RESUMO
BACKGROUND: Barrier films or dressings were reported to be effective in preventing radiation dermatitis (RD) in breast cancer patients, but their comparative efficacy is unknown. METHODS: A systematic literature search was performed on Embase, MEDLINE and Cochrane CENTRAL Registry of Clinical Trials from inception to October 20, 2023. Randomised controlled trials (RCTs) comparing barrier films or dressings to the standard of care (SOC) or other interventions were included. We estimated summary odds ratios and mean differences using network meta-analysis with random effects. This study was registered with PROSPERO (ID: CRD42023475021). RESULTS: Fourteen RCTs met inclusion criteria. Six interventions were analysed: 3M™ Moisturizing Double Barrier Cream (MDBC), 3M™ No Sting Barrier Film (BF), Hydrofilm® (HF), Mepitel® Film (MF), Silver Leaf Nylon Dressing and StrataXRT®. HF, MF and StrataXRT® reduced the incidence of moist desquamation compared to SOC (HF: OR = 0.08; p = 0.02; MF: OR = 0.31 p < 0.01; StrataXRT®: OR = 0.22, p = 0.04). The ranking of agents from most to least effective in preventing moist desquamation according to P-scores was HF (92.5%), MF (78.5%), StrataXRT® (70.1%), BF (46.4%), Silver Leaf Nylon Dressing (24.9%), MDBC (22.9%) and SOC (14.7%). Only four RCTs on HF and MF included patient-reported outcome (PRO) assessments that allowed pooling for analysis. HF and MF were more effective in reducing pain, itchiness and burning sensation compared to SOC (p < 0.01 for all symptoms). CONCLUSION: HF and MF were effective in preventing RD in breast cancer. Future RCTs should compare these interventions to effective cream preparations, such as topical corticosteroids.
RESUMO
Acute radiation dermatitis is a frequent adverse effect of radiotherapy, but standardisation of care for acute radiation dermatitis is lacking. Due to the conflicting evidence and variability in current guidelines, a four-round Delphi consensus process was used to compile opinions of 42 international experts on care for people with acute radiation dermatitis on the basis of the evidence in existing medical literature. Interventions for acute radiation dermatitis prevention or management that reached at least 75% consensus were recommended for clinical use. Six interventions could be recommended for the prevention of acute radiation dermatitis: photobiomodulation therapy and Mepitel film in people with breast cancer, Hydrofilm, mometasone, betamethasone, and olive oil. Mepilex Lite dressings were recommended for the management of acute radiation dermatitis. Most interventions were not recommended due to insufficient evidence, conflicting evidence, or lack of consensus to support use, suggesting a need for further research. Clinicians can consider implementing recommended interventions in their practice to prevent and manage acute radiation dermatitis until additional evidence becomes available.
Assuntos
Neoplasias da Mama , Radiodermite , Feminino , Humanos , Neoplasias da Mama/radioterapia , Consenso , Técnica Delphi , Radiodermite/prevenção & controle , Radiodermite/tratamento farmacológicoRESUMO
This paper highlights a collection of eleven recently published manuscripts on the prevention and management of acute radiation dermatitis. These meta-analyses provide additional evidence for the updated clinical practice guidelines by the Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology study group for prevention and management of acute radiation dermatitis. The collection of papers elucidate the currently available evidence on acute radiation dermatitis, highlighting consolidated knowledge, effective treatments, and proposed areas for future clinical trials. Overall, a total of 51 randomized controlled trials were retrieved and included for quantitative analysis of an initial systematic review of literature from 1946 to January 2023. Discussion of the clinical impact of various therapeutic interventions include: antiperspirant and deodorant use, barrier films and dressings, natural and miscellaneous agents, photobiomodulation therapy, topical corticosteroids, topical non-steroidal agents, skin hygiene and washing, as well as StrataXRT and Mepitel film in breast cancer patients. The comprehensive nature of the meta-analyses and their related findings may help reduce the discrepancies in in treatment of acute radiation dermatitis and facilitate consistency of therapeutic interventions employed in clinical practice worldwide.
Assuntos
Neoplasias da Mama , Dermatite , Terapia com Luz de Baixa Intensidade , Feminino , Humanos , Bandagens , Conhecimento , Literatura de Revisão como AssuntoRESUMO
Over several decades, research on the prevention and management of acute radiation dermatitis (RD) has continued to emerge, yet there remains no "gold standard" treatment for RD care. Recent guidelines on RD prevention and management were published in 2022 by the Oncodermatology Study Group of the Multinational Association of Supportive Care in Cancer (MASCC). As part of this guideline process, a collaborative effort was undertaken by international RD experts to quantitatively compare commonly studied RD skin interventions through meta-analyses and discern superiority of interventional treatments over another intervention, standard-of-care, or placebo in RD prevention and management. This paper summarizes the materials and methodology used in a set of meta-analysis studies that supplement the 2022 MASCC Clinical Practice Guidelines on RD Prevention and Management.
Assuntos
Mucosite , Neoplasias , Radiodermite , Estomatite , Humanos , Estomatite/tratamento farmacológico , Mucosite/tratamento farmacológico , Neoplasias/terapia , Radiodermite/etiologia , Radiodermite/prevenção & controleRESUMO
PURPOSE: While some authors have investigated the impact of antiperspirant /deodorant on the development of acute radiation dermatitis (RD) among patients undergoing radiotherapy (RT) for breast cancer, recommendations supporting the use of antiperspirant/deodorant during breast RT remain highly variable. This systematic review and meta-analysis aims to evaluate the evidence investigating the effect of antiperspirant/deodorant on the development of acute RD during post-operative breast RT. METHODS: A literature search has been performed using OVID MedLine, Embase, and Cochrane databases (1946 to September 2020) to identify randomized controlled trials (RCTs) that have investigated deodorant/antiperspirant use during RT. The meta-analysis was conducted using RevMan 5.4 to calculate pooled effect sizes and 95% confidence intervals (CI). RESULTS: Five RCTs met the inclusion criteria. The use of antiperspirant/deodorant did not significantly affect the incidence of grade (G) 1 + RD (OR 0.81, 95% CI 0.54-1.21, p = 0.31). Prohibition of deodorant use did not significantly prevent the occurrence of G2 + acute RD (OR 0.90, 95%, CI 0.65-1.25, p = 0.53). No significant effect was reported in preventing G3 RD between the antiperspirant/deodorant and control groups (OR 0.54, 95%, CI 0.26-1.12, p = 0.10). There was no significant difference in pruritus and pain between patients undergoing skin care protocols with or without antiperspirant/deodorant (OR 0.73, 95% CI 0.29, 1.81, p = 0.50, and OR 1.05, 95% CI 0.43-2.52, p = 0.92, respectively). CONCLUSIONS: The use of antiperspirant/deodorant during breast RT does not significantly affect the incidence of acute RD, pruritus, and pain. As such, the current evidence does not support recommendation against antiperspirant/deodorant use during RT.
Assuntos
Neoplasias da Mama , Desodorantes , Dermatite , Humanos , Feminino , Antiperspirantes , Dor , PruridoRESUMO
PURPOSE: This systematic review and meta-analysis aimed to evaluate the available literature describing the efficacy of natural and miscellaneous agents in preventing acute radiation dermatitis (RD) in cancer patients. METHODS: OVID MedLine, Embase, and Cochrane literature databases were searched from 1946 to January 2023 for randomized controlled trials studying the use of natural and miscellaneous agents to prevent RD. RevMan 5.4 was used for the meta-analysis to calculate the pooled effect sizes and 95% confidence intervals (CI) using the random effects analysis. RESULTS: For the systematic review and meta-analysis, 19 and 16 studies were included, respectively. Of the five studied natural products (aloe vera, oral enzymes, olive oil, calendula, and curcumin), only oral enzymes and olive oil significantly reduced the incidence of Radiation Therapy Oncology Group grade 2+ (RR: 0.42, 95%CI 0.30-0.58, p < 0.00001, RR: 0.66, 95% CI 0.51-0.85, p = 0.001, resp.). The oral enzymes also reduced the grade 3+ RD incidence (RR: 0.18, 95%CI 0.06-0.55, p = 0.003). The other agents demonstrated no significant effect. CONCLUSION: This review and meta-analysis on natural and miscellaneous agents in preventing RD in cancer patients demonstrated that oral enzymes and olive oil prevented RD severity. However, evidence supporting natural agents to prevent RD is inconsistent, mainly because of low studies numbers, low-quality study designs, and small sample sizes. Therefore, concrete conclusions cannot be made. Research on (new) natural or miscellaneous agents should focus on a randomized controlled double-blinded study design with a large patient population, a higher consistency in research methods, and clinician- and patient-reported outcomes.
Assuntos
Curcumina , Dermatite , Humanos , Azeite de Oliva , Bases de Dados Factuais , Medidas de Resultados Relatados pelo PacienteRESUMO
PURPOSE: This systematic review and meta-analysis aims to evaluate the effects of washing in patients receiving radiotherapy (RT) on radiation dermatitis (RD) severity. METHODS: A literature search was performed using Ovid MEDLINE, Embase, and Cochrane databases between January 1, 1946, and January 31, 2023. Four randomized controlled trials (RCTs) studying the effects of washing with or without soap on RD were identified. A meta-analysis was conducted for clinician-reported outcomes using RevMan 5.4 and a narrative synthesis for patient-reported outcomes due to a lack of reported data amenable to quantitative comparison in accordance with the Synthesis Without Meta-analysis (SWiM) guidelines. The Cochrane Risk of bias (RoB2) and Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria were used to assess risk of bias and certainty of evidence, respectively. RESULTS: Two RCTs met the inclusion criteria for meta-analysis. Washing with or without soap significantly reduced the incidence of severe RD (OR: 0.32, 95% CI: 0.19-0.55, p < 0.01) and moist desquamation (OR: 0.25, 95% CI: 0.12-0.52, p < 0.01). Two of four trials found an association between washing and reduced itching score (p = 0.38). Pain score was not found to be significantly different with or without washing in any of the four studies (p = 0.07). The two studies that assessed burn scores did not detect any difference between the washing group versus no washing group (p = 0.25). Washing was associated with improved quality of life (QoL) measures in one study. CONCLUSION: Washing with or without soap during RT resulted in less severe RD and less moist desquamation. Given the QoL benefits of washing, it should be advocated as part of routine skin care during RT.
Assuntos
Dermatite , Radioterapia (Especialidade) , Humanos , Sabões , Dermatite/etiologia , Dermatite/prevenção & controle , HigieneRESUMO
PURPOSE: This systematic review and meta-analysis aimed to evaluate the efficacy of barrier films and dressings in preventing acute radiation dermatitis (RD). METHODS: OVID Medline, Embase, and Cochrane databases were searched from 1946 to September 2020 to identify randomized controlled trials on the use of barrier films or dressings to prevent RD. For comparable outcomes between studies, pooled effect sizes and 95% confidence intervals (CI) were calculated using the random effects analysis in RevMan 5.4. RESULTS: Fourteen and 11 studies were included in the qualitative and quantitative analyses, respectively. Five types of barrier films used for RD were identified: Hydrofilm, StrataXRT®, Mepitel® Film, 3 M™ Cavilon™ No-Sting Barrier Film, and silver leaf nylon dressing. Hydrofilm and Mepitel Film significantly reduced the development of RD grade ≥ 2 in breast and head and neck cancer patients (RR 0.32, 95%CI 0.19, 0.56, p < 0.0001; RR 0.21, 95%CI 0.05, 0.89, p = 0.03, resp.). Moreover, Hydrofilm had a beneficial effect on patient-reported outcomes (PROs) (SMD -0.75, 95%CI -1.2, -0.29, p = 0.001). The meta-analyses on the other barrier films did not show any significant effect. CONCLUSION: This review and meta-analysis demonstrated that Hydrofilm and Mepitel Film could effectively reduce RD severity and improve PROs. The evidence is generally weak for all the studies on barrier films and dressings due to a limited study number, high risk of bias, small sample sizes, and minimal comparable outcome measures. It's potential has been proven, but future research in this field is recommended to confirm the efficacy of these products and assess real-world feasibility.
Assuntos
Bandagens , Dermatite , Humanos , Silicones , MamaRESUMO
Skin toxicities are very common in patients undergoing cancer treatment and have been found to occur with all types of cancer therapeutic interventions (cytotoxic chemotherapy, targeted therapies, immunotherapy, and radiotherapy). Further, skin toxicities can lead to interruption or even discontinuation of anticancer treatment in some patients, translating to suboptimal outcomes. Dermocosmetics (or cosmeceuticals)-defined as skincare solutions incorporating dermatologically active ingredients (beyond vehicle effects) that directly improve symptoms of various skin conditions-are increasingly being used in cancer care to prevent and manage skin toxicities. The active ingredients in these products have a measurable biological action in skin; they typically improve skin integrity (barrier function/hydration and other factors) while relieving skin symptoms. The Association Francophone des Soins Oncologiques de Support (AFSOS) and Multinational Association of Supportive Care in Cancer (MASCC) partnered to select a multidisciplinary group of healthcare professionals involved in the management of patients with cancer and skin toxicities. The group reviewed existing literature and created a summary of recommendations for managing these toxicities through online meetings and communication. In this publication, the group (1) reviews new skin toxicities seen with oncology drugs and (2) evaluates the role of dermocosmetics in improving patient outcomes and minimizing cancer treatment interruptions. We provide general recommendations for initiation and selection of skin care in all oncology patients as well as recommendations for what factors should be considered when using dermocosmetics in specific types of skin toxicities.
Assuntos
Neoplasias , Dermatopatias , Humanos , Consenso , Neoplasias/tratamento farmacológico , Neoplasias/etiologia , Pele , Imunoterapia/efeitos adversosRESUMO
PURPOSE: To evaluate the overall efficacy of StrataXRT, a topical gel dressing, in preventing acute radiation dermatitis (RD) in breast cancer patients undergoing radiotherapy (RT). METHODS: A systematic search was conducted on April 25, 2023 in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Randomized controlled trials (RCTs) assessing the effectiveness of StrataXRT in preventing acute RD in breast cancer patients undergoing adjuvant RT to the breast or chest wall with or without regional nodes were included. Pooled incidence odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effects model, with analysis and forest plots generated in RevMan v5.4. RESULTS: The analysis included three RCTs with a total of 189 patients assessed using per-protocol analysis. Two RCTs compared StrataXRT to standard of care, while the third compared it with Mepitel film and was reported separately. In the former RCTs, the odds ratio (OR) for developing acute grade 3 RD favored StrataXRT at 0.05 (95% CI, 0.01-0.22; P < 0.0001). The OR for developing acute grades 2-3 RD was 0.32 (95% CI, 0.03-3.18; P = 0.33). The RCT comparing StrataXRT with Mepitel film showed insignificant ORs for grade 3 and grades 2-3 RD. One RCT reported significantly lower erythema index (P = 0.008) and melanin index (P = 0.015) in StrataXRT patients. The use of StrataXRT did not raise additional safety concerns. CONCLUSION: StrataXRT may help prevent severe acute RD in breast cancer RT patients. Further high quality, large-scale studies are needed to confirm these findings.
Assuntos
Neoplasias da Mama , Radiodermite , Humanos , Feminino , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias da Mama/radioterapia , Silicones , Radiodermite/prevenção & controleRESUMO
PURPOSE: This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC) across randomized controlled trials (RCTs). METHODS: Embase, MEDLINE, and Cochrane Central Register of Controlled Trials were searched on 5 March 2023 to identify relevant RCTs. RD assessment tools and outcomes were compared across studies. Pooled effect sizes and 95% confidence intervals (CI) were estimated based on random-effects analysis using RevMan 5.4. RESULTS: Three RCTs conducted between 2018 and 2020 were included. Mepitel Film decreased RD severity when compared to Sorbolene or Biafine but not when compared to mometasone. A per-protocol analysis of two of the trials revealed that, overall, Mepitel Film significantly reduced the incidence of grade 2-3 RD (odds ratio (OR), 0.24; 95% CI, 0.09-0.65; p = 0.005) and moist desquamation (OR, 0.21; 95% CI, 0.10-0.46; p < 0.0001) and decreased average patient, researcher, and combined components of the Radiation-Induced Skin Reaction Assessment Scale (the standardized mean difference (SMD) for patient ratings, - 2.56; 95% CI, - 3.15 to - 1.96, p < 0.00001; SMD for researcher ratings, - 3.47; 95% CI, - 6.63 to - 0.31, p = 0.03; SMD for combined scores, - 3.68; 95% CI, - 6.43 to - 0.92, p = 0.009). Noted issues with Mepitel Film included itchiness and poor adherence. CONCLUSION: While there were discrepancies across studies, Mepitel Film demonstrated a decrease in the incidence of grade 2-3 RD and moist desquamation. These findings emphasize the need for further examining Mepitel Film's efficacy across diverse patient groups and the importance of standardizing RD severity assessment methodologies and control arms.
Assuntos
Dermatite , Neoplasias de Cabeça e Pescoço , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias de Cabeça e Pescoço/radioterapia , Filmes CinematográficosRESUMO
PURPOSE: This systematic review and meta-analysis aimed to evaluate the efficacy of Mepitel film in preventing or treating acute radiation dermatitis (RD) in patients with breast cancer in randomized controlled trials (RCTs). METHODS: Embase, APA PsychInfo, Journals@Ovid Full Text, Ovid MEDLINE, PubMed, and Cochrane Trials were searched until December 12, 2022, to identify RCTs on the use of Mepitel film for preventing or treating acute RD from breast cancer radiotherapy. Per-protocol analysis was used to compare outcomes, calculate pooled effect sizes, odds ratio (OR), and 95% confidence intervals (CI), and to create forest plots using random effects analysis in RevMan 5.4. RESULTS: Three RCTs were included in this review. Mepitel film significantly reduced the incidence of grade 3 RD (OR 0.15 95% CI 0.06, 0.37, p<0.0001) and grade 2 or 3 RD (OR 0.16 95% CI 0.04, 0.65, p=0.01) as scored on either the CTCAE or the RTOG scale. Additionally, Mepitel film significantly reduced RISRAS mean scores assessed by patients and combined researcher and patient (standardized mean difference (SMD) -7.59, 95% CI -14.42, -0.76, p=0.03; SMD -15.36, 95% CI -30.01, -0.71 p=0.04) but not the researcher component of the assessment tool (SMD -17.55, 95% CI -36.94, 1.84, p=0.08). CONCLUSION: Mepitel film reduced the incidence of acute RD and improved patient-reported outcomes with minimal side effects, the main one being itchiness. Future research should assess the feasibility of Mepitel film with respect to specific patient-reported outcomes such as health-related quality of life issues associated with its use.
Assuntos
Neoplasias da Mama , Radiodermite , Humanos , Feminino , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias da Mama/radioterapia , Neoplasias da Mama/complicações , Silicones , Radiodermite/prevenção & controle , Radiodermite/etiologiaRESUMO
PURPOSE: Radiation dermatitis (RD) is a common side effect of radiation therapy (RT). While many different treatment strategies are currently used to address RD, there is a lack of consensus and RD prophylaxis and management guidelines have remained largely unchanged over the last 10 years. This review aims to formulate unambiguous supportive care interventions by comparing RD clinical practice guidelines published between 2010 and 2021 by several organizations: Multinational Association for Supportive Care in Cancer (MASCC), British Columbia Cancer Agency (BCCA), Cancer Care Manitoba (CCMB), Oncology Nursing Society (ONS), Society and College of Radiographers (SCoR), and International Society of Nurses in Cancer Care (ISNCC). METHODS: Areas of agreement and discordance were assessed among the MASCC, BCCA, CCMB, ONS, SCoR, and ISNCC guidelines. RESULTS: Treatment recommendations across guidelines for acute RD and chronic RT-induced skin toxicities have been summarized. The strongest agreement among the guidelines exists for the use of topical corticosteroids, silver sulfadiazine, washing, and deodorant. All guidelines recommend the use of topical corticosteroids, and washing with water and soap is consistently supported. There is minimal consensus on an optimal dressing or barrier film for RD prophylaxis or management. MASCC weakly recommends prophylactic use of silver sulfadiazine to reduce RD, while BCCA, CCMB, and SCoR recommend its use upon signs of infection. MASCC and CCMB recommend the use of a long-pulsed dye laser to manage telangiectasia, a late effect of RT. CONCLUSIONS: Given the extent of discordance among guideline recommendations, further research is recommended to establish optimal treatments for RD prophylaxis and management.
Assuntos
Fármacos Dermatológicos , Neoplasias , Radiodermite , Corticosteroides/uso terapêutico , Humanos , Neoplasias/terapia , Guias de Prática Clínica como Assunto , Radiodermite/etiologia , Radiodermite/prevenção & controle , Sulfadiazina de Prata/uso terapêuticoRESUMO
Supportive oncodermatology is a burgeoning new field within dermatology tasked with caring for the unique dermatologic needs of patients with cancer. Patients with dermatologic adverse events (dAEs) from localized and systemic anti-cancer therapies commonly experience significant distress and reduced health-related quality of life (HRQoL). Emerging dAEs is often overlooked by clinicians and researchers, despite their considerable impacts on treatment completion and patient self-esteem. Specific HRQoL issues experienced by cancer patients with dAEs include psychosocial distress and treatment interruption or cessation. Existing HRQoL assessment indices unfortunately fall short when assessing HRQoL in patients with dAEs from anti-cancer therapies due to the lack of specificity to patients' symptoms and inability to fully encompass the unique needs of this population. Additionally, the variability in HRQoL assessments across studies is substantial, suggesting the need for a standardized HRQoL measure. Here, we review the burden of dAEs and the existing validated tools used to measure them, while outlining strategies for modification to achieve optimal HRQoL assessment in patients with dAEs from anti-cancer therapies and address the HRQoL gap in supportive oncodermatology. Amongst the current tools, Skindex-16 most closely addresses the required skin-specific HRQoL metrics, but still lacks a few key cancer-specific measures. Other general HRQoL tools are well-tailored to cancer patients, but lack skin-specific questions.
Assuntos
Neoplasias , Qualidade de Vida , Humanos , Neoplasias/tratamento farmacológicoRESUMO
Limited urgent access to board-certified dermatologists drives patients to seek dermatologic care at urgent care centers (UCC). UCC are staffed by clinicians with comparatively limited dermatology training, often resulting in lower quality care for acute dermatology conditions. This study investigates health care referral outcomes of patients seeking dermatologic care at UCC, examine the appropriateness of UCC dermatologic care, and assess the feasibility of referral management by eConsult. We utilize a retrospective cohort of 807 patients and a provider survey to examine referral outcomes of patients referred to University of Rochester Dermatology (UR-Derm), a tertiary care university-based teaching hospital, from UR UCC between January 1, 2021, and August 31, 2022. Outcomes for healthcare referrals included patient demographics, referral completion rates, UR-Derm appointment wait times, and diagnostic concordance rates between UCC and UR-Derm. Outcomes from the provider survey included appropriateness of UCC treatment plans, appropriateness of UCC referral to UR-Derm, and feasibility of referral management by eConsult. Patients who utilized UCC were predominately white (77.0%) females (53.9%) with a mean age of 37.9 years. Most patients referred by UCC did not complete an in-person UR-Derm evaluation (58.6%). Of those who did complete a UR-Derm visit, the average wait time was 38.3 days. Only 56% of UCC and UR-Derm diagnoses were concordant. Our surveyed dermatologists deemed 30% of the UCC treatment plans appropriate. The majority of referrals (83.5%) were viewed as manageable with an eConsult with only 10% of referrals requiring in-person visit. Several practice gaps exist in specialty care delivery in UCC and additional inefficiencies exist in the urgent referral process. These gaps could be addressed by targeted educational interventions and availability of dermatology consultation to support urgent care.
RESUMO
Background: Developing strategies to prevent breast cancer-related arm lymphoedema (BCRAL) is a critical unmet need because there are no effective interventions to eradicate it once it reaches a chronic state. Certain strategies such as prospective surveillance programs and prophylactic lymphatic reconstruction have been reported to be effective in clinical trials. However, a large variation exists in practice based on clinician preference, organizational standards, and local resources. Methods: A two-round international Delphi consensus process was performed from February 27, 2023 to May 25, 2023 to compile opinions of 55 experts involved in the care and research of breast cancer and lymphoedema on such interventions. Findings: Axillary lymph node dissection, use of post-operative radiotherapy, relative within-arm volume increase one month after surgery, greater number of lymph nodes dissected, and high body mass index were recommended as the most important risk factors to guide selection of patients for interventions to prevent BCRAL. The panel recommended that prospective surveillance programs should be implemented to screen for and reduce risks of BCRAL where feasible and resources allow. Prophylactic compression sleeves, axillary reverse mapping and prophylactic lymphatic reconstruction should be offered for patients who are at risk for developing BCRAL as options where expertise is available and resources allow. Recommendations on axillary management in clinical T1-2, node negative breast cancer patients with 1-2 positive sentinel lymph nodes were also provided by the expert panel. Routine axillary lymph node dissection should not be offered in these patients who receive breast conservation therapy. Axillary radiation instead of axillary lymph node dissection should be considered in the same group of patients undergoing mastectomy. Interpretation: An individualised approach based on patients' preferences, risk factors for BCRAL, availability of treatment options and expertise of the healthcare team is paramount to ensure patients at risk receive preventive interventions for BCRAL, regardless of where they are receiving care. Funding: This study was not supported by any funding. RJC received investigator grant support from the Australian National Health and Medical Research Council (APP1194051).
RESUMO
The requirements of the iPLEDGE program place burdens on both patients with severe recalcitrant nodular acne and prescribers of isotretinoin. We sought to investigate the changes in dermatologists' acne treatment patterns due to the administrative burden of iPLEDGE by assessing whether dermatologists chose not to prescribe isotretinoin to appropriate patients because of the labor of iPLEDGE requirements. Additionally, we investigated the medications that were substituted for isotretinoin. An anonymous online survey was created and posted on a dermatology group on social media. The survey respondents (N=510) consisted of board-certified dermatologists across the United States and comprised a wide variety of ages and practice types. This survey ultimately highlighted the burden of iPLEDGE for American clinicians and the need for a more streamlined risk-management program. This program is deterring some US clinicians, especially those younger than 46 years, from prescribing isotretinoin and limiting patient access to an effective medication.