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BACKGROUND: Surgical de-escalation aims to reduce morbidity without compromising oncological outcomes. Trials to de-escalate breast cancer (BC) surgery among exceptional responders after neoadjuvant systemic therapy (NST) are ongoing. Combined patient and clinician insights on this strategy are unknown. METHODS: The European Society of Surgical Oncology Young Surgeons Alumni Club (EYSAC) performed an online survey to evaluate the perspective of multidisciplinary teams (MDTs) on omission of surgery ("no surgery") following complete response to NST for early BC. The aim was to identify MDT considerations and perceived barriers to omission of BC surgery. Patient insights were obtained through a focused group discussion (FGD) with four members of the patient advocacy group, Guiding Researchers and Advocates to Scientific Partnerships (GRASP). RESULTS: The MDT survey had 248 responses, with 229 included for analysis. Criteria for a "no surgery" approach included: patient's tumor and nodal status before (39.7 %) and after (45.9 %) NST and comorbidities (44.3 %). The majority chose standard surgery for hypothetical cases with a complete response to NST. Barriers for implementation were lack of definitive trials (55.9 %), "no surgery" not being discussed in MDTs (28.8 %) and lack of essential diagnostic or therapeutic options (24 %). Patients expressed communication gaps about BC surgery, lack of trust regarding accuracy of imaging, fear of regret and psychosocial burden of choosing less extensive surgery. CONCLUSIONS: Before accepting "no surgery" after complete response to NST, MDTs and patients need level 1 evidence from clinical trials, access to standard diagnostic modalities and treatments. Patient's fear of regretting less surgery need to be acknowledged and addressed.
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OBJECTIVE: ILP has shown to achieve high response rates in patients with melanoma ITM. Possibly there is a synergistic mechanism of action of ILP and anti-PD1. The aim of this trial was to investigate the safety and efficacy of adding a single dose of systemic anti-PD1 to isolated limb perfusion (ILP) for patients with melanoma in-transit metastases (ITM). METHODS: In this placebo controlled double-blind phase Ib/II trial, patients with melanoma ITM were randomized 1:1 to either a single systemic dose of nivolumab or placebo one day prior to ILP. The primary endpoint was complete response (CR) rate at three months, and safety in terms of incidence and severity of adverse events (AEs). RESULTS: A total of 20 patients were included. AEs of any grade occurred in 90% of patients in the nivolumab arm and in 80% in the placebo arm within three months after ILP. Grade 3 AEs were reported in 40% and 30% respectively, most commonly related to wound infection, wound dehiscence, or skin necrosis. There were no grade 4 or 5 AEs reported. The CR rate was 75% in the nivolumab arm and 60% in the placebo arm. The 1-year local progression-free rate was 86% in the nivolumab arm and 67% in the placebo arm. The 1-year OS was 100% in both arms. CONCLUSION: For patients with melanoma ITM, the addition of a single systemic dose of nivolumab the day before ILP is considered safe and feasible with promising efficacy. Accrual will continue in a phase 2 trial.
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Quimioterapia do Câncer por Perfusão Regional , Melanoma , Nivolumabe , Neoplasias Cutâneas , Humanos , Melanoma/tratamento farmacológico , Melanoma/secundário , Melanoma/patologia , Nivolumabe/administração & dosagem , Nivolumabe/uso terapêutico , Método Duplo-Cego , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/patologia , Quimioterapia do Câncer por Perfusão Regional/métodos , Antineoplásicos Imunológicos/uso terapêutico , Antineoplásicos Imunológicos/administração & dosagem , Adulto , Extremidades , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: The key prognostic factors for staging patients with primary cutaneous melanoma are Breslow thickness, ulceration, and sentinel lymph node (SLN) status. The multicenter selective lymphadenectomy trial (MSLT-I) verified SLN status as the most important prognostic factor for patients with intermediate-thickness melanoma (Breslow thickness, 1-4 mm). Although most international guidelines recommend SLN biopsy (SLNB) also for patients with thick (> 4 mm, pT4) melanomas, its prognostic role has been questioned. The primary aim of this study was to establish whether SLN status is prognostic in T4 melanoma tumors. METHODS: Data for all patients with a diagnosis of primary invasive cutaneous melanoma of Breslow thickness greater than 1 mm in Sweden between 2007 and 2020 were retrieved from the Swedish Melanoma Registry, a large prospective population-based registry. A multivariable Cox proportional hazard model for melanoma-specific survival (MSS) was constructed based on Breslow thickness stratified for SLN status. RESULTS: The study enrolled 10,491 patients, 1943 of whom had a Breslow thickness greater than 4 mm (pT4). A positive SLN was found for 34% of these pT4 patients. The 5-year MSS was 71%, and the 10-year MSS was 62%. There was a statistically significant difference in MSS between the patients with a positive SLN and those with a negative SLN (hazard ratio of 2.4 (95% confidence interval CI 1.6-3.5) for stage T4a and 2.0 (95% CI 1.6-2.5) for satage T4b. CONCLUSION: Sentinel lymph node status gives important prognostic information also for patients with thick (> 4 mm) melanomas, and the authors thus recommend that clinical guidelines be updated to reflect this.
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Linfadenopatia , Melanoma , Linfonodo Sentinela , Neoplasias Cutâneas , Humanos , Melanoma/patologia , Neoplasias Cutâneas/patologia , Linfonodo Sentinela/patologia , Prognóstico , Estudos Prospectivos , Biópsia de Linfonodo Sentinela , Linfadenopatia/cirurgia , Linfonodos/patologia , Melanoma Maligno CutâneoRESUMO
INTRODUCTION: Malnutrition is common in patients suffering from malignant diseases and has a major impact on patient outcomes. Prevention and early detection are crucial for effective treatment. This study aimed to investigate current international practice in the assessment and management of malnutrition in surgical oncology departments. MATERIAL AND METHODS: The survey was designed by European Society of Surgical Oncology (ESSO) and ESSO Young Surgeons and Alumni Club (EYSAC) Research Academy as an online questionnaire with 41 questions addressing three main areas: participant demographics, malnutrition assessment, and perioperative nutritional standards. The survey was distributed from October to November 2021 via emails, social media and the ESSO website to surgical networks focussing on surgical oncologists. Results were collected and analysed by an independent team. RESULTS: A total of 156 participants from 39 different countries answered the survey, reflecting a response rate of 1.4%. Surgeons reported treating a mean of 22.4 patients per month. 38% of all patients treated in surgical oncology departments were routinely screened for malnutrition. 52% of patients were perceived as being at risk for malnutrition. The most used screening tool was the "Malnutrition Universal Screening Tool" (MUST). 68% of participants agreed that the surgeon is responsible for assessing preoperative nutritional status. 49% of patients were routinely seen by dieticians. In cases of severe malnutrition, 56% considered postponing the operation. CONCLUSIONS: The reported rate of malnutrition screening by surgical oncologists is lower than expected (38%). This indicates a need for improved awareness of malnutrition in surgical oncology, and nutritional screening.
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Isolated limb perfusion (ILP) is an effective locoregional treatment for melanoma in-transit metastasis, but the advent of modern effective immunotherapy, such as ICI (immune checkpoint inhibitors), has changed the treatment landscape. The primary aims of this study were to compare the characteristics of the patient population receiving ILP before and after the introduction of modern systemic treatments and to assess if outcomes after ILP were influenced by previous immunotherapy treatment. A single-centre analysis of patients that underwent ILP for melanoma in-transit metastasis between 2010 and 2021 was conducted, with patients grouped and compared by treatment time period: pre-ICI era (2010-2014) and ICI era (2017-2021). 218 patients were included. Patients undergoing ILP in the ICI era were slightly older (median age 73 vs. 68 years) compared to the pre-ICI era, with no other difference found. The overall response rate (ORR) was 83% vs. 84% and the complete response (CR) rate was 52% vs. 47% for the pre-ICI era and the ICI era, respectively. For patients that had received and failed immunotherapy prior to ILP (n = 20), the ORR was 75% and the CR rate was 50%. Melanoma-specific survival has improved, with a 3-year survival rate of 54% in the pre-ICI era vs. 86% in the ICI era. The patient population undergoing ILP for in-transit melanoma is largely unchanged in the current era of effective systemic treatments. Response rates have not decreased, and prior ICI treatment did not affect response rates, making ILP still a valid treatment option for this patient group.
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PURPOSE: Guidelines addressing melanoma in-transit metastasis (ITM) recommend immune checkpoint inhibitors (ICI) as a first-line treatment option, despite the fact that there are no efficacy data available from prospective trials for exclusively ITM disease. The study aims to analyze the outcome of patients with ITM treated with ICI based on data from a large cohort of patients treated at international referral clinics. METHODS: A multicenter retrospective cohort study of patients treated between January 2015 and December 2020 from Australia, Europe, and the USA, evaluating treatment with ICI for ITM with or without nodal involvement (AJCC8 N1c, N2c, and N3c) and without distant disease (M0). Treatment was with PD-1 inhibitor (nivolumab or pembrolizumab) and/or CTLA-4 inhibitor (ipilimumab). The response was evaluated according to the RECIST criteria modified for cutaneous lesions. RESULTS: A total of 287 patients from 21 institutions in eight countries were included. Immunotherapy was first-line treatment in 64 (22%) patients. PD-1 or CTLA-4 inhibitor monotherapy was given in 233 (81%) and 23 (8%) patients, respectively, while 31 (11%) received both in combination. The overall response rate was 56%, complete response (CR) rate was 36%, and progressive disease (PD) rate was 32%. Median PFS was ten months (95% CI 7.4-12.6 months) with a one-, two-, and five-year PFS rate of 48%, 33%, and 18%, respectively. Median MSS was not reached, and the one-, two-, and five-year MSS rates were 95%, 83%, and 71%, respectively. CONCLUSION: Systemic immunotherapy is an effective treatment for melanoma ITM. Future studies should evaluate the role of systemic immunotherapy in the context of multimodality therapy, including locoregional treatments such as surgery, intralesional therapy, and regional therapies.
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Inibidores de Checkpoint Imunológico , Melanoma , Humanos , Inibidores de Checkpoint Imunológico/uso terapêutico , Ipilimumab/uso terapêutico , Melanoma/patologia , Estudos Prospectivos , Estudos RetrospectivosRESUMO
INTRODUCTION: Multimodal treatment of patients with advanced pelvic malignancies (APM) is challenging and surgical expertise is usually concentrated in highly specialised centres. Given significant regional variation in APM surgery, surgical training represents a cornerstone in standardising and future-proofing of this complex therapy. The aim of this study was to describe the availability and current satisfaction levels with surgical training for APM. MATERIAL AND METHODS: An online questionnaire was developed and distributed through the Redcap© platform with 32 questions addressing participant and institution demographics, and training in APM surgeries. The survey was electronically disseminated in 2021 to surgical networks across Europe including all specialities treating APM via the European Society of Surgical Oncology (ESSO). All statistical analysis were performed using R. RESULTS: The survey received 280 responses from surgeons across 49 countries, representing general surgery (36%), surgical oncology (30%), gynaeoncology (15%), colorectal surgery (14%) and urology (5%). Fifty-three percent of participants report performing >25 APM procedures/year. Respondents were departmental chiefs (12%), consultants (34%), specialist surgeons (40%) and fellows (15%). 34% were happy/very happy with their training with 70% satisfaction about their exposure to surgical procedures. Respondents reported a lack of standardised training (72%), monitoring tools (41%) and mentorship (56%). 57% rated attended courses as useful for training, while 80% rated visiting expert centres as useful. CONCLUSION: This study has identified a learning need for improved structured training in APM, with low current satisfaction levels with exposure to APM training. Organisations such as ESSO provide an important platform for visiting expert centres, courses, and structured training.
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Neoplasias Pélvicas , Cirurgiões , Oncologia Cirúrgica , Urologia , Humanos , Neoplasias Pélvicas/cirurgia , Europa (Continente) , Urologia/educação , Oncologia Cirúrgica/educação , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Since there are no formal definition of health-related quality of life (HRQOL) there may be a lack of coherence and understanding of how to interpret HRQOL-data. The aim of this study is to summarize HRQOL-results that have used the FACT-M questionnaire in patients with melanoma, and specifically to summarize FACT-M between tumor stage. METHODS: This review was conducted in accordance with the PRISMA guidelines. INCLUSION CRITERIA: original studies on cutaneous melanoma between 2005 and 2020, written in English, containing "Functional Assessment of Cancer Therapy Melanoma" OR "Functional Assessment of Cancer Therapy M" OR FACT-M OR FACT/M OR FACTM OR "FACT M" OR FACT-melanoma OR "FACT Melanoma" together with FACT-M numbered data and basic patient characteristics, using the databases Scopus, Web of Science, PubMed and PsycINFO. RESULTS: 16 articles describing 14 patient cohorts published 2008-2020 were included. The majority of the studies did not report subscale scores in accordance with FACT-M guidelines. The results did indicate that FACT-M total scores were inversely correlated with AJCC stage. Subscale analysis demonstrated varying degrees of correlation with AJCC stage. The Melanoma Surgery Subscale score was lowest in stage III patients, probably reflecting more advanced surgical procedures in this group of patients. CONCLUSIONS: Though this review is based on a questionnaire limited to the assessment of melanoma patients, it highlights the universal need for clinical studies to describe their selected HRQOL-questionnaires, its definition of HRQOL and its dimensions, as well as comply with the questionnaire's guidelines when reporting HRQOL-data.
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Melanoma/fisiopatologia , Qualidade de Vida , Neoplasias Cutâneas/fisiopatologia , Humanos , Melanoma/psicologia , Neoplasias Cutâneas/psicologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Cutaneous melanoma has a rapidly increasing incidence in Sweden, and it has more than doubled in the last two decades. In recent years, new systemic treatments for patients with metastatic disease have increased overall survival. The role of surgery in the metastatic setting has been unclear, and no randomized data exist. Many surgeons still perform metastasectomies; however, the exact role probably has to be redefined. The aim of this single-institution study was to retrospectively examine the safety and efficacy of surgery in abdominal melanoma metastases and to identify prognostic and predictive factors. METHODS: Retrospective analysis of a consecutive series of all patients with stage IV melanoma with gastrointestinal metastases that underwent abdominal surgery at a single center between January 2010 and December 2018. Fifteen patients who underwent in total 18 abdominal procedures, both acute and elective, were identified and included in the study. RESULTS: Out of 18 laparotomies, six (33%) were emergency procedures due to ileus (n = 4), small bowel perforation (n = 1), and abdominal abscess (n = 1). Twelve procedures (66%) were elective with the most common indication being persistent anemia (58%, n = 7), abdominal pain and anemia (33%, n = 4), and abdominal pain (8%, n = 1). All procedures were performed by laparotomy. There were 19 small bowel resections, 3 partial colon resections, and 2 omental resections. Radical resection was possible in 56% (n = 10) of cases and 67% (n = 8) when only considering elective procedures. In 17 of 18 procedures (94%), there were mild or no surgical complications (Clavien-Dindo grades 0-I). The median overall survival was 14 months with a 5-year survival of 23%. CONCLUSIONS: Patients with abdominal melanoma metastases can safely undergo resection with a high grade of radical procedures when performed in the elective setting. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03879395 . Registered 15 March 2019.