EORTC QLQ-CR29 Research Articles

Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer.

BackgroundThe aim of this study was to compare the responsiveness of the European Organization for Research and Treatment (EORTC) quality of life questionnaires (QLQ-C30, QLQ-CR38) and the Functional Assessment of Cancer Therapy-colorectal version 4 questionnaire (FACT-C).MethodThis prospective study included 127 patients with colorectal cancer: 71 undergoing chemotherapy and 56 radiation therapy. Responsiveness statistics included the Standardized Response Mean (SRM) and the Effect Size (ES). The patient's overall assessment of his/her change in state of health status was the reference criterion to evaluate the responsiveness of the QoL questionnaires.Results34 patients perceived their health as stable and 17 as improved between the first and the fourth courses of chemotherapy. 21 patients perceived their health as stable and 22 as improved between before and the last week of radiotherapy.The responsiveness of the 3 questionnaires differed according to treatments. The EORTC QLQ-C30 questionnaire was more responsive in patients receiving chemotherapy, particulary functional scales (SRM > 0.55). The QLQ-CR38 and the FACT-C questionnaires provided little clinically relevant information during chemotherapy or radiotherapy.ConclusionThe EORTC QLQ-C30 questionnaire appears to be more responsive in patients receiving chemotherapy.

Early results of quality of life for curatively treated rectal cancers in Chinese patients with EORTC QLQ-CR29

PurposeTo assess the quality of life in curatively treated patients with rectal cancer in a prospectively collected cohort.MethodsPatients with stage I-III rectal cancer who were treated curatively in a single institution were accrued prospectively. Quality of life was assessed by use of the European Organization for Research and Treatment of Cancer questionnaire module for all cancer patients (QLQ-C30) and for colorectal cancer patients (QLQ-CR29). Quality of life among different treatment modalities and between stoma and nonstoma patients was evaluated in all patients.ResultsA total of 154 patients were assessed. The median time of completion for the questionnaires was 10 months after all the treatments. For patients with different treatment modalities, faecal incontinence and diarrhea were significantly higher in radiation group (p = 0.002 and p = 0.001, respectively), and no difference in male or female sexual function was found between radiation group and non-radiation group. For stoma and nonstoma patients, the QLQ-CR29 module found the symptoms of Defaecation and Embarrassment with Bowel Movement were more prominent in stoma patients, while no difference was detected in scales QLQ-C30 module.ConclusionsOur study provided additional information in evaluating QoL of Chinese rectal cancer patients with currently widely used QoL questionnaires. As a supplement to the QLQ-C30, EORTC QLQ-CR29 is a useful questionnaire in evaluating curatively treated patients with rectal cancer. Bowel dysfunction (diarrhea and faecal incontinence) was still the major problem compromising QoL in patients with either pre- or postoperative chemoradiotherapy.

Impact of Preoperative Radiotherapy on General and Disease-Specific Health Status of Rectal Cancer Survivors: A Population-Based Study

To date, few studies have evaluated the impact of preoperative radiotherapy (pRT) on long-term health status of rectal cancer survivors. Using a population-based sample, we assessed the impact of pRT on general and disease-specific health status of rectal cancer survivors up to 10 years post diagnosis. The health status of older (≥75 years old at diagnosis) pRT survivors was also compared with that of younger survivors. Survivors identified from the Eindhoven Cancer Registry treated with surgery only (SU) or with pRT between 1998 and 2007 were included. Survivors completed the Short Form-36 (SF-36) health survey questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 38 (EORTC QLQ-CR38) questionnaire. The SF-36 and EORTC QLQ-CR38 (sexuality subscale) scores of the survivors were compared to an age- and sex-matched Dutch normal population. A total of 340 survivors (response, 85%; pRT survivors, 71%) were analyzed. Overall, survivors had similar general health status. Both short-term (<5 years) and long-term (≥5 years) pRT survivors had significantly poorer body image and more problems with gastrointestinal function, male sexual dysfunction, and defecation than SU survivors. Survivors had comparable general health status but greater sexual dysfunction than the normal population. Older pRT survivors had general and disease-specific health status comparable to that of younger pRT survivors. For better survivorship care, rectal cancer survivors could benefit from increased clinical and psychological focus on the possible long-term morbidity of treatment and its effects on health status.

The EORTC quality of life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients

The EORTC Quality of Life (QL) Group has developed a questionnaire -the EORTC QLQ-CR29- for evaluating QL in colorectal cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQCR29 when applied to a sample of Spanish patients. Eighty-four locally advanced rectal cancer patients in the treatment follow-up period after receiving surgery and neoadjuvant chemoradiotherapy were included in the study. Seventy subjects also had adjuvant chemotherapy. Patients completed both the EORTC QLQC30 and the QLQ-CR29 once. The psychometric evaluation of the questionnaire's structure, reliability, and convergent, divergent and known-groups validity was performed. Multitrait scaling analysis showed that three of the multi-item scales met the standards of convergent and discriminant validity. These same scales reached the 0.7 Cronbach's coefficient criterion or were close to it. In both analyses exceptions were observed in the blood and mucus in stool scale. Correlations between the scales of the QLQC30 and the module were low (r<0.02) in most cases. A few areas with more related content had higher correlations (r<0.05). Group comparison analyses showed differences in QL between groups of patients based on age, comorbidity, performance status, receipt of adjuvant chemotherapy and surgery modality. The EORTC QLQ-CR29 is a reliable and valid instrument when applied to a sample of Spanish rectal cancer patients. These results are in line with those of the EORTC validation study.

Adaptation of Quality of Life Module EORTC QLQ-CR29 for Polish Patients with Rectal Cancer - Initial Assessment of Validity and Raeliability

Heath related quality of life has been an important object of interest in the clinical practice, focused on assessment of treatment effects from patient's point of view, with particular emphasis placed on effect of treatment on daily patient functioning. Concept of health-related quality of life needs valid and reliable instruments.The aim of the study was to present the process of validation of a new version of EORTC QLQ-CR29 module in Polish patients suffering from rectal cancer.Material and methods. EORTC QLQ-CR29 module comprises 29 questions, and was adapted to Polish cultural conditions based on EORTC procedure. Data collected from 20 patients were analyzed, their agreement with theoretical and empirical structure was assessed. Convergent and discriminant validity were analyzed with multi trait scaling.Reliability was assessed with Cronbach alpha coefficient. Known group validity was assessed in terms of differences between men and women, and between stoma and non-stoma patients. Exact Mann-Whitney test was used. P values lower than 0.05 were considered significant.Results. Scales built on bases of empirical model of module had higher validity and reliability than those based on theoretical model.There were no significant differences between men and women in health-related quality of life. Significantly higher values were observed in non-stoma patients on body image scale and for leakage of stool item. Reversed relationship was observed in case of abdominal and buttocks pain, as well as embarrassment because of bowel movements.Conclusions. Module CR29 is a valid and reliable tool, which enables standardized measurement of treatment effects, suggested for use as main tool measuring impact of disease itself and applied treatment on health-related quality of life of rectal cancer patients.

Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial

Purpose Few studies have evaluated the quality of life (QoL) of patients with rectal cancer. This report describes the quality of life of French patients who entered the 22921 EORTC trial that investigated the role and place of chemotherapy (CT) added to preoperative radiotherapy (preop-RT). Patients and Methods Patients without recurrences were evaluated with EORTC QLQ-C30 and QLQ-CR38 questionnaires, after a median time of 4.6 years from randomisation. Results All the scores of QLQ-C30 functions were high, from 78 up to 88, with those of global health quality of life scale (GHQL) status being 73. The mean scores of symptoms were low except for diarrhoea. For QLQ-CR38, the mean scores for “body image” and “future perspective” were high at 79.6 and 69.7 respectively. The scores for “sexual functioning” and “enjoyment” were low. Men had more sexual problems than females (62.5 vs 25 mean scores respectively). Chemotherapy was associated with more diarrhoea complaints, lower “role”, lower “social functioning” and lower global health quality of life scale. Conclusion The overall quality of life of patients with rectal cancer is quite good 4.6 years after the beginning preoperative treatments. However, adding chemotherapy to preoperative radiotherapy has a negative effect on diarrhoea complaints and some quality of life dimensions.

Impact of Short-Course Preoperative Radiotherapy for Rectal Cancer on Patients' Quality of Life: Data From the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 Randomized Clinical Trial

The Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 (MRC CR07/NCIC CTG C016) trial showed that, in patients with operable rectal cancer, short-course preoperative radiotherapy (PRE) reduced the rate of local recurrence compared with surgery followed by selective postoperative chemoradiotherapy for patients with a positive circumferential resection margin. However, the advantages of giving PRE to all patients needs to be balanced against any negative impact on patients' quality of life. All 1,350 patients were asked to complete the Medical Outcomes Study Short-Form 36-item (MOS SF-36) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal 38-item (EORTC QLQ-CR38) questionnaires. A priori hypotheses related to the impact of treatment on sexual, bowel, and physical function and general health. Male sexual dysfunction was significantly increased following surgery (P < .001), although there was no difference between treatment arms. However, a treatment difference had emerged at 6 months (PRE patients reporting significantly greater dysfunction; P = .004), which persisted out to at least 2 years (an insufficient number of female patients completed the sexual dysfunction questions to draw firm conclusions). Both treatment groups reported similar levels of decreased physical function at 3 months, but thereafter it returned to baseline levels. There was no evidence of any major changes between treatments or time points in terms of general health or bowel function, but exploratory analysis indicated a significant (P = .006 at 2 years) increase in the level of fecal incontinence with PRE. These results from a large randomized trial using validated patient-completed questionnaires show that, for males, the main adverse effect was sexual dysfunction, and the main cause of this was surgery, but that PRE also affected sexual and some aspects of bowel functioning.

Quality of life after coloanal anastomosis and abdominoperineal resection for distal rectal cancers: sphincter preservation vs quality of life

A permanent colostomy is considered to have an adverse impact on quality of life (QOL). However, functional outcomes following sphincter preservation also affect QOL. Our aim was to determine differences in QOL of patients undergoing coloanal anastomosis (CAA) or abdominoperineal resection (APR) for distal rectal cancer. Eighty-five patients underwent CAA (72 with intestinal continuity and 13 with a stoma because of complications) and 83 patients underwent APR for a distal rectal cancer between 1995 and 2001 at a single institution and responded to our survey. QOL was evaluated using the EORTC QLQ-C30 and QLQ-CR38. Patients with CAA were younger than APR patients (mean age 57 vs 62 years, P < 0.001), but gender distribution, tumour stage and proportion of subjects receiving radiotherapy was not significantly different. Patients undergoing CAA had higher scores (better QOL) for physical functioning; lower scores (fewer symptoms) for fatigue, pain, financial difficulties, weight loss and chemotherapy side effects; and higher scores (more symptoms) for constipation and gastrointestinal symptoms compared with APR patients. CAA patients had higher scores (better QOL) for body image in men but not in women. Sexual functioning scores in men and women were lower (worse QOL) in CAA patients compared with APR patients. QOL after APR is comparable to sphincter preservation, although there are some differences that need to be considered. QOL and functional results should be taken into account with the oncological outcome when devising management strategy for distal rectal cancer.

Quality of life and tumor control after short split-course chemoradiation for anal canal carcinoma

PurposeTo evaluate quality of life (QOL) and outcome of patients with anal carcinoma treated with short split-course chemoradiation (CRT).MethodsFrom 1991 to 2005, 58 patients with anal cancer were curatively treated with CRT. External beam radiotherapy (52 Gy/26 fractions) with elective groin irradiation (24 Gy) was applied in 2 series divided by a median gap of 12 days. Chemotherapy including fluorouracil and Mitomycin-C was delivered in two sequences. Long-term QOL was assessed using the site-specific EORTC QLQ-CR29 and the global QLQ-C30 questionnaires.ResultsFive-year local control, colostomy-free survival, and overall survival were 78%, 94% and 80%, respectively. The global QOL score according to the QLQ-C30 was good with 70 out of 100. The QLQ-CR29 questionnaire revealed that 77% of patients were mostly satisfied with their body image. Significant anal pain or fecal incontinence was infrequently reported. Skin toxicity grade 3 or 4 was present in 76% of patients and erectile dysfunction was reported in 100% of male patients.ConclusionsShort split-course CRT for anal carcinoma seems to be associated with good local control, survival and long-term global QOL. However, it is also associated with severe acute skin toxicity and sexual dysfunction. Implementation of modern techniques such as intensity-modulated radiation therapy (IMRT) might be considered to reduce toxicity.

Adaptación cultural del formulario EORTC QLQ CR-29 para su aplicación en pacientes con cáncer de recto en el Instituto Nacional de Cancerología de Colombia

ObjectiveTo validate a cross-cultural version of the EORTC QLQ CR-29 questionnaire version 2.0 (neutral Spanish) for use in Colombian patients. MethodsThe EORTC quality of life group algorithm was applied including translation, translation comparison, reverse translation, and pilot application of the questionnaire. ResultsThe terms used to define the answers across items were modified. In four items the instrument was also modified using different words. The pilot verified a better understanding after the changes. ConclusionsAn adapted version of the EORTC QLQ CR-29 is available for Colombia. Thus, validation of psychometric properties through its application in colorectal cancer patients is currently suitable.

Quality of Life in Stoma Patients: Appropriate and Inappropriate Stoma Sites

The objective of the cross-sectional study reported here was to compare the quality of life of patients with an appropriate stoma site and with that of patients with an inappropriate stoma site. Two groups of patients with permanent intestinal stomas were assessed, 174 patients with appropriate stoma sites and 174 patients with inappropriate stoma sites. We used the EORTC QLQ-C30 and the EORTC QLQ-CR38, which evaluate 26 quality of life (QoL) scales. Data analysis was performed with SPSS software. From a total of 9 functional scales, 3 scales in patients with an appropriate stoma site were significantly higher than in patients with an inappropriate stoma site: sexual enjoyment (71.2% vs. 63.2%; p = 0.02), physical functioning (74.3% vs. 68.2%; p = 0.005), and role functioning (74.3% vs. 64.4%; p < 0.0001). From the total of 16 symptom scales, patients with an inappropriate stoma site had significantly more problems than patients with an appropriate stoma site in 8 scales: micturation (27% vs. 22.5%; p = 0.04), gastrointestinal problems (32.6% vs. 27%; p = 0.01), weight loss (36.5% vs. 29.2%; p = 0.03), dyspnea (25.95% vs. 12.5%; p = 0.0001), pain (39.3% vs. 29.6%; p = 0.001), fatigue (43.5% vs. 34.5%; p < 0.0001), nausea and vomiting (18.15% vs. 12.8%; p = 0.03), and insomnia (39.8% vs. 31.1%; p = 0.01). Patients with an appropriate stoma site scored global QoL significantly higher than those with an inappropriate stoma site (56.2% vs. 49.7%; p = 0.007) A perfectly placed intestinal stoma is strongly related to good QoL for affected patients. From the total of 26 QoL scales assessed in the study, patients with appropriate stoma sites achieved better results in at least 50% of the scales.

Colonic Stenting Versus Emergency Surgery for Management of Acute Left-Sided Malignant Colonic Obstruction: A Multicenter Randomized Trial (Stent-In 2 Study)

Patients with acute left-sided malignant colonic obstruction are usually treated with emergency surgery. These operations have a high morbidity and mortality. Stent placement as bridge to elective surgery has been suggested to decrease morbidity, mortality and the number of colostomies. No adequately powered randomized controlled trials have been reported in the literature. The objective of this study is to compare the effectiveness and costs of these two treatment algorithms. Methods: This is a prospective multicenter (25 centers) randomized controlled trial. Patients with acute left-sided malignant colonic obstruction are randomly allocated to emergency surgery or colonic stenting as bridge to surgery. Inclusion criteria are ileus less than 1 week with malignant obstruction on imaging, exclusion criteria are serious complications demanding urgent surgery; ASA IV or V; distal tumor margin less than 10 cm from the anal verge. Effectiveness is evaluated in terms of quality of life, morbidity and mortality. Quality of life is measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). The total costs of treatment are evaluated by counting volumes and calculating unit prices. Patients are followed for a period of 6 months. Including 120 patients on a 1: 1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. After inclusion of 60 patients an interim analysis will be performed. Results: From 04/2007 until 10/2008 47 patients (24 men, mean age 69 years) have been enrolled in 17 participating centers. 24 Patients have been assigned to emergency surgery and 23 to stenting. All patients randomized for emergency surgery were treated accordingly. Of the patients randomized to stenting 7 did not receive an enteral stent: 4 appeared to have a diverticular stenosis, 1 patient had a tumor fistula to the small bowel and in 2 patients there was a technical failure. Pathology confirmed malignancy in 22 of the 24 patients assigned to emergency surgery and in 18 of the 23 patients allocated to enteral stenting. With the current inclusion rate, the interim analysis is expected in spring 2009 and the inclusion should be completed in 2011. Conclusion: Endoscopic colonic stent placement as bridge to elective surgery seems to be an attractive alternative to emergency surgery in patients with acute left-sided malignant colonic obstruction. Evidence for its wide-spread application is not yet available. Its effectiveness and costs are currently investigated in a multicenter randomized trial in the Netherlands.

Validation of the French version of the colorectal-specific quality-of-life questionnaires EORTC QLQ-CR38 and FACT-C

The aim of this study was to test the psychometric properties of the French version of the European Organization for Research and Treatment (EORTC) quality-of-life colorectal questionnaire (QLQ-CR38) and the functional assessment of cancer therapy-colorectal version 4 (FACT-C). This prospective study included 209 patients with colorectal cancer: 71 undergoing chemotherapy, 56 radiation, 15 surgery, and 67 survivors. Patients first completed in random order the FACT-C and the EORTC QLQ-CR38 and were asked if they had any preference for either questionnaire. The timing of administration of instruments differed according to patients' treatment to better assess psychometric properties. The FACT-C showed good acceptability, good reproducibility and excellent internal consistency. The QLQ-CR38 had lower internal consistency. Patients did not express a preference for one survey over another. This study confirms the value of the FACT-C and suggests some limits of the QLQ-CR38 for patients with colorectal cancer.

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)

BackgroundAcute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion.Methods/designPatients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics.DiscussionThe Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction.Trial registrationCurrent Controlled Trials ISRCTN46462267.

Quality of life in patients with rectal cancer after laparoscopic colectomy

To assess the quality of life in patients with rectal cancer after laparoscopic colectomy. From Sep.2004 to Dec. 2005, 51 patients with rectal cancer were recruited in this prospective, non-randomized study.Twenty-three patients underwent laparoscopic colectomy (LC), 28 patients had open colectomy (OC). EORTC QLQ-C30 and QLQ-CR38 questionnaire were applied to evaluate quality of life baseline, discharging and 3 months after operation. Before operation,the median score of role functioning in LC group was lower. However, LC group patients complained less financial difficulties. The differences were of statistical significance (P<0.05), but not of clinical significance. The median scores of other function domains and symptom domains were similar between two groups (P>0.05). Postoperatively, the most median scores of function domains and symptom domains between two groups were similar (P>0.05). The only score with statistically significant difference was the pain when patients left hospital (U=218.5, P=0.042). However, the difference was not of clinical significance, too. Only minimal benefits in short-term postoperative quality of life are found with laparoscopic colectomy in patients with rectal cancer compared with open colectomy.

Quality of life after transanal endoscopic microsurgery and total mesorectal excision in early rectal cancer

Total mesorectal excision (TME) is the gold standard in rectal cancer, if curation is intended. Transanal endoscopic microsurgery (TEM) is a much safer technique and seems to have comparable survival in early rectal cancer. The impact of both procedures on quality of life has never been compared. In this study we compared quality of life after TEM and TME. Fifty-four patients underwent TEM for a T1 carcinoma. Only patients without known locoregional or distant recurrences were included, resulting in 36 eligible patients in whom quality of life after TEM was studied. The questionnaires used included the EuroQol EQ-5D, EQ-VAS, EORTC QLQ-C30 and EORTC QLQ-CR38. The results were compared with a sex-and age-matched sample of T+N0 rectal cancer patients who had undergone sphincter saving surgery by TME and a sex- and age matched community-based sample of healthy persons. Thirty-one patients after TEM returned completed questionnaires (overall response rate 86%). Quality of life was compared with 31 TME patients and 31 healthy controls. From the patients' and social perspective quality of life did not differ between the three groups. Compared with TEM, significant defecation problems were seen after TME (P < 0.05). A trend towards better sexual functioning after TEM, compared with TME, was seen, especially in male patients, although it did not reach statistical significance. Transanal endoscopic microsurgery and TME do not seem to differ in quality of life postoperatively, but defecation disorders are more frequently encountered after TME. This difference could play a role in the choice of surgical therapy in (early) rectal cancer. Further prospective studies are needed to confirm our conclusions.

The influence of an Enhanced Recovery Programme on clinical outcomes, costs and quality of life after surgery for colorectal cancer

Optimizing peri-operative care using an enhanced recovery programme improves short-term outcomes following colonic resection. This study compared a prospective group of patients undergoing resection of colorectal cancer within an enhanced recovery programme, with a prospectively studied historic cohort receiving conventional care. Sixty patients underwent elective resection within an enhanced recovery programme (ERP). This incorporated pre-operative counselling, epidural analgesia, early feeding and mobilization. Clinical outcomes were compared with 86 prospectively studied historic control patients receiving conventional care (CC). All patients completed EORTC QLQ-C30, QLQ-CR38 and health economics questionnaires up to three months after surgery. Baseline clinical data were similar in both groups. Postoperative hospital stay was significantly reduced in the ERP, with patients staying 49% as long as those in the CC group including convalescent hospital stay (95% CI 39% to 61%P < 0.001). There were no differences in the number of complications, readmissions or re-operations. There were no significant differences in quality of life or health economic outcomes. Patients undergoing colorectal resection within an ERP stay in hospital half as long as those receiving conventional care, with no increased morbidity, deterioration in quality of life or increased cost.

Quality of life after total mesorectal excision for rectal cancer

After total mesorectal excision for rectal cancer, many surgeons try to avoid an abdominoperineal resection (APR) by performing a transanally double stapled low colo-rectal anastomosis (LRA), frequently without a pouch. This policy is mainly based on the assumption that the quality of life after such LRA is higher than after APR. It has been suggested that a better functional outcome and therefore a higher quality of life might be achieved by a colo-anal J-pouch anastomosis (CPA). The aim of this study was to assess quality of life among disease-free survivors after APR, LRA and CPA. The charts of 301 consecutive patients who had undergone surgery for cancer in the middle or lower third of the rectum were analysed. Two hundred four patients were eligible for inclusion. The quality of life among these patients was assessed using one generic (EQ-5D) and two disease-specific questionnaires (EORTC QLQ-C30 and EORTC QLQ-CR38). The response rate was 82%. The median follow-up was 31 months. Overall, quality of life was good but CPA patients had better quality of life scores than APR and LRA patients. This difference was not only due to the better functional outcome but also to the lower incidence of disturbed micturition and sexual problems in the CPA group. The quality of life after colo-anal J-pouch anastomosis is better than after abdominoperineal resection (APR) and low colo-rectal anastomosis (LRA). The quality of life after APR is similar to that after LRA.

Quality of life and functional outcome following anterior or abdominoperineal resection for rectal cancer

AimsThe aims of the study were (1) to evaluate quality of life (QoL) and functional outcome in patients following anterior resection (AR) or abdominoperineal resection (APR) for rectal cancer, and (2) whether these outcomes were dependent on the level of anastomosis. MethodsPatients who were without recurrent or metastatic disease were identified from the Norwegian Rectal Cancer Registry. QoL was assessed by the EORTC questionnaires QLQ-C30 and QLQ-CR38, and rectal function by a short questionnaire. Of 319 patients studied, 229 had undergone AR and 90 APR. The median age was 73 years, and the median time since surgery was 64 months. ResultsMean QoL scores for body image and male sexual problems were better following AR than APR (P<0.01), also in patients with a low (≤3cm) anastomosis. Patients who had undergone AR had higher mean scores for constipation (P<0.001) and more often used anti-diarrhoeal medication (P=0.005), than patients who had undergone APR. Patients with a low anastomosis (≤3cm) had more incontinence for gas and solid stools (P<0.05), and had more incontinence (P=0.006) compared with patients with higher anastomosis, but there was no difference in QoL. Subgroup analysis showed that irradiated patients (n=34) had worse rectal function in terms of frequency, urgency, and incontinence (P<0.01). ConclusionsAlthough rectal function was impaired in patients with low anastomosis, patients who had undergone AR had better QoL than patients who had undergone APR.

Phase II study of vitamin E and pentoxifylline in patients with late side effects of pelvic radiotherapy

Background and purposeRadiation-induced tissue fibrosis is a common adverse effect of curative treatment for pelvic cancer. Pilot studies testing alpha-tocopherol and pentoxifylline provide evidence of clinical regression of superficial radiation fibrosis after radiotherapy. Patients and methodsTwenty-seven eligible research volunteers with a minimum of one grade 3 or 4 disability (LENT SOMA) due to previous radiotherapy were entered into the study. Volunteers were given dl-alpha tocopheryl acetate 500mg twice a day orally plus pentoxifylline 400mg twice a day orally over a period of 6 months. Clinical assessment of late side effects recorded using LENT SOMA scales was selected as the primary endpoint, taken at baseline and at 6 and 12 months post-registration. Patient self-assessment of function and quality of life was assessed as a secondary endpoint using the EORTC QLQ-C30 core questionnaire and the EORTC QLQ-CR38 pelvic module. Magnetic resonance imaging was undertaken in 13/23 evaluable volunteers before and after 6 months of therapy. ResultsAt 12 months post-registration there were 4 out of 23 responders. At 6 months post-registration there was a statistically significant improvement (i.e. reduction) in the median of the LENT SOMA summed scores in all areas assessed apart from ‘male sexual dysfunction’, ‘vulva’ and ‘vagina’ which were unchanged at 6 months. The median total LENT SOMA score at baseline and 6 months was 49 and 34, respectively, with a median change in total LENT SOMA score between baseline and 6 months of 9 (IQR 7–18) (P<0.001). The maximum LENT SOMA scores improved over the study period, with a total number of 82 maximum grade 3 or 4 normal tissue scores at baseline (median of four complications per person) reduced to a total number of 67 maximum grade 3 or 4 scores at 6 months post-registration (median of 3 complications per person), i.e. a median reduction in severe complications of one per person. LENT SOMA scores at 12 months were similar to those observed at 6 month suggesting no further improvement nor deterioration in late side effects. These findings were, however, not reflected in the patient self-assessment of function and quality of life, raising question about the possibility of observer bias in recording LENT SOMA scores. No significant changes were reported on magnetic resonance images at 6 months from baseline. ConclusionsDespite only seeing four a priori defined responders in this pilot study testing dl-alpha tocopheryl acetate plus pentoxifylline in patients suffering complications of pelvic radiotherapy, changes in LENT SOMA scores suggest beneficial effects. However, we are not convinced that these effects are real, since no significant changes in symptoms and functional status were recorded by detailed prospective patient self-assessments.