Longitudinal assessment of peri-implant diseases in patients with and without history of periodontitis: A 20-year follow-up study.

PURPOSE: To longitudinally assess the prevalence of peri-implant health, peri-implant mucositis and peri-implantitis in a cohort of patients with and without history of periodontitis over a 20-year period. MATERIALS AND METHODS: Eighty-four patients who attended a specialist private periodontal practice were evaluated prospectively 10 and 20 years after prosthesis delivery. Following successful completion of periodontal/implant therapy, patients (172 implants) were enrolled on an individualised supportive periodontal care programme. Clinical and radiographic parameters were collected to assess the prevalence of peri-implant health and diseases. Prevalence of peri-implantitis and peri-implant mucositis was calculated based on the case definition set out in 2018. A multilevel logistic regression analysis was conducted to assess potential risk or protective factors. RESULTS: The analysis was performed on 22 periodontally healthy and 62 periodontally compromised patients rehabilitated with 39 and 130 implants, respectively. The 10-year prevalence of peri-implant health, peri-implant mucositis and peri-implantitis was 21.4%, 67.9% and 10.6%, respectively, whereas the 20-year prevalence was 29.8%, 47.6% and 33.3%, respectively. Non-compliant periodontally compromised patients showed a statistically significantly increased risk at 20 years of both peri-implant mucositis (odds ratio 11.1; 95% confidence interval 1.8-68.6) and peri-implantitis (bone loss and probing depth) (odds ratio 14.3; 95% confidence interval 1.8-32.9). High full-mouth plaque and bleeding scores were associated with higher odds of both peri-implant mucositis and peri-implantitis. CONCLUSIONS: Peri-implant diseases were prevalent in patients rehabilitated with dental implants and followed up for a period of 20 years. History of periodontal disease and a lack of compliance with a tailored supportive periodontal care programme were identified as risk factors for peri-implant diseases.

Reliability assessment of the 2018 classification case definitions of peri-implant health, peri-implant mucositis, and peri-implantitis.

BACKGROUND: The purpose of this study was to evaluate the reliability and accuracy in the assignment of the case definitions of peri-implant health and diseases according to the 2018 Classification of Periodontal and Peri-implant Diseases and Conditions. METHODS: Ten undergraduate students, 10 general dentists, and 10 experts in implant dentistry participated in this study. All examiners were provided with clinical and radiographic documentation of 25 dental implants. Eleven out the 25 cases were also accompanied by baseline readings. Examiners were asked to define all cases using the 2018 classification case definitions. Reliability among examiners was evaluated using the Fleiss kappa statistic. Accuracy was estimated using percentage of complete agreement and quadratic weighted kappa for pairwise comparisons between each rater and a gold standard diagnosis. RESULTS: The Fleiss kappa was 0.50 (95% CI: 0.48 to 0.51) and the mean quadratic weighted kappa value was 0.544. Complete agreement with the gold standard diagnosis was achieved in 59.8% of the cases. Expertise in implantology affected accuracy positively (p < 0.001) while the absence of baseline readings affected it negatively (p < 0.001). CONCLUSION: Both reliability and accuracy in assigning case definitions to dental implants according to the 2018 classification were mostly moderate. Some difficulties arose in the presence of specific challenging scenarios.

Assessment of salivary alpha amylase and mucin-4 before and after non-surgical treatment of peri-implant mucositis.

BACKGROUND: The present study was based on the null hypothesis that there is no difference in clinicoradiographic parameters and whole salivary alpha amylase (AA) and mucin-4 levels before and after non-surgical mechanical debridement (NSMD) of patients with peri-implant mucositis (PM). The aim was to assess whole salivary AA and mucin-4 levels before and after treatment of PM. METHODS: Patients with PM (Group-1) and individuals without peri-implant diseases (Group-2) were included. Demographic data was collected and peri-implant modified plaque and bleeding indices (mPI and mBI, respectively), probing depth (PD) and crestal bone loss were measured at baseline. Levels of AA and mucin-4 were assessed in unstimulated whole saliva samples. All patients underwent full-mouth non-surgical periodontal therapy (NSPT) and NSMD; and clinical parameters and salivary biomarkers were re-assessed after 3 months. Level of significance was set at P < 0.01. RESULTS: Twenty-six and 32 individuals were included in groups 1 and 2, respectively. None of the participants had periodontitis. At baseline clinical periodontal parameters (PI [P < 0.001], GI [P < 0.001], clinical AL [P < 0.001] and PD [P < 0.001]) were significantly high in Group-1 than Group-2. At 3-month follow-up, there was a statistically significant reduction in clinical periodontal and peri-implant parameters (PI [P < 0.01], GI [P < 0.01], and PD [P < 0.01]) in Group-1 compared with their baseline values. At baseline, salivary AA levels were significantly high in Group-1 than Group-2 (P < 0.01). At 3-month follow-up, there was no significant difference in whole salivary AA levels among patients in groups 1 and 2. CONCLUSIONS: The AA and mucin-4 levels are potential biomarkers for evaluation of peri-implant diseases including PM. Mechanical instrumentation continues to be the most predictable treatment option for the management of peri-implant diseases.

Development and Validation of the Mucosal Inflammation Noninvasive Index For Pediatric Crohn's Disease.

BACKGROUND & AIMS: Mucosal healing (MH) has become a goal of therapy for Crohn's disease (CD), but frequent endoscopies are not feasible. We aimed to develop and validate a non-invasive index to assess mucosal inflammation in children with CD. METHODS: We collected data from the multi-center prospective ImageKids study, in which children with CD underwent ileocolonoscopy with magnetic resonance enterography. We investigated the association of pediatric CD activity index (PCDAI) items and laboratory test results with the simple endoscopic score for CD (SESCD). We used these data in a blended mathematical judgmental clinimetric approach to develop a weighted categorized index to identify children with CD who have MH, which we called the MINI index. We validated the index using data from 3 independent patient cohorts. The derivation and validation cohorts included 154 and 168 children, respectively (age 14.1 ± 2.5 years and 14.2 ± 3.9 years), of whom 16% and 36% had MH (defined as SESCD<3). RESULTS: In multivariable models, the stooling item of the PCDAI, erythrocyte sedimentation rate, and level of fecal calprotectin were associated with SESCD (all P < .05). We added data on level of C-reactive protein to develop the MINI index. MINI scores below 8 identified children with MH with 88% sensitivity and 85% specificity in the derivation cohort and with 84% sensitivity and 87% specificity in the validation cohorts. Ninety percent of the patients in the validation cohort with scores of 8 or more had active mucosal inflammation, yet 78% of patients with scores below 8 had MH. Scores below 6 increase the positive predictive value to 86%. CONCLUSIONS: We developed an index to non-invasively assess mucosal inflammation in children with CD. This index, identifies children with MH with high sensitivity and specificity. The added benefit of MINI over measurement of fecal calprotectin was small but significant, especially for patients with concentrations of fecal calprotectin from 100 to 599 µg/g. ClinicalTrials.gov no: NCT01881490.

"Just Living With Them": Symptom Management Experiences of Rural Residents With Advanced Cancer.

PURPOSE: To understand how rural residents with advanced cancer experience and manage their symptoms. PARTICIPANTS & SETTING: 16 adult patients with a diagnosis of advanced cancer, who were receiving antineoplastic treatment and living in rural areas of southeastern Iowa, participated in the study. METHODOLOGIC APPROACH: Data were collected through semistructured, audio-recorded interviews using open-ended questions. Data were analyzed using content and dimensional analyses. FINDINGS: Four themes were developed from the completed interviews, including (a) barriers and challenges associated with rural cancer care, (b) physical symptoms experienced from the time of diagnosis through the cancer trajectory, (c) symptom management strategies used to control physical symptoms, and (d) perceptions of having cancer and the use of technology in managing symptoms. IMPLICATIONS FOR NURSING: Rural residents with advanced cancer experience a wide range of physical symptoms that may affect their quality of life. Although residents may develop self-management strategies to cope with symptoms, additional guidance on and interventions for how best to manage physical symptoms are needed.

Prophylactic antibiotics reduce hospitalisations and cost in locally advanced head and neck cancer patients treated with chemoradiotherapy: A randomised phase 2 study.

BACKGROUND: Platinum-based chemoradiotherapy for locally advanced head and neck cancer (LAHNC) induces a high rate of acute toxicity, including dysphagia and aspiration pneumonia. We hypothesised that prophylactic antibiotics can prevent pneumonia and hospitalisations and can be cost-effective. PATIENT AND METHODS: In this multicentre randomised trial, patients with LAHNC treated with chemoradiotherapy received prophylactic amoxicillin/clavulanic acid from day 29 after the start of treatment until 14 days after completion of chemoradiotherapy or standard care without prophylaxis. The primary objective was to observe a reduction in pneumonias. Secondary objectives were to evaluate the hospitalisation rate, adverse events, costs and health-related quality of life. RESULTS: One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group. A pneumonia during chemoradiotherapy and follow-up until 3.5 months was observed in 22 (45.8%) of 48 patients in the standard group and in 22 (46.8%) of 47 patients in the prophylaxis group (p = 0.54). Hospitalisation rate was significantly higher in the standard group versus the prophylaxis group, 19 of 48 pts (39.6%) versus 9 of 47 pts (19.1%), respectively (p = 0.03). Significantly more episodes with fever of any grade were observed in the standard group (29.2% vs 10.2%, p = 0.028). A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group. CONCLUSION: Although prophylactic antibiotics during chemoradiotherapy for patients with LAHNC did not reduce the incidence of pneumonias, it did reduce hospitalisation rates and episodes with fever significantly and consequently tended to be cost-effective.

US oncology-wide incidence, duration, costs and deaths from chemoradiation mucositis and antimucositis therapy benefits.

Approximate oncology-wide incidence, duration, costs and deaths associated with mucositis and identify health economic benefits of antimucositis therapies. Review the literature relevant to the clinical experience of mucositis by pathophysiology, incidence, duration, costs and deaths. Use US insurance actuarial and epidemiology on cancer to generalize an oncology-wide impact of toxic mucositis. Toxic mucositis causes oropharyngoesophageal ulcerations, chemo-induced nausea, vomiting and diarrhea. Acutely, it lasts 102 days/six cycles of chemotherapy, 60 days in human stem-cell transplantation patients and 70-84 days in head and neck cancer patients at annual costs of US$13.23 billion/522,166 treated patients (US$20,892/erosive-type mucositis patient, US$25,337/physiologic mucositis patient) and 46,699 deaths. Using antimucositis therapies prior to 2013 provided fractional benefits at high costs. By completely preventing and rapidly reversing mucositis, high-potency polymerized cross-linked sucralfate promises superior health economic benefits.

Association of human papillomavirus and p16 status with mucositis and dysphagia for head and neck cancer patients treated with radiotherapy with or without cetuximab: Assessment from a phase 3 registration trial.

BACKGROUND: Mucositis and dysphagia are common adverse effects of radiotherapy (RT) treatment of locally advanced squamous cell cancer of the head and neck (LA-SCCHN). Chemotherapy added to RT increases survival rates but causes worse mucositis and dysphagia. The aim of this analysis was to assess the impact of p16 status on mucositis, dysphagia, and feeding tube use in LA-SCCHN among patients treated with RT±cetuximab in the phase 3 IMCL-9815 trial. METHODS: Patients received RT plus weekly cetuximab or RT alone. Subgroup analyses were conducted on patients with p16-positive (n=75) or p16-negative (n=106) oropharyngeal cancer (OPC), as determined by immunohistochemical analysis. The onset and duration of mucositis and dysphagia by treatment arm and p16 status were displayed using Kaplan-Meier curves and the log-rank test. P values for the incidence of mucositis and dysphagia were calculated using the Fisher exact test. Feeding tube use was assessed as the percent of patients reporting use. RESULTS: The baseline characteristics of patients treated with RT±cetuximab were similar in both the p16-positive and p16-negative OPC subgroups. Patients within the p16-positive OPC subgroup had higher Karnofsky scores and were more likely to have stage T1-T3 cancer and be from the United States. Regardless of p16 status, there was no difference in the onset or duration of grade 3/4 mucositis or dysphagia in patients receiving RT plus cetuximab compared with those receiving RT alone. In the overall population, and the p16-positive and p16-negative OPC subpopulations, feeding tube use was not different for patients receiving RT plus cetuximab compared with RT alone. CONCLUSION: Regardless of p16 status, the addition of cetuximab to RT did not alter the incidence, time to onset, severity, or duration of mucositis and dysphagia and did not impact the frequency of feeding tube use.

The assessment of general well-being using spontaneous burrowing behaviour in a short-term model of chemotherapy-induced mucositis in the rat.

Mucositis is a common and serious side-effect experienced by cancer patients during treatment with chemotherapeutic agents. Consequently, programmes of research focus on the elucidation of novel therapeutics for alleviation of mucositis symptoms, and these frequently use animal models. However, although these models are assumed to be painful and distressing to the animal, endpoints are difficult to determine. The aim of this study was to evaluate whether a change in burrowing behaviour could provide an indication of disease onset and potentially be applied as a humane endpoint. Baseline burrowing behaviour was measured in healthy animals on three occasions by determining the weight of gravel displaced from a hollow tube. Mucositis was then induced in the same animals by intraperitoneal injection of 5-fluorouracil (150 mg/kg) and burrowing behaviour recorded over three consecutive days. Standard measures of disease progression, including body weight loss and clinical score, were also made. The presence of mucositis was confirmed at necropsy by findings of decreased duodenal and colon lengths, and reduced liver, spleen and thymus weights in comparison with non-treated control animals. Histological score of the jejunum and ileum was also significantly increased. Mucositis onset coincided with a decrease in mean burrowing behaviour which was progressive, however this result did not achieve statistical significance (P = 0.66).We conclude that burrowing may be a useful indicator of inflammation in the mucositis model, although this requires further characterization. Pre-selection of animals into treatment groups based on their prior burrowing performance should be pursued in further studies.

Pharmacoeconomic analysis of palifermin to prevent mucositis among patients undergoing autologous hematopoietic stem cell transplantation.

Trials have shown benefits of palifermin in reducing the incidence and severity of oral mucositis in patients with hematological malignancies undergoing autologous hematopoietic stem cell transplantation (HSCT) with total body irradiation (TBI)-based conditioning regimens. Similar outcome data are lacking for patients receiving non-TBI-based regimens. We performed a retrospective evaluation on the pharmacoeconomic benefit of palifermin in the setting of non-TBI-based conditioning and autologous HSCT. Between January 2002 and December 2010, 524 patients undergoing autologous HSCT for myeloma (melphalan 200 mg/m²) and lymphoma (high-dose busulfan, cyclophosphamide, and etoposide) as preparative regimen were analyzed. Use of patient-controlled analgesia (PCA) was significantly lower in the palifermin-treated groups (myeloma: 13% versus 53%, P < .001; lymphoma: 46% versus 68%, P < .001). Median total transplant charges were significantly higher in the palifermin-treated group, after controlling for inflation (myeloma: $167,820 versus $143,200, P < .001; lymphoma: $168,570 versus $148,590, P < .001). Palifermin treatment was not associated with a difference in days to neutrophil engraftment, length of stay, and overall survival and was associated with an additional cost of $5.5K (myeloma) and $14K (lymphoma) per day of PCA avoided. Future studies are suggested to evaluate the cost-effectiveness of palifermin compared with other symptomatic treatments to reduce transplant toxicity using validated measures for pain and quality of life.

[Radio-induced oral and pharyngeal mucositis: management updates]. / Mucites radio-induites buccopharyngées : actualités sur la prise en charge.

Mucositis is a major side effect induced by radiotherapy and/or chemotherapy of head and neck cancer. This toxicity impacts patient's quality of life and may compromise optimal treatments. Pathophysiology, risk factors, incidence and consequences of mucositis will be discussed in this review. Its management remains principally supportive (pain medication and nutritional support); however, in recent years several studies have revealed that the use of low level energy laser is particularly useful in the prevention and treatment of chemo- and radio-induced mucositis.

Vanderbilt Head and Neck Symptom Survey version 2.0: report of the development and initial testing of a subscale for assessment of oral health.

BACKGROUND: The prevalence, severity, and functional implications of adverse oral health outcomes attributed to head and neck cancer therapy are largely undefined. We report development of an oral health outcome subscale for the Vanderbilt Head and Neck Symptom Survey (VHNSS). METHODS: Oral health outcome questions were formulated through literature review and consultation with an expert panel. Questions were incorporated into the VHNSS resulting in a 50-item survey, scored 0 (none) to 10 (severe). The tool was administered to 70 subjects who completed radiation to assess for feasibility. RESULTS: Patient acceptance was high with a completion time <10 minutes. A full range of scores was noted for 46 of 50 questions. Oral health symptom burden was high early and late posttreatment. CONCLUSIONS: The VHNSS version 2.0 was feasible and could be completed in a timely manner. Validation studies are ongoing. The high prevalence of adverse oral health outcomes warrants further study.

Decision tree for the management of periimplant diseases.

The development of implants reflects one of the foremost breakthroughs of dentistry. As the market keeps growing exponentially, the implantologist faces an unavoidable challenge, that is, how to deal with the complications associated with implants. Literature published so far has focused in dealing with the technical and surgical aspects of implant therapy. Information regarding the management of periimplant diseases is rather lacking. Hence, the purpose of this article is to provide an overview and description of periimplant diseases, along with treatment recommendations.

Assessment of early toxicity and response in patients treated with proton and carbon ion therapy at the Heidelberg ion therapy center using the raster scanning technique.

UNLABELLED: PUROPOSE: To asses early toxicity and response in 118 patients treated with scanned ion beams to validate the safety of intensity-controlled raster scanning at the Heidelberg Ion Therapy Center. PATIENTS AND METHODS: Between November 2009 and June 2010, we treated 118 patients with proton and carbon ion radiotherapy (RT) using active beam delivery. The main indications included skull base chordomas and chondrosarcomas, salivary gland tumors, and gliomas. We evaluated early toxicity within 6 weeks after RT and the initial clinical and radiologic response for quality assurance in our new facility. RESULTS: In all 118 patients, few side effects were observed, in particular, no high numbers of severe acute toxicity were found. In general, the patients treated with particle therapy alone showed only a few single side effects, mainly Radiation Therapy Oncology Group/Common Terminology Criteria grade 1. The most frequent side effects and cumulative incidence of single side effects were observed in the head-and-neck patients treated with particle therapy as a boost and photon intensity-modulated RT. The toxicities included common radiation-attributed reactions known from photon RT, including mucositis, dysphagia, and skin erythema. The most predominant imaging responses were observed in patients with high-grade gliomas and those with salivary gland tumors. For skull base tumors, imaging showed a stable tumor outline in most patients. Thirteen patients showed improvement of pre-existing clinical symptoms. CONCLUSIONS: Side effects related to particle treatment were rare, and the overall tolerability of the treatment was shown. The initial response was promising. The data have confirmed the safe delivery of carbon ions and protons at the newly opened Heidelberg facility.

Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management.

Oral mucositis is a debilitating complication of anticancer treatment, characterised by erythematous, atrophic, erosive or ulcerative lesions. Oral mucositis is almost always painful, affects eating, sleeping, and speech and affects the physiological and social well-being of the patient. The pathophysiology of the condition is not well understood. Guidelines to the treatment of oral mucositis are often contradictory so that there is no evidence based standard treatment protocol. Therefore the treatment is empiric. This paper offers a brief review of current knowledge of the pathophysiology and treatment of oral mucositis.

Treatment of head and neck cancers: issues for clinical pharmacists.

Head and neck cancers are a heterogeneous group of diseases involving the oral cavity, pharyngeal tube, and larynx. Given the drug therapy options available, clinical pharmacists can play an important role in the care of this patient population. They can recommend a regimen based on efficacy, toxicity, and patient-specific factors; ensure that the prescribed regimen has been studied and reported in the literature; verify dosages; and monitor and counsel patients about adverse effects. Chemotherapy plus radiation (chemoradiation) is often the standard treatment for patients with stage III or nonmetastatic stage IV head and neck cancer. Cisplatin-based regimens are preferred, although carboplatin may be appropriate in some circumstances. Induction therapy with a docetaxel-based regimen is recommended for some patients; however, this therapy has been associated with a high frequency of grade 3 and 4 neutropenia and febrile neutropenia. Cetuximab, an epidermal growth factor receptor inhibitor, is the newest agent approved for treatment of head and neck cancer. Although evidence supports cetuximab combined with cisplatin versus cisplatin alone for patients with metastatic disease, the role of combination therapy is less clear in patients undergoing chemoradiation. Patients with head and neck cancer may experience swallowing difficulties or mouth pain, possibly interfering with drug administration and adherence; thus, pharmacists in all practice settings should be knowledgeable about different regimens and alternative routes of administration. Xerostomia and mucositis are common adverse effects of radiation therapy, and it is critical that good oral hygiene practices are maintained. Patients may achieve symptomatic relief from xerostomia with saliva substitutes, and clinical experience suggests that use of pilocarpine is worthwhile. Until more evidence becomes available, prevention of xerostomia and mucositis with amifostine is still controversial. Salt-water rinses, bioadherent oral gel, and honey are relatively inexpensive and nontoxic agents for managing mucositis. Because of the expense of palifermin, it is best reserved for refractory cases. Skin toxicities are common with radiation. Rash is also a common adverse effect of cetuximab. When used together, they may produce complicated skin toxicities. It is important to become familiar with the grading of these rashes so that appropriate therapy can be recommended. As pharmacotherapy for head and neck cancers continues to evolve, clinical pharmacists will continue to have an important role in optimizing treatment for patients by balancing efficacy and toxicity.

Evaluating the supportive care costs of severe radiochemotherapy-induced mucositis and pharyngitis : results from a Northwestern University Costs of Cancer Program pilot study with head and neck and nonsmall cell lung cancer patients who received care at a county hospital, a Veterans Administration hospital, or a comprehensive cancer care center.

BACKGROUND: Few studies have examined the costs of supportive care for radiochemotherapy-induced mucosits/pharyngitis among patients with head and neck cancer (HNC) or lung cancers despite the documented negative clinical impact of these complications. METHODS: The authors identified a retrospective cohort of patients with HNC or nonsmall lung cancer (NSCLC) who had received radiochemotherapy at 1 of 3 Chicago hospitals (a Veterans Administration hospital, a county hospital, or a tertiary care hospital). Charts were reviewed for the presence/absence of severe mucositis/pharyngitis and the medical resources that were used. Resource estimates were converted into cost units obtained from standard sources (hospital bills, Medicare physician fee schedule, Red Book). Estimates of resources used and direct medical costs were compared for patients who did and patients who did not develop severe mucositis/pharyngitis. RESULTS: Severe mucositis/pharyngitis occurred in 70.1% of 99 patients with HNC and in 37.5% of 40 patients with NSCLC during radiochemotherapy. The total median medical costs per patient were USD 39,313 for patients with mucositis/pharyngitis and USD 20,798 for patients without mucositis/pharyngitis (P = .007). Extended inpatient hospitalization accounted for USD 12,600 of the increased medical costs (median 14 days [USD 19,600] with severe mucositis/pharyngitis vs 5 days [USD 7,000] without; P = .017). For patients who had HNC with mucositis/pharyngitis, incremental inpatient hospitalization costs were USD 14,000, and total medical costs were USD 17,244. For patients who had NSCLC with mucositis/pharyngitis, these costs were USD 11,200 and USD 25,000, respectively. CONCLUSIONS: In the current study, the medical costs among the patients with HNC and NSCLC who received radiochemotherapy were greater for those who developed severe mucositis/pharyngitis than for those who did not.

Assessment of febrile neutropenia episodes in children with acute leukemia treated with BFM protocols.

The authors overviewed 239 febrile neutropenia (FN) episodes in 82 pediatric leukemia cases treated with BFM treatment protocols. FN was observed mostly during consolidation therapy. Mucositis was the most identified focus; gram-negative microorganisms were the most identified pathogens. Five patients developed invasive fungal infections. Fever resolved after mean 5.3 days and mean antibiotic administration time was 12.7 days. Addition of G-CSF to antimicrobial therapy shortened the duration of neutropenia, but it did not affect duration of fever resolution and antibiotic administration. The duration of neutropenia, fever resolution, and antibiotic administration was significantly longer in children with acute myeloid leukemia. The authors conclude that children with acute leukemia have severe prolonged neutropenia and are in high risk. In these patients, prediction of the risk of bacteremia based on clinical and laboratory features is important for immediate empiric broad-spectrum antimicrobial therapy and for higher survival rate.

Reduced incidence and severity of acute radiation mucositis by WF10 (IMMUNOKINE) as adjunct to standard of cure in the management of head & neck cancer patients.

OBJECTIVE: To evaluate the role of WF10-immunotherapy in reducing oro-pharyngeal complications in head and neck cancer chemoradiotherapy. MATERIAL AND METHOD: Thirteen patients were enrolled and assigned either to WF10- (n = 6) or control group (n = 7). After completion of their initial (neoadjuvant) chemotherapy, patients received WF10 intravenous infusions at 0.5 mL/kg body weight/day for five consecutive days and repeated every 3 weeks, concomitantly to standard radiotherapy (6,600-7,500 cGy, 200 cGy/day). Control patients received radiotherapy alone. RESULTS: Patients in the WF10-group had a lower incidence of oro-pharyngeal complications grade > 2, including oral mucositis (1 vs. 5), dysphagia (2 vs. 7), oral pain (3 vs. 5), taste alteration (4 vs. 6) and weight loss (2 vs. 4). The statistical significances were achieved for the parameters of oral mucositis (p = 0. 048) and dysphagia (p = 0.009). CONCLUSION: WF10 appears to reduce severity of oro-pharyngeal complications associated with standard chemoradiotherapy for head and neck cancer.

Ensuring accurate oral mucositis assessment in the European Group for Blood and Marrow Transplantation Prospective Oral Mucositis Audit.

Oral mucositis (OM) has substantial negative clinical, quality-of-life, and economic consequences for patients with haematologic malignancies who require myeloablative chemotherapy or radiotherapy. Uniform training in OM assessment is infrequent in clinical practice, so the true incidence and duration of OM are unknown. Nurses and physicians from the European Group for Blood and Marrow Transplantation recently undertook an audit of 214 patients (197 evaluable patients) treated at 25 centres, the Prospective Oral Mucositis Audit (POMA), to determine the incidence, severity, and duration of OM. To standardise the assessment of OM severity, the World Health Organization (WHO) Oral Toxicity Scale was used across centres. This article focuses on the quality control analyses that were conducted to ensure that OM was accurately assessed across all 25 centres. Twenty-two trainers, who received comprehensive training about POMA study design, pathobiology of OM, and endpoint assessment, educated staff at the 25 transplantation centres about OM assessment. The trained staff collected data by completing daily worksheets for each patient. Three quality control analyses, of 82, 1949, and 4111 worksheets respectively, showed a nurse assessment accuracy rate of 74%, 90%, and 90%. The most common errors were in assigning WHO grade 0 or 1. This analysis shows that training of nursing staff had a positive effect on assessment of OM severity, which should ultimately lead to improvement in the quality of supportive care.