Development of a core outcome set for cutaneous squamous cell carcinoma trials: identification of core domains and outcomes

BackgroundThe lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials.ObjectivesTo develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC.MethodsOne hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants.ResultsA core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival.ConclusionsIn order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes

Mucosite bucal rádio e quimioinduzida Radiation therapy and chemotherapy-induced oral mucositis

O aumento da intensidade da quimioterapia e radioterapia no tratamento do câncer tem elevado a incidência de efeitos colaterais, em especial da mucosite bucal. OBJETIVO E MÉTODO: Através de revisão bibliográfica realizou-se atualizar informações quanto à definição, características clínicas, incidência, etiologia, patofisiologia, morbidade associada, prevenção e tratamento dessa manifestação clínica. RESULTADOS: Estudos atuais definem a mucosite bucal como uma inflamação e ulceração dolorosa bastante freqüente na mucosa bucal apresentando formação de pseudomembrana. Sua incidência e severidade são influenciadas por variáveis associadas ao paciente e ao tratamento a que ele é submetido. A mucosite é conseqüência de dois mecanismos maiores: toxicidade direta da terapêutica utilizada sobre a mucosa e mielossupressão gerada pelo tratamento. Sua patofisiologia é composta por quatro fases interdependentes: fase inflamatória/vascular, fase epitelial, fase ulcerativa/bacteriológica e fase de reparação. É considerada fonte potencial de infecções com risco de morte, sendo a principal causa de interrupção de tratamentos antineoplásicos. Algumas intervenções mostraram-se potencialmente efetivas para sua prevenção e tratamento. Entretanto, faz-se necessária a realização de novos estudos clínicos mais bem conduzidos para obtenção de melhor evidência científica acerca do agente terapêutico de escolha para o controle da mucosite bucal, permitindo a realização da quimioterapia e radioterapia do câncer em parâmetros ideais.<br>Tincreasing the intensity of radiation therapy and chemotherapy in the management of cancer has increased the incidence of adverse effects, especially oral mucositis. AIM AND METHODS: a bibliographical review was conducted on the definition of oral mucositis, its clinical findings, the incidence, its etiology, the pathofisiology, associated morbidity, prevention and treatment. RESULTS: current studies define oral mucositis as a very frequent and painful inflammation with ulcers on the oral mucosa that are covered by a pseudo membrane. The incidence and severity of lesions are influenced by patient and treatment variables. Oral mucositis is a result of two major mechanisms: direct toxicity on the mucosa and myelosuppression due to the treatment. Its pathofisiology is composed of four interdependent phases: an initial inflammatory/vascular phase&#894; an epithelial phase&#894; an ulcerative/bacteriological phase&#894; and a healing phase. It is considered a potential source of life-threatening infection and often is a dose-limiting factor in anticancer therapy. Some interventions have been shown to be potentially effective to prevent and treat oral mucositis. Further intensive research through well-structured clinical trials to obtain the best scientific evidence over the standard therapy of oral mucositis is necessary to attain ideal parameters for radiotherapy and chemotherapy