Clinical decision-making in managing changes in gastrointestinal function following cancer therapies: Is experience enough?

In patients with gastrointestinal (GI) disorders, identical symptoms may occur for many different reasons. This prospective study assessed whether experienced clinicians can predict accurately the underlying diagnosis or diagnoses contributing to specific symptoms based on the history and physical examination. Three clinicians assessed 47 patients referred for management of troublesome GI symptoms identified after treatment for cancer. Investigations were requested following our comprehensive, peer-reviewed algorithm. The clinicians then recorded their predictions as to the results of those investigations. After each patient had completed all their investigations, had received optimal management and had been discharged from the clinic, the predicted diagnoses were compared to those made. The clinicians predicted 92 diagnoses (1.9 per patient). After investigation, a total of 168 unique diagnoses were identified (3.5 per patient). Of the 92 predicted diagnoses, 41 (43%) matched the diagnosis. Of the 168 actual diagnoses identified, only 24% matched the prediction. None of the clinicians predicted the correct combination of diagnoses contributing to bowel symptoms. Clinical acumen alone is inadequate at determining cause for symptoms in patients with GI symptoms developing after cancer therapy.

Nutritional status, the development and persistence of malnutrition and dietary intake in oesophago-gastric cancer: a longitudinal cohort study.

BACKGROUND: Patients with oesophago-gastric (OG) cancer may be at risk of malnutrition, troublesome gastrointestinal symptoms (GI) and reduced dietary intake in view of the tumour location and multimodality curative treatment approach. Longitudinal research is lacking. The present study aimed to assess (i) nutritional status and how it evolved over the first year; (ii) the association between nutritional status scores and GI symptom scores; and (iii) the nutrient and food group intake pattern. METHODS: This was a prospective, observational study of patients with an OG lesion planned for radical treatment, with assessment at diagnosis, 3 months and 12 months after the start of treatment. Nutritional assessment was performed using the Patient-Generated Subjective Global Assessment, GI symptoms measured using the modified Gastrointestinal Symptom Rating Scale and dietary intake assessed using a semi-quantitative food frequency approach. RESULTS: Eighty patients (61 males, 19 females; aged 46-89 years) were recruited. At baseline, 3 (n = 68) and 12 months (n = 57), 61%, 62% and 60%, respectively, were moderately/severely malnourished. Higher symptom burden was associated with poorer nutritional status at baseline (r = 0.55, P < 0.001), 3 months (r = 0.51, P < 0.001) and 12 months (r = 0.42, P = 0.001). At each respective time point, 37%, 38% and 42% were meeting their estimated average requirement for energy. No change in mean (SD) intake of energy, fibre, nutrient and food groups was observed over time. CONCLUSIONS: Patients with OG cancer have progressive weight loss, with malnutrition present over the majority of the 12-month study period. Optimising nutritional status and symptom management throughout the treatment pathway should be a clinical priority.

Are bile acid malabsorption and bile acid diarrhoea important causes of loose stool complicating cancer therapy?

AIM: Gastrointestinal (GI) symptoms during and after cancer therapy can significantly affect quality of life and interfere with treatment. This study assessed whether bile acid malabsorption (BAM) or bile acid diarrhoea (BAD) are important causes of diarrhoea associated with cancer treatment. METHOD: A retrospective analysis was carried out of consecutive patients assessed for BAM using ((75) Se) Selenium homocholic acid taurocholate (SeHCAT) scanning, after reporting any episodes of loose stool, attending a gastroenterology clinic in a cancer centre. RESULTS: Between 2009 and 2013, 506 consecutive patients (54.5% male; age range: 20-91 years), were scanned. BAM/BAD was diagnosed in 215 (42.5%). It was mild in 25.6%, moderate in 29.3% and severe in 45.1%. Pelvic chemoradiation had induced BAM in > 50% of patients. BAM was also frequent after treatment for conditions not previously associated with BAM, such as anal and colorectal cancer, and was present in > 75% of patients referred after pancreatic surgery. It was also unexpectedly frequent in patients who were treated for malignancy outside the GI tract, such as breast cancer and haematological malignancy. CONCLUSION: BAM/BAD are very common and under-appreciated causes of GI symptoms after cancer treatment. Health professionals should have a low threshold in suspecting this condition, as diagnosis and treatment can significantly improve quality of life.

The utility of hyperbaric oxygen therapy to treat recurrent acute bowel obstruction after previous pelvic radiotherapy: a case series.

BACKGROUND AND OBJECTIVE: Repeated episodes of acute bowel obstruction is a potential complication following pelvic radiation therapy. It has been previously thought that hyperbaric oxygen therapy (HBOT) may not be useful for treatment of such obstructive episodes. We report our experience with the use of HBOT for recurrent radiation-induced acute bowel obstruction. METHODS: This is a retrospective case series. Radiological imaging had excluded the presence of recurrent or new cancer. Possible predisposing causes for acute obstruction had been treated and had not led to resolution of symptoms or had been excluded. RESULTS: During 2007-2010, five patients with recurrent episodes of acute obstructive bowel symptoms following previous therapeutic pelvic irradiation were referred for HBOT (four females and one male; median age 56; range 48-72). The primary tumours sites were the endometrium (n = 2), ovary, cervix and prostate (n = 1 each), and patients were treated 2-17 (median 9) years previously with radiotherapy. Before HBOT, patients were experiencing acute obstructive bowel symptoms at 1-6 weekly intervals. Four patients had progressive weight loss. Patients received 100 % oxygen in a multiplace hyperbaric chamber at a pressure of 2.4 atm absolute for up to 90 min once a day, 5 to 7 days weekly. All patients were initially referred for 40 sessions of HBOT. Three patients required a further extra 20 sessions for complete resolution of bowel symptoms. HBOT was well tolerated with no side effects. Patients have remained well after 6-24 months of follow-up. CONCLUSIONS: HBOT may be an effective treatment of radiation-induced bowel obstruction and deserves prospective evaluation.

Gastrointestinal symptoms after pelvic radiotherapy: a national survey of gastroenterologists.

PURPOSE: Seventeen thousand patients receive treatment with radical pelvic radiotherapy annually in the UK. Up to 50% develop significant gastrointestinal symptoms. The National Cancer Survivorship Initiative has identified access to specialist medical care for those with complications after cancer as one of their four key needs. We aimed to determine the current practice of British gastroenterologists with regards to chronic gastrointestinal symptoms after pelvic radiotherapy. METHODS: A questionnaire was developed and sent up to a maximum of five times to all UK consultant gastroenterologists. RESULTS: Eight hundred sixty-six gastroenterologists were approached and 165 (20%) responded. Sixty-one percent saw one to four patients annually with bowel symptoms after radiotherapy. Eighteen percent rate the current treatments as effective "often" or "most of the time". Forty-seven percent of gastroenterologists consider themselves "confident with basic cases", with 11% "confident in all cases". Fifty-nine percent thinks a gastroenterologist with a specialist interest should manage these patients. Although only 29% thinks a specific service is required for these patients, 34% rates the current service as inadequate. The ideal service was considered to be gastroenterology-led, multidisciplinary and regional. Low referral rates, poor evidence-base and poor funding are cited as reasons for the current patchy services. CONCLUSIONS: The low response rate contrasts with that from a parallel survey of clinical oncologists. This may reflect the opinion that radiation-induced bowel toxicity is not a significant issue, which may be because only a small proportion of patients are referred to gastroenterologists. The development of new, evidence-based gastroenterology-led services is considered the optimal way to meet the needs of these patients.

Clinical trial: Efficacy of a low or modified fat diet for the prevention of gastrointestinal toxicity in patients receiving radiotherapy treatment for pelvic malignancies.

BACKGROUND: Inflammatory responses to pelvic radiotherapy can result in severe changes to normal gastrointestinal function with potentially severe long-term effects. Reduced or modified fat diets may confer benefit. METHODS: This randomised controlled trial recruited patients with gynaecological, urological or lower gastrointestinal malignancy due to receive radical radiotherapy. Patients were randomised to a low fat (20% total energy from long chain triglycerides), modified fat (20% from long chain triglycerides and 20% from medium chain triglycerides) or normal fat diet (40% total energy from long chain triglycerides). The primary outcome was a difference in change in Inflammatory Bowel Disease Questionnaire--Bowel (IBDQ-B) score, from the start to end of radiotherapy. RESULTS: A total of 117 patients with pelvic tumours (48% urological; 32% gastrointestinal; 20% gynaecological), with mean (SD) age: 65 (11.0) years, male:female ratio: 79:38, were randomised. The mean (SE) fall in paired IBDQ-B score was -7.3 (0.9) points, indicating a worsening toxicity. Differences between groups were not significant: P = 0.914 (low versus modified fat), P = 0.793 (low versus normal fat) and P = 0.890 (modified versus normal fat). The difference in fat intake between low and normal fat groups was 29.5 g [1109 kJ (265 kcal)] amounting to 11% (of total energy intake) compared to the planned 20% differential. Full compliance with fat prescription was only 9% in the normal fat group compared to 93% in the low fat group. CONCLUSIONS: A low or modified fat diet during pelvic radiotherapy did not improve gastrointestinal symptom scores compared to a normal fat intake. An inadequate differential in fat intake between the groups may have confounded the results.

Simple nutritional intervention in patients with advanced cancers of the gastrointestinal tract, non-small cell lung cancers or mesothelioma and weight loss receiving chemotherapy: a randomised controlled trial.

BACKGROUND: Weight loss in patients with cancer is common and associated with a poorer survival and quality of life. Benefits from nutritional interventions are unclear. The present study assessed the effect of dietary advice and/or oral nutritional supplements on survival, nutritional endpoints and quality of life in patients with weight loss receiving palliative chemotherapy for gastrointestinal and non-small cell lung cancers or mesothelioma. METHODS: Participants were randomly assigned to receive no intervention, dietary advice, a nutritional supplement or dietary advice plus supplement before the start of chemotherapy. Patients were followed for 1 year. Survival, nutritional status and quality of life were assessed. RESULTS: In total, 256 men and 102 women (median age, 66 years; range 24-88 years) with gastrointestinal (n = 277) and lung (n = 81) cancers were recruited. Median (range) follow-up was 6 (0-49) months. One-year survival was 38.6% (95% confidence interval 33.3-43.9). No differences in survival, weight or quality of life between groups were seen. Patients surviving beyond 26 weeks experienced significant weight gain from baseline to 12 weeks, although this was independent of nutritional intervention. CONCLUSIONS: Simple nutritional interventions did not improve clinical or nutritional outcomes or quality of life. Weight gain predicted a longer survival but occurred independently of nutritional intervention.

Gastrointestinal Toxicity of Pelvic Radiotherapy: Are We Letting Women Down?

For all cancers there are four areas of importance: prevention, early diagnosis, optimising therapy and living with and beyond. For women diagnosed with gynaecological cancers, progress in these first three areas has been immense. However, living with and beyond has largely been ignored as a significant issue. As a group, patients treated for gynaecological cancer are more often young and more often suffer the most difficult long-term issues. Despite the growing number of long-term survivors, little has been done to ensure appropriate assessment and treatment of side-effects of cancer therapies, especially when radiotherapy has been used. For many affected patients their symptoms become part of everyday life, 'normality' is adjusted and these changes are tolerated even when severely limiting activities. Data show that even expert clinicians frequently do not appreciate the true impact of these problems and the focus of treatment and of follow-up remains fixed on 5-year survival and cancer recurrence, respectively. Many clinicians are unaware of what experts can do for toxicity and do not know where to refer their patients. However, rapid identification of patients with significant symptoms can lead to earlier diagnosis of treatable pathologies and improvement in patients' quality of life. In addition, the underlying pathophysiology of radiation-induced damage is potentially amenable to disease-modifying therapies. This review focuses on the factors that contribute to patients developing pelvic radiation disease, what can be done to mitigate the toxicity of treatment and highlights the challenges that must be addressed to reduce the gastrointestinal toxicity of pelvic radiotherapy.

The clinical needs of patients with chronic gastrointestinal symptoms after pelvic radiotherapy.

BACKGROUND: After radiotherapy for pelvic cancer, gastrointestinal symptoms affecting quality of life are common. How they affect daily living is unknown. AIM: To investigate the day-to-day impact of gastrointestinal symptoms in patients after pelvic radiotherapy. METHODS: New patients referred for gastroenterological evaluation of radiotherapy-induced symptoms were sent a questionnaire. RESULTS: Over 15 months, 75 of 100 questionnaires were completed before the gastroenterology appointment by 45 men (median age 70) and 30 women (median age 57) treated for urological (n = 44), gynaecological (n = 27) and gastrointestinal (n = 4) cancers. Time since radiotherapy was 3 years (median) for women and 1.5 years (men). Women experienced 6 (median) symptoms whilst men experienced 4. Having someone listen to problems was often as important as treatment. Urgency, diarrhoea, pain, rectal bleeding, flatulence and bloating were particularly troublesome. 57% women and 33% men were 'very affected'. Symptoms rarely improved with time and in 33% had been present for more than 2 years. Gastrointestinal symptoms affected quality of life through change of routine (F 37%, M 22%), social limitation (F 17%, M 33%), physical limitations (F 33%, M 16%), emotional difficulties (F 47%, M 18%) and sexual problems (F 30%, M 51%). CONCLUSIONS: Patients experience a high number of physical symptoms for long periods before referral. Clinicians must focus systematically on physical, emotional and psychosexual issues.

Gastrointestinal problems after pelvic radiotherapy: the past, the present and the future.

Up to 300,000 patients per year undergo pelvic radiotherapy worldwide. Nine out of 10 will develop a permanent change in their bowel habit as a result. Five out of 10 of all patients will say that this change in their bowel habit affects quality of life and two to three out of 10 will say that this effect on quality of life is moderate or severe. Between one in 10 and one in 20 patients will develop very serious complications within the first 10 years after treatment. This number will increase to two out of 10 by 20 years from the end of treatment. Although research carried out into the basic molecular, cytokine and physiological changes underlying radiation-induced bowel symptoms and the optimal treatment that should be provided to symptomatic patients is scant, it does seem probable that a significant proportion of these patients can be cured or improved by specialist gastroenterological intervention. However, most patients never get referred to a specialist gastroenterologist and research into late radiation bowel damage has not been considered a priority. With the advent of more effective cancer therapies leading to greater numbers of affected long-term survivors, much more emphasis is urgently required to provide better information to patients at the start and after treatment, developing techniques that might reduce the frequency of significant bowel toxicity and researching better ways of measuring and treating late-onset side-effects.

What are the gastrointestinal endoscopic requirements of a cancer centre?

AIMS: To describe the elective endoscopy requirements of a cancer centre. MATERIALS AND METHODS: A prospective register of all patients referred from a cancer centre to our unit over a period of 1 year was maintained. Emergency procedures out of hours were not included. RESULTS: The Endoscopic Unit at the Chelsea and Westminster Hospital provides a service to the local population of southwest London and the Fulham Road branch of the Royal Marsden Hospital. Between 1 January and 31 December 2003, 3720 new National Health Service patients with cancer were seen at the Royal Marsden Hospital; 1423 of these patients were seen at the Fulham Road branch. In the same period, the Endoscopy Unit at the Chelsea and Westminster Hospital investigated 5270 patients. Of these, 426 patients (8.1%) were referred from the Royal Marsden Hospital. In total, these patients underwent 491 procedures. Two hundred and fifty-three patients were men, with a median age of 65 years (range 22-100), and 173 were women, with a median age of 58 years (range 18-100). The diagnostic procedures carried out included colonoscopy (n=125), upper gastrointestinal endoscopy (n=136), flexible sigmoidoscopy (n=90), endoscopic ultrasound (n=24), anorectal physiology measurement (n=5) and endoscopic retrograde cholangio-pancreatography (ERCP) (n=1). Therapeutic procedures included ERCP (biliary stents/sphincterotomy/stone extraction) (n=38), placement of percutaneous endoscopic gastrostomy (n=29), balloon dilatation of oesophageal strictures (n=25), oesophageal, gastric, duodenal or colonic stent insertion or laser therapy (n=16), naso-jejunal tube insertion (n=1) and banding of oesophageal varices (n=1). All patients were treated as day cases. Four patients were admitted for observation after their investigation. All others were discharged home or back to the Royal Marsden Hospital. CONCLUSIONS: Cancer centres increasingly require diagnostic, palliative and therapeutic endoscopic support as part of the acute and follow-up management of patients. Many procedures are urgent. This study suggests that a significant number of patients being managed in a cancer centre will require endoscopic intervention and the range of procedures, equipment and skills required is wide.

Failure of dietetic referral in patients with gastrointestinal cancer and weight loss.

This study examined whether staff working within a cancer centre treating patients with gastrointestinal malignancy routinely identified individuals from outpatients for referral to a dietitian. A nutrition screening tool is employed only for in-patient admissions. Height, current and usual weight were recorded prospectively in all patients referred for consideration of treatment. First appointment with the dietitian, first hospital admission, demographic and clinical details were obtained from hospital records. Time from first appointment to referral to a dietitian was examined. Between September 2002 and March 2004, 920 patients were included. Five hundred and seventeen patients had lost weight, of whom 223 patients had lost between 5% and 10% and 294 patients had lost more than 10% of their pre-morbid weight. Three hundred and twenty-seven patients (36%) were referred to dietitians. Twenty eight (9%) of referrals were made by staff in outpatients. Two hundred and ninety-nine were referred during or after an inpatient admission but only 39% of these occurred within the first seven days following admission. One third of patients with more than 10% weight loss were not referred for dietary assessment, even following admission. The likelihood of referral was significantly associated with the degree of weight loss (univariate analysis hazard ratio (HR) 1.75, 95% Confidence Interval (CI) 1.4-2.19, multivariate HR 1.65, 95% CI 1.22-2.23) and was independent of factors such as performance status and clinical setting. Few patients were identified early in their treatment for referral to a dietitian. Since most chemotherapy is now given on an outpatient basis, patients are unlikely to be referred if they do not require admission. This study suggests that an out-patient dietetic screening tool is urgently required. Such screening is likely to result in considerable improvements to the clinical care of cancer patients with weight loss.

A "field change" of inhibited apoptosis occurs in colorectal mucosa adjacent to colorectal adenocarcinoma.

BACKGROUND: Colorectal cancer is associated with a "field change" of increased proliferation throughout the colonic and rectal mucosa. Both proliferation and apoptosis are disrupted during carcinogenesis. Whether altered apoptosis contributes to this field change of microscopic abnormality is, however, unclear. Bcl-xL is an anti-apoptotic protein that inhibits apoptosis by preventing release of cytochrome c, a recognised pathway to cell death. AIM: To determine whether Bcl-xL inhibition of apoptosis is increased in colorectal mucosa adjacent to colorectal adenocarcinoma over that in normal non-neoplastic colorectal mucosa. PATIENTS: PATIENTS undergoing surgical resection for neoplastic (adenocarcinoma) or non-neoplastic disease of the colorectum (rectal prolapse, diverticular disease or volvulus). METHODS: Formalin-fixed, paraffin-wax-embedded surgical colorectal resection specimens were immunostained for Bcl-xL protein. Labelling indices were determined by counting the proportion of positively stained cells in mucosal crypts. RESULTS: 85 patients were studied. Bcl-xL immunostaining was most marked in the upper third of mucosal crypts. It occurred in a minority of samples from non-neoplastic colorectal mucosa, but was seen in most mucosal samples adjacent to colorectal adenocarcinoma. Significant increases (p<0.001) were observed in Bcl-xL labelling indices in the mucosa at 1 cm (n = 46, median labelling index 31.8%, interquartile range 8.3-43.9%) and at 10 cm (n = 52, median labelling index 22.0%, interquartile range 0.0-36.3%) from colorectal carcinoma, compared with normal, non-neoplastic colorectal mucosa (n = 22, median labelling index 0.0%, interquartile range 0.0-0.0%). CONCLUSIONS: The findings are consistent with a field change of inhibited apoptosis in mucosa adjacent to colorectal carcinoma.

Is supplementation with elemental diet feasible in patients undergoing pelvic radiotherapy?

BACKGROUND: Acute gastrointestinal upset occurs in approximately 80% of patients undergoing radiotherapy for pelvic cancers. Underlying changes relate to denudation of the mucosal layer which renders the small intestine vulnerable to additional damage from proteolytic enzymes and bile acids. Severe acute bowel symptoms may predispose to progressive fibrotic and ischaemic changes. Elemental diet given during treatment may reduce acute and chronic bowel symptoms induced by pelvic radiotherapy. METHODS: This study aimed to assess compliance with elemental diet during pelvic radiotherapy. Patients with gynaecological, urological or rectal malignancy undergoing radical or adjuvant pelvic radiotherapy were randomised to one of five groups. Each group was assigned a target quantity of three different elemental sip feeds (Group 1, 20%, Group 2, 50%, Group 3, 75% of calorie requirements taken as E028 extra liquid; Group 4, 50% of calorie requirements taken as E028 extra powder; Group 5, 50% of calorie requirements taken as Emsogen powder). Compliance was assessed using a diary card and weekly assessment. Statistical analyses were conducted on an intention to treat basis. RESULTS: Fifty patients (44 female, six male) mean age 58 yr (95% CI 55-61), were recruited to the study (24 endometrial, 17 cervical, 7 rectal, 1 vulval and 1 bladder carcinoma). Mean weight at baseline was 74.5 kg (95% CI 69-80) and this did not change during treatment. Full compliance was achieved in three patients, all from Group 1. By week 5, only 46% of patients were consuming elemental diet. Post hoc analysis of variance with repeated measures indicated that there were no significant differences in volume of elemental diet consumed between groups (P = 0.937). There was a significant inverse linear relationship between intake of elemental diet and time (P < 0.001). CONCLUSIONS: Different formulations of elemental diet do not influence compliance. Patients are unlikely to be able to consume more than one-third of their calorie requirements in the form of an elemental sip feed. Further investigation is warranted to determine if intervention with this volume of elemental diet is beneficial.

Patient and physician reporting of symptoms and health-related quality of life in trials of treatment for early prostate cancer: considerations for future studies.

AIMS: Clinical trials in early prostate cancer (EPC) have used a variety of outcome measures, including patient-reported outcomes (PROs) and physician-reported data. We review published studies and suggest a set of outcome measures and a portfolio of more detailed questionnaire options to produce a more homologous data set for future clinical trials. MATERIALS AND METHODS: A literature search combining the terms 'quality of life' or 'symptoms' and 'prostate cancer' or 'prostate adenocarcinoma' was carried out. Relevant papers were reviewed to assess key areas of toxicity and quality of life (QoL). These were discussed by a panel with a special interest in the assessment of QoL measures and PROs. RESULTS: Twenty-one validated candidate questionnaires were identified. The Short Form 12 was recommended due to its combination of brevity and assessment of pain, general and mental health, physical, social and emotional function. Specific questionnaires should assess localised symptoms after treatment, including sexual function, erectile dysfunction, bowel function and lower urinary tract symptoms (LUTS). The modular use of separate symptom indices was recommended. For sexual function, the International Index of Erectile Function and the International Continence Society questionnaire were considered the best available. The International Continence Society Male Short Form questionnaire best addressed LUTS. Incontinence of stool (solid, liquid or gas) and its effect on function should be assessed. The Vaizey questionnaire is recommended. The Radiation Therapy Oncology Group scale, which is physician administered, remains helpful in studies including radiotherapy, as it places current trials within appropriate historical context. Rates of procedures to treat complications and pharmaceutical interventions for treatment-related symptoms should be recorded at the time of each questionnaire follow-up. CONCLUSION: Although novel therapies may produce different toxicities, the current recommendations should help to produce trial protocols that will allow comparable data to be generated within clinical trials comparing outcome from surgery, radiotherapy and other targeted ablative therapies for EPC.

The significance of rectal bleeding after pelvic radiotherapy.

BACKGROUND: Rectal bleeding after pelvic radiotherapy is often attributed to radiation proctitis and patients do not routinely undergo flexible endoscopy. AIMS: To assess the significance of bleeding after radiotherapy. METHODS: We maintained a prospective register of all such patients referred to our endoscopy unit. RESULTS: One hundred and thirty-nine men (median age 70 years; range 31-82), and 32 women (median age 61 years; range 30-81) were referred with rectal bleeding (median 2 years; range 0-21) after pelvic radiotherapy. Primary tumour sites were urological (n = 139), gastrointestinal (n = 7) and gynaecological (n = 25). Ninety patients had bleeding alone; 81 had other symptoms. One hundred and forty-one had typical radiation proctitis; in 65 this was the sole diagnosis; eight had cancer, nine had high-risk adenomas, and six had three or more small adenomas. Ninety-five other diagnoses were made. Eleven (73%) patients with advanced polyps or cancer required only flexible sigmoidoscopy to make the diagnosis, while four (27%) diagnoses were made only after colonoscopy; 47% of these patients had no other symptoms apart from rectal bleeding. CONCLUSIONS: After pelvic radiotherapy, clinical symptoms are not reliable in differentiating between radiation proctitis alone or more significant pathology. It is mandatory that all patients with new onset rectal bleeding are investigated with, at least, flexible sigmoidoscopy.

Faecal incontinence: A late side-effect of pelvic radiotherapy.

AIMS: Despite advances in pelvic radiotherapy, damage to normal tissue can lead to chronic gastrointestinal problems. The frequency with which this affects quality of life is controversial. Faecal incontinence is not widely perceived to be a major issue after pelvic radiotherapy. The aim of this paper is to review the frequency and mechanisms for the development of faecal incontinence after pelvic radiotherapy, and to review treatment options for faecally incontinent patients. MATERIALS AND METHODS: A search of original literature was carried out using MEDLINE and EMBASE databases from 1966 to 2005. RESULTS: The reliability of the published data is poor because patients frequently fail to admit to faecal incontinence, and because prospective studies are lacking that assess faecal incontinence as a specific end point using adequate, validated and reproducible methodology. The published rates of late new-onset faecal incontinence after pelvic radiation are between 3% and 53%. Patients treated for prostate rather than gynaecological, bladder, rectal or anal cancer may have a lower rate. Only 8-56% of affected patients state that faecal incontinence reduces their quality of life. Studies examining the physiological changes occurring after radiotherapy are generally not adequately controlled or powered, assessment of ano-rectal function is rarely comprehensive and loss of patients to follow-up frequently makes it difficult to extrapolate results to a wider population. Where there is agreement over the physiological changes that occur after radiotherapy, it is not clear at what threshold these changes cause symptoms. No prospective studies of any non-surgical treatment for faecal incontinence after radiotherapy have been published. Surgery other than colostomy probably carries a high risk of complications in this group of patients, but few data have been published. CONCLUSIONS: Now that improvements in outcome from combination treatments, including radiotherapy for pelvic cancer, are being achieved, it is time that serious attention is paid to determining how frequently significant gastrointestinal toxicity arises, and how best to optimise the quality of life of long-term survivors.

Topical phenylephrine in the treatment of radiation-induced faecal incontinence.

AIMS: Acute bowel toxicity after pelvic radiotherapy is defined as occurring within 3 months of the start of treatment; chronic gastrointestinal toxicity may continue after the acute phase or start after a latent period. One in five patients develop chronic faecal incontinence affecting quality of life; how best to treat these patients is not known. This retrospective study aimed to determine the effects of a new agent, phenylephrine gel, in the treatment of chronic radiation-induced faecal incontinence. MATERIALS AND METHODS: Patients prescribed phenylephrine gel for new-onset faecal incontinence after radiotherapy were identified from our database of patients treated in a specialist radiation-induced bowel damage clinic since 2000. Changes in the level of faecal incontinence were assessed using the Vaizey faecal incontinence scoring system before and after treatment. RESULTS: Fifteen patients (nine men and six women) of mean age 70.5 years (standard deviation 8.2, age range 56-82 years) were treated with phenylephrine gel a median of 43 months after completing radiotherapy. The median Vaizey score before treatment with phenylephrine gel was 17 (interquartile range [IQR] 14-20) and after treatment was 14 (IQR 11-18) (P = 0.005). The median length of treatment with phenylephrine gel was 28 days (IQR 28-365). Scores improved in 11 out of 15 patients; four out of 15 patients showed substantial improvements of 7 or more points; and seven patients considered the gel helpful. CONCLUSION: Topical phenylephrine gel for the treatment of radiation-induced faecal incontinence has not been previously reported. This small, retrospective study suggests that it may help most patients and, in some, the improvement may be substantial. However, larger placebo-controlled prospective studies are required.

Do serum levels of eosinophil granule-derived protein change in patients undergoing pelvic radiotherapy?

AIMS: Eosinophils have an important role in the pathogenesis of inflammatory bowel disease, with faecal levels of the eosinophil granule proteins, eosinophil cationic protein (ECP) and eosinophil protein X (EPX) reflecting disease activity. Eosinophil crypt abscesses are a characteristic histological finding in acute gastrointestinal radiation-induced mucosal damage. This pilot study aimed to investigate changes in serum levels of ECP/EPX during pelvic radiotherapy. MATERIALS AND METHODS: Patients with no history of inflammatory bowel disease, starting a 5-week course of pelvic radiotherapy, had serum ECP/EPX levels measured before radiotherapy and during the fourth week of treatment. Bowel toxicity was graded at week 4 using the Common Toxicity Criteria Scale. RESULTS: Fifteen patients who were to undergo adjuvant radiotherapy for gynaecological cancer were recruited. The mean serum levels of ECP and EPX before treatment were 17.3 microg/l (range 2.0-49.3 microg/l) and 37.3 microg/l (range 12.0-94.0 microg/l), respectively. The mean serum levels during week 4 of radiotherapy for ECP and EPX were 43.0 microg/l (range 2.4-164.0 microg/l) and 38.7 microg/l (range 9.0-79.0 microg/l), respectively. Serum ECP levels increased at week 4 compared with levels before radiotherapy (P = 0.02). Acute bowel toxicity was seen in 12 patients (80%) at week 4: Grade 1 in 25% patients and Grade 2 in 75%. In this small study, no correlation was seen between acute bowel toxicity at week 4 and serum ECP or EPX levels. CONCLUSIONS: Serum ECP levels increase in response to pelvic irradiation. This may reflect the known involvement of eosinophils in the acute response to radiotherapy. Further study is required to determine when levels start to rise and their relationship to the degree of acute bowel toxicity.