Estudo randomizado, aberto, utilizando protetor cutâneo em spray à base de terpolímero acrílico versus hidratante padrão na prevenção de radiodermatite aguda em pacientes com câncer de canal anal e reto / An open randomized study using a skin protector spray made of acrylic terpolymers versus and standardized moisturizer in preventing acute radiodermatitis in patients with anal and rectal cancer

Pacientes com câncer de canal anal e reto em tratamento por radioterapia apresentam alta prevalência de radiodermatite com descamação úmida, desfecho que causa impactos clínicos, econômicos e sociais. Estudos sobre a efetividade de produtos na prevenção das radiodermatites representam uma lacuna de conhecimento na área oncológica, podendo o seu desenvolvimento contribuir para a diminuição dos impactos negativos desse evento, do tempo ocioso do equipamento pela interrupção do tratamento e da possibilidade de falha local da doença. Objetivou-se analisar a efetividade do protetor cutâneo em spray à base de terpolímero acrílico na prevenção da radiodermatite com descamação úmida nos pacientes com câncer de canal anal e reto em comparação com um hidratante padronizado na instituição à base de Calendula officinalis L. e Aloe barbadensis. Ensaio clínico randomizado, aberto, em instituição única, referência nacional no tratamento de doenças oncológicas, com amostra 63 pacientes que foram randomizados nos grupos: experimental, com uso do protetor cutâneo em spray, e controle, usando o hidratante Dnativ Revita Derm. Os pacientes foram acompanhados na consulta de enfermagem, com cegamento do avaliador da pele quanto ao uso da intervenção. A escala de avaliação de pele utilizada foi a da Radiation Therapy Oncology Group. A coleta de dados ocorreu por meio dos formulários de avaliação inicial e subsequente, sendo o desfecho principal medido a ocorrência de radiodermatite com descamação úmida, e os secundários a ocorrência de interrupção temporária da radioterapia por radiodermatite, de eventos adversos aos produtos e de severidade da radiodermatite. As análises se deram por Intenção de Tratar e Protocolo, sendo utilizadas as estatísticas descritiva, analítica e inferenciais no tratamento dos dados, com nível de significância de ≤ 0,10. Pesquisa aprovada pelo Comitê de Ética sob parecer nº 5.322.985 e registrado no Clinical Trials sob número: NCT04067310T. A regressão logística binária mostrou que os participantes expostos ao protetor cutâneo em spray tiveram menor chance de apresentar a radiodermatite com descamação úmida quando comparados ao grupo controle. A redução absoluta do risco de radiodermatite foi de 18% no grupo experimental. A incidência geral de radiodermatite foi de 100%, sendo 36,5% graus mais severos. A incidência de radiodermatite Grau 1 foi maior no grupo experimental, enquanto os graus mais severos (Graus 3 e 4) tiveram maior incidência no grupo controle; 17,5% dos participantes tiveram interrupção da radioterapia por radiodermatite, variando de 3 a 15 dias, com média de seis dias interrompidos. Apesar de relevantes clinicamente, esses resultados sobre a interrupção temporária do tratamento e a severidade da radiodermatite não tiveram significância estatística. Foram considerados fatores de risco para a descamação úmida: sexo feminino, diagnóstico C.21 e C.21.8, altas doses de radioterapia (5400-6000cGy), tipo histológico carcinoma espinocelular, umidade antes e durante a radioterapia e uso de proteção íntima. Concluiu-se que o protetor cutâneo em spray é um produto efetivo na prevenção da radiodermatite com descamação úmida nos pacientes com câncer de canal anal e reto, afirmação que sustenta a tese defendida. Nesse sentido, os resultados podem orientar a revisão dos protocolos assistenciais de prevenção da radiodermatite utilizados pelo enfermeiro no âmbito da consulta de enfermagem em radioterapia, com vistas a reduzir os impactos no seguimento terapêutico e na qualidade de vida dos pacientes com câncer de canal anal e reto.

Patients' ongoing anal and rectal cancer radiotherapy exhibit a high prevalence of radiodermatitis with moist desquamation, impairing clinical, economic, and social outcomes. Clinical trials targeting product efficacy in preventing radiodermatitis are lacking in the current literature. These products could contribute to diminishing adverse effects, reducing equipment idle time by therapy interruption, and increasing the cure rate. Our goal is to evaluate the effectiveness of cutaneous spray based on acrylic terpolymers in preventing radiodermatitis with moist desquamation in patients with rectal or anal cancer. Spray effectiveness was defied against a standardized moisturizer in the institution made of Calendula officinalis L. and Aloe barbadensis extracts. An open, single-blind, randomized clinical study was conducted in a single institution, reference in national treatment in oncological diseases, with a sample size (n) of 63 patients. Patients were randomized into two groups: (i) experimental, using cutaneous protector spray; and (ii) control, using moisturizer Dnativ Revita Derm. RTOC's scale was used for evaluating skin condition. Data was collected in forms, which considered: (i) the primary outcome of radiodermatitis with moist desquamation occurrence; and (ii) the secondary outcome of radiotherapy interruption caused by radiodermatitis occurrence and severity, and product adverse effects. Analyses were performed by intention to treat and per protocol, using descriptive, analytical, and inferential statistics, with a significance level of ≤ 0.10 (α). Research was approved by the Ethics committee under approval nº 5.322.985 and registered in Clinical Trials under number NCT04067310T. Binary logistic regression demonstrated that patients exposed to cutaneous spray protector were less prone to develop radiodermatitis with moist desquamation compared to the control group. Absolute reduction in radiodermatitis risk was 18% in the experimental group. The radiodermatitis overall incidence was 100%, with 36.5% of higher severity. The incidence of grade 1 radiodermatitis was higher in the experimental group, while the more severe grades (3 and 4) had a higher incidence in the control group; 17.5% of the participants had an interruption of radiotherapy due to radiodermatitis, ranging from 3 to 15 days, with an average of six interrupted days. Despite being clinically relevant, these results regarding the temporary interruption of treatment and the severity of radiodermatitis were not statistically significant. Risk factors for moist desquamation were considered: female gender, diagnosis of C.21 and C.21.8, high radiation doses (5400 to 6000 cGy), histological type squamous cell carcinoma, humidity before and during radiotherapy, and use of intimate protection. In conclusion, the skin protector spray is an effective product in the prevention of radiodermatitis with moist desquamation in patients with anal and rectal cancer. In this sense, the results can guide the review of care protocols for the prevention of radiodermatitis used by nurses in the context of nursing consultations in radiotherapy to reduce the impacts on therapeutic follow-up and the quality of life of patients with cancer of the anal canal and straight.

Los pacientes con cáncer de canal anal y recto en tratamiento con radioterapia tienen una alta prevalencia de radiodermatitis con descamación húmeda, desenlace que genera impactos clínicos, económicos y sociales. Los estudios sobre la efectividad de los productos en la prevención de la radiodermatitis representan un vacío de conocimiento en el área de oncología y pueden contribuir para la reducción de los impactos negativos, el tiempo de inactividad de los equipos por interrupción del tratamiento y la posibilidad de falla local de la enfermedad. El objetivo de este estudio fue analizar la eficacia de un protector cutáneo en spray a base de terpolímero acrílico en la prevención de la radiodermatitis con descamación húmeda en pacientes con cáncer anal y rectal frente a una crema hidratante estandarizada de la institución a base de Calendula officinalis L. y Aloe barbadensis. Ensayo clínico aleatorizado, abierto, en una sola institución, referente nacional en el tratamiento de enfermedades oncológicas, con una muestra de 63 pacientes que fueron aleatorizados en grupos: experimental, utilizando spray protector para la piel, y control, utilizando Dnativ Revita Derm hidratante. Los pacientes fueron seguidos en la consulta de enfermería, cegándose el evaluador de piel en cuanto al uso de la intervención. La escala de valoración de la piel utilizada fue la del RTOC. Los datos se recopilaron mediante formularios de evaluación inicial y posterior, siendo el resultado principal medido la aparición de radiodermatitis con descamación húmeda y los resultados secundarios la interrupción temporal de la radioterapia debido a la radiodermatitis, los eventos adversos de los productos y la gravedad de la radiodermatitis. Los análisis fueron realizados por Intención de Tratar y Protocolo, utilizando estadística descriptiva, analítica e inferencial en el procesamiento de datos, con nivel de significación ≤ 0,10. Investigación aprobada por el Comité de Ética con dictamen nº 5.322.985 y registrada en Ensayos Clínicos con el número: NCT04067310T. La regresión logística binaria mostró que los participantes expuestos al protector de piel en aerosol tenían menos probabilidades de tener radiodermatitis con descamación húmeda en comparación con el grupo de control. La reducción absoluta del riesgo de radiodermatitis fue del 18 % en el grupo experimental. La incidencia global de radiodermatitis fue del 100%, siendo el 36,5% grados más graves. La incidencia de radiodermatitis Grado 1 fue mayor en el grupo experimental, mientras que los grados más severos (3 y 4) tuvieron mayor incidencia en el grupo control; El 17,5% de los participantes tuvo interrupción de la radioterapia por radiodermatitis, variando de 3 a 15 días, con un promedio de seis días de interrupción. A pesar de ser clínicamente relevantes, estos resultados en cuanto a la interrupción temporal del tratamiento y la gravedad de la radiodermatitis no fueron estadísticamente significativos. Se consideraron factores de riesgo para descamación húmeda: sexo femenino, diagnóstico C.21 y C.21.8, dosis altas (5400-6000cGy), carcinoma epidermoide de tipo histológico, humedad antes y durante la radioterapia y uso de protección íntima. Se concluyó que el spray protector de piel es un producto eficaz en la prevención de la radiodermatitis con descamación húmeda en pacientes con cáncer anal y rectal, afirmación que sustenta la tesis defendida. En ese sentido, los resultados pueden orientar la revisión de los protocolos de atención para la prevención de la radiodermitis utilizados por los enfermeros en el contexto de las consultas de enfermería en radioterapia, con el objetivo de reducir los impactos en el seguimiento terapéutico y en la calidad de vida de los pacientes con cáncer del canal anal y recto.

Conventional and liquid-based cytology (Liqui-PREP™) anal findings in male HIV anoreceptive patients in a referral University hospital in Rio de Janeiro, Brazil / Achados de citologia convencional e de citologia em base líquida (Liqui-PREP®) anal em pacientes masculinos HIV soropositivos anorreceptivos, em um hospital universitário de referência do Rio de Janeiro, Brasil

Introduction: The anal lesions seem to have a natural history that closely resembles cervical lesions, with signs that precede the invasion. Cytological changes of anal epithelium induced by HPV can be detected through cytology, as it is considered an effective screening method. Objective: To identify the frequency of atypical epithelial conventional cytology results by comparing anal samples through Liqui-PREPTM technology in HIV-positive men. Methods: Cross-sectional descriptive and analytical study of 33 men who have sex with men (MSM), HIV-positive and anoreceptive attended at the Gaffrèe and Guinle University Hospital (HUGG), Rio de Janeiro, from June to July, 2016. Collection of anal samples for the conventional cytology and Liqui-PREPTM cytology was carried out. For significance of findings, Fisher exact test with 95% confidence interval was used and cytological Kappa index was employed for concordance between the two cytological methods. Results: The age ranged from 23 to 60 years (mean=39.06). The CD4 cell count was between 200 to 500/mm3 on 16 (48.5%) and 13 (39.4%), and 50% was diagnosed with HIV for more than 6 years. In conventional cytology one case was considered unsatisfactory (3%). Among the cases considered satisfactory, 9 (28.1%) were diagnosed with ASC-US; 4 (12.5%) LSIL; 2 (6.3%) ASC-H, and 2 (6.3%) HSIL. Through Liqui-PREPTM method, 7 cases were considered unsatisfactory (21.2%). Among the satisfactory cases, 7 showed ASC-US (26.9%); 4 (15.4%) ASC-H; 2 (7.7%) LSIL; and 2 (7.7%) HSIL. The difference of unsatisfactory cases between both methods, although higher for Liqui-PREPTM, was not statistically significant (p=0.054). The correlation was moderate (0503; p<0.006 [0.1765­0.8298]). Conclusion: The cytologic atypia is common among MSM HIV (+), and the anal conventional cytology and liquid by Liqui-PREPTM cytology are equivalent, although they are more unsatisfactory in the latter technique.

Introdução: As lesões anais parecem ter uma história natural, que se assemelha às de lesões de colo uterino, com sinais que precedem a invasão. As alterações citológicas do epitélio anal induzidas pelo HPV podem ser detectadas por citologia, um método de rastreio considerado efetivo. Objetivo: Identificar a frequência de atipias epiteliais nos resultados da citologia convencional comparando amostras anais pela tecnologia Liqui-PREP® em homens HIV positivos. Métodos: Estudo transversal, descritivo e analítico de 33 homens que fazem sexo com homens (HSH), HIV positivos e anorreceptivos atendidos no Hospital Universitário Gaffrèe e Guinle (HUGG), Rio de Janeiro, no período de junho a julho de 2016. Os pacientes foram submetidos à coleta de amostras anais para citologia convencional e citologia Liqui-PREP®. Para significância de achados, foi usado o teste exato de Fisher com intervalo de confiança de 95%, e para concordância entre os dois métodos citológicos, foi utilizado o índice de Kappa. Resultados: A idade variou de 23 a 60 anos (média=39,06). A contagem de células CD4 foi entre 200 e 500/mm3 para 16 (48,5%) e 13 (39,4%) dos casos analisados, e 50% tinham o diagnóstico de HIV há mais de seis anos. Na citologia convencional, um caso foi considerado insatisfatório (3%). Entre os casos considerados satisfatórios, 9 (28,1%) foram diagnosticados como células escamosas atípicas de significado indeterminado possivelmente não neoplásicas (ASC-US); 4 (12,5%) como lesão intraepitelial de baixo grau (LSIL); 2 (6,3%) como células escamosas atípicas não sendo possível excluir lesão intraepitelial de alto grau (ASC-H) e 2 (6,3%) como lesão intraepitelial de alto grau (HSIL). Pelo método Liqui-PREP®, 7 casos foram considerados insatisfatórios (21,2%). Entre os casos satisfatórios, 7 como ASC-US (26,9%); 4 (15,4%) como ASC-H; 2 (7,7%) como LSIL e 2 (7,7%) como HSIL. A diferença de insatisfatório entre os métodos, embora maior para Liqui-PREP®, não foi estatisticamente significativa (p=0,054). A concordância foi moderada (0,503; p<0,006 [0,1765­0,8298]). Conclusão: É frequente a atipia citológica entre HSH HIV (+), e as citologias anal convencional e em meio líquido pela técnica Liqui-PREPTM se equivalem, embora sejam mais insatisfatórias na técnica citológica Liqui-PREP®.

Clinical efficacy of preoperative SIB-IMRT for 26 cases of locally-advanced low rectal cancer / 中华放射肿瘤学杂志

Objective To evaluate the feasibility and clinical efficacy of preoperative simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) combined with neoadjuvant chemotherapy of capecitabine in patients with locally-advanced low rectal cancer.Methods Between 2015 and 2016,26 patients admitted to 301 Hospital who were diagnosed with locally-advanced low rectal cancer,which was located within 5 cm from the anal verge,were enrolled in this investigation.Dose fractionation pattern was delivered:58.75 Gy in 25 fractions (2.35 Gy/fraction) for rectal cancer and lymph node metastasis and 50 Gy in 25 fractions for the pelvic lymphatic drainage area and simultaneously combined with capecitabine chemotherapy (825 mg/m2,bid d 1-5 weekly).One cycle of capecitabine (1 250 mg/m2,twice daily,d 1-14)was given at one week after the completion of chemoradiotherapy (CRT).Total mesorectal excision (TME)was performed at 6 to 8 weeks after the completion of CRT.The primary endpoints included pathological complete response rate (ypCR) and sphincter-preserving rate.The secondary endpoints included acute toxicity,tumor downstaging rate and postoperative complications.Results Twenty-six patients successfully completed neoadjuvant CRT,25 of them underwent surgical resection and one patient failed to receive surgery due to pxrianal edema.Postoperative ypCR rate was 32％ (8/25),the sphincter-preserving rate was 60％ (15/25),the tumor downstaging rate was 92％ (23/25) and the R0 resection rate was 100％.During the period of CRT,grade 1 and 2 adverse events occurred in 24 patients,grade 3 radiation dermatitis was noted in 2 cases.No ≥ grade 4 acute adverse event was observed.Postoperative complications included ureteral injury in one case and intestinal obstruction in one patient.Conclusions Preoperative SIB-IMRT combined with neoadjuvant chemotherapy of capecitabine is a feasible and safe treatment for patients with locallyadvanced low rectal cancer,which yields expected ypCR rate,R0 resection rate and sphincter-preserving rate.Nevertheless,the long-term clinical benefits remain to be elucidated.Clinical Trial Registry Chinese Clinical Trial Registry,registration number:ChiCTR-ONC-12002387.

A Case of Synchronous Colorectal Adenocarcinoma with Anal Squamous Cell Carcinoma / 대한소화기내시경학회지

Synchronous anal squamous cell carcinoma with colorectal adenocarcinoma is a very rare and interesting disease entity because these neoplasms are essentially different from each other in terms of their anatomical locations, clinical behaviors, histopathological characteristics and treatment. To date, there have been very few case reports regarding the concurrent occurrence of these two distinct neoplasms. Nonetheless, it is recommended that patients with squamous cell carcinoma of the anus and who are older than 50 years should undergo colonoscopy in order to rule out a synchronous colorectal neoplasm. We recently encountered a 72-year-old woman who presented with synchronous squamous cell carcinoma of the anal canal and adenocarcinoma of the rectosigmoid junction. The patient underwent curative surgical resection for the colorectal adenocarcinoma and chemoradiotherapy for the concurrent anal squamous cell carcinoma. We describe here our clinical experience with this unusual case and we also conduct a short review of relevant literature.

Perianal Extramammary Paget's Disease Associated with an Anal Duct Adenocarcinoma: A Case Report

Extramammary Paget's disease occurs commonly on the external female genitalia and rarely occurs in the perianal region. Recently, we experienced a case of perianal extramammary Paget's disease associated with an anal duct adenocarcinoma. The patient was a 60-year-old man. The perianal skin lesion was eczematous and encircled the anus. A wide-excision, split-thickness skin graft and temporal T-loop colostomy were performed. Histopathologically, the tumor was a well-differentiated anal duct adenocarcinoma. There was a prominent pagetoid spread of about 6x4 cm. The tumor cell was positive for carcinoembryonic antigen, but the paget cell was negative. The patient was treated with radiation therapy and with single 5-FU chemotherapy six times. Five months later, the perianal region was nearly normal.

Patterns of Failure and Prognostic Factors in Anal Cancer Treated with Radiotherapy / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: To analyze the patterns of failure and prognostic factors affecting the local control and survivals in anal cancer treated with definitive radiotherapy, and to find the most effective treatment modality. MATERIALS AND METHODS: Thirty consecutive patients, with primary cancers of the anal canal, were treated using radiotherapy, both with and without 5-FU based concurrent chemotherapy. According to the AJCC tumor stage, six patients hadwere stage I, 11 had stage II, 2 had stage IIIA, and 11 had stage IIIB tumors. The median radiation dose was 45 Gy (30-72 Gy), and with 23 patients receivinged concurrent chemotherapy (5-FU and mitomycin C in 12 patients, 5-FU and cisplatin in 7, and other drugs in 4). The Mmedian follow up period was 43 months, (ranginge, from 8- to 99 months). RESULTS: Among the 1630 patients who16 were treated without surgical resection beforeprior to the radiotherapy, and a complete remission was observed in 12 patients (75%), a partial remission in 3 (19%), and a local progression in the other one patient. The Llocal failures, including persistent disease, were observed in 10 (33%), and the patients with higher T-stages (T3-4) had higher rates of local failure rates (T1-2, 21% vs. T3-4, 72%, p=0.03). Distant metastases were found in 4 patients (13%). The five year survival and disease free survival rates were 64% and 53%, respectively. The factors which affectinged the 5 year local relapse free survival were T-stage (74.9% in T1-2 vs. 28.6% in T3-4, p=0.01), and the existence of a gross tumor beforeprior to radiotherapy (84.6%, no residual vs. 45.1% with residual, p=0.03). CONCLUSION: A Llocal recurrence was the major failure pattern in anal cancers, and the factors affecting a local failure were the T-stage and tumor volume beforeprior to radiotherapy. A Rradiation dose around 45 Gy was sufficient to control tumors of the earlier T stage tumors, but a higher dose should be considered for with more advanced lesions.