European Organization For The Research And Treatment Of Cancer Research Articles

Translation and validation of the Hindi, Marathi, and Bangla versions of the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire: Anal Cancer (QLQ-ANL27) module: A prospective cohort study

Background: The European Organization for the Research and Treatment of Cancer (EORTC) has developed a commonly used validated questionnaire specific to anal cancer (EORTC QLQ-ANL27). It is used as an adjunct to the core EORTC quality-of-life (QoL) questionnaire QLQ-C30. This validated questionnaire was not available in any Indian language, and therefore, Indian patients not familiar with English could not fill it. Objective: We aimed to translate and validate the EORTC QLQ-ANL27 module in Hindi, Marathi, and Bangla languages. Materials and Methods: This study was conducted in the Department of Radiation Oncology at the Tata Memorial Hospital, a tertiary cancer center in Mumbai, India, from September 01, 2022, to March 31, 2023. The QLQ-ANL27 questionnaire was translated into Hindi, Marathi, and Bangla languages using the standard EORTC guidelines. The overall process comprised two independent forward translations of the original English questionnaire into the target languages, followed by reconciliation between the two forward translations. The reconciled version was then back translated to English. The report generated was sent to the EORTC translation unit (TU) for review. Once approved by the EORTC TU, these translated versions were pilot tested on 30 patients (10 for each language) with cancer of the rectum or anal canal. After responding to the questionnaires, each patient was individually interviewed to explore any difficulty encountered while answering the QoL questionnaire. The interviewer specifically asked whether the patients found any words or sentences difficult to answer, confusing, or upsetting, and for suggestions on better phrasing. Results: The EORTC QLQ-ANL27 was translated to Hindi, Marathi, and Bangla, followed by back translation into English within a period of 2 months between September 2022 and October 2022. The translated versions were approved by the EORTC TU in October 2022. Validation of the translated versions was conducted between December 2022 and March 2023 in 30 patients diagnosed with anorectal cancer. The median age of the patients was 55 (interquartile range, 29–77); the male-to-female ratio was 2:1. There were no suggestions or doubts in the Hindi, Marathi, and Bangla questionnaires during the pilot testing. After reviewing the pilot testing reports, the EORTC TU approved the translated versions of QLQ-ANL27. The reliability of the translated questionnaires was confirmed using Cronbach’s alpha, which were 0.838, 0.743, and 0.808 for the Hindi, Marathi, and Bangla versions, respectively. Conclusions: The Hindi, Marathi, and Bangla translations of the QLQ-ANL27 module have been validated and approved by the EORTC and are now available for use (Clinical Trials Registry-India, CTRI/2022/12/047970).

Short-Term Outcomes and Quality of Life Following Minimally Invasive Esophagectomy in a Tertiary Care Center in Southern India.

With the advent of multimodality therapy and minimally invasive surgical approaches, patients suffering from carcinoma esophagus are showing promising outcomes. Hence, the frontier needs to be widened to assess the postoperative quality of life (QoL) of those surviving carcinoma esophagus. The objective of the study was to determine the short-term outcomes of minimally invasive esophagectomy (MIE) /hybrid esophagectomies in carcinoma esophagus and the organ-specific QoL in survivors of MIE for carcinoma esophagus, and to compare health-related QoL in patients following MIE for carcinoma esophagus with the general population. A longitudinal study design was used to evaluate the short-term postoperative outcomes of patients undergoing MIE for carcinoma esophagus between July 1, 2021, to July 15, 2022, and analyze the QoL of those patients who survived at one year without tumor recurrence. QoL was assessed using the European Organization for the Research and Treatment of Cancer (EORTC) QoL Questionnaire (EORTC QLQ-C30) and the EORTC QoL Questionnaire - Oesophageal Cancer Module (EORTC QLQ-OES18). A total of 15 patients who underwent minimal invasive/hybrid esophagectomy for esophageal carcinomawere included. Of these, 13 patients underwent hybrid esophagectomy while two patients underwent thoraco-laparoscopic esophagectomy. Squamous cell carcinoma was observed as the most common histological variant (60%) while 33% were adenocarcinoma and 6.7% lymphoma. The most common site of the tumor was the lower one-third esophagus (60%). Nine out of 15 patients developed postoperative complications needing prolonged ICU stay. One major anastomotic leak as well as one conduit necrosis was observed among 15 cases operated. Median length of hospital stay was 16 (IQR 12-24). QoL was assessed among 12 patients at the one-year follow-up excluding mortality cases and patients with tumor recurrence. The patients following MIE for carcinoma esophagus were observed to have low scores in physical functioning, role functioning, and social functionwhen compared with the general population. Cognitive functioning and emotional function were not found to be significantly different. No statistically significant difference was observed in the global health status among the two groups. There was no significant difference found in the general symptoms score comparison of the MIE patients with the general population. When it comes to organ-specific symptom scales, reflux was observed as a major issue among the patients who survived carcinoma esophagus after undergoing MIE. Dysphagia and dry mouth received low scores suggestive of minor issues. Though analysis of global health QoL scores of those with postoperative complications and those who had uneventful recovery at one year revealed a higher score for the latter, it was not statistically significant. Postoperative complications can prolong hospital stay, delay resuming normal work, and affect the global QoL of patients compared with those who recovered uneventfully. Physical and role functions were observed to be deficient among survived patients when compared with the normal population. Nutritional prehabilitation, cutting-edge surgical practice including minimally invasive techniques, minimizing deviation from normal postoperative recovery by high-quality ICU care, and postoperative rehabilitation are the cornerstones to ensure better QoL.

Serial Changes in Parotid Gland Volume and Symptoms After Radiation Therapy in Oropharyngeal Cancer.

Objective: To evaluate the serial changes in the volume of the parotid gland and clinical symptoms after a course of radiation therapy (RT) in patients with oropharyngeal cancer. Methods: A total of 33 patients who were diagnosed with oropharyngeal cancer and had been treated with RT or concurrent chemoradiation therapy were evaluated. Parotid gland volumes were measured serially by head and neck computed tomography with contrast-enhanced images before RT, and 6 months, 1 year, and 2 years after RT. Patients also filled out EORTC (European Organization for the Research and Treatment of Cancer) QLQ-C30 questionnaires on the quality of life (QOL) at the same time. This questionnaire included questions about salivary gland function: dry mouth, sticky saliva, and taste disorder. Higher scores on EORTC questionnaire translates to worse QOL. Results: All patients received more than 60 Gy irradiation in total. The mean volume of parotid gland decreased from 23.30 mL before RT to 15.80 mL, 15.93 mL, and 16.67 mL after 6 months, 1 year, and 2 years, respectively (P < 0.001 between pre-RT and all other 3 periods). The scores on the QOL questionnaire were higher (worsened QOL) at all 3 times after radiation than in the pre-RT period. The mean score of QOL increased from pre-RT to 2 years post-RT: "dry mouth" from 1.65 to 2.70, "sticky saliva" from 1.19 to 2.00, and "taste disorder" from 1.12 to 1.94. All 3 of these parameters were correlated with the volume of the parotid gland (P < 0.005 each). Conclusions: The volume of the parotid gland decreases significantly after RT for oropharyngeal cancer and does not recover significantly for at least 2 years. There was a significant correlation between decreased parotid volume and a lower QOL involving salivation.

Quality of life among colorectal cancer survivors participating in a pilot randomized controlled trial of a web-based dietary intervention with text messages

PurposeWe aimed to estimate the effect of a 12-week web-based dietary intervention with text messages on quality of life (QoL) among colorectal cancer (CRC) survivors.MethodsBetween 2017 and 2018, 50 CRC survivors were randomized (1:1) to receive a 12-week web-based dietary intervention with daily text messages or wait-list control. Health-related QoL was assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Core 30 (QLQ-C30) and colorectal quality of life module (QLQ-CR29) at baseline, 12, and 24 weeks. Within- and between-group mean changes in health-related QoL with 95% confidence intervals (CI) were calculated for both arms.ResultsCompared to the controls, participants receiving the intervention had an improvement in emotional functioning (mean change: 14.3; 95% CI: 3.0, 25.6) at 12 weeks and social functioning (mean change: 13.8; 95% CI: 2.1, 25.5) at 24 weeks. A decrease of fatigue from baseline was also observed in the intervention arm (mean change: − 9.1; 95% CI: − 17.1, − 1.1) at 24 weeks. No other changes in QoL scores were associated with the intervention.ConclusionCRC survivors randomized to receive a web-based dietary intervention with text messages experienced higher emotional and social functioning. Further study with a larger population may be warranted.Trial registrationclinicaltrials.gov, NCT02965521. Registered 16 November 2016, https://clinicaltrials.gov/ct2/keydates/NCT02965521

Correlation between Quality of Life and Burden in Caregivers of Advanced Stage Cancer Patients on Best Supportive Care.

Patients with advanced cancer with incurable diseases are generally cared for by their families in India. There is a lack of data on the perceived caregiver burden, quality of life (QOL) of patients and caregivers in India, especially among cancer patients not on any oncologic management. We conducted a cross-sectional study among 220 patients of advanced cancer on best supportive care and their respective 220 family caregivers. Our primary objective was to identify a correlation between caregiver burden and QOL. After taking informed consent from both patients and caregivers, we assessed the QOL of the patient using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative Care (QLQ C15PAL) questionnaire from the patient, assessing the Caregiver Burden using Zarit Burden Interview, assessing the QOL of the caregiver using the WHO QOL BREF Questionnaire, in a single session during their routine follow-up in the Palliative Care Clinic of our institution. We noticed a statistically significant negative (Spearman) correlation between the Caregiver Burden as assessed by Zarit Burden Interview (ZBI) and the psychological (r = -0.302, P < 0.01), social (r= -0.498, P < 0.01) and environmental (r = -0.396, P < 0.01) domains of the WHO QOL BREF Questionnaire. Caregiving Burden as assessed ZBI total score was noted to have a statistically significant negative correlation with physical functioning (r = -0.37, P < 0.01), emotional functioning (r = -0.435, P < 0.01) and global QOL scores (r = -0.499, P < 0.01) assessed from the patient using the EORTC QLQ C15 PAL questionnaire. It also had a statistically significant small positive correlation with EORTC QLQ C15 PAL symptom scores, such as dyspnoea, insomnia, constipation, nausea, fatigue and pain. The median caregiver burden score was 39, showing higher burden as compared to previous studies. Caregivers who were spouses of the patient, illiterate, homemakers, with low-income families reported higher burden. A high perceived caregiving burden is associated with impaired QOL in family caregivers of advanced cancer patients on best supportive care. Multiple patient related factors and demographic factors tend to affect burden of the caregiver.

Adherence to Contouring and Treatment Planning Requirements Within a Multicentric Trial: Results of the Quality Assurance of the SAKK 09/10 trial

To evaluate the results of the radiation therapy (RT) quality assurance (QA) program of the phase 3 randomized SAKK 09/10 trial in patients with biochemically recurrent prostate cancer after prostatectomy. Within the Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK) 09/10 trial testing 64-Gy versus 70-Gy salvage RT, a central collection of treatment plans was performed and thoroughly reviewed by a dedicated medical physicist and radiation oncologist. Adherence to the treatment protocol and specifically to the European Organization for the Research and Treatment of Cancer (EORTC) guidelines for target volume definition (classified as deviation observed yes vs no) and its potential correlation with acute and late toxicity (Common Terminology Criteria for Adverse Events version 4.0) and freedom from biochemical progression (FFBP) were investigated. The treatment plans for 344 patients treated between February 2011 and April 2014 depicted important deviations from the EORTC guidelines and the recommendations per trial protocol. For example, in up to half of the cases, the delineated structures deviated from the protocol (eg, prostate bed in 48.8%, rectal wall [RW] in 41%). In addition, variations in clinical target volume (CTV) and planning target volume (PTV) occurred frequently (eg, CTV and PTV deviations in up to 42.4% and 25.9%, respectively). The detected deviations showed a significant association with a lower risk of grade ≥2 gastrointestinal acute toxicity when the CTV did not overlap the RW versus when the CTV overlapped the RW (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.22-0.85; P=.014), and a higher rate of grade ≥2 late genitourinary (GU) toxicity when the CTV overlapped the RW (OR, 2.58; 95% CI, 1.17-5.72; P=.019). A marginally significant lower risk of grade ≥2 late GU toxicity was observed when the prostate bed did not overlap versus did overlap the RW (OR, 0.51; 95% CI, 0.25-1.03; P=.06). In addition, a marginally significant decrease in FFBP was observed in patients with PTV not including surgical clips as potential markers of the limits of the prostate bed (hazard ratio, 1.44; 95% CI, 0.96-2.17; P=.07). Despite a thorough QA program, the central review of a phase 3 trial showed limited adherence to treatment protocol recommendations, which was associated with a higher risk of toxicity by means of acute or late gastrointestinal or GU toxicity and showed a trend toward worse FFBP. Data from this QA review might help to refine future QA programs and prostate bed delineation guidelines.

Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC

AbstractThe number of patients with primary cutaneous lymphoma (PCL) relative to other non-Hodgkin lymphomas (NHLs) is small and the number of subtypes large. Although clinical trial guidelines have been published for mycosis fungoides/Sézary syndrome, the most common type of PCL, none exist for the other PCLs. In addition, staging of the PCLs has been evolving based on new data on potential prognostic factors, diagnosis, and assessment methods of both skin and extracutaneous disease and a desire to align the latter with the Lugano guidelines for all NHLs. The International Society for Cutaneous Lymphomas (ISCL), the United States Cutaneous LymphomaConsortium (USCLC), and the Cutaneous Lymphoma Task Force of the European Organization for the Research and Treatment of Cancer (EORTC) now propose updated staging and guidelines for the study design, assessment, endpoints, and response criteria in clinical trials for all the PCLs in alignment with that of the Lugano guidelines. These recommendations provide standardized methodology that should facilitate planning and regulatory approval of new treatments for these lymphomas worldwide, encourage cooperative investigator-initiated trials, and help to assess the comparative efficacy of therapeutic agents tested across sites and studies.

Quality of life with first-line pembrolizumab for PD-L1–positive advanced gastric/gastroesophageal junction adenocarcinoma: results from the randomised phase III KEYNOTE-062 study

BackgroundIn the randomised phase III KEYNOTE-062 study, pembrolizumab was non-inferior to chemotherapy for overall survival in patients with programmed death-ligand 1 (PD-L1)-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (GEJ) cancer. We present findings of prespecified health-related quality-of-life (HRQOL) analyses for pembrolizumab versus chemotherapy in this population.Materials and methodsHRQOL, a secondary endpoint, was measured in patients who received ≥1 dose of study treatment and completed ≥1 HRQOL questionnaire [European Organisation for the Research and Treatment of Cancer (EORTC) 30-question quality-of-life (QLQ-C30), EORTC 22-question quality-of-life gastric-cancer-specific module (QLQ-STO22)]. Least squares mean (LSM) change (baseline to week 18) in global health status/quality of life (GHS/QOL; EORTC QLQ-C30) and time to deterioration (TTD) in GHS/QOL, nausea/vomiting and appetite loss scores (EORTC QLQ-C30) and abdominal pain/discomfort scores (EORTC QLQ-STO22) were evaluated.ResultsThe HRQOL population comprised 495 patients with CPS ≥1 (pembrolizumab, 252; chemotherapy, 243). Compliance rates at week 18 were similar for pembrolizumab and chemotherapy (EORTC QLQ-C30, 87.9% and 81.9%; EORTC QLQ-STO22, 87.9% and 81.3%, respectively). There was no between-arm difference in LSM score change in GHS/QOL [−0.16; 95% confidence interval (CI) −5.01 to 4.69; P = 0.948]. The LSM score change for most subscales showed comparable worsening in both arms. TTD for GHS/QOL [hazard ratio (HR), 0.96; 95% CI, 0.67-1.38; P = 0.826], appetite loss (HR, 0.83; 95% CI, 0.58-1.20; P = 0.314) and pain (HR, 1.22; 95% CI, 0.78-1.91; P = 0.381) were similar between arms. Longer TTD was observed for pembrolizumab versus chemotherapy for nausea/vomiting (HR, 0.61; 95% CI, 0.44-0.85; P = 0.003).ConclusionsHRQOL was maintained with first-line treatment with pembrolizumab in patients with PD-L1–positive advanced gastric/GEJ cancer and was similar between pembrolizumab and chemotherapy in this population.

Observational cohort study in older women with early breast cancer: Use of radiation therapy and impact on health-related quality of life and mortality

BackgroundRadiotherapy reduces in-breast recurrence risk in early breast cancer (EBC) in older women. This benefit may be small and should be balanced against treatment effect and holistic patient assessment. This study described treatment patterns according to fitness and impact on health-related quality-of-life (HRQoL). MethodsA multicentre, observational study of EBC patients aged ≥ 70 years, undergoing breast-conserving surgery (BCS) or mastectomy, was undertaken. Associations between radiotherapy use, surgery, clinico-pathological parameters, fitness based on geriatric parameters and treatment centre were determined. HRQoL was measured using the European Organisation for the Research and Treatment of Cancer (EORTC) questionnaires. ResultsIn 2013–2018 2811 women in 56 UK study centres underwent surgery with a median follow-up of 52 months. On multivariable analysis, age and tumour risk predicted radiotherapy use. Among healthier patients (based on geriatric assessments) with high-risk tumours, 534/613 (87.1%) having BCS and 185/341 (54.2%) having mastectomy received radiotherapy. In less fit individuals with low-risk tumours undergoing BCS, 149/207 (72.0%) received radiotherapy. Radiotherapy effects on HRQoL domains, including breast symptoms and fatigue were seen, resolving by 18 months. ConclusionRadiotherapy use in EBC patients ≥ 70 years is affected by age and recurrence risk, whereas geriatric parameters have limited impact regardless of type of surgery. There was geographical variation in treatment, with some fit older women with high-risk tumours not receiving radiotherapy, and some older, low-risk, EBC patients receiving radiotherapy after BCS despite evidence of limited benefit. The impact on HRQoL is transient.

Health Related Quality of Life and Biochemical Markers for Cachexia Evaluation in Head and Neck Cancer Patients

Cachexia is a multifactorial syndrome related to unintentional weight loss and to loss of muscle and fat mass. In head and neck cancer (HNC) its incidence is important and not only related to a deficient intake of food due to the impact of the disease in the vital functions. A complex disturbance in the normal metabolism of the patient promotes a persistent inflammatory state and a shifting in the metabolism balance toward a catabolic predominance affecting primarily the skeletal muscle. This leads to severe impairment of the functional, emotional and social status and quality of life of the patients that will compromise response to treatment and the disease prognosis. Understanding this deleterious syndrome and mainly identifying it in early stages of the disease is of a major importance in achieving better outcomes to head and neck cancer patients. This study pretends to identify clinical aspects related to cachexia in HNC in a clinical perspective for application on the routine clinical practice. In our study, 30 HNC patients were enrolled and evaluated in terms of nutritional values (actual and loss of weight in the past 6 months, body mass index (BMI), nutritional risk index (NRI), malnutrition universal screening tool), serum biochemical markers (albumin, total proteins, cholesterol, triglycerides, urea, C-reactive protein (CRP), interleukin-6 (IL-6), tumour necrosis factor-α (TNF-α) and myostatin) and health related quality of life (HRQoL) evaluation (using European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ): EORTC QLQ-C30 and EORTC QLQ-HN43). A minimum follow-up of 48 months was considered for all patients. Our results showed that NRI is a good and sensitive index to identify cachexia. This index uses two parameters, one constitutional (loss of weight) and one biochemical (level of serum albumin). According to this criterion, 16 patients were assigned to the No-cachexia group and 14 patients to the Cachexia group. Significant differences in the constitutional and nutritional values between the two groups were found: the median weight loss was 4.44 kg in the No-cachexia group and 11.29 kg in the Cachexia group, while the BMI was 21.88 and 18.33, respectively. In terms of biochemical markers, significant low values of albumin and cholesterol in the Cachexia group were encountered when compared to the No-cachexia group. Regarding the inflammatory and cachexia biomarkers studied, the results show that patients in the Cachexia group had significantly higher levels of CRP and of the proinflammatory cytokines IL-6 and TNF-α and presented significantly raised levels of the myostatin. In terms of HRQoL evaluation, the scores of the EORTC QLQ-C30 revealed that all the scales and the Summary Score showed lower scores in the Cachexia group, indicating worst quality of life evaluation. The items scores were globally higher in the Cachexia group indicating more important problems related to those items in the Cachexia group. The difference encountered between the groups was significant (p < 0.001) in all considered scales but two: Dyspnoea and Constipation. Considering the EORTC QLQ-HN43 all the scales and in all single items but one (Wound Healing) the scores were higher in the Cachexia group, indicating a worst degree of problems affecting these group of patients. The difference found between the groups was significant (p < 0.001) in all scales and items but six: Dry Mouth and Sticky Saliva, Skin problems, Problems with Teeth, Trismus, Social Contact and Wound Healing. There were no significant differences in the clinical presentation of the disease between the two groups. The median survival was of 13.5 months in the Cachexia group, significantly lower when compared to the No-cachexia group (p < 0.0001), confirming the major impact of cachexia in survival and clinical outcomes in HNC patients. These results of our study show that HRQoL evaluation and serum biochemical markers are sensitive and important tools in identifying and screening cachexia in HNC patients. The methodology followed in this study correlating HRQoL with biochemical markers supports the development of clinical protocols in HNC that include cachexia evaluation. Hopefully this new approach can help to improve prognosis of the disease.

Choosing the right survey: the lung cancer surgery.

Radical and palliative treatments for non-small cell lung cancer (NSCLC) have faced a significant evolution during last decades, which in turn has modified their effects on the patient quality of life (QoL). QoL data collection is becoming methodologically rigorous, with published recommendations and societal statements. In lung cancer surgery, there is no standardization in collecting and analyzing this outcome yet. However, to face the evolution in lung cancer therapies, few initiatives like the European Organization for the Research and Treatment of Cancer (EORTC) lung cancer module update project or the Patient-Reported Outcomes Measurement Information System (PROMIS), have now the potential to help thoracic surgeons to collect QoL data with validated dynamic instruments to make this outcome comparable to the clinical ones. This review aims to give an overview of the available and most commonly used QoL questionnaires in lung cancer surgery in order to facilitate future research and practical implementation.

Early experience with a nutrition and survivorship clinic in esophageal cancer.

Improved cure rates in esophageal cancer care have increased focus on health-related quality of life (HRQL) in survivorship. To optimize recovery after esophagectomy, particularly nutritional well-being, a personalized multidisciplinary survivorship clinic was established at this center. Assessments at 6 and 12months postoperatively include validated European Organization for the Research and Treatment of Cancer (EORTC) symptom and health-related quality of life (HRQL) questionnaires, functional status review, anthropometry, and biochemical screening for micronutrient deficiencies. 75 patients, at a mean age of 63years, 84% male, 85% with adenocarcinoma, and 73% receiving multimodal therapy were included. Mean preoperative body mass index (BMI) was 27.5 (4.3) kg m -2. 6- and 12-month assessments were completed by 66 (88%) and 37 (93%) recurrence-free patients, respectively. Mean body weight loss at 6 months was 8.5 ± 6.6% and at 12months 8.8 ± 7.3%. Of the 12-month cohort, micronutrient deficiency was present in 27 (79.4%) preoperatively and 29 (80.6%) after 1 year (P = 0.727), most commonly iron deficiency (preoperative: 16 [43.2%] and postoperative: 17 [45.9%] patients, P = 0.100). 26 (70.3%) of these patients also had clinically significant dumping syndrome persisting to 12months after surgery. We describe a novel follow-up support structure for esophageal cancer patients in the first year of survivorship. This may serve as an exemplar model with parallel application across oncological care.

Validation of Malayalam Translation of the European Organization for the Research and Treatment of Cancer Quality of Life Instrument OG25 for Esophagogastric Junction Cancers.

Background:Quality of life questionnaire (QLQ) OG25 is the questionnaire used for measuring quality of life (QOL) of patients with esophago-gastric junction (OG) cancers. QLQ-OG 25 is a disease-specific tool to capture the QOL parameters of patients with OG junction cancers. OG 25 was developed by the European Organization for the Research and Treatment of Cancer (EORTC) using inspiration from their questionnaires for carcinoma stomach (STO22) and carcinoma esophagus (OES18). It is usually used along with QLQ-C30, which is a general tool applicable for all cancers. This questionnaire is in the English language. In order to use this questionnaire in a non-English speaking population, the English questionnaire has to be initially translated to the local languages. Malayalam is the language spoken by 38.5 million people residing in the South Indian state, Kerala, India. We have translated and validated the QLQ-OG 25 to Malayalam language in an attempt of enabling it to be used for future studies at this geographic region.Methods:The translation was done by the standard protocol adopted by EORTC. QLQ-C30 and QLQ-OG25 questionnaires were then filled in by patients with OG junction cancers. These patients had cancers of various subsites of the OG junction and were at different stages of treatment, at the time of interview. The interview was done twice, at an interval ranging from 48 h to 1 week between the two interviews.Results:A total of 46 patients with OG junction tumors at varying stages of treatment completed the questionnaire. There were no missing data. The average time to finish the interview was 12.12 min. The Cronbach's alpha, which signifies the internal consistency of the questionnaire, was found to be >0.7 in all the domains studied, except in cognitive function. The intraclass correlation coefficients varied from 0.63 to 0.93.Conclusion:The Malayalam translation of the QOL tool QLQ-OG25 has been found to be an acceptable and valid tool in assessing the QOL parameters of patients with OG junction cancers.

Advantages of Distal Subtotal Gastrectomy over Total Gastrectomy in the Quality of Life of Long-Term Gastric Cancer Survivors.

PurposeThis study evaluated differences and shifting patterns in the health-related quality of life (HRQoL) of 5-year gastric cancer survivors after either a distal subtotal gastrectomy (DSG) or total gastrectomy (TG).Materials and MethodsWe analyzed the prospectively collected HRQoL data of 528 patients who survived 5 years without recurrence using the European Organization for the Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire and the EORTC Quality of Life Questionnaire-Stomach module according to the type of surgery. The purpose was to identify the proportion of patients with deteriorating HRQoL and to assess the clinical significance of these changes.ResultsDeteriorating HRQoL was prevalent in both groups, including a large proportion of the DSG group. Decreased overall health status and scores on several function scales were less in the DSG group, while increases on the symptom scales were higher in the TG group. For most of the scales, gaps in HRQoL during the early postoperative period did not merge within the 5 years. Scores on the diarrhea and body image scales revealed “moderate changes” in both groups.ConclusionsDuring the 5-year period after surgery, the TG group suffered from inferior HRQoL compared to the DSG group. However, a large proportion of the DSG group also suffered HRQoL deterioration. In general, the TG group experienced more HRQoL decline, with diarrhea and body image being the major concerns for both groups. To improve HRQoL after gastrectomy, patients must be better informed about post-gastrectomy symptoms. These symptoms must be vigorously investigated, and medical interventions should be available parallel to nutritional support. Favorable evidence of function-preserving gastrectomy should be established and disseminated to improve the HRQoL of early gastric cancer patients.

Chronological changes in quality of life and body composition after gastrectomy for locally advanced gastric cancer.

PurposeWe evaluated the changes in body composition (BC) and quality of life (QoL) in patients who underwent gastrectomy for advanced gastric cancer.MethodsBC data using segmental multifrequency bioelectrical impedance analysis and QoL data from the EORTC (European Organisation for the Research and Treatment of Cancer) gathered via QLQ-C30 and QLQ-STO22 questionnaires were obtained from 300 patients preoperatively and at 1, 2, and 3 years after surgery. In total, 114 patients underwent total gastrectomy (TG group) and 186 underwent distal gastrectomy (DG group).ResultsAccording to BC analysis, at 3 years postoperatively, the average body weight (P = 0.002), protein mass (P = 0.028), body fat mass (P = 0.009), skeletal muscle mass (P = 0.037), and visceral fat area (P = 0.012) was significantly decreased in the TG group than in the DG group compared to the preoperative. In the QLQ-C30, physical functioning (P = 0.001), role functioning (P = 0.013), and fatigue (P = 0.005) showed significantly worse QoL in the TG group than in the DG group at 2 and 3 years postoperatively. In the QLQ-STO22, pain (P = 0.001), reflux symptoms (P = 0.009), eating restrictions (P = 0.001), anxiety (P = 0.008), taste (P = 0.011), and body image (P = 0.014) showed greater continuous deterioration postoperatively in the TG group than in the DG group.ConclusionPersistent deterioration of BC and QoL is a serious concern following total gastrectomy. Long-term management of BC is required after gastrectomy and efforts should be made to improve the QoL in patients as soon as possible, postoperatively.

Quality of life of oral and oropharyngeal cancer patients attending a tertiary care institute in Kolkata

Background: Assessment of quality of life (QOL) helps to find out factors associated with disease progression and response to treatment, identify vulnerable groups. The objective of this study was to assess the QOL (based on physical, mental, social, emotional and spiritual dimensions) of oral and oropharyngeal cancer patients.Methods: A hospital based cross sectional study was conducted among 126 oral and oropharyngeal cancer patients attending radio therapy department of Calcutta Medical College. QOL was assessed by using validated Bengali version of two self-administered questionnaires: European Organization for the Research and Treatment of Cancer (EORTC)-30 and EORTC-35.Results: Among total 81 patients, most of the patients (45.67%) had stage III diseases. Median global health score (GHS) for all patients were 41.67. GHS deteriorated with advancement of the diseases (p=0.000), GHS significantly improved with increasing level of education (p=0.019). GHS was poorer among female patients (median for male was 45.66 and for female was 36.45; p=0.178) and patients with oropharyngeal cancer (median for oral cancer was 50.00, oropharyngeal cancer was 41.67, p=0.215). As per EORTC-35, pain was the major symptom for both type of cancer and was more among patients with oropharyngeal cancer.Conclusions: QOL deteriorates with advancement of the disease and is poorer among females. Co-morbidity status does not affect the QOL. Pain is a major problem of cancer patients, which is more with oropharyngeal cancer patients. Early detection of the cancer and proper pain management and counselling with special focus on females can improve the quality of life.

External validation of the EORTC and NCCN bladder cancer recurrence and progression risk calculators in a U.S. community-based health system

ObjectivesTo externally validate the European Organization for the Research and Treatment of Cancer (EORTC) risk calculator and National Comprehensive Cancer Network (NCCN) guidelines in a contemporary population of U.S. non–muscle-invasive bladder cancer (NMIBC) patients treated in a community-based setting and compare our findings to those from another U.S. health system. Materials and methodsWe identified 1,491 NMIBC patients with a median follow-up of 2.1 years (recurrence) and 4.1 years (progression). We calculated NCCN risk groupings and EORTC prognostic index for recurrence and progression. We followed Royston and Altman's guidelines for the external validation of prognostic calculators. ResultsFor predicting recurrence using the EORTC framework, Harrell's C (a measure of discrimination) was smaller in our sample (0.66) than in the European Association of Urology sample (0.61), whereas for progression, Harrell's C was larger in our sample (0.78 vs. 0.75). The EORTC calculator overestimated progression risk in the highest stratum for our sample; calibration and discrimination were adequate for all groups except the highest risk group. For NCCN risk groupings, Harrell's C was 0.54 for recurrence and 0.62 for progression, suggesting poor to fair discrimination in our sample. The NCCN framework had slightly better performance for predicting progression vs. recurrence. ConclusionsExisting NMIBC risk-stratification frameworks have acceptable accuracy to predict outcomes. However, further innovation in NMIBC care will require predictive tools with more granularity to reflect the differential risks of subgroups of NMIBC recurrence, prior treatment histories, and other prognostic variables.

The low anterior resection syndrome in a reference population: prevalence and predictive factors in the Netherlands.

The low anterior resection syndrome (LARS) severely affects quality of life (QoL) after colorectal cancer surgery. There are no data about these complaints and the association with QoL in a reference population. The aim of this study was to assess LARS and the association with QoL in a reference population. Six hundred patients who visited the outpatient clinic because of general or trauma surgical indications were asked to participate in this study. They received an invitation letter containing three validated questionnaires to assess LARS (assessed with the LARS score) and both general [European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30] and colorectal-specific (EORTC QLQ-CR29) QoL. Five hundred and one respondents could be included for the analyses. The median age at inclusion was 68years and 47.3% were men. Major LARS was observed in 15% of patients (11.4% in men and 18.9% in women, P=0.021). Women reported more urgency (P=0.070) and incontinence for both flatus (P<0.001) and stool (P=0.063) compared to men. In univariate analyses, women reported major LARS significantly more often than men (OR1.82; 95% CI 1.10-3.01). Patients with major LARS scored significantly worse in most QoL domains compared to patients with no/minor LARS. This is the first study demonstrating major LARS and the association with QoL in a reference population of patients without colorectal cancer. Our data can assist in the interpretation of LARS in past and future research about abdominal complaints after colorectal cancer surgery.

Impact of body mass index on quality of life after distal gastrectomy for gastric cancer.

PurposeFew studies have evaluated changes in quality of life (QoL) in relation to changes in body mass index (BMI) after gastrectomy. This study aimed to evaluate the impact of postoperative changes in BMI on QoL after distal gastrectomy in gastric cancer patients.MethodsQoL data from the European Organization for the Research and Treatment of Cancer (EORTC) gathered via the QLQ-C30 and QLQ-STO22 questionnaires were obtained from 1,036 patients preoperatively and at 1 year postoperatively. The patients were divided into 2 groups: group 1 - decreased postoperative BMI and group 2 - unchanged or increased postoperative BMI.ResultsThere were 577 patients in group 1 and 459 in group 2. According to global health status and functional scales, emotional functioning (P = 0.035) was significantly worse in group 1 than in group 2 at 1 year postoperatively. Furthermore, there were significant decreases in QoL symptom scale scores, including fatigue (P = 0.016), nausea and vomiting (P = 0.002), and appetite loss (P = 0.001) scores, in group 1 compared with group 2. Regarding QLQ-STO22, reflux symptoms (P = 0.020), anxiety (P = 0.003), and body image (P = 0.003) were significantly worse in group 1 than in group 2 at 1 year after surgery.ConclusionBMI changes after distal gastrectomy influence QoL. Focus on controlling gastrointestinal symptoms and providing psychological support is essential in patients with decreased BMI after surgery. Patients should be offered follow-up care to assist them in maintaining BMI, for example, through dietary-behavior modifications and via intensive nutritional support, to prevent QoL deterioration after distal gastrectomy.

Quality of Life in NSCLC Survivors — A Multicenter Cross-Sectional Study

IntroductionThe objective was to assess quality of life (QoL) in lung cancer survivors, compare it to the general population, and identify factors associated with global QoL, physical functioning, emotional functioning, fatigue, pain, and dyspnea. MethodsData from NSCLC patients who had survived 1 year or longer after diagnosis were collected cross-sectionally in a multicenter study. QoL was assessed with the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the lung cancer module QLQ-LC13 across different clinical subgroups and compared to age- and sex-standardized general population reference values. Multivariable linear regression analyses were performed to test the associations of patient-, tumor-, and treatment-related factors with the six primary QoL scales. ResultsSix hundred fifty-seven NSCLC patients participated in the study with a median time since diagnosis of 3.7 years (range, 1.0–21.2 years). Compared to the age- and sex-standardized general population, clinically meaningful differences in the QoL detriment were found on almost all domains: lung cancer survivors had clinically relevant poorer global QoL (10 points, p < 0.001). Whereas in 12 months or longer treatment-free patients this detriment was small (8.3), it was higher in patients currently in treatment (16.0). Regarding functioning and symptom scales, respective detriments were largest for dyspnea (41 points), role function (33 points), fatigue (27 points), social function (27 points), physical function (24 points), and insomnia (21 points) observed across all subgroups. The main factor associated with poorer QoL in all primary QoL scales was mental distress (β |19-31|, all p < 0.001). Detriments in QoL across multiple primary QoL scales were also observed with current treatment (β |8-12|, p < 0.01), respiratory comorbidity (β |4-5|, p < 0.01), and living on a disability pension (β |10-11|, p < 0.01). The main factor associated with better QoL in almost all primary QoL scales was higher physical activity (β |10-20|, p < 0.001). Better QoL was also observed in patients with high income (β |10-14|, p < 0.01). ConclusionsLung cancer survivors experience both functional restrictions and symptoms that persist long term after active treatment ends. This substantiates the importance of providing long-term supportive care.