EORTC QLQ-CR29 Research Articles

Turkish Validation and Reliability of the EORTC QLQ-CR29 Quality of Life Scale for Colorectal Cancer.

This study aims to test the validity and reliability of the Turkish version of the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Colorectal Cancer Scale, and to evaluate the relationship between the factors affecting the quality of life in patients with colorectal cancer (CRC). 117 patients diagnosed with CRC and treated at the Training and Research Hospital were included. A Personal Information Form, questionnaires on the Quality of Life in Cancer Patients, Quality of Life in Patients with CRC, and the Adaptation Scale for Individuals with Ostomy were used. The validity and reliability of the KKHYK scale were found significant (P < .05). From the demographic data of the patients, the differences between 3 sub-dimensions, grouping according to gender, and 2 sub-dimensions were statistically significant. In the characteristics related to the disease, the differences between the groups were significant; for one for the diagnosis time of the disease, 2 dimensions in the adaptation parameter (P < .05). The Turkish version of the scale is a measurement tool with validity and reliability indicators to measure the quality of life of patients with CRC. It was concluded that patients did not have sufficient knowledge about their disease, and that this increased the burden of nursing care.

Prognosis and complications of local excision for rectal cancer after neoadjuvant chemoradiotherapy

Objective: To investigate the prognosis and postoperative complications of local excision for rectal cancer after neoadjuvant chemoradiotherapy (nCRT). Methods: A descriptive case series study was carried out. Patient inclusion criteria: (1) patients who underwent local excision by transanal endoscopic microsurgery (TEM) after nCRT; (2) magnetic resonance evaluated tumor regression grade (mrTRG) as 1, 2 after nCRT;(3) American Society of Anesthesiologists class I to III. Patient exclusion criteria: (1) with multiple primary colorectal cancers; (2) with other malignant tumors within five years; (3) with emergency surgicery indications like digestive tract obstruction, perforation or bleeding. Clinicopathological and follow-up data of rectal cancer patients with obvious tumor regression after nCRT who underwent local excision in Peking Union Medical College Hospital from January 2010 to August 2019 were retrospectively collected. Outcome measures included disease-free survival (DFS), short-term postoperative complications, and at postoperative 1-year during follow up, gas continence, fecal continence, and quality of life (using the EORTC QLQ-CR29 scale, higher score indicated worse quality of life) at postoperative 1-year. Results: A total of 40 patients were included in this study. There were 27 males and 13 females with an average age of (66.7±12.3) years. Preoperative rectal ultrasound and other imaging examinations indicated that the tumor was located in the anterior wall in 16 cases, the lateral wall in 12 cases, and the posterior wall in 12 cases. The distance between the lower margin of the tumor and the anal verge was (4.3±1.2) cm before nCRT and (5.1±0.9) cm after nCRT. According to mrTRG, 31 cases were assessed as mrTRG 1 and 9 cases as mrTRG 2. All the patients received local extended excision of rectal cancer using TEM platform. A total of 19 cases(47.5%) suffered from complications within one month postoperatively. Clavien-Dindo grade I complications happened in 14 cases, grade II in 3 patients, and grade III in 2 cases, who all were healed by conservative treatment. Except that 2 patient presented severe low anterior resection syndrome (LARS) at 1 year postoperatively, no severe anal dysfunction was found in this cohort patients. EORTC QLQ CR29 scale results for quality of life showed that at 1 year after TEM excision, except taste (Z=-1.968, P=0.049), anxiety (Z=-3.624, P<0.001) and skin irritation (Z=-2.420, P=0.023) were worse than the situation before neoadjuvant therapy, there were no statistically significant differences in other assessment results between pre-operation and post-operation (all P>0.05). Postoperative pathological results indicated complete tumor regression (pTRG0) in 17 cases, moderate remission (pTRG1) in 13, and mild remission (pTRG2) in 10. During the follow-up of (49.1±29.6) months, 3 patients had local recurrence and 4 had distant metastasis (3 patients with liver metastasis and 1 patient with lung metastasis followed by liver metastasis). No death was found and the 5-year disease-free survival (DFS) was 84.3%. Conclusions: Local excision through TEM following nCRT not only can be adopted as an important means to accurately determine complete clinical remission (cCR), but also has high therapeutic value for rectal cancer patients presenting cCR or near cCR, with little impact on defecatory function and quality of life. However, the morbidity of complication of TEM excision after nCRT is relatively high and there is a risk of recurrence and metastasis. Therefore, it is still necessary to strictly select the indications of local excision.

Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): an open-label, randomised, phase 3 trial

In the KEYNOTE-177 study, pembrolizumab monotherapy provided statistically significant and clinically meaningful improvements in progression-free survival versus chemotherapy as first-line treatment in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. To further support the efficacy and safety findings of the KEYNOTE-177 study, results of the health-related quality of life (HRQOL) analyses are reported here. KEYNOTE-177 is an open-label, randomised, phase 3 trial being done at 192 cancer centres in 23 countries, in patients aged 18 years and older with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and who had not received previous systemic therapy for metastatic disease. Eligible patients were randomly assigned (1:1) centrally by use of interactive voice response or integrated web response technology to receive pembrolizumab 200 mg intravenously every 3 weeks or investigator's choice chemotherapy (mFOLFOX6 [leucovorin, fluorouracil, and oxaliplatin] or FOLFIRI [leucovorin, fluorouracil, and irinotecan] intravenously every 2 weeks with or without intravenous bevacizumab or cetuximab). Patients and investigators were not masked to treatment assignment. The primary endpoints were progression-free survival (previously reported) and overall survival (data to be reported at the time of the final analysis). HRQOL outcomes were evaluated as prespecified exploratory endpoints. The analysis population comprised all randomly assigned patients who received at least one dose of study treatment and completed at least one HRQOL assessment. HRQOL outcomes were mean change from baseline to prespecified week 18 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scale and item scores, and in the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) visual analogue scale and health utility scores; the proportion of patients with improved, stable, or deteriorated scores from baseline to prespecified week 18 in EORTC QLQ-C30 scales and items; and time to deterioration in EORTC QLQ-C30 global health status/quality of life (GHS/QOL), physical functioning, social functioning, and fatigue scores and EORTC QLQ-CR29 urinary incontinence scores. The threshold for a small and clinically meaningful mean difference in EORTC QLQ-C30 score was 5-8 points. This study is registered with ClinicalTrials.gov, NCT02563002 and is ongoing; recruitment is closed. Between Feb 11, 2016, and Feb 19, 2018, 307 patients were enrolled and randomly assigned to receive pembrolizumab (n=153) or chemotherapy (n=154). The HRQOL analysis population comprised 294 patients (152 receiving pembrolizumab and 142 receiving chemotherapy). As of Feb 19, 2020, median time from randomisation to data cutoff was 32·4 months (IQR 27·7-37·8). Least squares mean (LSM) change from baseline to prespecified week 18 showed a clinically meaningful improvement in EORTC QLQ-C30 GHS/QOL scores with pembrolizumab versus chemotherapy (between-group LSM difference 8·96 [95% CI 4·24-13·69]; two-sided nominal p=0·0002). Median time to deterioration was longer with pembrolizumab versus chemotherapy for GHS/QOL (hazard ratio 0·61 [95% CI 0·38-0·98]; one-sided nominal p=0·019), physical functioning (0·50 [95% CI 0·32-0·81]; one-sided nominal p=0·0016), social functioning (0·53 [95% CI 0·32-0·87]; one-sided nominal p=0·0050), and fatigue scores (0·48 [95% CI 0·33-0·69]; one-sided nominal p<0·0001). Pembrolizumab monotherapy led to clinically meaningful improvements in HRQOL compared with chemotherapy in patients with previously untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. These data, along with the previously reported clinical benefits, support pembrolizumab as a first-line treatment option for this population. Merck Sharp & Dohme, a subsidiary of Merck & Co, Kenilworth, NJ, USA.

Quality of life after rectal cancer surgery (systematic review)

Aim: search for modifiable and unmodifiable risk factors affecting the quality of life of patients after rectal cancer surgery.Materials and methods: the literature search was done according to the keywords: quality of life, rectal cancer, low anterior resection syndrome. Twelve prospective randomized studies, 2 cohort studies, and 2 meta-analyses are included in the study. The quality of life was assessed in the analyzed studies by using questionnaires for cancer patients and updated questionnaires for colorectal cancer: EORTC QLQ-CR29, QLQ-C30, QLQ-CR38, BIQ.Results: the literary data on influence of gender, age, surgery, stoma, and chemoradiotherapy on life quality of patients after rectal cancer surgery was analyzed.Conclusion: the most significant factor affecting the life quality of patients with rectal cancer is a violation of the body image if it is necessary to form the stoma on the anterior abdominal wall. The manifestations of the low anterior resection syndrome and the urination problems are significant risk factors in the case of restoration of bowel continuity.

Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method.

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients' organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients' representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

The Italian version of the LARS score: cross-cultural adaptation and validation. An Italian Society of Surgical Oncology-Colorectal Cancer Network (SICO-CCN) collaborative study.

The LARS score is an internationally well-accepted questionnaire to assess low anterior resection syndrome, but currently there is no formally validated Italian version. The purpose of this study was to test the reliability and validity of the Italian version among Italian patients submitted to sphincter-sparing surgery for rectal cancer. The English version of the LARS score was translated into Italian following the forward-and-back translation process. A total of 147 patients filled out our version. Among them, 40 patients answered the questionnaire twice for the test-retest reliability phase. The validity of the LARS score was tested using convergent and discriminant validity indicators by correlating the EORTC QLQ-C30 and QLQ-CR29 questionnaires. The LARS score capability to differentiate groups of patients with different demographic or clinical features was also assessed. The test-retest reliability was excellent in 87.5% of patients, remained in the same LARS category in both tests. The convergent validity phase showed a relevant relationship of the LARS score with the EORTC domains, which was significant for 7 of 15 EORTC QLQ-C30 subscales, and for 14 of 29 EORTC QLQ-CR29 subscales. The LARS score was able to discriminate patients who received radiotherapy (p = 0.0026), TME vs. PME (p = 0.0060), tumour site at < 10 cm from the anal verge (p = 0.0030) and history of protective stoma (p < 0.0001). The Italian version of the LARS score is a valid and reliable tool for measuring LARS in Italian patients after SSS for rectal cancer.

Determination of Quality of Life and Self-Care Agency in Patients Who Underwent Colorectal Cancer Surgery: A Prospective Descriptive Study

Knowledge about the relationship between quality of life and self-care among patients with colorectal cancer in Turkey is limited. This prospective, descriptive study evaluated the quality of life and self-care agency of patients who underwent surgery for colorectal cancer. Patients were recruited to participate preoperatively from the general surgery clinics in 2 hospitals in Turkey. Sociodemographic variables were collected preoperatively, and the Quality of Life Scale for Cancer Patients (EORTC QLQ-C30) Turkish Version 3.0, the Quality of Life Scale for Colorectal Cancer Patients (EORTC QLQ-CR29), and the Self-Care Agency Scale were completed preoperatively and at 1, 3, and 6 months postoperatively. Thirty-seven (37) patients (average age 59.49 years [±10.84]) who met the inclusion criteria participated in the study. The majority were male (22 patients; 60%), and 25 (67%) did not have a stoma postoperatively. Compared with preoperative scores, QLQ-C30 general well-being, functional status, physical functions, and role performance scores decreased in the first month after surgery and increased in the third and sixth months (58.3 [preoperative] vs 75.0 [month 3] vs 83.3 [month 6]; P = .000). The preoperative QLQ-CR29 excretory system pleasure scores were higher than the postoperative third- and sixth-month scores (1.7 [preoperative] vs 1.0 [month 3] vs 1.0 [month 6]; P = .001). The Self-Care Agency scores at 6 months were higher than the postoperative first month (109.62 ± 11.62 vs 115.19 ± 14.22; P = .006). A positive correlation was found between Self-Care Agency scores and functional status scores of the QLQ-C30 scale at 3 and 6 months postoperatively (P = .000). Quality of life and Self-Care Agency scores decreased immediately after surgery but increased in the following 6 months. A positive correlation was found between quality of life and self-care agency.

Characterisation of long-term cancer survivors and application of statistical cure models: a protocol for an observational follow-up study in patients with colorectal cancer

BackgroundImproved colorectal cancer (CRC) survival rates have been reported over the last years, with more than half of these patients surviving more than 5 years after the initial diagnosis. Better understanding these so-called long-term survivors could be very useful to further improve their prognosis as well as to detect other problems that may cause a significant deterioration in their health-related quality of life (HRQoL). Cure models provide novel statistical tools to better estimate the long-term survival rate for cancer and to identify characteristics that are differentially associated with a short or long-term prognosis. The aim of this study will be to investigate the long-term prognosis of CRC patients, characterise long-term CRC survivors and their HRQoL, and demonstrate the utility of statistical cure models to analyse survival and other associated factors in these patients.MethodsThis is a single-centre, ambispective, observational follow-up study in a cohort of n = 1945 patients with CRC diagnosed between 2006 and 2013. A HRQoL sub-study will be performed in the survivors of a subset of n = 485 CRC patients for which baseline HRQoL data from the time of their diagnosis is already available. Information obtained from interviews and the clinical records for each patient in the cohort is already available in a computerised database from previous studies. This data includes sociodemographic characteristics, family history of cancer, comorbidities, perceived symptoms, tumour characteristics at diagnosis, type of treatment, and diagnosis and treatment delay intervals. For the follow-up, information regarding local recurrences, development of metastases, new tumours, and mortality will be updated using hospital records. The HRQoL for long-term survivors will be assessed with the EORTC QLQ-C30 and QLQ-CR29 questionnaires.An analysis of global and specific survival (competitive risk models) will be performed. Relative survival will be estimated and mixture cure models will be applied. Finally, HRQoL will be analysed through multivariate regression models.DiscussionWe expect the results from this study to help us to more accurately determine the long-term survival of CRC, identify the needs and clinical situation of long-term CRC survivors, and could be used to propose new models of care for the follow-up of CRC patients.

Stereotactic Body Radiotherapy vs Transarterial Chemoembolization In Locally Advanced Hepatocellular Carcinoma (HERACLES: Hepatocellular Carcinoma Stereotactic Radiotherapy Clinical Efficacy Study)

Aim of this prospective trial (HERACLES Study) was to evaluate the role SBRT in comparison to TACE in patients with locally advanced hepatocellular carcinoma (HCC). Patients who were discussed in a multidisciplinary tumor board over a predefined period of 12 months were included in the study. Patients received SBRT when TACE was contraindicated, in case of progressive disease after TACE or when TACE was rejected by the patient. All other patients received TACE. The impact of predefined patient and treatment related factors on QOL (EORTC QLQ-C30 and EORTC QLQ-CR29) was evaluated. Primary endpoint was feasibility. Between 06/2016 and 06/2017 19 patients received TACE and 19 patients SBRT, of whom one patient dropped out during SBRT because of lung progression. In the TACE-arm the median age was 69 years, median tumor size was 32 mm and median Child-Pugh Score (CPS) 5 points; two patients were BCLC stage A, fourteen B and two C. Patients in the SBRT-arm had a median of 73 years, median tumor diameter was 52 mm and median CPS was 5 points, 9 patients were BCLC stage B and 9 C, 3 of them had a metastatic disease. A portal vein thrombosis was present in 6 patients only in the SBRT group. Seven patients in the TACE group received further TACEs and 1 patient a liver transplantation. In the SBRT group 1 and 2-year overall survival rate was 56% and 74% in the TACE group (p = 0.1). The 1-year local control rate (LCR) was 90% in the SBRT group and 70% in the TACE group (p = 0.2). There was no statistically significant difference in the QOL at baseline for both groups, and no difference between baseline and follow-up. One patient had a grade 5 fistula in the SBRT group and one patient had a grade 5 hepatic failure in the TACE group, 2 a hepatic failure grade 3, 1 grade 3 pancreatitis, 1 grade 3 cholangitis and one abscess in the TACE group. The primary endpoint feasibility was achieved with 38 patients included during 12 months in a single center. SBRT leads to good local control in far advanced HCC with acceptable toxicity compare with TACE despite of more advanced disease in the SBRT group.

Preoperative handgrip strength is not associated with complications and health-related quality of life after surgery for colorectal cancer

Colorectal cancer (CRC) treatment is associated with a high morbidity which may result in a reduced health-related quality of life (HRQoL). The pre-operative measurement of handgrip strength (HGS) might be a tool to predict the patient’s outcome after CRC surgery. The aim of this study was to evaluate the association of pre-operative HGS with the occurrence of postoperative complications and postoperative HRQoL. Stage I to III CRC patients ≥ 18 years were included at diagnosis. Demographic and clinical data as well as HGS were collected before start of treatment. HGS was classified as weak if it was below the gender-specific 25th percentile of our study population; otherwise HGS was classified as normal. The occurrence of postoperative complications within 30 days after surgery was collected from medical records. Cancer-specific HRQoL was measured 6 weeks after treatment using the EORTC QLQ-C30 and the EORTC QLQ-CR29 questionnaire. Of 295 patients who underwent surgical treatment for CRC, 67 (23%) patients had a weak HGS while 228 (77%) patients had normal HGS. 118 patients (40%) developed a postoperative complication. Complications occurred in 37% of patients with a weak HGS and in 41% of patients with a normal HGS (p = 0.47). After adjustment for age, sex, ASA, BMI and TNM, no significant associations between pre-operative HGS and the occurrence of postoperative complications and between HGS and HRQoL were found. We conclude that a single pre-operative HGS measurement was not associated with the occurrence of postoperative complications or post-treatment HRQoL in stage I–III CRC patients.

Ileocecal valve syndrome and vitamin b12 deficiency after surgery: a multicentric prospective study

Patients undergoing colon resection are often concerned about their functional outcomes after surgery. The primary aim of this prospective, multicentric study was to assess the intestinal activity and health-related quality-of-life (HRQL) after ileocecal valve removal. The secondary aim was to evaluate any vitamin B12 deficiency. The study included patients undergoing right colectomy, extended right colectomy and ileocecal resection for either neoplastic or benign disease. Selected items of GIQLI and EORTC QLQ-CR29 questionnaires were used to investigate intestinal activity and HRQL before and after surgery. Blood samples for vitamin B12 level were collected before and during the follow-up period. The empirical rule effect size (ERES) method was used to explain the clinical effect of statistical results. Linear mixed effect (LME) model for longitudinal data was applied to detect the most important parameters affecting the total score. A total of 158 patients were considered. Applying the ERES method, the analysis of both questionnaires showed clinically and statistically significant improvement of HRQL at the end of the follow-up period. Applying the LME model, worsening of HRQL was correlated with female gender and ileum length when using GIQLI questionnaire, and with female gender, open approach, and advanced cancer stage when using the EORTC QLQ-CR29 questionnaire. No significant deficiency in vitamin B12 levels was observed regardless of the length of surgical specimen. In our series, no deterioration of HRQL and no vitamin B12 deficiency were found during the follow-up period. Nevertheless, warning patients about potential changes in bowel habits is mandatory. In our series, no deterioration of HRQL and no vitamin B12 deficiency were found during the follow-up period. Nevertheless, warning patients about potential changes in bowel habits is mandatory.

Association of laparoscopic colectomy versus open colectomy on the long-term health-related quality of life of colon cancer survivors

BackgroundLaparoscopic colectomy (LC) is a less invasive alternative to open colectomy (OC) in the treatment of stage I–III colon cancer. Research on the long-term (5-year post-diagnosis) health-related quality of life (HRQOL) of LC patients is scarce. Our study aimed to compare the long-term HRQOL and psychological well-being of stage I–III colon cancer survivors treated either with LC or OC.MethodsThis study used a German population-based cohort of patients treated with either LC (n = 86) or OC (n = 980). LC patients were matched to OC patients using a propensity score. At 5-year follow-up, patients completed assessments on HRQOL (EORTC QLQ-C30 and EORTC QLQ-CR29) and psychological well-being (distress and disease/treatment burden). Least square mean scores of HRQOL were derived using linear regression. Proportions of patients with moderate/high distress and disease/treatment burden were compared with Chi-square tests.ResultsIn total, 81 LC patients were matched to 156 OC patients. Generally, LC patients had HRQOL comparable to OC patients, albeit LC patients reported significantly better body image (87.1 versus 81.0, p = 0.03). Distress levels were generally low and comparable between the two groups, even though LC patients were more likely to experience disease recurrence (16% versus 7%, p = 0.02) than OC patients. OC patients were more likely to feel moderate/high levels of burden associated with the treatment (72% versus 56%, p = 0.01) and the time after treatment completion (43% versus 28%, p = 0.02).ConclusionLC patients reported comparable long-term HRQOL outcomes but higher levels of psychological well-being than OC patients 5 years after diagnosis, even though LC was associated with higher risk of disease recurrence.

Translation and Validation of the Sinhala Version of the EORTC-QLQ-CR29 Questionnaire.

Purpose:To validate the Sinhalese version of the EORTC QLQ-CR29 quality of life questionnaire for colorectal cancer. Method:We translated and pilot-tested (n=10) the questionnaire in Sri Lanka. We then assessed the reliability, factor structure and construct validity according to the EORTC guidelines. The testing was done in two tertiary care hospitals in Sri Lanka. Results:Of 110 participants, 103 (93%) returned the questionnaire, and 15 out of 20 (75%) returned the repeat-test questionnaire within a period of two weeks. Out of the original four scales three had better reliability than the original scales: urinary frequency (Cronbach α - 0.82), blood and mucus in stools (α-0.85), defaecation problems (α-0.76). The body image scale showed low reliability (α – 0.33). However, when one of the 3 items in the scale was omitted, it showed sufficient reliability (α – 0.74). Factor analysis showed good reliability for overall assessment of the two item scale for stool frequency (α – 0.82) and six item scale for defaecation problems (α – 0.76). Correlations between the subscales of CR29 and C30 questionnaires were below 0.40, except for body image, which correlated moderately (r-0.44) with emotional functioning. This confirmed satisfactory overall construct validity Conclusion:The scales for urinary frequency, blood and mucus in stools and defaecation problems which were reliable and had good validity. Body image scale failed to show sufficient reliability with the three-item scale and we suggest omitting one of the items to improve the overall reliability of the questionnaire. Construct validity was comparable to published data.

659P - Quality of life (QoL) in metastatic colorectal cancer (mCRC) in the real world: Final results of a European survey

BackgroundDigestive Cancers Europe (DiCE), a European digestive cancer patients umbrella organization, planned and executed a cross-sectional survey in 15 European countries on the Unmet Needs of Patients Living with mCRC to examine the challenges and needs and QoL of those living with mCRC. MethodsDiCE partner organisations, together with clinicians and nurses recruited patients for the survey (paper-based and online). The survey included demographics, data on discovery of the disease, diagnosis and treatment and the EORTC QLQ-C30 and CR29. Single data entry from the paper surveys was done by DiCE. Descriptive statistics and regression analyses were run to examine the global QoL score, function (F) - and symptom-specific scores, the item on financial difficulties and CR29 scores and their association with patient and disease characteristics and care setting by country and overall. Results883 surveys from Austria, Belgium, Cyprus (CY), Germany, Hungary (HU), Italy, Netherlands (NL), Norway, Serbia (RS), Poland, Spain (SP), UK, Portugal, Turkey and Ireland were collected. Only 8 countries with samples over 35 were analyzed on their own. Completion rates across QoL items were high (91-94%). Large variation across countries have been observed in mean scores (Table). Eastern vs Western Europe contrasted sharply, with Serbia and Poland reporting lower functional and much higher symptom scores for fatigue, nausea, vomiting, pain and insomnia. Regression analyses indicated that after adjustment for age, gender and care setting country differences remained significant. Patterns in results across dimensions of EORTC QLQ-CR29 were similar.Table659PTableMean (SD)Global QoLPhysical FRole FEmotional FCognitive FSocial FLowest score55.94 (21.10) RS69.06 (23.93) CY62.58 (34.73) CY53.51 (28.35) RS71.31 (24.6) RS54.04 (25.91) RSHighest score69.26 (20.68) HU84.29 (17.87) SP81.76 (25.41) SP80.92 (21.04) NL87.86 (19.13) HU80.91 (24.63) HUOVERALL62.02 (21.75)74.25 (20.85)71.41 (28.76)68.25 (26.41)78.58 (23.39)68.56 (28.99) ConclusionsCountry specific mean QoL scores in all function/symptom dimensions varied greatly across countries. This study indicates that care setting and other country-specific circumstances have important associations to QoL. Real-world mCRC patients’ QoL may be lower than those recruited in clinical trials. Legal entity responsible for the studyEuropaColon / Digestive Cancers Europe. FundingMerck, BMS, Sandoz and Sirtex. DisclosureAll authors have declared no conflicts of interest.

Mapping EORTC-QLQ-C30 and QLQ-CR29 onto EQ-5D-5L in Colorectal Cancer Patients.

Patient-level utility data are needed for cost-utility analysis; in oncology, however, the data are commonly gathered using disease-specific questionnaires that are often not appropriate. Present study aimed to derive an algorithm which can map the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) scales and the Colorectal Cancer-Specific Quality Of Life Questionnaire (QLQ-CR29) scales onto the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) values in patients with colorectal cancer (CRC). Using the Ordinary Least Square (OLS) model, a cross-sectional dataset of 252 patients with CRC were gathered from three academic centers of cancer treatment in Tehran in 2017. The predicted R2 (Pred R2) and adjusted R2 (Adj R2) are used to evaluate model goodness of fit. Additionally, mean absolute error (MAE), root mean square error (RMSE), Spearman's correlation coefficients (ρ), and intraclass correlation (ICC) are applied to assess predictive ability of models. The tenfold cross-validation procedure was applied for validation models. According to the results of our study, the model C4 from EORTC QLQ-C30 was the best predictive model (Pred R2 = 66.57%, Adj R2 = 67.67%, RMSE = 0.10173, MAE = 0.07840). Also, the model R4 from QLQ-CR29 performed the best for EQ-5D-5L (Adj R2 = 48.42%, Pred R2 = 45.54%, MAE = 0.10051, RMSE = 0.12997). The mapping algorithm successfully mapped the EORTC QLQ-C30 and QLQ-CR29 scales onto the EQ-5D-5L values; therefore, it enables policymakers to convert cancer-specific questionnaires scores to the preference-based scores.

Health-related quality of life in Slovenian patients with colorectal cancer: a single tertiary care center study.

BackgroundThe aim of this study was to evaluate the influence of the surgical treatment on Slovenian colorectal cancer patients’ health-related quality of life and to compare the results to the health-related quality of life of the general Slovenian population.Patients and methodsA total of 413 patients with colorectal cancer operated on at the Abdominal Surgery Department at the Ljubljana University Medical Center between January 1st, 2016 and December 31st, 2017 were sent two standardized and validated questionnaires: the EORTC QLQ-C30 version 3 and EORTC QLQ-CR29. The questionnaires were returned by 197 patients.ResultsCompared to the general population, poorer physical (p < 0.001), role (p = 0.002), cognitive (p = 0.021), and social functioning (p < 0.001) with higher frequency of constipation (p < 0.001), diarrhea (p < 0.001), and financial difficulties (p < 0.001) were reported by the colorectal patients. Female patients reported lower cognitive (p = 0.034) and emotional (p = 0.008) functioning, as well as higher frequency of bloating (p = 0.049) and hair loss (p = 0.01). Compared to the younger group of patients, lower physical functioning (p < 0.001) and higher urinary frequency (p = 0.007), urinary incontinence (p = 0.007), buttock pain (p = 0.007), and anxiety regarding body weight (p = 0.031) were detected among the older group of colorectal patients.ConclusionsThe global health status of colorectal patients in Slovenia is comparable to that of the general Slovenian population, but there is a significantly lower level in some of the quality-of-life scales.

Quality of life following salvage surgery for squamous cell carcinoma of the anus

IntroductionSquamous cell carcinoma of the anus is a rare condition. First line treatment is combined chemo-radio therapy. As many as a third of patients undergoing chemo-radiotherapy will experience recurrence. These patients often undergo salvage surgery with an extended abdominoperineal excision. The aim of this study was to examine the quality of life in disease free survivors following salvage surgery for squamous cell carcinoma of the anus. Material and methodsPatients undergoing salvage surgery for SCCA at Copenhagen University Hospital Herlev between 1st of January 2011 and 31st December 2016 were identified and quality of life was assessed with EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires. Results47 patients underwent salvage surgery for relapse or residual tumor in the period. From this cohort 25 disease-free survivors were identified. Fourteen (56%) patients returned a completed questionnaire. Overall median global health status was 75(range 20–100). Functional scores were generally high. In General, symptom scores were low, however all men reported impotence with a median symptom score of 100(range 67–100) and half the women reported dyspareunia. Urinary impairment was present in half the patients. Abdominal and buttock pain scores were low. ConclusionQuality of life following salvage surgery for squamous cell carcinoma of the anus is affected but at an acceptable level. However, there are considerable side-affects in the form of impotence, dyspareunia and urinary impairment.

Colorectal cancer survivors: an investigation of symptom burden and influencing factors

BackgroundColorectal cancer is a significant issue internationally, with over 1.3 million people diagnosed annually. Survival rates are increasing as treatments improve, although physical symptoms can persist despite eradication of the tumour. In order to optimize survivorship care, further research is warranted in relation to symptom burden. Therefore, the objectives of this study are to (i) investigate frequency of physical symptoms in colorectal cancer survivors (ii) identify which symptoms occur together (iii) examine the associations between demographic and clinical variables, and symptoms.MethodsParticipants nine months to three years post diagnosis were identified from the population-based National Cancer Registry Ireland. Respondents completed the EORTC QLQ-C30 and EORTC QLQ-CR29. Reported physical symptom frequencies were transformed into continuous scale variables, which were then analysed using one way analysis of variance, general linear modelling and Spearman rank correlations.ResultsThere were 496 participants. Fatigue, insomnia and flatulence were the most frequent symptoms, with ≥20% of respondents reporting these to be often present in the previous week. Eight other symptoms were experienced often by 10–20% of respondents. At least one of these eleven most common symptoms was experienced frequently by almost every respondent (99%). 66% of respondents experienced at least two of these symptoms together, and 16% experienced five or more together. Current stoma was the single most common variable associated with increased symptom scores, although statistically significant relationships (p ≤ 0.05) between symptom frequency scores and clinical/demographic variables were generally weak (R-sq value ≤0.08).ConclusionFindings may inform targeted interventions during the nine month to three year post diagnosis timeframe, which would enable supported self-management of symptoms.

PCN76 - Transcultural Adaptation of EORTC-QLQ-CR29 Scale into Turkish, and Assessment of Validity and Reliability in Turkish Patients with Colorectal Cancer

. This study was conducted to perform the transcultural adaptation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) into Turkish, and to assess its validity and the reliability in Turkish colorectal cancer patients. . All necessary steps for forward-backward translation and pilot testing of the scale was performed in accordance with the procedures by EORTC-QLQ group. Each translated item was pilot-tested on 20 patients (12 male, 8 female) diagnosed with colorectal carcinomas (ICD-10: C18-C20), whom all were native speakers in Turkish. All of the patients were interviewed in the hospital, either in outpatient chemotherapy unit, or during outpatient policlinic visit. Following transcultural adaptation phase, test-retest assessments were completed by using Turkish versions of QLQ-C30 and CR-29 scales. . A total of 328 patients have completed the EORTC core quality of life scale (QLQ-C30), and QLQ-CR29. Retest procedure was completed with 120 of these patients. Mean age of the patients was 59±10.7 years, and 70.4% were males. Age distribution was similar between sexes (p=0.10). Overall internal consistency of QLQ-CR29 was satisfactory (a=0.895) for male patients. The sexual interest domain in females was found to be problematic and decreased the overall consistency of the scale (a=0.324). Overall test-retest reliability was satisfactory, and inter-item correlations (r) ranged between 0.56 to 0.84. Correlations between QLQ-C30 domains and CR-29 domains were moderate (r=0.32 to r=0.56). CR29 scale had ability to distinguish between males and females, and patients with and without a stoma. . Turkish version of the EORTC-CR29 scale was found to be a valid and reliable tool to assess the quality of life of the patients with colorectal cancer. Evaluators should be aware of the underassessment in sexual interest domain for female patients.

Comparative analysis of quality of life after laparoscopic and open procedures for upper and middle rectal cancer

Background. In the last decades laparoscopic technologies have been actively implemented for rectal cancer surgery, however randomized control trials have not demonstrated overt advantages of laparoscopic technique comparing to open surgery. The improvement of quality of life is expected to be one of advantages of laparoscopic approach. Objective: a prospective study of the dependence of the quality of life on the type of operative access (open or laparoscopic) in patients with rectal cancer after low anterior resection of the rectum. Materials and methods. There were 30 patients in the study: 20 of them were operated laparoscopically and 10 were underwent open surgery. The current versions of the general questionnaire EORTC QLQ-C30 and the special module for patients with colorectal cancer EORTC QLQ-CR29 were used in the study, that were filled on the day before the surgery and also on days 3, 7 and 60 after the surgery. Results. In the first 7 days after laparoscopic operations patients had less frequent dysuric dysfunctions (p = 0.047), less pain syndrome (p = 0.0005) and flatulence (p = 0.007) comparing to open operations. At 60 days after surgery patients that were operated laparoscopically were satisfied by their appearance more often (p = 0.047) than patients after open surgery, more rarely had anxiety (p = 0.007) and discomfort in the area of postoperative wounds (p = 0.079). Conclusion. It has been proven that laparoscopic surgery of rectal cancer evidently improves quality of life in postoperative period.