Health-related quality of life outcomes after neoadjuvant chemoradiotherapy for rectal cancer in NRG Oncology/NSABP R-04.

BACKGROUND: There has been limited evaluation of health-related quality of life (HRQOL) in rectal cancer patients receiving neoadjuvant chemoradiotherapy. HRQOL outcomes in the National Surgical Adjuvant Breast and Bowel Project R-04 trial are examined in this article. METHODS: Between 2004 and 2010, R-04 patients were invited to enroll in the HRQOL substudy, with questionnaires administered before randomization, after completion of chemoradiotherapy, and 1-year after surgery. HRQOL measures included: Functional Assessment of Cancer Therapy for colorectal cancer (FACT-C); Short Form-36v.2 Vitality scale; a treatment-specific symptom scale; and the FACT neurotoxicity scale. A 5-year postsurgery assessment was added to the protocol in 2012. Mixed-effects models examined neoadjuvant therapy treatment effects in the 1-year sample and models that explored associations of host factors and treatment impact on 5-year HRQOL. RESULTS: A total of 1373 patients completed baseline HRQOL and at least one additional assessment. The average age was 58 years (range, 23-85 years), male (68%), and 59% Stage II. There were no statistically significant differences in HRQOL outcomes by treatment arm, but HRQOL worsened from baseline to postneoadjuvant chemoradiotherapy, with statistically significant effect sizes changes ranging from 0.6 (Vitality) to 0.9 (FACT-C Trial Outcome Index). Neurotoxicity was greater in the oxaliplatin-treated groups. Obese/overweight patients had statistically significantly worse FACT-C Trial Outcome Index scores than did underweight/normal weight groups. At 5 years, younger patients and those with normal baseline weight had statistically significantly better physical function scores and older patients had better mental health outcomes. CONCLUSIONS: HRQOL did not differ across the four R-04 treatment arms; however, host factors explained significant variation in posttreatment HRQOL. CLINICALTRIALS: gov: NCT00058474 (https://ClinicalTrials.gov/ct2/show/NCT00058474). LAY SUMMARY: This article reports on the health-related quality of life (HRQOL) outcomes of patients treated with four different chemotherapy regimens combined with radiation in rectal cancer patients before definitive surgical treatment. There were no significant differences in HRQOL by treatment regimen, but all patients experienced decreased vitality (energy) and physical functioning. By 1 year after treatment, most patients had returned to pretreatment vitality and physical functioning, with the exception of increased neurotoxicity. In a subsample of patients assessed at 5 years after surgery, physical function was better in those who at pretreatment were younger, normal weight, and had better performance status. Mental function was better in those who at pretreatment were older and had better performance status.

Functional Outcomes and Quality of Life After Transanal Total Mesorectal Excision for Rectal Cancer: A Prospective Observational Study.

BACKGROUND: Few studies have addressed the functional impact after transanal total mesorectal excision. OBJECTIVE: This study aimed to evaluate function and health-related quality of life among patients with rectal cancer treated with transanal total mesorectal excision. DESIGN: Consecutive patients treated between 2016 and 2018 were selected. Their function and quality of life were studied preoperatively and at 3 and 12 months after surgery. SETTING: This is a prospective case series. PATIENTS: Patients were eligible if they had primary anastomosis, their diverting stoma had been reversed, and they did not have anastomotic leakage. Forty-five patients were finally included. A total of 31 (68.8%) and 32 patients (71.1%) completed the 3- and 12-month surveys. INTERVENTIONS: Standard transanal total mesorectal excision was performed. MAIN OUTCOME MEASURES: The primary end point was functional and quality-of-life outcomes using validated questionnaires. Secondary end points included values obtained with endoanal ultrasounds, anorectal manometries, and rectal sensation testing. RESULTS: Wexner and Low Anterior Resection Syndrome scores significantly increased 3 months after surgery but returned to baseline values at 12 months. The rate of "major low anterior resection syndrome" at the end of follow-up was 25.0% (+11.7% compared with baseline, p = 0.314). Sexual and urinary functions remained stable throughout the study, although a meaningful clinical improvement was detected in male sexual interest. Among quality-of-life domains, all deteriorations returned to baseline values 12 months after surgery, except worsening of flatulence symptoms, and improvement in insomnia and constipation. At 12 months, an expected decrease in the mean width of the internal sphincter, the anal resting pressure, and the tenesmus threshold volume was found. LIMITATIONS: This study was limited by its small sample size, the absence of a comparative group, and significant missing data in female sexual difficulty and in ultrasounds and manometries at 3 months. CONCLUSIONS: Patients undergoing transanal total mesorectal excision report acceptable quality-of-life and functional outcomes 12 months after surgery. See Video Abstract at http://links.lww.com/DCR/B541. RESULTADOS FUNCIONALES Y CALIDAD DE VIDA DE LOS PACIENTES DESPUS DE LA ESCISIN MESORRECTAL TOTAL TRANSANAL PARA CNCER DE RECTO UN ESTUDIO PROSPECTIVO OBSERVACIONAL: ANTECEDENTES:Pocos estudios han abordado el impacto funcional después de la escisión mesorrectal total transanal.OBJETIVO:Evaluar la función y la calidad de vida relacionada con la salud en pacientes con cáncer de recto tratados con escisión mesorrectal total transanal.DISEÑO:Se seleccionaron pacientes consecutivos tratados entre 2016 y 2018. Se estudió su función y calidad de vida, en la etapa preoperatoria, a los tres y doce meses postoperatorios.METODO:Serie de casos prospectivos.PACIENTES:Los pacientes eran incluidos en presencia de anastomosis primaria, cierre del estoma de derivación y en ausencia de fuga anastomótica. Finalmente se incluyeron cuarenta y cinco pacientes. Un total de 31 (68,8%) y 32 pacientes (71,1%) completaron las encuestas de tres y doce meses, respectivamente.INTERVENCIONES:Escisión mesorrectal total transanal estándar.PRINCIPALES MEDIDAS DE RESULTADO:Los criterio de evaluación principal fueron los resultados funcionales y de calidad de vida mediante cuestionarios previamente validados. Los criterios de evaluación secundarios incluyeron los valores obtenidos con ecografía endoanal, manometría anorrectal y prueba de sensibilidad rectal.RESULTADOS:La escala de Wexner y el síndrome de resección anterior baja aumentaron significativamente tres meses después de la cirugía, pero volvieron a los valores iniciales a los doce meses. La tasa de "síndrome de resección anterior inferior grave" al final del seguimiento fue del 25,0% (+ 11,7% en comparación con el valor inicial, p = 0,314). La función sexual y urinaria se mantuvo estable durante todo el estudio, aunque se detectó una mejora clínica significativa en la libido masculina. Entre los criterios que evalúan la calidad de vida, todas las alteraciones en la misma volvieron a los valores iniciales, doce meses después de la cirugía, excepto el aumento de flatulencia, la mejoría del insomnio y el estreñimiento. A los doce meses, se encontró una disminución esperada en el grosor medio del esfínter interno, la presión anal en reposo y el volumen umbral para la presencia de tenesmo.LIMITACIONES:Tamaño de muestra limitado, ausencia de un grupo comparativo, falta significativa de datos para identificar la dificultad para la actividad sexual femenina y el efectuar ecografía y manometría a los tres meses.CONCLUSIONES:Los pacientes sometidos a escisión mesorrectal total transanal refieren una calidad de vida y resultados funcionales aceptables a los doce meses después de la cirugía. Consulte Video Resumen en http://links.lww.com/DCR/B541.

Anal preservation on the psychology and quality of life of low rectal cancer.

INTRODUCTION: The aims of this study are to evaluate depression and quality of life (QOL) after laparoscopic abdominoperineal resection (LAPR) or transanal total mesorectal excision (TaTME) surgery in low rectal cancer (RC) patients. METHODS: This is a prospective observational cohort study. Patients were divided into two groups: either TaTME surgery or LAPR. Psychosocial distress and QOL were assessed using a questionnaire before surgery, at 6 months postsurgery, and 12 months postsurgery. The Hospital Anxiety and Depression Scale was used to assess symptoms of anxiety and depression. The European Organization for Research and Treatment of Cancer-QOL questionnaire core was used to estimate the QOL. RESULTS: In the TaTME group, the scores of psychosocial distress and QOL showed an obvious tendency to decrease and then recover. Meanwhile, in the LAPR group, these scores deteriorated significantly at 6 and 12 months, and the recovery was less pronounced. Multivariable analysis suggested that surgical options and tumor stage were significantly associated with psychosocial distress and QOL. CONCLUSION: For low RC, TaTME could significantly improve patients' QOL and reduce psychological distress as compared to patients with LAPR at 12 months after surgery.

Experiences of Losing Bowel Control After Lower Anterior Resection With Sphincter Saving Surgery for Rectal Cancer: A Qualitative Study.

BACKGROUND: Rectal cancer patients who have undergone lower anterior resection with sphincter-saving surgery often experience loss of bowel control. We currently do not have suitable treatment regimens for such patients. OBJECTIVE: The aim of this study was to explore the experiences of losing bowel control in patients who have undergone lower anterior resection with sphincter-saving surgery for rectal cancer in Taiwan. METHODS: A descriptive phenomenological study design was adopted. Purposive sampling and one-on-one semistructured interviews were conducted for data collection. Narratives were analyzed using Colaizzi's method. RESULTS: Data saturation was achieved after interviewing 12 patients (8 men, 4 women) whose average age was 61 years. Three themes and 11 subthemes emerged: physical problems (pain from broken perianal skin, insomnia, decreased physical strength, and body weight loss), adverse psychological reactions (worries, helplessness, and social isolation), and the use of coping strategies (avoidance of inappropriate foods to reduce bowel irritation and peristalsis, reduction of food intake, and use of antidiarrheal drugs and perianal skincare products). CONCLUSION: The study supports the importance of having a good understanding of patient experiences by healthcare professionals to provide more effective healthcare. Furthermore, awareness of the cultural issue of social isolation was deemed important for providing individualized healthcare. IMPLICATIONS FOR PRACTICE: Education, counseling, and psychological support can enhance patients' abilities to use coping strategies to overcome the physical and mental challenges of bowel symptoms. For example, appropriate diet-related education programs must be developed to reduce the trial-and-error learning process commonly adopted by patients to identify inappropriate foods.

Evaluation of Pre-radiotherapy Sleep Disorders in Patients With Rectal or Anal Cancer.

BACKGROUND/AIM: Radiotherapy and radiochemotherapy are common treatments for rectal and anal cancer. Anticipation of treatment may cause distress and sleep disorders. This study aimed to identify risk factors for sleep disorders. PATIENTS AND METHODS: In 42 patients with rectal or anal cancer scheduled for radiotherapy, 16 characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, gender, performance score, comorbidity, patient's or family history of additional cancer/melanoma, distress score, emotional/physical/practical problems, tumor site and stage, surgery and relation to COVID-19 pandemic. RESULTS: Overall prevalence of pre-radiotherapy sleep disorders was 42.9%. Sleep disorders were significantly associated with Karnofsky performance score 60-80 (p=0.044), Charlson comorbidity index ≥3 (p=0.0012), distress score 6-10 (p=0.00012), and more emotional (p=0.0012), physical (p=0.0004) or practical (p=0.033) problems. A trend was found for female gender (p=0.061). CONCLUSION: Sleep disorders were common in patients with rectal or anal cancer scheduled for radiotherapy. Risk factors can help identify patients requiring psychooncological support already prior to the start of radiotherapy.

Patient-reported distress and age-related stress biomarkers among colorectal cancer patients.

OBJECTIVE: Distress among cancer patients has been broadly accepted as an important indicator of well-being but has not been well studied. We investigated patient characteristics associated with high distress levels as well as correlations among measures of patient-reported distress and "objective" stress-related biomarkers among colorectal cancer patients. METHODS: In total, 238 patients with colon or rectal cancer completed surveys including the Distress Thermometer, Problem List, and the Hospital Anxiety and Depression Scale. We abstracted demographic and clinical information from patient charts and determined salivary cortisol level and imaging-based sarcopenia. We evaluated associations between patient characteristics (demographics, clinical factors, and psychosocial and physical measures) and three outcomes (patient-reported distress, cortisol, and sarcopenia) with Spearman's rank correlations and multivariable linear regression. The potential moderating effect of age was separately investigated by including an interaction term in the regression models. RESULTS: Patient-reported distress was associated with gender (median: women 5.0, men 3.0, p < 0.001), partnered status (single 5.0, partnered 4.0, p = 0.018), and cancer type (rectal 5.0, colon 4.0, p = 0.026); these effects varied with patient age. Cortisol level was associated with "emotional problems" (ρ = 0.34, p = 0.030), anxiety (ρ = 0.46, p = 0.006), and depression (ρ = 0.54, p = 0.001) among younger patients. We found no significant associations between patient-reported distress, salivary cortisol, and sarcopenia. CONCLUSIONS: We found that young, single patients reported high levels of distress compared to other patient groups. Salivary cortisol may have limited value as a cancer-related stress biomarker among younger patients, based on association with some psychosocial measures. Stress biomarkers may not be more clinically useful than patient-reported measures in assessing distress among colorectal cancer patients.

Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial.

BACKGROUND: Treatment of locally advanced rectal cancer with chemoradiotherapy, surgery, and adjuvant chemotherapy controls local disease, but distant metastases remain common. We aimed to assess whether administering neoadjuvant chemotherapy before preoperative chemoradiotherapy could reduce the risk of distant recurrences. METHODS: We did a phase 3, open-label, multicentre, randomised trial at 35 hospitals in France. Eligible patients were adults aged 18-75 years and had newly diagnosed, biopsy-proven, rectal adenocarcinoma staged cT3 or cT4 M0, with a WHO performance status of 0-1. Patients were randomly assigned (1:1) to either the neoadjuvant chemotherapy group or standard-of-care group, using an independent web-based system by minimisation method stratified by centre, extramural extension of the tumour into perirectal fat according to MRI, tumour location, and stage. Investigators and participants were not masked to treatment allocation. The neoadjuvant chemotherapy group received neoadjuvant chemotherapy with FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2 intravenously every 14 days for 6 cycles), chemoradiotherapy (50 Gy during 5 weeks and 800 mg/m2 concurrent oral capecitabine twice daily for 5 days per week), total mesorectal excision, and adjuvant chemotherapy (3 months of modified FOLFOX6 [intravenous oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2, followed by intravenous 400 mg/m2 fluorouracil bolus and then continuous infusion at a dose of 2400 mg/m2 over 46 h every 14 days for six cycles] or capecitabine [1250 mg/m2 orally twice daily on days 1-14 every 21 days]). The standard-of-care group received chemoradiotherapy, total mesorectal excision, and adjuvant chemotherapy (for 6 months). The primary endpoint was disease-free survival assessed in the intention-to-treat population at 3 years. Safety analyses were done on treated patients. This trial was registered with EudraCT (2011-004406-25) and ClinicalTrials.gov (NCT01804790) and is now complete. FINDINGS: Between June 5, 2012, and June 26, 2017, 461 patients were randomly assigned to either the neoadjuvant chemotherapy group (n=231) or the standard-of-care group (n=230). At a median follow-up of 46·5 months (IQR 35·4-61·6), 3-year disease-free survival rates were 76% (95% CI 69-81) in the neoadjuvant chemotherapy group and 69% (62-74) in the standard-of-care group (stratified hazard ratio 0·69, 95% CI 0·49-0·97; p=0·034). During neoadjuvant chemotherapy, the most common grade 3-4 adverse events were neutropenia (38 [17%] of 225 patients) and diarrhoea (25 [11%] of 226). During chemoradiotherapy, the most common grade 3-4 adverse event was lymphopenia (59 [28%] of 212 in the neoadjuvant chemotherapy group vs 67 [30%] of 226 patients in the standard-of-care group). During adjuvant chemotherapy, the most common grade 3-4 adverse events were lymphopenia (18 [11%] of 161 in the neoadjuvant chemotherapy group vs 42 [27%] of 155 in the standard-of-care group), neutropenia (nine [6%] of 161 vs 28 [18%] of 155), and peripheral sensory neuropathy (19 [12%] of 162 vs 32 [21%] of 155). Serious adverse events occurred in 63 (27%) of 231 participants in the neoadjuvant chemotherapy group and 50 (22%) of 230 patients in the standard-of-care group (p=0·167), during the whole treatment period. During adjuvant therapy, serious adverse events occurred in 18 (11%) of 163 participants in the neoadjuvant chemotherapy group and 36 (23%) of 158 patients in the standard-of-care group (p=0·0049). Treatment-related deaths occurred in one (<1%) of 226 patients in the neoadjuvant chemotherapy group (sudden death) and two (1%) of 227 patients in the standard-of-care group (one sudden death and one myocardial infarction). INTERPRETATION: Intensification of chemotherapy using FOLFIRINOX before preoperative chemoradiotherapy significantly improved outcomes compared with preoperative chemoradiotherapy in patients with cT3 or cT4 M0 rectal cancer. The significantly improved disease-free survival in the neoadjuvant chemotherapy group and the decreased neurotoxicity indicates that the perioperative approach is more efficient and better tolerated than adjuvant chemotherapy. Therefore, the PRODIGE 23 results might change clinical practice. FUNDING: Institut National du Cancer, Ligue Nationale Contre le Cancer, and R&D Unicancer.

Effects of Evidence-Based Continuing Care Bundle on Health Outcomes in Rectal Cancer Patients With Temporary Stomas: A Multicenter Randomized Controlled Trial.

BACKGROUND: The patients with temporary stomas after anterior resection for rectal cancer may experience significant impact on their health outcomes, and hence continuing care is necessary and important for these patients. However, the effects of some single continuing care interventions remain unclear. Continuing care bundle may be an effective approach to address this uncertainty. OBJECTIVE: The aim of this study was to investigate the effects of an evidence-based continuing care bundle on selected health outcomes in patients with temporary stomas after anterior resection for rectal cancer. METHODS: This was a multicenter randomized controlled trial. A total of 124 patients with temporary stomas after anterior resection for rectal cancer were recruited from 4 general tertiary hospitals in Guangzhou, China, and were randomly assigned to a control group or an intervention group. Both groups received usual care, whereas the intervention group additionally received evidence-based continuing care bundle. Self-efficacy, quality of life, and stoma-related complications were collected at baseline and 4 and 12 weeks after surgery. Satisfaction and outcomes of stoma reversal were collected at the end of the observation. RESULTS: The intervention group had significantly improved the self-efficacy (F = 11.88, P = .001), quality of life (F = 17.99, P < .001) over time, satisfaction (t = 4.08, P < .001), and outcomes of stoma reversal (χ2 = 5.93, P = .015) and reduced the incidence of complications (P < .05). CONCLUSIONS: Evidence-based continuing care bundle can be an effective method to improve the health outcomes among these patients. IMPLICATION FOR PRACTICE: By using the evidence-based continuing care bundle, nurses can help these patients improve their health outcomes in stoma-specific nursing.

Factors influencing anterior/low anterior resection syndrome after rectal or sigmoid resections

Background/aim: Sphincter-preserving surgery is one of the main goals in the treatment of rectal cancer because it improves the quality of life (QoL). However, some patients may experience disrupted symptoms called anterior or low anterior resection syndrome (LARS). This study was designed to evaluate the frequency and influencing factors of LARS in patients who underwent sigmoid or rectal resection. Materials and methods: In this retrospective, clinical study, patients who underwent rectal or sigmoid resection and anastomosis due to any benign and malignant reasons were evaluated in terms of LARS between January 2010 and November 2019 at Medical Faculty Hospital of Mersin University. The frequency and severity of LARS were determined by using a standard scale. Furthermore, influencing factors including lesion localization, operation, the proximity of anastomosis to the anal verge, creation of stoma, chemotherapy, and radiotherapy application were investigated. Results: Out of a total of 550 patients, 276 were included in this study. The major LARS incidence was found as 27.2%. Very low anterior resection (VLAR) (OR = 42.40 (95% CI [11.14­161.36], P < 0.0001), protective ileostomy (OR = 12.83 (95% CI [6.58­25.0], P < 0.0001), end colostomy (OR = 8.55 (95% CI [1.36­53.61], P = 0.022), receiving chemotherapy (OR = 3.08 (95% CI [1.71­5.53], P < 0.0001), and radiotherapy (OR = 2.51 (95% CI [1.38­4.57], P = 0.003) and the ROC analysis showed that creating an anastomosis placed at most 8.5 cm from the anal verge was found to be a major influencing factor on LARS (P < 0.05). Conclusions: LARS may frequently occur in patients who have undergone rectal resection. In this study, the most important factors influencing LARS were found to be the proximity of anastomosis to the anal canal and creating a protective stoma. Receiving chemoradiotherapy also plays an important role in LARS.

Quality of life in rectal cancer patients with or without oxaliplatin in the randomised CAO/ARO/AIO-04 phase 3 trial.

BACKGROUND: The CAO/ARO/AIO trial has shown that oxaliplatin added to preoperative chemoradiotherapy and postoperative chemotherapy significantly improved disease-free survival in locally advanced rectal cancer (LARC). Here, we present a post-hoc analysis of quality of life (QoL) in disease-free patients. PATIENTS AND METHODS: Between 2006 and 2010, 1236 patients with LARC were randomly assigned either to preoperative chemoradiotherapy followed by total mesorectal excision and postoperative chemotherapy (N = 623) or combined with oxaliplatin (N = 613). QoL questionnaires (EORTC QLQ-C30, colorectal module CR38) were completed at baseline, after postoperative chemotherapy and during follow-up. Analysis was performed according intent-to-treat. RESULTS: Available questionnaires (baseline) were 82% (N = 512) in the control and 84% (N = 513) in the investigational group. Response rates were 49% (533 of 1086) at 1 year and 43% (403 of 928) at 3 years. Global health status (GHS) for disease-free patients was stable in both groups (range 0-100). At baseline: standard arm 62.0 (mean, SD 21.6; N = 491) versus oxaliplatin arm 63.2 (mean, SD 22; N = 503); at 3 years: 69.4 (SD 19.3; N = 187) versus 65.4 (SD 22.2; N = 202). After treatment and at 3 years, no significant differences (≥10 points) between groups were found in QoL subscales. Disease-free patients experiencing neurotoxic side-effects (grade 1-4) showed reduced GHS at 3 years versus patients without neurotoxicity (mean 59.2 versus 69.3; P < 0.001), while grade 3-4 rate was low. CONCLUSION: The addition of oxaliplatin was not associated with worse overall QoL. This information is of interest to patients in many ongoing rectal cancer trials. TRIAL REGISTRATION INFORMATION: NCT00349076.

Colonic J-Pouch or Straight Colorectal Reconstruction After Low Anterior Resection For Rectal Cancer: Impact on Quality of Life and Bowel Function: A Multicenter Prospective Randomized Study.

BACKGROUND: Patient-reported outcomes associated with different bowel reconstruction techniques following anterior resection for rectal cancer are still a matter of debate. OBJECTIVE: This study aimed to assess quality of life and bowel function in patients who underwent colonic J-pouch or straight colorectal anastomosis reconstruction after low anterior resection. DESIGN: Bowel function and quality of life were assessed within a multicenter randomized trial. Questionnaires were administered before the surgery (baseline) and at 6, 12, and 24 months after surgery. SETTINGS: Patients were enrolled by 19 centers. The enrollment started in October 2009 and was stopped in February 2016. The study was registered at www.clinicaltrials.gov (Identifier: NCT01110798). PATIENTS: Patients who underwent low anterior resection for primary mid-low rectal cancer and who were randomly assigned in a 1:1 ratio to receive either stapled colonic J-pouch or straight colorectal anastomosis were selected. MAIN OUTCOME MEASURES: The primary outcomes measured were quality of life and bowel function. RESULTS: Of the 379 patients who were evaluable, 312 (82.3%) completed the baseline, 259 (68.3%) the 6-month, 242 (63.9%) the 12-month, and 199 (52.5%) the 24-month assessment. Bowel functioning and quality of life did not significantly differ between arms for almost all domains. The total bowel function score, the urgency, and the stool fractionation scores significantly worsened after surgery and remained impaired over time in both arms (p < 0.0032), whereas constipation improved after surgery but recovered to baseline levels from 1 year onward (p < 0.0036). All patients showed a significant and continuous improvement in emotional functioning (p < 0.0013) and future perspective (p < 0.0001) from baseline to the end of the study. LIMITATIONS: Limitations of the study include missing data, which increased over time; the possibility that some treatments have slightly changed since the study was conducted; and investigators not blind to treatment allocation. CONCLUSION: The findings of this study do not support the routine use of colonic J-pouch reconstruction in patients with rectal cancer who undergo a low anterior resection. See Video Abstract at http://links.lww.com/DCR/B328. BOLSA J COLÓNICA O RECONSTRUCCIÓN COLORRECTAL RECTA DESPUÉS DE RESECCIÓN ANTERIOR BAJA PARA CÁNCER RECTAL: IMPACTO EN LA CALIDAD DE VIDA Y LA FUNCIÓN INTESTINAL: UN ESTUDIO ALEATORIZADO PROSPECTIVO MULTICÉNTRICO: Los resultados informados por el paciente asociados con diferentes técnicas de reconstrucción intestinal después de la resección anterior para el cáncer de recto aún son tema de debate.Evaluar la calidad de vida y la función intestinal en pacientes que se sometieron a una bolsa en J colónica o reconstrucción de anastomosis colorrectal recta después de una resección anterior baja.La función intestinal y la calidad de vida se evaluaron en un ensayo aleatorizado multicéntrico. Los cuestionarios se administraron antes de la cirugía (basal) y a los 6, 12 y 24 meses después de la cirugía.Los pacientes fueron incluidos en 19 centros. La inscripción comenzó en Octubre de 2009 y se detuvo en Febrero de 2016. El estudio se registró en www.clinicaltrials.gov (Identificador: NCT01110798).Pacientes que se sometieron a resección anterior baja por cáncer rectal primario medio-bajo y que fueron aleatorizados en una proporción de 1: 1 para recibir bolsa J colónica con grapas o anastomosis colorrectal recta.calidad de vida y función intestinal.De los 379 pacientes que fueron evaluables, 312 (82.3%) completaron la evaluación inicial, 259 (68.3%) a los 6 meses, 242 (63.9%) a los 12 meses y 199 (52.5%) a los 24 meses. . El funcionamiento intestinal y la calidad de vida no difirieron significativamente entre los dos grupos en casi todos los dominios. La puntuación total de la función intestinal, la urgencia y las puntuaciones de fraccionamiento de las heces empeoraron significativamente después de la cirugía y continuaron con el tiempo extra en ambos grupos (p <0.0032), mientras que el estreñimiento mejoró después de la cirugía pero se recuperó a los niveles basales a partir de 1 año en adelante (p <0.0036). Todos los pacientes mostraron una mejora significativa y continua en el funcionamiento emocional (p <0.0013) y la perspectiva futura (<0.0001) desde el inicio hasta el final del estudio.Datos faltantes, que aumentaron con el tiempo; la posibilidad de que algunos tratamientos hayan cambiado ligeramente desde que se realizó el estudio; investigadores no cegados a la asignación del tratamiento.Los hallazgos de este estudio no respaldan el uso rutinario de la reconstrucción de la bolsa J colónica en pacientes con cáncer rectal que se someten a una resección anterior baja. Consulte Video Resumen en http://links.lww.com/DCR/B328. (Traducción-Dr. Yesenia Rojas-Khalil).

Deterioration of Health-Related Quality of Life Scores under Treatment Predicts Longer Survival.

OBJECTIVES: Baseline health-related quality of life (HRQoL) scores predict survival, which has already been demonstrated in various studies. However, we were interested in whether changes in baseline scores during treatment are also significant predictors of survival. METHODS AND MATERIALS: We analysed the data of 400 consecutive cancer patients receiving radiochemotherapy. Leading diagnoses were head and neck cancer (34.5%), rectal cancer (24.5%), and lung cancer (13%). HRQoL was studied at baseline, six weeks after therapy and after each completed year after the start of therapy until drop out of the study using the EORTC QLQ-C30 questionnaire. The change score was calculated as the baseline score subtracted from the score after therapy. Statistics included Kaplan-Meier estimates and Cox regression. RESULTS: High global health status (p = 0.005) and low pain scores (p = 0.040) at baseline were related to favourable overall survival. Change scores of role functioning (p = 0.027), global health status (p < 0.018), and pain (p < 0.001) were predictive of overall survival. Pain was the superior predictor of survival (p = 0.001) among all variables and QoL scores studied by multivariate analysis. A deterioration in pain was associated with a 2.8 times higher chance of survival (HR 0.36). CONCLUSIONS: Deterioration of HRQoL baseline pain score by cancer treatment is a favourable and superior prognostic factor for survival.

Survival outcomes after isolated local recurrence of rectal cancer and risk analysis affecting its resectability.

BACKGROUND AND OBJECTIVES: This study aimed to investigate the clinical course and prognostic factors after isolated local recurrence (iLR) and to identify the predictive factors for R0 resection of locally recurrent rectal cancer (LRRC). METHODS: We retrospectively reviewed the medical records of 76 patients with iLR who had undergone radical surgery for a primary tumor from 2003 to 2015. RESULTS: The iLR rate was 2.5%. From 76 patients, 39 patients underwent R0 resection for iLR. Multivariate analysis revealed that initial open surgery, neoadjuvant chemoradiation, and p/ypT ≥ 3 were poor prognostic factors after iLR as regard to the variables related to the primary tumor; and symptom presence at the time of iLR diagnosis, higher fixity, and no chemotherapy after iLR were associated with shorter overall survival after iLR, and R0 resection of LRRC was the only favorable prognostic factor for progression-free survival after iLR as regard to the variables related to LRRC. Higher tumor level, negative pathologic circumferential margin of the primary tumor, and low fixity of LRRC were favorable factors in achieving R0 resection of LRRC. CONCLUSIONS: Early detection of iLR before symptom development, use of chemotherapy after iLR and R0 resection of LRRC should be considered to improve survival outcomes after iLR.

International variation in managing locally advanced or recurrent rectal cancer: prospective benchmark analysis.

BACKGROUND: Tumour extension beyond the mesorectal plane (ymrT4) occurs in 5-10 per cent of patients with rectal cancer and 10 per cent of patients develop locally recurrent rectal cancer (LRRC) after primary surgery. There is global variation in healthcare delivery for these conditions. METHODS: An international benchmark trial of the management of ymrT4 tumours and LRRC was undertaken in France and Australia between 2015 and 2017. Heterogeneity in management and operative decision-making were analysed by comparison of surgical resection rates, blinded intercountry reading of pelvic MRI, quality-of-life assessment and qualitative evaluations. RESULTS: Among 154 patients (97 in France and 57 in Australia), 31·8 per cent had ymrT4 disease and 68·2 per cent LRRC. The surgical resection rates were 88 and 79 per cent in France and Australia respectively (P = 0·112). The concordance in operative planning was low (κ = 0·314); the rate of pelvic exenteration was lower in France than Australia both in clinical practice (36 of 78 versus 34 of 40; P < 0·001) and in theoretical conditions (10 of 25 versus 50 of 57; P = 0·002). The R0 resection rate was lower in France than Australia for LRRC (25 of 49 versus 18 of 21; P = 0·007) but not for ymrT4 tumours (21 of 26 versus 15 of 15; P = 0·139). Morbidity rates were similar. Patients who underwent non-exenterative procedures had higher scores on the mental functioning subscale at 12 months (P = 0·047), and a lower level of distress at 6 months (P = 0·049). Qualitative analysis highlighted five categories of psychosocial factors influencing treatment decisions: patient, strategy, specialist, organization and culture. CONCLUSION: This international benchmark trial has highlighted the differences in worldwide treatment of locally advanced and LRRC. Standardized care should improve outcomes for these patients.

ANTECEDENTES: La extensión del tumor más allá del plano del meso-rrecto (ymrT4) ocurre en el 5-10% de los pacientes con cáncer de recto y el 10% de los pacientes desarrollan recidiva local del cáncer de recto (locally recurrent rectal cáncer, LRRC) después de una cirugía primaria. Existe una variación global en la prestación de la asistencia sanitaria para esta pato-logía. MÉTODOS: Se realizó un ensayo de referencia internacional sobre el manejo de ymrT4 y LRRC en Francia y Australia entre 2015 y 2017. La heterogeneidad en el manejo y la toma de decisiones quirúrgicas se analizaron mediante la comparación de las tasas de resección quirúrgica, la lectura a ciegas de la resonancia magnética (RM) pélvica entre países, la evaluación de la calidad de vida y las evaluaciones cualitativas. RESULTADOS: De 154 pacientes (97 en Francia versus 57 en Australia), el 32% tenía ymrT4 y el 68% tenía cáncer de recto con recidiva local. Las tasas de resección quirúrgica fueron del 87,6% versus 77,8% (P = 0,112). La tasa de concordancia en la decisión quirúrgica fue baja (coeficiente kappa = 0,314) con una tasa más baja de exenteración pélvica en Francia, tanto en la práctica clínica (46% versus 85%; P < 0,0001) como en condiciones teóricas (40% versus 88%; P = 0,002). La tasa de resección R0 fue menor en Francia para la LRRC (51% versus 86%, P = 0,007) pero no para el ymrT4 (81% versus 100%, P = 0,139). Las tasas de morbilidad fueron similares. Los pacientes que se sometieron a procedimientos no exenterativos tuvieron una subescala de funcionamiento mental más alta a los 12 meses (P = 0,04) y un nivel de angustia más bajo a los 6 meses (P = 0,04). El análisis cualitativo destacó 5 categorías de factores psicosociales que afectaron a la decisión del tratamiento: paciente, estrategia, especialista, organización y cultura. CONCLUSIÓN: Este ensayo de referencia internacional destaca las diferencias en el tratamiento mundial del cáncer de recto localmente avanzado y de la LRR. La aten-ción estandarizada debería mejorar los resultados para estos pacientes.

Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer: A Post Hoc Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial.

Importance: Despite numerous published phase 3 trials, the association of treatment adherence with outcomes for patients with rectal cancer remains largely unexplored. Objective: To analyze the association of treatment adherence with disease-free survival (DFS) among patients with rectal cancer in the CAO/ARO/AIO-04 trial. Design, Setting, and Participants: This post hoc analysis of a phase 3 randomized clinical trial was conducted from July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma. Statistical analysis was performed from May 5, 2019, to February 2, 2020. Interventions: A total of 625 patients received neoadjuvant fluorouracil-based chemoradiotherapy (nCRT), and a total of 607 patients received fluorouracil-based nCRT with addition of oxaliplatin. Of the 1126 patients who underwent curative surgery, 439 started fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin. Main Outcomes and Measures: The association of adherence with nCRT and adjuvant chemotherapy with DFS was assessed in both groups in the as-treated population. Results: Among the 625 patients (442 men; mean age, 63.0 years) who received fluorouracil nCRT and the 607 patients (430 men; mean age, 63.0 years) who received fluorouracil-based nCRT with addition of oxaliplatin, after a median follow-up of 50 months (interquartile range, 38-61 months), 3-year DFS in the as-treated population was 71.1% in the fluorouracil group and 75.8% in the fluorouracil-oxaliplatin group (hazard ratio [HR], 0.803; 95% CI, 0.651-0.990; P = .04). Overall, 419 patients in the fluorouracil nCRT group (67.0%) and 434 patients in the fluorouracil-oxaliplatin nCRT group (71.5%) received full doses of preoperative nCRT. Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the fluorouracil-oxaliplatin group (32.0%) received full doses of adjuvant chemotherapy. Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses. In contrast, adjuvant chemotherapy was not associated with DFS in both the fluorouracil group (complete vs near complete: HR, 0.900; 95% CI, 0.559-1.448; P = .66; complete vs incomplete: HR, 1.057; 95% CI, 0.807-1.386; P = .69) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.155; 95% CI, 0.716-1.866; P = .56; complete vs incomplete: HR, 1.073; 95% CI, 0.790-1,457; P = .65). Conclusions and Relevance: To our knowledge, this is the first analysis of a phase 3 trial to assess the association of treatment adherence with some clinical outcomes for patients with rectal cancer. The findings emphasize the need for appropriate trial design with optimized nCRT dose and schedule and supportive strategies to facilitate good adherence and precision delivery, especially for intensified nCRT. Trial Registration: ClinicalTrials.gov Identifier: NCT00349076.

Treatment of stage I-III rectal cancer: Who is refusing surgery?

BACKGROUND AND OBJECTIVES: Surgical resection is a cornerstone in the management of patients with rectal cancer. Patients may refuse surgical treatment for several reasons although the rate of refusal is currently unknown. METHODS: The National Cancer Database was utilized to identify patients with stage I-III rectal cancer. Patients who refused surgical resection were compared to patients who underwent curative resection. RESULTS: A total of 509 (2.6%) patients with stage I and 2082 (3.5%) patients with stage II/III rectal cancer refused surgery. In multivariable analysis for stage I disease, older age, Black race, and Medicaid/no insurance were independent predictors of surgery refusal. Patients were less likely to refuse surgery if they had a higher income or lived further distances from the treatment facility. In multivariable analysis for stage II/III disease, older age, Black race, insurance other than private, and rural county were independent predictors of surgery refusal. Patients were less likely to refuse surgery if they had higher Charlson comorbidity scores, lived further distances from the treatment facility, or underwent chemoradiation. There was a significant decrease in survival for patients refusing surgery compared to patients undergoing recommended surgery. CONCLUSIONS: A small proportion of patients refuse surgery for rectal cancer, and this treatment decision significantly affects survival.

Anal function and quality of life analysis after laparoscopic modified Parks for ultra-low rectal cancer patients.

BACKGROUND: To assess postoperative anal function and quality of life of ultra-low rectal cancer patients treated by laparoscopic modified Parks surgery. METHODS: From February 2017 to March 2019, 114 patients with ultra-low rectal cancer above T2 were treated respectively with ultra-low anterior resection (Dixon), modified coloanal anastomosis (modified Parks), and Miles according to the preoperative stage and anastomotic position. The postoperative anal function and Fecal Incontinence Quality of Life Scale (FIQL) of each patient were collected and synthetically analyzed. RESULTS: Compared with the Dixon group, the postoperative anal function and FIQL in the Parks group were poor at the early stage. However, from 6 to 12 months after surgery, the scores of anal function and FIQL in the Parks group were similar to those in the Dixon group (P > 0.05). Compared with the Miles group, the FIQL of the two groups were similar in the early postoperative stage. However, with the passage of time, from 3 to 9 months after surgery, the four domains of FIQL in the Parks group were higher than those in the Miles group successively (P < 0.05). CONCLUSIONS: Laparoscopic modified Parks is a safe, effective, and economical anus-preserving surgery. Although its early anal function and FIQL were poor, it could gradually recover to the similar level as Dixon. Moreover, it can save the anus and obtain a better postoperative quality of life for some patients who previously could only undergo Miles.

Prediagnosis social support, social integration, living status, and colorectal cancer mortality in postmenopausal women from the women's health initiative.

BACKGROUND: We evaluated associations between perceived social support, social integration, living alone, and colorectal cancer (CRC) outcomes in postmenopausal women. METHODS: The study included 1431 women from the Women's Health Initiative who were diagnosed from 1993 through 2017 with stage I through IV CRC and who responded to the Medical Outcomes Study Social Support survey before their CRC diagnosis. We used proportional hazards regression to evaluate associations of social support (tertiles) and types of support, assessed up to 6 years before diagnosis, with overall and CRC-specific mortality. We also assessed associations of social integration and living alone with outcomes also in a subset of 1141 women who had information available on social ties (marital/partner status, community and religious participation) and living situation. RESULTS: In multivariable analyses, women with low (hazard ratio [HR], 1.52; 95% CI, 1.23-1.88) and moderate (HR, 1.21; 95% CI, 0.98-1.50) perceived social support had significantly higher overall mortality than those with high support (P [continuous] < .001). Similarly, women with low (HR, 1.42; 95% CI, 1.07-1.88) and moderate (HR, 1.28; 95% CI, 0.96-1.70) perceived social support had higher CRC mortality than those with high social support (P [continuous] = .007). Emotional, informational, and tangible support and positive interaction were all significantly associated with outcomes, whereas affection was not. In main-effects analyses, the level of social integration was related to overall mortality (P for trend = .02), but not CRC mortality (P for trend = .25), and living alone was not associated with mortality outcomes. However, both the level of social integration and living alone were related to outcomes in patients with rectal cancer. CONCLUSIONS: Women with low perceived social support before diagnosis have higher overall and CRC-specific mortality.

The role of off-topic discussions in online health support groups: insights from a content analysis of an online rectal cancer group.

PURPOSE: Both off-topic discussions and exchanges of social support are important to the success of online health support groups. Analyzing their relationship could enhance our understanding of the nature of helpful interactions in online cancer support groups and ways promoting their success. METHODS: A total of 15,284 messages were collected and analyzed from an online support group for rectal cancer. Two coders coded and categorized the messages into 211 threads using directed content analysis and a social support classification system. The relationship between off-topic discussions and social support was explored using the quadratic assignment procedure. RESULTS: There are 91 threads of off-topic discussions, 83 threads of informational support, 22 threads of emotional support, seven threads of tangible support, five threads of network support, and three threads of esteem support. More of the off-topic discussions are associated with more emotional and tangible support. Both off-topic discussions and informational support are mutually influenced by the mediating role of emotional support. In addition, off-topic discussions and network support are mutually influenced by the mediating role of emotional and tangible support, and off-topic discussions and esteem support are mutually influenced by the mediating role of tangible support. CONCLUSIONS: Off-topic discussions directly or indirectly promote different types of social support in an online rectal cancer support group.

Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis.

PURPOSE: An ostomy poses significant health-related quality of life (HRQOL) issues for cancer survivors. Survivors must learn to manage pouching appliances and adjust to the psychosocial consequences of living with an ostomy. We explored, through qualitative analysis, the challenges with self-management and ostomy appliances reported by cancer survivors. METHODS: Pooled data from two studies with a question on the greatest challenge of living with an ostomy and intervention session notes were analyzed using content analysis approach. The themes were reviewed and agreed upon by the research team, and counts were tallied for each theme based on the number of times they were mentioned by participants. RESULTS: Of the 928 greatest challenge responses and session notes, a total of 106 mentions (11%) were focused on ostomy appliances, associated repercussions, and time taken for ostomy care. Eight themes emerged: bleeding, pain, leakage, skin problems/irritation/rash, wafer-related issues, materials getting under the wafer, time to care for ostomy, and solutions to clean the stoma. Challenges described included poor wafer adherence, allergic reactions to adhesives, and pain around the stoma site. These challenges resulted in anxiety related to leakage, odor, and/or skin irritation, which negatively impacted on participation in social activities and self-confidence with ostomy care. CONCLUSIONS: Cancer survivors living with an ostomy experience multiple obstacles with ostomy appliances and caring for their ostomy. Continued innovation in ostomy appliance design and technology is needed to help cancer survivors with successfully managing ostomy care.