Quality indicators for evaluating cancer care in low-income and middle-income country settings: a multinational modified Delphi study.

This Policy Review sourced opinions from experts in cancer care across low-income and middle-income countries (LMICs) to build consensus around high-priority measures of care quality. A comprehensive list of quality indicators in medical, radiation, and surgical oncology was identified from systematic literature reviews. A modified Delphi study consisting of three 90-min workshops and two international electronic surveys integrating a global range of key clinical, policy, and research leaders was used to derive consensus on cancer quality indicators that would be both feasible to collect and were high priority for cancer care systems in LMICs. Workshop participants narrowed the list of 216 quality indicators from the literature review to 34 for inclusion in the subsequent surveys. Experts' responses to the surveys showed consensus around nine high-priority quality indicators for measuring the quality of hospital-based cancer care in LMICs. These quality indicators focus on important processes of care delivery from accurate diagnosis (eg, histologic diagnosis via biopsy and TNM staging) to adequate, timely, and appropriate treatment (eg, completion of radiotherapy and appropriate surgical intervention). The core indicators selected could be used to implement systems of feedback and quality improvement.

Hospital admission and the occurrence of delirium in older adults with physical frailty: cross-sectional study.

OBJECTIVE: To analyze the relationship between hospitalization and the occurrence of delirium in older adults with physical frailty. METHOD: Cross-sectional study carried out in a public hospital in southern Brazil. Hospitalized older adults aged ≥ 60 years participated. Sociodemographic and clinical data were collected, physical frailty phenotype tests were performed and the Confusion Assessment Method was used. Descriptive analyzes were carried out and odds ratio values were estimated for the frailty and delirium variables. RESULTS: Of the 320 older adults evaluated, 21.14% presented delirium, 49% were identified as pre-frail and 36.2% as frail. Of those affected by delirium, 71.6% were classified as frail and 28.3% as pre-frail (p < 0.001). An association was observed between the occurrence of delirium and frailty (OR 1.22; 95% CI 1.07 to 1.38), age ≥ 80 years (OR 1.14; 95% CI 1.01 to 1.32), epilepsy (OR 1.38; 95% CI 1.09 to 1.76), dementia (OR 1.58; 95% CI 1.37 to 1.82), and history of stroke (OR 1.14; 95% CI 1.03 to 1.26). CONCLUSION: There was a high frequency of pre-frail and frail older adults, and the occurrence of delirium in frail was significantly higher. Special attention should be paid to frail older adults to prevent the occurrence of delirium during hospitalization.

Does sentinel node mapping impact morbidity and quality of life in endometrial cancer?

OBJECTIVES: To evaluate the prevalence of post-operative complications and quality of life (QoL) related to sentinel lymph node (SLN) biopsy vs systematic lymphadenectomy in endometrial cancer. METHODS: A prospective cohort included women with early-stage endometrial carcinoma who underwent lymph node staging, grouped as follows: SLN group (sentinel lymph node only) and SLN+LND group (sentinel lymph node biopsy with addition of systematic lymphadenectomy). The patients had at least 12 months of follow-up, and QoL was assessed by European Organization for Research and Treatment of Cervical Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30) and EORTC-QLQ-Cx24. Lymphedema was also assessed by clinical evaluation and perimetry. RESULTS: 152 patients were included: 113 (74.3%) in the SLN group and 39 (25.7%) in the SLN+LND group. Intra-operative surgical complications occurred in 2 (1.3%) cases, and all belonged to SLN+LND group. Patients undergoing SLN+LND had higher overall complication rates than those undergoing SLN alone (33.3% vs 14.2%; p=0.011), even after adjusting for confound factors (OR=3.45, 95% CI 1.40 to 8.47; p=0.007). The SLN+LND group had longer surgical time (p=0.001) and need for admission to the intensive care unit (p=0.001). Moreover, the incidence of lymphocele was found in eight cases in the SLN+LND group (0 vs 20.5%; p<0.001). There were no differences in lymphedema rate after clinical evaluation and perimetry. However, the lymphedema score was highest when lymphedema was reported by clinical examination at 6 months (30.1 vs 7.8; p<0.001) and at 12 months (36.3 vs 6.0; p<0.001). Regarding the overall assessment of QoL, there was no difference between groups at 12 months of follow-up. CONCLUSIONS: There was a higher overall rate of complications for the group undergoing systematic lymphadenectomy, as well as higher rates of lymphocele and lymphedema according to the symptom score. No difference was found in overall QoL between SLN and SLN+LND groups.

Hospital admission and the occurrence of delirium in older adults with physical frailty: cross-sectional study / Ingreso hospitalario y aparición de delirio en adultos mayores con fragilidad física: estudio transversal / Internação hospitalar e a ocorrência de delirium em idosos na condição de fragilidade física: estudo transversal

ABSTRACT Objective To analyze the relationship between hospitalization and the occurrence of delirium in older adults with physical frailty. Method Cross-sectional study carried out in a public hospital in southern Brazil. Hospitalized older adults aged ≥ 60 years participated. Sociodemographic and clinical data were collected, physical frailty phenotype tests were performed and the Confusion Assessment Method was used. Descriptive analyzes were carried out and odds ratio values were estimated for the frailty and delirium variables. Results Of the 320 older adults evaluated, 21.14% presented delirium, 49% were identified as pre-frail and 36.2% as frail. Of those affected by delirium, 71.6% were classified as frail and 28.3% as pre-frail (p < 0.001). An association was observed between the occurrence of delirium and frailty (OR 1.22; 95% CI 1.07 to 1.38), age ≥ 80 years (OR 1.14; 95% CI 1.01 to 1.32), epilepsy (OR 1.38; 95% CI 1.09 to 1.76), dementia (OR 1.58; 95% CI 1.37 to 1.82), and history of stroke (OR 1.14; 95% CI 1.03 to 1.26). Conclusion There was a high frequency of pre-frail and frail older adults, and the occurrence of delirium in frail was significantly higher. Special attention should be paid to frail older adults to prevent the occurrence of delirium during hospitalization.

RESUMEN Objetivo Analizar la relación entre la hospitalización y la aparición de delirio en adultos mayores con fragilidad física. Método Estudio transversal realizado en un hospital público del sur de Brasil. Participaron adultos mayores hospitalizados con edad ≥ 60 años. Se recogieron datos sociodemográficos y clínicos, se realizaron pruebas de fenotipo de fragilidad física y se utilizó el Confusion Assessment Method. Se realizaron análisis descriptivos y se estimaron los odds ratio para las variables fragilidad y delirio. Resultados De los 320 adultos mayores evaluados, el 21,14% presentó delirio, el 49% fueron identificados como prefrágiles y el 36,2% como frágiles. De los adultos mayores afectados por delirio, el 71,6% fueron clasificados como frágiles y el 28,3% como prefrágiles (p < 0,001). Se observó asociación entre la aparición de delirio y fragilidad (OR 1,22; IC 95% 1,07 a 1,38), edad ≥ 80 años (OR 1,14; IC 95% 1,01 a 1,32), epilepsia (OR 1,38; IC 95% 1,09 a 1,76), demencia (OR 1,58; IC del 95%: 1,37 a 1,82) y antecedentes de accidente cerebrovascular (OR 1,14; IC del 95%: 1,03 a 1,26). Conclusión Hubo una alta frecuencia de adultos mayores prefrágiles y frágiles y la aparición de delirio en los frágiles fue significativamente mayor. Se debe prestar especial atención a los adultos mayores frágiles para prevenir la aparición de delirio durante la hospitalización.

RESUMO Objetivo Analisar a relação entre hospitalização e ocorrência de delirium em idosos na condição de fragilidade física. Método Estudo transversal desenvolvido em hospital público no Sul do Brasil. Participaram idosos hospitalizados, idade ≥ 60 anos. Foram coletados dados sociodemográficos e clínicos, e feitos testes do fenótipo da fragilidade física, bem como o Confusion Assessment Method. Realizaram-se análises descritivas e estimaram-se as odds ratio para as variáveis fragilidade e delirium. Resultados Dos 320 idosos avaliados, 21,14% apresentaram delirium, 49% foram identificados como pré-frágeis e 36,2% frágeis. Dos idosos acometidos por delirium, 71,6% foram classificados como frágeis e 28,3% pré-frágeis (p< 0,001). Observou-se associação entre ocorrência de delirium e fragilidade (OR 1,22; IC 95% 1,07 a 1,38), idade ≥ 80 anos (OR 1,14; IC 95% 1,01 a 1,32), epilepsia (OR 1,38; IC 95% 1,09 a 1,76), demência (OR 1,58; IC 95% 1,37 a 1,82), e história de acidente vascular encefálico (OR 1,14; IC 95% 1,03 a 1,26). Conclusão Observou-se alta frequência de idosos pré-frágeis e frágeis e ocorrência de delirium expressivamente maior nos frágeis. Atenção especial deve ser empregada a idosos frágeis para prevenir a ocorrência de delirium durante a hospitalização.

Participation of Lower and Upper Middle-Income Countries in Clinical Trials Led by High-Income Countries.

Importance: Many randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle-income countries (LMICs) and upper middle-income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which countries participate in RCTs and how this participation may contribute to global research. Objective: To describe which UMICs and LMICs participate in RCTs led by HICs. Design, Setting, and Participants: A cross-sectional study of all oncology RCTs published globally during January 1, 2014, to December 31, 2017, was conducted. The study cohort was restricted to RCTs led by HICs that enrolled participants from LMICs and UMICs. Study analyses were conducted in November 1, 2021, to May 31, 2022. Main Outcomes and Measures: A bibliometric approach (Web of Science 2007-2017) was used to explore whether RCT participation was proportional to other measures of cancer research activity. Participation in RCTs (ie, percentage of RCTs in the cohort in which each LMIC and UMIC participated) was compared with country-level cancer research bibliometric output (ie, percentage of total cancer research bibliometric output from the same group of countries that came from a specific LMIC and UMIC). Results: Among the 636 HIC-led RCTs, 186 trials (29%) enrolled patients in LMICs (n = 84 trials involving 11 LMICs) and/or UMICs (n = 181 trials involving 26 UMICs). The most common participating LMICs were India (42 [50%]), Ukraine (39 [46%]), Philippines (23 [27%]), and Egypt (12 [14%]). The most common participating UMICs were Russia (115 [64%]), Brazil (94 [52%]), Romania (62 [34%]), China (56 [31%]), Mexico (56 [31%]), and South Africa (54 [30%]). Several LMICs are overrepresented in the cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (27% RCTs, 1% output), and Georgia (8% RCTs, 0.2% output). Overrepresented UMICs include Russia (64% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output), and South Africa (30% RCTs, 1% output). Conclusions and Relevance: In this cross-sectional study, a substantial proportion of RCTs led by HICs enrolled patients in LMICs and UMICs. The LMICs and UMICs that participated in these trials did not match overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity-strengthening activities require further study.

Cancer risk-reducing surgery: Brazilian society of surgical oncology guideline part 1 (gynecology and breast).

BACKGROUND: Risk-reducing operations are an important part of the management of hereditary predisposition to cancer. In selected cases, they can considerably reduce the morbidity and mortality associated with cancer in this population. OBJECTIVES: The Brazilian Society of Surgical Oncology (BSSO) developed this guideline to establish national benchmarks for cancer risk-reducing operations. METHODS: The guideline was prepared from May to December 2021 by a multidisciplinary team of experts to discuss the surgical management of cancer predisposition syndromes. Fourteen questions were defined and assigned to expert groups that reviewed the literature and drafted preliminary recommendations. Following a review by the coordinators and a second review by all participants, the groups made final adjustments, classified the level of evidence, and voted on the recommendations. RESULTS: For all questions including risk-reduction bilateral salpingo-oophorectomy, hysterectomy, and mastectomy, major agreement was achieved by the participants, always using accessible alternatives. CONCLUSION: This and its accompanying article represent the first guideline in cancer risk reduction surgery developed by the BSSO, and it should serve as an important reference for the management of families with cancer predisposition.

Cancer risk-reducing surgery: Brazilian Society of Surgical Oncology Guideline Part 2 (Gastrointestinal and thyroid).

BACKGROUND: Risk-reducing operations are an important part of the management of hereditary predisposition to cancer. In selected cases, they can considerably reduce the morbidity and mortality associated with cancer in this population. OBJECTIVES: The Brazilian Society of Surgical Oncology (BSSO) developed this guideline to establish national benchmarks for cancer risk-reducing operations. METHODS: The guideline was prepared from May to December 2021 by a multidisciplinary team of experts to discuss the surgical management of cancer predisposition syndromes. Eleven questions were defined and assigned to expert groups that reviewed the literature and drafted preliminary recommendations. Following a review by the coordinators and a second review by all participants, the groups made final adjustments, classified the level of evidence, and voted on the recommendations. RESULTS: For all questions including risk-reducing colectomy, gastrectomy, and thyroidectomy, a major agreement was achieved by the participants, always using accessible alternatives. CONCLUSION: This and its accompanying article represent the first guideline in cancer risk reduction surgery developed by the BSSO and it should serve as an important reference for the management of families with cancer predisposition.

Brazilian Society of Surgical Oncology consensus on fertility-sparing surgery for cervical cancer.

OBJECTIVE: Several controversies remain on conservative management of cervical cancer. Our aim was to develop a consensus recommendation on important and novel topics of fertility-sparing treatment of cervical cancer. METHODS: The consensus was sponsored by the Brazilian Society of Surgical Oncology (BSSO) from March 2020 to September 2020 and included a multidisciplinary team of 55 specialists. A total of 21 questions were addressed and they were assigned to specialists' groups that reviewed the literature and drafted preliminary recommendations. Further, the coordinators evaluated the recommendations that were classified by the level of evidence, and finally, they were voted by all participants. RESULTS: The questions included controversial topics on tumor assessment, surgical treatment, and surveillance in conservative management of cervical cancer. The two topics with lower agreement rates were the role of minimally invasive approach in radical trachelectomy and parametrial preservation. Additionally, only three recommendations had <90% of agreement (fertility preservation in Stage Ib2, anti-stenosis device, and uterine transposition). CONCLUSIONS: As very few clinical trials have been developed in surgery for cervical cancer, most recommendations were supported by low levels of evidence. We addressed important and novel topics in conservative management of cervical cancer and our study may contribute to literature.

Contingency planning for cancer care in low- and middle-income countries during the COVID-19 pandemic: a rapid assessment for future disaster resilience.

BACKGROUND: Many countries appear to be ill-prepared in their emergency responses towards the Corona Virus Disease 2019 (COVID-19) pandemic, particularly in managing chronic diseases such as cancer. We aimed to gain insight on the preparedness of health systems within low- and middle-income countries (LMICs) in maintaining delivery of cancer care amid the pandemic. METHODS: We performed a rapid review of publications focusing on emergency contingency plans for cancer care during the pandemic in LMICs. An online desk research was conducted to identify relevant policy documents, guidelines or scientific publications. RESULTS: Very few LMICs had readily accessible documents to ensure continuity in delivery of cancer care during the pandemic. A majority of publications were focused on delivery of cancer treatment whereas early detection, diagnosis and delivery of supportive and survivorship care received very little attention. Far fewer of the published guidelines appear to have been formulated at the national level by governmental agencies. A vast majority of publications constituted consensus guidelines from professional societies, followed by sharing of best practices from local institutions. Overall, three main strategies have been recommended to maintain delivery of cancer care amid the pandemic in LMICs: 1) Modification of cancer treatment regimens, 2) Changes in methods of administration of curative and supportive cancer care and 3) Implementation of generic measures to reduce the risk of COVID-19 infection in healthcare settings. CONCLUSION: All LMICs should consider collating best practices from the current pandemic and translating them into an explicit cancer preparedness plan, which can be escalated during future disasters.

Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial).

BACKGROUND: Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking. PRIMARY OBJECTIVES: The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes. STUDY HYPOTHESIS: We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy. TRIAL DESIGN: This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy. MAJOR INCLUSION AND EXCLUSION CRITERIA: Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy. PRIMARY ENDPOINTS: The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer. SAMPLE SIZE: 178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027. TRIAL REGISTRATION NUMBER: NCT03366051.

Open Versus Minimally Invasive Radical Hysterectomy in Cervical Cancer: The CIRCOL Group Study.

PURPOSE: To analyze the survival outcomes of patients in a Brazilian cohort who underwent minimally invasive surgery (MIS) compared with open surgery for early stage cervical cancer. METHODS: A multicenter database was constructed, registering 1280 cervical cancer patients who had undergone radical hysterectomy from 2000 to 2019. For the final analysis, we included cases with a tumor ≤ 4 cm (stages Ia2 to Ib2, FIGO 2018) that underwent surgery from January 2007 to December 2017. Propensity score matching was also performed. RESULTS: A total of 776 cases were ultimately analyzed, 526 of which were included in the propensity score matching analysis (open, n = 263; MIS, n = 263). There were 52 recurrences (9.9%), 28 (10.6%) with MIS and 24 (9.1%) with open surgery (p = 0.55); and 34 deaths were recorded, 13 (4.9%) and 21 (8.0%), respectively (p = 0.15). We noted a 3-year disease-free survival (DFS) rate of 88.2% and 90.3% for those who received MIS and open surgery, respectively (HR 1.32; 95% CI: 0.76-2.29; p = 0.31) and a 5-year overall survival (OS) rate of 91.8% and 91.1%, respectively (HR 0.80; 95% CI: 0.40-1.61; p = 0.53). There was no difference in 3-year DFS rates between open surgery and MIS for tumors ≤ 2 cm (95.7% vs. 90.8%; p = 0.16) or > 2 cm (83.9% vs. 85.4%; p = 0.77). Also, the 5-year OS between open surgery and MIS did not differ for tumors ≤ 2 cm (93.1% vs. 93.6%; p = 0.82) or > 2 cm (88.9% vs. 89.8%; p = 0.35). CONCLUSIONS: Survival outcomes were similar between minimally invasive and open radical hysterectomy in this large retrospective multicenter cohort.

Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.

BACKGROUND: Minimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer. OBJECTIVE: We aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy. STUDY DESIGN: This was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005-2017 at 18 centers in 12 countries. Eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 patients were entered into the study database. However, 69 patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental. RESULTS: Of 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20-42) years for open surgery vs 31 (18-45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0-31) mm for open surgery and 12 (0.8-40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20-16.70) years for open surgery and 3.1 years (0.02-11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.7%) with open surgery and 18 of 288 patients (6.2%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6-97.0) for open surgery and 91.5% (95% confidence interval, 87.6-95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6-99.7) for open surgery and 99.0% (95% confidence interval, 79.0-99.8) for minimally invasive surgery. CONCLUSION: The 4.5-year disease-free survival rates did not differ between open radical trachelectomy and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.

Impact of the COVID-19 Pandemic on Cancer Researchers in 2020: A Qualitative Study of Events to Inform Mitigation Strategies.

Introduction: The COVID-19 pandemic has had an unprecedented impact on global health systems and economies. With ongoing and future challenges posed to the field due to the pandemic, re-examining research priorities has emerged as a concern. As part of a wider project aiming to examine research priorities, here we aimed to qualitatively examine the documented impacts of the COVID-19 pandemic on cancer researchers. Materials and Methods: We conducted a literature review with the aim of identifying non-peer-reviewed journalistic sources and institutional blog posts which qualitatively documented the effects of the COVID-19 pandemic on cancer researchers. We searched on 12th January 2021 using the LexisNexis database and Google, using terms and filters to identify English-language media reports and blogs, containing references to both COVID-19 and cancer research. The targeted search returned 751 results, of which 215 articles met the inclusion criteria. These 215 articles were subjected to a conventional qualitative content analysis, to document the impacts of the pandemic on the field of cancer research. Results: Our analysis yielded a high plurality of qualitatively documented impacts, from which seven categories of direct impacts emerged: (1) COVID measures halting cancer research activity entirely; (2) COVID measures limiting cancer research activity; (3) forced adaptation of research protocols; (4) impacts on cancer diagnosis, cases, and services; (5) availability of resources for cancer research; (6) disruption to the private sector; and (7) disruption to supply chains. Three categories of consequences from these impacts also emerged: (1) potential changes to future research practice; (2) delays to the progression of the field; and (3) potential new areas of research interest. Discussion: The COVID-19 pandemic had extensive practical and economic effects on the field of cancer research in 2020 that were highly plural in nature. Appraisal of cancer research strategies in a post-COVID world should acknowledge the potential for substantial limitations (such as on financial resources, limited access to patients for research, decreased patient access to cancer care, staffing issues, administrative delays, or supply chain issues), exacerbated cancer disparities, advances in digital health, and new areas of research related to the intersection of cancer and COVID-19.

ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer.

OBJECTIVE: The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer. METHODS: From April 2010 to March 2019, a prospective, single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2-IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size <2 cm; (4) no lymphovascular space invasion; (5) depth of invasion <10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an 'inadvertent' simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the above inclusion criteria and underwent a second surgery with pelvic lymph node dissection only. RESULTS: 100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23-67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectomy specimen was noted in 1/40 patients-that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0-68.3). Three patients developed recurrent disease within 2 years of surgery-that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%). DISCUSSION: Our prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.

Uterine transposition for gynecological cancers.

OBJECTIVE: Uterine transposition has emerged as an alternative for fertility preservation in women with pelvic malignancies that require radiotherapy. The goal of this study was to evaluate the short-term outcomes of patients undergoing uterine transposition after trachelectomy for cervical cancer or before chemoradiation for vaginal cancer. METHODS: We retrospectively evaluated patients with early stage cervical cancer after radical trachelectomy or with vaginal cancer with indication for pelvic radiation who had uterine transposition performed as fertility sparing strategy. RESULTS: Four patients with cervical cancer and one patient with vaginal cancer were included. Median age was 32 years (range 28-38). All patients had squamous cell carcinomas. All patients with cervical cancer had radical trachelectomies with sentinel lymph node dissection (SLN). Two of these patients also had pelvic lymphadenectomies. Indications for adjuvant radiotherapy was due to Sedlis criteria in two patients and to lymph node metastasis in the other two patients. The patient with stage IIB vaginal cancer was recommended primary chemoradiation. All patients underwent uterine transposition before radiotherapy. The median uterine transposition surgical time was 90 min (range 80-205) and no early complications (30 days) occurred. Average time from uterine transposition to start of radiotherapy was 16 days (10-28). After radiation, the uterus along with the ovaries and tubes were repositioned and the residual cervix sutured to the vagina. One patient declined uterine reimplantation after radiation and underwent a hysterectomy. After a median follow-up of 25 months (range 1-30), all patients were without evidence of disease. All patients with preserved uterus have normal menses after treatment. One patient has attempted to conceive with IVF techniques without success. CONCLUSIONS: Uterine transposition may be an option in selected patients with cervical and vaginal cancers who want to preserve fertility. However, further studies that address its oncological safety and obstetrical outcomes are encouraged.

Stepwise Laparoscopic Myomectomy and the Baseball Closure.

STUDY OBJECTIVE: To demonstrate the importance of planning all the steps of laparoscopic myomectomy, including incision, techniques to reduce blood loss, and suturing. DESIGN: Step-by-step video demonstration of the technique, with narration in the background. The video was approved by the local institutional review board. SETTING: Live surgery at Hospital PIO XII, Institute for Research into Cancer of the Digestive System and American Institute of Telesurgery, Barretos. INTERVENTIONS: We describe a case of a 33-year-old woman with no pregnancy and diagnosed with endometriosis and chronic pelvic pain associated with a 5-cm posterior transmural myoma. We performed a laparoscopic myomectomy, with temporary clipping of the uterine arteries associated with the treatment of endometriosis lesions. Specimen extraction was performed inside a bag [1]. The patient was discharged the next day with no complications. Ten months after the procedure, the patient reported that there was no pain, and that her menses were normal. CONCLUSION: The laparoscopic approach remains the gold standard for myomectomy [2]. Planning the steps before execution is fundamentally important to ensure the security of the procedure. A seromuscularis baseball suture associated with figure-of-8 knotting with an H3H2 sequence at the internal layers seems to be an adequate technique for myometrium closure [3]. Choosing the correct angle for the incision, clipping the uterine artery, and developing the suture in 2 layers results in less bleeding, reduced operating time, decrease in hospital length of stay, and fewer complications.

Surgical versus clinical staging prior to primary chemoradiation in patients with cervical cancer FIGO stages IIB-IVA: oncologic results of a prospective randomized international multicenter (Uterus-11) intergroup study.

OBJECTIVE: Revised staging of patients with locally advanced cervical cancer is based on clinical examination, imaging, and potential surgical findings. A known limitation of imaging techniques is an appreciable rate of understaging. In contrast, surgical staging may provide more accurate information on lymph node involvement. The aim of this prospective study was to evaluate the impact of pre-treatment surgical staging, including removal of bulky lymph nodes, on disease-free survival in patients with locally advanced cervical cancer. METHODS: Uterus-11 was a prospective international multicenter study including patients with locally advanced cervical cancer who were randomized 1:1 to surgical staging (experimental arm) or clinical staging (control arm) followed by primary platinum-based chemoradiation. Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIB-IVA underwent gynecologic examination and pre-treatment imaging including abdominal computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI). Patients had chest imaging (any of the following: X-ray, CT, or PET-CT). The primary endpoint was disease-free survival and the secondary endpoint was overall survival. An ad hoc analysis was performed after trial completion for cancer-specific survival. Randomization was conducted from February 2009 to August 2013. RESULTS: A total of 255 patients (surgical arm, n=130; clinical arm, n=125) with locally advanced cervical cancer were randomized. Of these, 240 patients were eligible for analysis. The two groups were comparable with respect to patient characteristics. The surgical approach was transperitoneal laparoscopy in most patients (96.6%). Laparoscopic staging led to upstaging in 39 of 120 (33%) patients. After a median follow-up of 90 months (range 1-123) in both arms, there was no difference in disease-free survival between the groups (p=0.084). For patients with FIGO stage IIB, surgical staging is superior to clinical staging with respect to disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011). In the post-hoc analysis, surgical staging was associated with better cancer-specific survival (HR 0.61, 95% CI 0.40 to 0.93, p=0.020). CONCLUSION: Our study did not show a difference in disease-free survival between surgical and clinical staging in patients with locally advanced cervical cancer. There was a significant benefit in disease-free survival for patients with FIGO stage IIB and, in a post-hoc analysis, a cancer-specific survival benefit in favor of laparoscopic staging. The high risk of distant metastases in both arms emphasizes the need for further evaluation.

Early removal of indwelling urinary catheter after radical surgery for early-stage cervical cancer-A cohort study.

OBJECTIVE: To evaluate the difference between early and delayed removal of indwelling urinary catheter after radical hysterectomy (RH) or radical trachelectomy (RT). METHODS: An ambispective study was conducted in early-stage cervical cancer patients who underwent RH or RT. Delayed indwelling urinary catheter removal occurred on a postoperative day (POD) 7 in the retrospective group (January 2012-November 2013), and early removal occurred on POD 1 in the prospective group (May 2014-June 2017). The postvoid residual (PVR) test was performed after indwelling catheter removal in both groups. RESULTS: Our sample included 47 patients in the delayed group and 48 in the early one. There was no difference in age, body mass index, tumor size, histology, stage, surgical approach, and intraoperative and postoperative complications. Indwelling urinary catheter reinsertion was needed in 16 (34%) patients in the delayed group and 12 (25%) in the early group (P = .37), with no statistical difference between the median PVR volumes -82.5 and 45 mL (P = .06), respectively. Seven (14.9%) patients in the delayed group presented with 30-day urinary tract infection vs two (4.2%) in the early group (P = .09). CONCLUSIONS: Early indwelling urinary catheter removal, in regard to the rate of catheter reinsertion and PVR volume, does not differ from delayed removal.