Severity Of Skin Reactions Research Articles

ATNT-27ASSESSING THE SAFETY OF COMBINATION THERAPY WITH BEVACIZUMAB AND OPTUNETM FOR HIGH GRADE GLIOMAS

BACKGROUND: The prognosis for patients with high grade gliomas remains dismal. In addition to cytotoxic therapy, the FDA has approved bevacizumab and OptuneTM (Tumor Treating Fields) for recurrent glioblastoma. Given the prognosis and multiple treatment options, many clinicians have elected to offer combined therapy. We examined our patient population at two institutions where combination therapy has been used. METHODS: We retrospectively reviewed clinical courses of all patients receiving OptuneTM who have been concurrently managed with bevacizumab or experienced prior therapy with bevacizumab. Toxicity was described for those patients. Patients who received OptuneTM for at least 4 weeks with concurrent bevacizumab were analyzed for overall survival from time of initiation of concurrent therapy. RESULTS: We identified 37 patients, 26 males and 11 females. Of those, 33 patients received concurrent therapy, and all of those patients had prior bevacizumab exposure. OptuneTM was started as single therapy in 4 patients after bevacizumab exposure and failure. 6 patients experienced contact dermatitis which did not delay therapy. 1 patient had a small skin erosion which did not delay therapy. 2 patients had small skin erosions which delayed OptuneTM therapy. 1 patient had folliculitis and skin erosions and ulcers which necessitated cessation of therapy. 1 patient had a grade 2 intracranial bleed with no clinical sequelae aside from the need to hold bevacizumab. 29 patients received this therapy for at least 4 weeks. Median duration of concurrent therapy was 4 months. Median OS from initiation of concurrent therapy was 5.3 months. CONCLUSIONS: In our dataset, there was no toxicity appreciated aside from mild skin toxicity in the majority of patients. Combining bevacizumab and OptuneTM does not appear to significantly increase risk of bleeding or stroke. The incidence and severity of skin reactions were comparable to those described previously. Additional trials to investigate this combination are ongoing.

ATNT-28MANAGING RECURRENT GRADE III GLIOMAS WITH COMBINATION THERAPY OF BEVACIZUMAB AND OPTUNETM

BACKGROUND: The prognosis for patients with high grade gliomas remains dismal. Given that grade III gliomas are rare, we often extrapolate therapy from glioblastoma. In addition to cytotoxic therapy, the FDA has also approved bevacizumab and OptuneTM (Tumor Treating Fields) for recurrent glioblastoma. In one series of recurrent grade III gliomas, average survival following progression on bevacizumab was approximately 10 months. Given the prognosis and multiple treatment options, many clinicians have elected to offer combined therapy. We examined our patient population at a single institution where combination therapy has been used. METHODS: We retrospectively reviewed clinical courses of all patients with recurrent grade III gliomas receiving OptuneTM who have been concurrently managed with bevacizumab or experienced prior therapy with bevacizumab. Toxicity, tolerability, and survival data were reviewed. Patients who received OptuneTM for at least 4 weeks with concurrent bevacizumab were analyzed for survival. RESULTS: We identified 9 patients, 6 males and 3 females, each having one to three prior recurrences. Of those, 8 patients had anaplastic astrocytomas and 1 patient had an anaplastic oligoastrocytoma. All but 3 patients had failed therapy with bevacizumab. OptuneTM was started as single therapy in 1 patient after bevacizumab exposure and failure. 1 patient was treated for contact dermatitis that did not delay therapy. No intracranial bleeding or strokes were identified. There was no increased incidence of seizures. Median duration of concurrent therapy was 4 months. At time of analysis, five patients are still living. CONCLUSIONS: Combining bevacizumab and OptuneTM does not appear to significantly increase risk of skin reactions, ulcerations, or erosions in this population. There is no increased incidence of bleeding or stroke in our population. The incidence and severity of skin reactions were comparable to those described previously. Additional trials to investigate this combination are ongoing.

Three-Arm Randomized Phase III Trial: Quality Aloe and Placebo Cream Versus Powder as Skin Treatment During Breast Cancer Radiation Therapy

BackgroundThe efficacy of aloe extract in reducing radiation-induced skin injury is controversial. The purpose of the present 3-arm randomized trial was to test the efficacy of quality-tested aloe extract in reducing the severity of radiation-induced skin injury and, secondarily, to examine the effect of a moist cream versus a dry powder skin care regimen. Materials and MethodsA total of 248 patients with breast cancer were randomized to powder, aloe cream, or placebo cream. Acute skin toxicity was scored weekly and after treatment at weeks 1, 2, and 4 using a modified 10-point Catterall scale. The patients scored their symptom severity using a 6-point Likert scale and kept an acute phase diary. ResultsThe aloe formulation did not reduce acute skin toxicity or symptom severity. Patients with a greater body mass index were more likely to develop acute skin toxicity. A similar pattern of increased skin reaction toxicity occurred with both study creams compared with the dry powder regimen. ConclusionNo evidence was found to support prophylactic application of quality aloe extract or cream to improve the symptoms or reduce the skin reaction severity. Our results support a dry skin care regimen of powder during radiation therapy.

Adverse skin reactions during treatment with cetuximab plus radiotherapy: Multidisciplinary approach to minimize radio-chemotherapy interruption

Background: Antibodies against the epidermal growth factor receptor (EGFR), such as cetuximab, are effective in loco-regional advanced squamous cell carcinoma of the head and neck (SCCHN) in association with radiotherapy. Cutaneous reactions are well known as adverse events during treatment with EGFR inhibitors.Objective: To identify a multidisciplinary approach for mucous-cutaneous toxicity during cetuximab-radiotherapy treatment in order to reduce the risk of an early radio-chemotherapy interruption.Methods: The data of 38 patients with SCCHN receiving cetuximab and radiotherapy were retrospectively analyzed. The control group (n = 15) received the standardized treatments according to the severity of skin reactions with dermatologic visits only for high degrees of toxicity. The experimental group (n = 23) was monitored and daily treated by dermatologists since grade 1 of cutaneous toxicity. The primary end-point of our study was the mean days of antitumor therapy interruption.Results: The mean number of days of antitumor therapy suspension was 12.6 (7.6) in the standard treatment group and 5.0 (6.6) in the experimental group (p = 0.002). This difference was observed for each grade of toxicity.Conclusion: The early interruption of radio-chemotherapy has a negative impact on survival in patients with SCCHN. In our study, a closer dermatological examination and treatment for all degrees of toxicity reduced early interruptions of chemo-radiotherapy.

Protecting the radiation-damaged skin from friction: a mini review.

Radiation-induced skin reactions are an unavoidable side effect of external beam radiation therapy, particularly in areas prone to friction and excess moisture such as the axilla, head and neck region, perineum and skin folds. Clinical studies investigating interventions for preventing or managing these reactions have largely focussed on formulations with moisturising, anti-inflammatory, anti-microbial and wound healing properties. However, none of these interventions has emerged as a consistent candidate for best practice. Much less emphasis has been placed on evaluating ways to protect the radiation-damaged skin from friction and excess moisture. This mini review analyses the clinical evidence for barrier products that form a protective layer by adhering very closely to the skin folds and do not cause further trauma to the radiation-damaged skin upon removal. A database search identified only two types of barrier products that fitted these criteria and these were tested in two case series and six controlled clinical trials. Friction protection was most effective when the interventions were used from the start of treatment and continued for several weeks after completion of treatment. Soft silicone dressings (Mepilex Lite and Mepitel Film) and Cavilon No Sting Barrier Film, but not Cavilon Moisturizing Barrier Cream, decreased skin reaction severity, most likely due to differences in formulation and skin build-up properties. It seems that prophylactic use of friction protection of areas at risk could be a worthwhile addition to routine care of radiation-damaged skin.

Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients

PurposeSafetac-based soft silicone dressings used in a management setting decrease the severity of radiation-induced acute skin reactions but do not affect moist desquamation rates. Here we investigate the prophylactic use of another Safetac product, Mepitel Film, on moist desquamation rates. Material and methodsA total of 80 breast cancer patients receiving radiation therapy were recruited between October 2012 and April 2013; 78 participants contributed data for analysis. Lateral and medial halves of the skin areas to be irradiated were randomised to Mepitel Film or aqueous cream; skin dose was measured using thermoluminescent dosimeters; skin reaction severity was assessed using RISRAS and RTOG scales. ResultsOverall skin reaction severity was reduced by 92% (p<0.0001) in favour of Mepitel Film (RISRAS). All patients developed some form of reaction in cream-treated skin which progressed to moist desquamation in 26% of patients (RTOG grades I: 28%; IIA: 46%; IIB: 18%; III: 8%). Only 44% of patients had a skin reaction under the Film, which did not progress to moist desquamation in any of the patients (RTOG grades I: 36%; IIA: 8%). ConclusionsMepitel Film completely prevented moist desquamation and reduced skin reaction severity by 92% when used prophylactically in our cohort.

561P - Quality of Life Analysis in Patients with Kras Wild-Type Metastatic Colorectal Cancer Treated with First-Line Folfiri Plus Cetuximab

ABSTRACT Background In the CRYSTAL study adding cetuximab to first-line FOLFIRI significantly improved clinical outcome in patients (pts) with KRAS wild-type metastatic colorectal cancer (mCRC). Quality of life (QoL) was assessed and associations with tumor response and survival were studied. Material and methods The European Organization for Research and Treatment of Cancer QoL questionnaire core-30 was used. The primary analysis was a pattern-mixture analysis for the global health score (GHS)/QoL and social functioning scales. Exploratory analyses included the change from baseline QoL scores by severity of skin reactions, the change in reported symptoms from baseline according to tumor response and treatment, and the effect of symptomatic status at baseline on response and survival. Results QoL was evaluable in 627/666 pts (94%) with KRAS wild-type tumors, 52% received FOLFIRI, and 48% FOLFIRI plus cetuximab. No significant differences for GHS/QoL (p = 0.12) and social functioning scores (p = 0.43) were found between the treatment arms. In pts receiving cetuximab, the mean change from baseline in GHS/QoL was 3.00 in pts without skin reactions compared with -1.09 and -0.51 in those with grade I and grade II-IV early skin reactions, respectively. Social functioning score worsened in pts with no skin reactions (mean -6.41) compared with a slight improvement in those with grade I (mean 1.64) and grade II-IV (mean 1.48) early skin reactions, respectively. Tumor response was higher (58% vs 40%, p = 0.0002) and survival longer (hazard ratio 1.68, p Conclusions Adding cetuximab to FOLFIRI improved clinical outcome without negatively impacting on QoL, improving response despite baseline symptoms and leading to earlier symptom relief in pts whose tumors had responded. Symptom status at baseline was demonstrated to be a useful prognostic factor in mCRC. Disclosure C. Kohne: The author reports honoraria from Pfizer and Merck KGaA. G. Folprecht: The author reports consultant/advisory roles for Merck KGaA, Roche and BMS, honoraria from Merck KGaA, Pfizer, Roche and Novartis and research funding from Merck KGaA. P. Rougier: The author reports, in relation to the topic concerned, honoraria for three years from Merck KGaA for participation at scientific boards and symposia. D. Curran: The author acted as a consultant (on statistical and QoL analysis) for Merck KGaA. U. Sartorius: The author is an employee of Merck KGaA. I. Griebsch: At the time of this research, the author was an employee of Merck KGaA. E. Van Cutsem: The author has received research funding from Merck KGaA. All other authors have declared no conflicts of interest.

Randomized Intra-patient Controlled Trial of Mepilex Lite Dressings versus Aqueous Cream in Managing Radiation-Induced Skin Reactions Postmastectomy

Objective: Severe acute radiation-induced skin reactions occur in a significant proportion of women who receive radiation therapy for breast cancer. We previously showed that Mepilex Lite dressings decreased the severity of erythema. Here we report their effect on the full range of skin reactions in 74 breast cancer patients post-mastectomy. Methods: A total of 80 women were recruited from four hospitals in New Zealand with 74 women contributing a full data set for analysis. The first skin area on the chest wall to develop erythema was randomly divided into two similar halves; one half was treated with Mepilex Lite dressings, the other half with aqueous cream. Skin reactions were assessed using the Radiation-Induced Skin Reaction Assessment Scale. Results: Compared with aqueous cream, Mepilex Lite dressings did not significantly reduce the incidence of moist desquamation but did reduce the overall severity of skin reactions by 41% (p<0.001), the average moist desquamation score by 49% (p=0.043) and the sum of the moist desquamation time for all patches by 28% from 25 to 18 weeks. Most patients preferred the dressings, found them easy to use and very comfortable to wear.

Frequency and severity of skin reactions in patients with breast cancer undergoing adjuvant radiotherapy, the usefulness of two assessment instruments – A pilot study

Acute radiation skin reactions (ARSR) are a major problem in curative radiotherapy (RT). A number of studies have failed to show a positive effect of different skin care products to reduce or prevent ARSR. The aims for this study were to describe frequency and severity of ARSR in patients with breast cancer undergoing adjuvant RT and to test the suitability in clinical use of two assessment instruments.A majority (93%) of the 93 patients with breast cancer included in this study developed ARSR, most of them mild reactions. Low scores for pain and itching (VAS) were reported. ARSR were assessed using the modified version of RTOG/EORTC acute radiation morbidity scoring criteria and the World Health Organisation (WHO) grading system for acute and subacute toxicity by two independent observers after the completion of RT. The percentages of discordant assessment between the two observers were 21% for the WHO scale and 32% for the RTOG/EORTC. Severe ARSR, classified as grades 2–4 on both instruments resulted in good agreement between the two instruments. However, the assessments using RTOG/EORTC resulted in an almost 10% higher proportion of severe ARSR. Comparisons of health related quality of life and sleep revealed no statistically significant differences between patients with mild or severe ARSR assessed by the RTOG/EORTC scale with the exception of cognitive functioning.The use of assessment instruments to describe treatment-related symptoms is complicated and clinical experience is not always enough. More research is needed to validate these instruments to guarantee sound and precise assessments.

SU-E-T-528: Thermal Tomography for Skin Toxicity Prediction in Radiotherapy: Effect of Surface Heat Penetration

Purpose: Dermal side effects of breast cancerradiotherapy vary from minor erythema to moist desquamation, and are difficult to predict. While the worst skin reactions can necessitate treatment breaks thereby worsening treatment outcome, skin‐sparing measures such as IMRT or topical treatments are widely considered too costly to distribute universally. We have previously presented a method of evaluating skin reactions shortly after exposure (3–5 days) with three‐dimensional thermal tomography. The resultant thermal effusivity is a property which appears to be correlated to peak skin reaction at a later date. The analyzable depth was limited by assumptions that all heat from the flash prior to imaging is deposited on the surface. In this study we explore improvements to reconstruction method which models heat penetration. Methods: Eleven hairless mice irradiated to a 40Gy regional skindose in a single fraction were imaged daily by a 2.5 ms flash followed by ∼6 s infrared image acquisition. Sequential infrared images were used to calculate the depth‐effusivity distribution for each pixel using custom software. The relative mean effusivity within the treated area and the contralateral control were compared to the eventual severity of skin reaction. Results: Modeling of the temperature penetration of the flash allowed calculation of effusivity at shallow depths, which were previously impossible. At depth, a drop in relative effusivity between the irradiated and control areas occurred earlier in mice which eventually developed moist desquamation (mean 1.7 days post irradiation) than those that did not (mean 4.4 days post irradiation). At newly viewable shallow depths, the relative effusivity rose shortly before erythema occurred. Conclusion: In prior work, it was found that effusivity at depth 0.3–0.6 mm was predictive of clinical endpoint in hairless mice. We can now view shallow slices which are more sensitive to spatial variation and may yield stronger predictive power. Support provided by a grant from the Brian Piccolo Cancer Research Foundation

Mild soaps and radiotherapy: a survey of the UK public to identify brands of soap considered mild and analysis of these to ascertain suitability for recommendation in radiotherapy departments

Cancer agencies recommend that patients use mild soap when undergoing external beam radiotherapy to minimise skin reactions. They define 'mild soap' as non-alkaline, lanolin free, unperfumed soap with a neutral pH. This study aimed to identify which soaps the UK public perceive as mild and ascertain if these were clinically mild and could potentially be recommended within radiotherapy departments. A survey of 237 participants identified eight top brands of mild soap, which were then tested for pH and analysed for potential irritants. All soaps were lanolin free and non-alkaline, with Simple and Johnson's the closest to pH 5.5. All contained fragrances except Simple and E45. Dove, Pears and Imperial Leather contained the highest concentration of fragrances. All soaps except E45 contained potential irritants. Only Simple and E45 fit the cancer agencies' definition of mild soap and could therefore be recommended for radiotherapy patients. Future research should identify current practices and recommendations in the UK as anecdotal evidence suggests large variations in skin care advice. Further scientific analysis could potentially identify cheaper brands that fit the definition of 'mild'. UK recommendations should be standardised and consistent with best practice to reduce skin reaction severity in radiotherapy patients.

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

Radiation therapy is a common treatment for cancer patients. One of the most common side effects of radiation is acute skin reaction (radiation dermatitis) that ranges from a mild rash to severe ulceration. Approximately 85% of patients treated with radiation therapy will experience a moderate-to-severe skin reaction. Acute radiation-induced skin reactions often lead to itching and pain, delays in treatment, and diminished aesthetic appearance-and subsequently to a decrease in quality of life. Surveys have demonstrated that a wide variety of topical, oral, and intravenous agents are used to prevent or to treat radiation-induced skin reactions. We conducted a literature review to identify trials that investigated products for the prophylaxis and management of acute radiation dermatitis. Thirty-nine studies met the pre-defined criteria, with thirty-three being categorized as prophylactic trials and six as management trials.For objective evaluation of skin reactions, the Radiation Therapy Oncology Group criteria and the U.S. National Cancer Institute Common Toxicity Criteria were the most commonly used tools (65% of the studies). Topical corticosteroid agents were found to significantly reduce the severity of skin reactions; however, the trials of corticosteroids evaluated various agents, and no clear indication about a preferred corticosteroid has emerged. Amifostine and oral enzymes were somewhat effective in preventing radiation-induced skin reactions in phase II and phase III trials respectively; further large randomized controlled trials should be undertaken to better investigate those products. Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) was found not to be superior to standard regimes in the prevention of radiation-induced skin reactions (n = 6).In conclusion, the evidence is insufficient to support the use of a particular agent for the prevention and management of acute radiation-induced skin reactions. Future trials should focus on comparing agents and approaches that, in phase I and II trials, suggest efficacy. These future phase III randomized controlled trials must clearly distinguish between preventive and management strategies for radiation-induced dermatitis. Only then can evidence-based guidelines be developed, with the hope of standardizing the approach across centres and of improving the prevention and management of radiation-induced dermatitis.

TriVerse versus molecular resonance–harvested grafts in single-stage Baha surgery

Objectives To assess complications occurring in patients with a bone-anchored cochlear stimulator (Baha) following split-thickness skin graft harvested with two surgical modalities: the TriVerse (TV) system and the molecular resonance generator (MR). Study Design Prospective, randomized, two-group (TV and MR) study of 24 patients who underwent Baha surgery. Setting Tertiary care institution. Subjects and Methods All patients (5 children, age range 6-14 yrs, median 8.3 yrs, and 16 adults, age range 30-73 yrs, median 60 yrs) underwent the one-stage procedure. The skin flap was harvested by use of the TV in 12 cases (2 children, 10 adults) and the MR generator in 12 (3 children, 9 adults). The main outcome measures were wound healing time, number of follow-up visits, degree of soft tissue reactions around the abutment, and need for revision surgery were examined. Results There was a clear difference between the TV- and MR-harvested skin graft groups in relation to severity of skin reactions and complete healing time. The TV group required from three to seven (median 4) visits as outpatients during the initial observation period until healing was complete. The MR group required only one to three (median 2) visits. Complete healing time was significantly lower in the MR group (range 7-12 days, median 10 days) compared to the TV group (range 15-28 days, median 16 days). In the TV group, two patients required in-office revision of the skin graft because of partial necrosis. Conclusions In our experience, the MR-harvested split-thickness skin graft is superior to the TV technique.

RTOG criteria to evaluate acute skin reaction and its risk factors in patients with breast cancer submitted to radiotherapy

Evaluate and classify skin reactions through the Radiation Therapy Oncology Group (RTOG) criteria and characterize factors that can intervene in these reactions. Prospective study, with 86 women submitted to adjuvant breast radiotherapy with a total dose of 5040cGy, in a 6 MeV Linear Accelerator. Personal data were collected and breast size was measured (distance between field separation and breast height). The treated skin area was evaluated weekly. Breast height and treatment technique were significant factors in the univariate analysis for the incidence of degree 3 skin reactions. However, only breast height was a significant factor in the multivariate analysis for the severity of skin reactions. The chances of occurring degree 3 reactions increase 2.61 times for each increase in height unit (cm). These findings allow nurses to plan more adequate and individualized procedures for each patient and contribute to the optimization of treatment.

A Pilot Study to Evaluate the Validity of Skin Care Protocols Followed by Women with Breast Cancer Receiving External Radiation

A Pilot Study to Evaluate the Validity of Skin Care Protocols Followed by Women with Breast Cancer Receiving External Radiation

Two studies from the JP Wilmot Cancer Center on the relationship of treatment, expectations, and race with post-treatment skin reactions reported by cancer patients

18560 Background: Cancer patients may experience skin problems while undergoing treatment. Frequency of skin reactions may be influenced skin pigmentation and/or psychological factors. Methods: A Symptom Inventory (SI) completed by 411 cancer patients nationwide before and after treatment was analyzed to determine if treatment type, race (Black versus White), and pre-treatment expectations influenced post-treatment skin reactions. Subsequent analysis of a SI completed weekly for five weeks by 167 local patients receiving radiotherapy examined severity of reported skin reactions. Results: One-way between-group ANOVA, with Bonferroni correction, showed significantly more patients receiving radiotherapy had stronger expectations of skin problems (62%) compared to patients receiving chemotherapy (40%, p = 0.001) or chemotherapy plus radiotherapy (45%, p = 0.003). Overall, expectations did not correlate with patient reported skin problems post-treatment (Spearman’s rho = 0.02, p = 0.70). Likewise, a Kruskal Wallis test showed no significant difference in severity of skin reactions reported by patients receiving radiotherapy (n = 138) and/or chemotherapy (n = 273, p = 0.56). Severe skin problems were reported more frequently by 10/18 (56%) Blacks than 90/393 (23%) Whites (p = 0.001), although no significant difference was found between Blacks and Whites in their pre-treatment expectations of skin problems (p = 0.32). Further, pre-treatment expectations of skin problems did not influence post-treatment reporting of skin problems in Blacks (Spearman’s rho = −0.02, p = 0.93) or Whites (Spearman’s rho = 0.02, p = 0.65). Similarly, the local study showed that significantly more Blacks (38%) reported severe skin reactions at the treatment site than Whites (6%). Total radiation exposure was significantly related to the severity of skin problems reported by Blacks (Spearman’s rho = 0.90, p = 0.04), but not Whites (Spearman’s rho = −0.06 p = 0.52). Conclusions: Overall, Blacks reported more severe post-treatment skin problems than Whites. How this self-reported skin damage correlates with clinical findings remains to be determined. Supported by NCI PHS grants 1R25CA102618 and U10CA37420. No significant financial relationships to disclose.

Elevated body mass index does not increase the risk of palmar–plantar erythrodysesthesia in patients receiving pegylated liposomal doxorubicin

Objectives. The dose-limiting toxicity of pegylated liposomal doxorubicin (PLD) is palmar–plantar erythrodysesthesia (PPE). Some physicians are reluctant to use this drug in overweight patients, postulating that larger size increases the likelihood of PPE. We sought to determine whether a correlation exists between body mass index (BMI) and the frequency or severity of skin reactions during PLD chemotherapy. Methods. The records of all patients receiving PLD chemotherapy for gynecologic malignancy at our institution were reviewed for chemotherapy history, BMI at start of treatment, dose, infusion time, and adverse outcomes. Skin reaction sites, grade, and treatments were recorded. Possible predisposing factors were extracted, as well as the reason for drug discontinuation. Results. Over 7 years, 103 patients were treated with PLD for gynecologic malignancies. 429 cycles were given, and PPE occurred in 36% of patients treated. Of those with PPE, reactions were grades 1, 2, or 3 in 54%, 32%, and 14% of patients, respectively. The BMI of patients with PPE (29.0) was not significantly different from that of patients without PPE (28.8). Analysis using finer subsets of weight also revealed no association. Finally, logistic regression revealed no relationship between BMI and rash grade. Conclusions. Elevated BMI does not appear to correlate with occurrence of PPE in our population. Of interest, among patients discontinuing PLD due to skin toxicity, 25% had clinical evidence of response. The identification of predisposing risk factors may help guide treatment decisions; however, elevated BMI does not appear to be such a risk factor.

Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomised controlled trial

Background and purposeEvidence on which to base decisions about the management of radiation skin reactions is lacking. The purpose of this study was to investigate whether sucralfate or aqueous cream reduced acute skin toxicity during radiotherapy to the head and neck, breast or anorectal area (phase A), and to evaluate the effect of hydrogels and dry dressings on moist desquamation (phase B). This paper presents the results of phase A. Patients and methodsThree hundred and fifty seven patients were randomised to apply aqueous cream, sucralfate cream or no cream to the irradiated area from day one of radical radiotherapy treatment. All patients were instructed to wash using unperfumed soap. Acute skin toxicity was measured using a modified radiation therapy oncology group (RTOG) score, reflectance spectrophotometry, patient diary card and dermatology life quality index (DLQI). A cost minimisation approach was used to compare the costs of each skin care approach. ResultsNo consistent differences were found in the severity of skin reactions or levels of discomfort suffered by patients in each of the randomised groups. Patients with a higher body mass index, who smoked, received concomitant chemotherapy, boost or bolus during treatment were more likely to develop skin reactions. ConclusionsThere is no evidence to support the prophylactic application of either of the creams tested for the prevention of radiation skin reactions. Our results show that it is possible to predict which patients are at greatest risk of skin reactions. We suggest that known risk factors should be incorporated into future study protocols.

Hypersensitivity to aspirin: Common eicosanoid alterations in urticaria and asthma

BackgroundAspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) can precipitate adverse reactions in two apparently different clinical conditions: bronchial asthma and chronic idiopathic urticaria (CIU). Recent evidence indicates that the reactions are triggered by the drugs that inhibit cyclooxygenase-1 but not cyclooxygenase-2. ObjectiveTo assess whether patients with CIU and aspirin sensitivity share common eicosanoid alterations with patients who have aspirin-sensitive asthma. MethodsSeventy-four patients with CIU and a history of sensitivity to aspirin and NSAIDs underwent placebo-controlled oral aspirin challenge tests. Concentrations of urinary leukotriene E4 (uLTE4) were measured by ELISA and plasma stable prostaglandin D2 metabolite, 9α,11β prostaglandin F2 by GC/MS. All measurements were carried out at baseline and after aspirin dosing. Patients were genotyped for the leukotriene C4 synthase (LTC4S) promoter single nucleotide polymorphism. ResultsIn 30 of 74 patients, the aspirin challenge was positive, resulting in urticaria/angioedema. In these 30 patients, baseline uLTE4 levels were higher than in nonresponders and the healthy control subjects and increased further (significantly) after the onset of clinical reaction. No such increase occurred in subjects with negative aspirin challenge. Baseline uLTE4 levels correlated with severity of skin reactions. Plasma 9α,11β prostaglandin F2 levels rose significantly in both aspirin responders and nonresponders, although in the latter group the increase occurred later than in the former. In patients who reacted to aspirin, frequency of −444C allele of LTC4S was significantly higher than in patients who did not react. ConclusionsCIU with aspirin sensitivity is characterized by the eicosanoid alterations, which are similar to those present in aspirin-induced asthma.

Hypersensitivity to aspirin: Common eicosanoid alterations in urticaria and asthma

Rationale To assess whether patients with chronic idiopathic urticaria (CIU) and aspirin sensitivity share common eicosanoid alterations with patients suffering from aspirin-sensitive asthma. Methods 74 patients with CIU and a history of sensitivity to aspirin and NSAIDs underwent placebo-controlled oral aspirin challenge tests. Concentrations of urinary leukotriene E4 (uLTE4) were measured by ELISA, and plasma stable prostaglandin D2 metabolite, 9α,11βPGF2, by GC/MS. All measurements were carried out at base, and after aspirin dosing. Patients were genotyped for the leukotriene C4 synthase (LTC4S) promoter single nucleotide polymorphism. Results In 30 of 74 patients the aspirin challenge was positive, resulting in urticaria/angioedema. In these 30 patients baseline uLTE4 were higher than in non-responders and healthy controls, and increased further significantly after the onset of clinical reaction. No such increase occurred in subjects with negative aspirin challenge. Baseline uLTE4 levels correlated with severity of skin reactions. Plasma 9α,11βPGF2 levels rose significantly in both aspirin-responders and non-responders, although in the latter group the increase occurred later than in the former. In patients who reacted to aspirin, frequency of −444C allele of LTC4S was significantly higher than in patients who did not react. Conclusions CIU with aspirin sensitivity is characterized by the eicosanoid alterations which are similar to those present in aspirin-induced asthma.