL) in liver cancer (LC) patients over time. METHODS: We performed a prospective cohort study in 128 patients who had 4 time point data newly diagnosed with LC at two hospitals in Taiwan. Different functional QoL was measured by QLQ-C30. Specific characteristics were predictors for distinct functional QoL, estimated by a generalised estimating equation (GEE). RESULTS: Patients who received liver resection or radiofrequency ablation therapy (RFA) versus transarterial chemoembolisation (TACE) or transcatheter arterial embolisation (TAE) experienced a decrease in physical function from baseline to 1 month. In addition, patients who underwent liver resection versus RFA experienced a significant recovery in cognitive functioning from baseline to 6 months. Patients with advanced stage compared to those in early stage had a reduction in physical functioning from baseline to 1 month. The alcohol intake, hepatitis C infection and the job also affected the changes in physical and cognitive functioning. CONCLUSION: Healthcare professionals should pay attention to changes after treatment in the short term; additionally, they need to provide health education to modifiable factors such as alcohol intake attributed to the deterioration in QoL.

Outcomes of Elderly Patients with Advanced Soft Tissue Sarcoma Treated with First-Line Chemotherapy: A Pooled Analysis of 12 EORTC Soft Tissue and Bone Sarcoma Group Trials.

BACKGROUND: Almost half of patients diagnosed with soft tissue sarcoma (STS) are older than 65 years; however, the outcomes of elderly patients with metastatic disease are not well described. PATIENTS AND METHODS: An elderly cohort of patients aged ≥65 years was extracted from the European Organization for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group database of patients treated with first-line chemotherapy for advanced STS within 12 EORTC clinical trials. Endpoints were overall survival (OS), progression-free survival (PFS), and response rate (RR). RESULTS: Of 2,810 participants in EORTC trials, there were 348 elderly patients (12.4%, median 68 years; interquartile range [IQR], 67-70; maximum 84 years) and 2,462 patients aged <65 years (median 49 years; IQR, 39-57). Most elderly patients had a performance status of 0 (n = 134; 39%) or 1 (n = 177; 51%). Leiomyosarcoma (n = 130; 37%) was the most common histological subtype. Lung metastases were present in 181 patients (52%) and liver metastases in 63 patients (18%). Overall, 126 patients (36%) received doxorubicin, 114 patients (33%) doxorubicin + ifosfamide, 43 patients (12%) epirubicin, 39 patients (11%) trabectedin, and 26 patients (7%) ifosfamide. Overall RR was 14.9% (n = 52), median PFS was 3.5 months (95% confidence interval [CI], 2.7-4.3), and median OS was 10.8 months (95% CI, 9.43-11.83). In patients aged <65 years, overall RR was 20.3% (n = 501), median OS was 12.3 months (95% CI, 11.9-12.9), and median PFS was 4.3 months (95% CI, 3.9-4.6). CONCLUSION: Elderly patients with metastatic STS treated with first-line chemotherapy were largely underrepresented in these EORTC STS trials. Their outcomes were only slightly worse than those of younger patients. Novel trials with broader eligibility criteria are needed for elderly patients. These trials should incorporate geriatric assessments and measurements of age-adjusted health-related quality of life. IMPLICATIONS FOR PRACTICE: This analysis demonstrates that elderly patients with advanced soft tissue sarcoma are underrepresented in clinical trials of first-line chemotherapy by the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Furthermore, the elderly participants were generally of excellent performance status, which is not representative of an unselected elderly population. These data provide rationale for development of novel trials for elderly patients that are not only for "elite" patients but include comprehensive geriatric assessments for risk stratification. Because chemotherapy for advanced soft tissue sarcomas is largely given with palliative intent, incorporation of health-related quality of life measures with traditional endpoints will provide a more holistic approach to future clinical trials.

An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) 24954 phase 3 randomized clinical trial compared 2 schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx: sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy. The current study reports detailed effects of both treatment arms on health-related quality of life (HRQOL) and symptoms. METHODS: A total of 450 patients aged 35 years to 76 years (World Health Organization performance status (WHO PS) ≤ 2) with untreated, resectable advanced squamous cell carcinoma of the larynx (tumor classification of T3-T4) or hypopharynx (tumor classification of T2-T3-T4) with regional lymph nodes in the neck classified as N0 to N2 with no metastases were randomized in this prospective phase 3 trial into either the sequential arm (control) or the alternating arm (experimental). QOL assessment was performed at randomization; at baseline; at 42 days; and at 6, 12, 24, 36, and 48 months. RESULTS: There were no observed differences with regard to the primary endpoint of Fatigue and secondary endpoint of Dyspnea. Significant differences were found in the secondary endpoints of Swallowing and Speech problems at 42 days after randomization in favor of patients in the sequential arm. Explanatory and sensitivity analysis revealed that the primary analysis favored the sequential arm, but the majority of differences in HRQOL did not exist at the end of treatment, and returned to baseline levels. CONCLUSIONS: In the current study, a trend toward worse scores was noted in the patients treated on the alternating chemoradiotherapy arm but very few differences reached the level of statistical significance. The HRQOL scores of the majority of patients returned to baseline after therapy.

Quantitative dosimetry for yttrium-90 radionuclide therapy: tumor dose predicts fluorodeoxyglucose positron emission tomography response in hepatic metastatic melanoma.

PURPOSE: To assess a new method for generating patient-specific volumetric dose calculations and analyze the relationship between tumor dose and positron emission tomography (PET) response after radioembolization of hepatic melanoma metastases. METHODS AND MATERIALS: Yttrium-90 ((90)Y) bremsstrahlung single photon emission computed tomography (SPECT)/computed tomography (CT) acquired after (90)Y radioembolization was convolved with published (90)Y Monte Carlo estimated dose deposition kernels to create a three-dimensional dose distribution. Dose-volume histograms were calculated for tumor volumes manually defined from magnetic resonance imaging or PET/CT imaging. Tumor response was assessed by absolute reduction in maximum standardized uptake value (SUV(max)) and total lesion glycolysis (TLG). RESULTS: Seven patients with 30 tumors treated with (90)Y for hepatic metastatic melanoma with available (90)Y SPECT/CT and PET/CT before and after treatment were identified for analysis. The median (range) for minimum, mean, and maximum dose per tumor volume was 16.9 Gy (5.7-43.5 Gy), 28.6 Gy (13.8-65.6 Gy) and 36.6 Gy (20-124 Gy), respectively. Response was assessed by fluorodeoxyglucose PET/CT at a median time after treatment of 2.8 months (range, 1.2-7.9 months). Mean tumor dose (P = .03) and the percentage of tumor volume receiving ≥ 50 Gy (P < .01) significantly predicted for decrease in tumor SUV(max), whereas maximum tumor dose predicted for decrease in tumor TLG (P < .01). CONCLUSIONS: Volumetric dose calculations showed a statistically significant association with metabolic tumor response. The significant dose-response relationship points to the clinical utility of patient-specific absorbed dose calculations for radionuclide therapy.

AB035. Validation of EORTC brain cancer module (EORTC QLQ-BN20) for assessment of health-related quality of life in glioma patients in Singapore.

BACKGROUND: Existing international data has shown that glioma patients suffer from poorer health-related quality of life (HRQoL). The European Organization for Research and Treatment of Cancer (EORTC) brain cancer-specific Quality of Life Questionnaire (QLQ-BN20) was developed to be together with EORTC Core Quality of Life Questionnaire (QLQ-C30) for cancer patients, highlighting issues particularly relevant to brain tumor patients. It has since been translated and validated across numerous cohorts. However, its psychometric properties have yet to be examined in Singapore. This study aimed to validate the use of QLQ-BN20 in a nationally representative sample of glioma patients in Singapore. METHODS: Eighty-seven patients who had undergone neurosurgery for glioma from six hospitals in Singapore completed three self-reported measures of HRQoL (the EuroQol EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-BN20). Descriptive statistics summarized their characteristics and scores on the questionnaires. Psychometric properties of QLQ-BN20 examined included convergent and discriminant validity, internal consistency (Cronbach's alpha), and construct validity (Spearman's correlation). Clinical validity of QLQ-BN20 was determined based on whether QLQ-BN20 scores could differentiate patients with good and poor functional status as measured by Karnofsky Performance Scale and Barthel's Index. RESULTS: The QLQ-BN20 was demonstrated to have good convergent validity (item-own scale correlation >0.70) and discriminant validity (item-own scale correlation higher than item-other scale correlation). There is high internal consistency, both overall (α=0.88) and within multi-item subscales (α=0.74-0.88). Conceptually similar subscales between different tools were more strongly correlated. For instance, the QLQ-C30 physical functioning subscale and the QLQ-BN20 motor dysfunction subscale (r=-0.65, P<0.001), and the QLQ-C30 cognitive functioning subscale and the QLQ-BN20 cognitive deficits subscale (r=-0.51, P<0.001). QLQ-BN20 was also able to distinguish between functional statuses of patients (P<0.05). CONCLUSIONS: This study supports the validity and reliability of the EORTC QLQ-BN20 among patients with glioma in Singapore. There is good convergent and discriminant validity, internal consistency, construct validity, and clinical validity. The QLQ-BN20 is a valuable supplement to the QLQ-C30. Hence, we recommend expanding its use for all glioma patients and possibly brain cancer patients in Singapore.

Internal Responsiveness of EQ-5D-5L and EORTC QLQ-C30 in Dutch Breast Cancer Patients during the First Year Post-Surgery: A Longitudinal Cohort Study.

The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care.

Longitudinal Assessment of the Quality of Life in Oral Squamous Cell Carcinoma Patients.

Background Studies evaluating the quality of life (QoL) among oral cancer patients in the Indian population are scarce. Regular follow-ups and QoL assessment in oral squamous cell carcinoma (OSCC) patients can aid in comprehensive support strategies to improve their QoL outcomes. Aim and objectives This study aimed to assess the QoL of oral cancer patients and correlate the QoL with demographic and treatment parameters.  Materials and methods The study included oral cancer patients who had previously reported to the Department of Oral and Maxillofacial Surgery. QoL assessment was done using the EORTC QLQ-C30 and QLQ-HN43 questionnaires before and after treatment. The clinico-demographic details, treatment data, follow-up data, and recorded mean QoL were procured from the patient records in Dental Information Archival Software. Assessment of QoL was done before treatment and at intervals of one month, three months, six months, 12 months, 24 months, and 36 months postoperatively after treatment. Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 23 (released 2015; IBM Corp., Armonk, New York, United States). A repeated measures analysis of variance (ANOVA) was utilized for comparing the average QoL scores and frequency of follow-ups across various intervals. Chi-square tests assessed differences in mean QoL among genders, across different sites, and between primary closure and graft placement. The significance was set at a p-value of less than 0.05. Results A total of 90 OSCC patients had reported to the department. A preoperative assessment of QoL was done for 90 (100%) patients. Out of these patients, surgery has been performed on 41 (45%). Twenty-five out of 41 (60%) patients had responded to regular follow-up, and QoL was assessed for these patients. After the immediate postoperative phase, only 12 (48%) had reported after three months. Only six (24%) had a 12-month follow-up, five (20%) had a two-year follow-up, and one (4%) had a three-year follow-up. There was a constant decrease in the number of follow-ups after the treatment of OSCC (p=0.00). Prior to treatment, the mean QoL index was 4.64. Females had a slightly higher preoperative QoL of 4.76 compared to males, with a score of 4.67 (p=0.157). Immediately after the treatment of OSCC, a decline in QoL scores was noted, with a mean score of 4.25 (p=0.32). Patients who underwent primary closure after excision had a mean post-op QoL score of 4.9, while patients who underwent graft placement had a mean score of 4.6 (p=0.157). Conclusion This study highlights the enduring impact of oral cancer on a patient's quality of life and emphasizes the need for ongoing research to explore specific interventions that can contribute to sustained improvement in QoL. It emphasizes personalized, holistic care approaches for such patients.

Adjuvant and salvage radiotherapy after prostatectomy: AUA/ASTRO Guideline.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the use of radiotherapy after radical prostatectomy as adjuvant or salvage therapy. MATERIALS AND METHODS: A systematic literature review using the PubMed®, Embase, and Cochrane databases was conducted to identify peer-reviewed publications relevant to the use of radiotherapy after prostatectomy. The review yielded 294 articles; these publications were used to create the evidence-based guideline statements. Additional guidance is provided as Clinical Principles when insufficient evidence existed. RESULTS: Guideline statements are provided for patient counseling, the use of radiotherapy in the adjuvant and salvage contexts, defining biochemical recurrence, and conducting a re-staging evaluation. CONCLUSIONS: Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy (i.e., seminal vesicle invasion, positive surgical margins, extraprostatic extension) and should offer salvage radiotherapy to patients with prostatic specific antigen or local recurrence after prostatectomy in whom there is no evidence of distant metastatic disease. The offer of radiotherapy should be made in the context of a thoughtful discussion of possible short- and long-term side effects of radiotherapy as well as the potential benefits of preventing recurrence. The decision to administer radiotherapy should be made by the patient and the multi-disciplinary treatment team with full consideration of the patient's history, values, preferences, quality of life, and functional status. Please visit the ASTRO and AUA websites (http://www.redjournal.org/webfiles/images/journals/rob/RAP%20Guideline.pdf and http://www.auanet.org/education/guidelines/radiation-after-prostatectomy.cfm) to view this guideline in its entirety, including the full literature review.

Primary cutaneous marginal zone B-cell lymphoma: response to treatment and disease-free survival in a series of 137 patients.

BACKGROUND: Primary cutaneous marginal zone B-cell lymphomas are low-grade lymphomas running an indolent course. Skin relapses have been frequently reported but little information about disease-free survival (DFS) is available. OBJECTIVE: We sought to evaluate relapse rate and DFS in patients with primary cutaneous marginal zone B-cell lymphomas. METHODS: Clinical features, European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas stage, light chain restriction, clonality, treatments, skin relapses, DFS, stage progression, extracutaneous disease, and outcome are analyzed in a series of 137 patients. RESULTS: Patients were classified as solitary lesion (T1) (n = 70; 51%), regional skin involvement (T2) (n = 40; 29%), and generalized skin lesions (T3) (n = 27; 20%). Surgical excision, local radiotherapy, or a combination were the initial treatment in 118 patients (86%). In 121 of 137 patients (88%) a complete remission was observed after initial treatment, including 99 of 106 patients (93%) with solitary or localized disease and 22 of 31 patients (71%) with multifocal lesions. Cutaneous relapses were observed in 53 patients (44%). Median DFS was 47 months. Patients with multifocal lesions or T3 disease showed higher relapse rate and shorter DFS. No significant differences were observed between surgery and radiotherapy, but surgery alone was associated with more recurrences at initial site. Overall survival at 5 and 10 years was 93%. Six patients (4%) developed extracutaneous disease during follow-up. LIMITATIONS: This was a case series retrospective study. CONCLUSION: Our results support long-term follow-up in patients with primary cutaneous marginal zone B-cell lymphomas. Disseminated skin lesions have higher relapse rate and shorter DFS suggesting further investigation on systemic therapies in such a group of patients.