Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer.

INTRODUCTION: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. METHODS: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. RESULTS: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. CONCLUSIONS: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer / Avaliação da qualidade de vida em ensaio clínico de fase 2 envolvendo quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração no momento da citorredução de intervalo em pacientes com câncer de ovário de grande volume tumoral

ABSTRACT Introduction: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. Methods: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. Results: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. Conclusions: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

RESUMO Objetivo: avaliar o impacto da quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração (i.e.: 30 minutos) na qualidade de vida (QoL) relacionada à saúde (HRQoL) no contexto de ensaio clínico terapêutico piloto; NCT02249013. Métodos: avaliou-se o desfecho secundário predeterminado de HRQoL em ensaio clínico de fase 2 de segurança e eficácia, aberto, multicêntrico, de braço único, utilizando-se o questionário European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30, versão 3.0). As pacientes foram solicitadas a responder o questionário de HRQoL antes do tratamento, após a HIPEC, e ao fim do tratamento interdisciplinar. As variações da HRQoL ao longo do tempo foram avaliadas pelas medianas dos escores de cada domínio e analisadas pelo teste de Friedman, considerando-se nível de significância estatística bicaudal de 5%. Resultados: quinze pacientes com câncer de ovário de grande volume tumoral foram recrutadas do sistema de saúde pública (i.e.: SUS) entre fevereiro de 2015 e julho 2019. Um questionário basal e pelo menos um questionário de acompanhamento foram coletados de todas as pacientes. Não se observou diferença significativa ao longo do tempo na HRQoL em nenhum dos domínios ou sintomas estudados (p> 0,05). O comprometimento transitório da HRQoL imediatamente após a HIPEC de curta duração tendeu a retornar à linha de base ao final do tratamento multimodal. Conclusões: não se observou impacto significativo da HIPEC de curta duração sobre a HRQoL no contexto deste protocolo de tratamento interdisciplinar.

Hyperbaric oxygen therapy as adjuvant for treating wound complications after extensive resection for vulvar malignancy.

INTRODUCTION: Necrosis, wound breakdown, and infection represent major complications associated with radical vulvectomy. We aimed to analyze the feasibility of hyperbaric oxygen (HBO2) therapy as an adjunctive treatment for such complications. METHODS: We performed a retrospective analysis of the medical records, clinical charts, and operative records of vulvar cancer patients who underwent hyperbaric oxygen therapy after extensive surgical resection in our institute between 2012 and 2016, with a comparison of the clinical outcomes of patients with similar surgical procedures andsevere wound complications who did not undergo HBO2. RESULTS: A total of 16 patients were included in the study. In the subgroup treated with HBO2, seven patients were identified. Two patients had primary surgery, while five had recurrent surgery (of these, two had previously undergone radiation therapy). Six patients received reconstructive flaps (five myocutaneous and onefasciocutaneous), while one patient had primary suture. Dehiscence, ischemia and necrosis were estimated to cover 30%-80% of the surgical surface area. Surgical debridement was performed in six patients. Daily 90-minute sessions in the hyperbaric chamber were performed at a pressure of 2.2 atmospheres absolute, with partial oxygen pressure of 1672 mbar. Infection control and satisfactory healing were achieved using 10-61 sessions. All patients in the subgroup who did not receive HBO2 required surgical debridement due to partial or near-total flap necrosis, with two reconstructive interventions required. CONCLUSIONS: Hyperbaric oxygen therapy was an efficient adjuvant for wound healing and infection control in managing wound complications after extensive vulvar resections.