Background The optimal follow-up strategy to detect recurrence after fertility-sparing surgery for early stage cervical cancer is unknown. Tailored surveillance based on individual risks could... Show moreBackground The optimal follow-up strategy to detect recurrence after fertility-sparing surgery for early stage cervical cancer is unknown. Tailored surveillance based on individual risks could contribute to improved efficiency and, subsequently, reduce costs in health care. The aim of this study was to establish the predictive value of cervical cytology and high-risk human papillomavirus (HPV) testing to detect recurrent cervical intraepithelial neoplasia grade 2 or worse (CIN2+; including recurrent cervical cancer) after fertility-sparing surgery.Methods In this nationwide, population-based, retrospective cohort study, we used data from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Databank. All patients aged 18-40 years with cervical cancer of any histology who received fertility-sparing surgery (ie, large loop excision of the transformation zone, conisation, or trachelectomy) between Jan 1, 2000, and Dec 31, 2020, were included. Pathology data from diagnosis, treatment, and during follow-up were analysed. The primary and secondary outcomes were the cumulative incidence of recurrent CIN2+ and recurrence-free survival, overall and stratified by results for cytology and high-risk HPV.Findings 1548 patients were identified, of whom 1462 met the inclusion criteria. Of these included patients, 19 568 pathology reports were available. The median age at diagnosis was 31 years (IQR 30-35). After a median follow-up of 6.1 years (IQR 3.3-10.8), recurrent CIN2+ was diagnosed in 128 patients (cumulative incidence 15.0%, 95% CI 11.5-18.2), including 52 patients (cumulative incidence 5.4%, 95% CI 3.7-7.0) with recurrent cervical cancer. The overall 10-year recurrence-free survival for CIN2+ was 89.3% (95% CI 87.4-91.3). By cytology at first follow-up visit within 12 months after fertility-sparing surgery, 10-year recurrence-free survival for CIN2+ was 92.1% (90.2-94.1) in patients with normal cytology, 84.6% (77.4-92.3) in those with low-grade cytology, and 43.1% (26.4-70.2) in those with high-grade cytology. By high-risk HPV status at first follow-up visit within 12 months after surgery, 10-year recurrence-free survival for CIN2+ was 91.1% (85.3-97.3) in patients who were negative for high-risk HPV and 73.6% (58.4-92.8) in those who were positive for high-risk HPV. Cumulative incidence of recurrent CIN2+ within 6 months after any follow-up visit (6-24 months) in patients negative for high-risk HPV with normal or low-grade cytology was 0.0-0.7% and with highgrade cytology was 0.0-33.3%. Cumulative incidence of recurrence in patients positive for high-risk HPV with normal or low-grade cytology were 0.0-15.4% and with high-grade cytology were 50.0-100.0%. None of the patients who were negative for high-risk HPV without high-grade cytology, at 6 months and 12 months, developed recurrence.Interpretation Patients who are negative for high-risk HPV with normal or low-grade cytology at 6-24 months after fertility-sparing surgery, could be offered a prolonged follow-up interval of 6 months. This group comprises 80% of all patients receiving fertility-sparing surgery. An interval of 12 months seems to be safe after two consecutive negative tests for high-risk HPV with an absence of high-grade cytology, which accounts for nearly 75% of all patients who receive fertility-sparing surgery. Copyright (c) 2023 Elsevier Ltd. All rights reserved. Show less
Nakisige, C.; Fouw, M. de; Kabukye, J.; Sultanov, M.; Nazrui, N.; Rahman, A.; ... ; Beltman, J.J. 2023
Introduction Visual inspection with acetic acid is limited by subjectivity and a lack of skilled human resource. A decision support system based on artificial intelligence could address these... Show moreIntroduction Visual inspection with acetic acid is limited by subjectivity and a lack of skilled human resource. A decision support system based on artificial intelligence could address these limitations. We conducted a diagnostic study to assess the diagnostic performance using visual inspection with acetic acid under magnification of healthcare workers, experts, and an artificial intelligence algorithm. Methods A total of 22 healthcare workers, 9 gynecologists/experts in visual inspection with acetic acid, and the algorithm assessed a set of 83 images from existing datasets with expert consensus as the reference. Their diagnostic performance was determined by analyzing sensitivity, specificity, and area under the curve, and intraand inter-observer agreement was measured using Fleiss kappa values. Results Sensitivity, specificity, and area under the curve were, respectively, 80.4%, 80.5%, and 0.80 (95% CI 0.70 to 0.90) for the healthcare workers, 81.6%, 93.5%, and 0.93 (95% CI 0.87 to 1.00) for the experts, and 80.0%, 83.3%, and 0.84 (95% CI 0.75 to 0.93) for the algorithm. Kappa values for the healthcare workers, experts, and algorithm were 0.45, 0.68, and 0.63, respectively. Conclusion This study enabled simultaneous assessment and demonstrated that expert consensus can be an alternative to histopathology to establish a reference standard for further training of healthcare workers and the artificial intelligence algorithm to improve diagnostic accuracy. Show less
Introduction: In early-stage vulvar squamous cell carcinoma (VSCC) a sentinel lymph node (SLN) procedure is regarded successful if at least one SLN is removed with minimal residual radioactivity.... Show moreIntroduction: In early-stage vulvar squamous cell carcinoma (VSCC) a sentinel lymph node (SLN) procedure is regarded successful if at least one SLN is removed with minimal residual radioactivity. An inguinofemoral lymphadenectomy is considered if not all SLNs visualized on lymphoscintigraphy can be found, with subsequent increased morbidity. We correlated lymphoscintigraphy findings with surgical outcome and groin recurrence with focus on number of SLNs found. Methods: This study concerns a retrospective cohort of 171 women treated for early-stage VSCC who underwent a SLN procedure between 2000 and 2020. The risk of groin recurrence was compared after either a successful or complete SLN procedure, i.e. removal of all SLNs that were visualized on lymphoscintigraphy. Results: In 13 (7.6%) groins of 171 patients SLN visualization on lymphoscintigraphy failed. In 230 of the 246 (93.5%) groins in which a SLN was visualized, at least one SLN was found during surgery. In 224 of the 246 (91.1%) groins the SLN procedure was regarded either successful (n = 14) or complete (n = 210). An isolated groin recurrence was documented in 5 out of 192 (2.6%, 95%-CI; 0.34 to 4.9) SLN-negative groins after a median follow-up of 47.0 months. All recurrences were noted in the complete SLN group (5/180 groins). The difference with the successful SLN group (0/12 groins) was not significant. Conclusion: Risk of groin recurrence was 2.6% after SLN negative biopsy in early-stage VSCC. The risk appeared not increased if at least one SLN was found with minimal residual radioactivity, in case more SLNs were visualized on lymphoscintigraphy. Show less
Fouw, M. de; Stroeken, Y.; Niwagaba, B.; Musheshe, M.; Tusiime, J.; Sadayo, I.; ... ; Beltman, J.J. 2023
IntroductionEvidence-based preventive strategies for cervical cancer in low-resource setting have been developed, but implementation is challenged, and uptake remains low. Women and girls... Show moreIntroductionEvidence-based preventive strategies for cervical cancer in low-resource setting have been developed, but implementation is challenged, and uptake remains low. Women and girls experience social and economic barriers to attend screening and human papillomavirus (HPV) vaccination programs. Male support has been proven successful in uptake of other reproductive healthcare services. This qualitative study with focus groups aimed to understand the perspectives of males on cervical cancer screening and HPV vaccination in Western-Uganda This knowledge could be integrated into awareness activities to increase the attendance of cervical cancer screening and HPV vaccination programs.Materials and methods Focus group discussions were conducted with men aged 25 to 60 years, who were married and/or had daughters, in Kagadi district, Mid-Western Uganda. All interviews were transcribed verbatim and thematically analyzed using an inductive approach.Results Eleven focus group discussions were conducted with 67 men. Men were willing to support their wives for screening and their daughters for HPV vaccination. Misperceptions such as family planning and poor personal hygiene leading to cervical cancer, and misperception of the preventative aspect of screening and vaccination were common. Women with cervical cancer suffer from stigmatization and family problems due to loss of fertility, less marital sexual activity, domestic violence and decreased economic productivity.Conclusions Ugandan men were willing to support cervical cancer prevention for their wives and daughters after being informed about cervical cancer. Limited knowledge among men about the risk factors and causes of cervical cancer, and about the preventative aspect of HPV vaccination and screening and their respective target groups, can limit uptake of both services. Screening and vaccination programs should actively involve men in creating awareness to increase uptake and acceptance of prevention. Show less
Sultanov, M.; Zeeuw, J. de; Koot, J.; Schans, J. van der; Beltman, J.J.; Fouw, M. de; ... ; Stekelenburg, J. 2022
Background: High-risk human papillomavirus (hrHPV) testing has been recommended by the World Health Organization as the primary screening test in cervical screening programs. The option of self... Show moreBackground: High-risk human papillomavirus (hrHPV) testing has been recommended by the World Health Organization as the primary screening test in cervical screening programs. The option of self-sampling for this screening method can potentially increase women's participation. Designing screening programs to implement this method among underscreened populations will require contextualized evidence. Methods: PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC) will use a multi-method approach to investigate the feasibility of implementing a cervical cancer screening strategy with hrHPV self-testing as the primary screening test in Bangladesh, India, Slovak Republic and Uganda. The primary outcomes of study include uptake and coverage of the screening program and adherence to follow-up. These outcomes will be evaluated through a pre-post quasi-experimental study design. Secondary objectives of the study include the analysis of client-related factors and health system factors related to cervical cancer screening, a validation study of an artificial intelligence decision support system and an economic evaluation of the screening strategy. Discussion: PRESCRIP-TEC aims to provide evidence regarding hrHPV self-testing and the World Health Organization's recommendations for cervical cancer screening in a variety of settings, targeting vulnerable groups. The main quantitative findings of the project related to the impact on uptake and coverage of screening will be complemented by qualitative analyses of various determinants of successful implementation of screening. The study Continued from previous page) will also provide decision-makers with insights into economic aspects of implementing hrHPV self-testing , as well as evaluate the feasibility of using artificial intelligence for task-shifting in visual inspection with acetic acid. Show less
Objective: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases... Show moreObjective: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate. Patients and Methods: 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL). Results: Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly. Conclusions: Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. Show less
Olthof, E.P.; Wenzel, H.; Velden, J. van der; Spijkerboer, A.M.; Bekkers, R.; Beltman, J.J.; ... ; Mom, C. 2022
Objective Treatment strategies for bulky lymph nodes in patients with locally advanced cervical cancer scheduled for definitive chemoradiation include nodal boosting with radiotherapy, surgical... Show moreObjective Treatment strategies for bulky lymph nodes in patients with locally advanced cervical cancer scheduled for definitive chemoradiation include nodal boosting with radiotherapy, surgical debulking, or both. The aim of this retrospective cohort study was to compare survival and toxicity in patients receiving these treatments and to compare them with a group that received neither form of treatment. Methods Women diagnosed between January 2009 and January 2017 with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2, IIA2-IVA cervical cancer with lymph nodes >= 1.5 cm without upper limit on pretreatment imaging and treated with definitive chemoradiation were selected from the Netherlands Cancer Registry. Patients were categorized by intention-to-treat strategy: boosting, debulking, or neither treatment, with subgroup analysis for patients receiving both treatments, that is, debulking with boosting. Overall and relapse-free survival outcomes were compared by Kaplan-Meier and Cox regression analyses and toxicity by logistic regression analysis. Results Of 190 patients, 101 (53%) received only nodal boosting, 31 (16%) debulking alone, 29 (15%) debulking combined with boosting, and 29 (15%) received neither treatment. The 5 year overall and relapse-free survival for the treatment groups were 58%, 45% and 45% (p=0.19), and 47%, 44% and 46% (p=0.87), respectively. Multivariable Cox regression analyses demonstrated no differences in overall and relapse-free survival. Combination of debulking with boosting was associated with decreased overall and relapse-free survival compared with debulking alone (HR 2.47, 95% CI 1.22 to 5.00; and HR 2.37, 95% CI 1.14 to 4.93). Nodal boosting was independently associated with a decreased toxicity risk compared with debulking strategy (OR 0.37, 95% CI 0.16 to 0.83). Conclusions This study showed no survival benefit from either nodal boosting or debulking strategy in patients with suspicious bulky nodes. Nodal boosting might, however, be associated with less toxicity. Dual treatment with debulking and boosting showed a worse survival outcome because this group probably represents patients with poor prognostic factors. Show less
Objective To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics ... Show moreObjective To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). Methods A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width <= 0.2 standard deviations of the logit odds of the estimated propensity score. Results We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). Conclusions In this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death. Show less
Laven, P.; Beltman, J.J.; Bense, J.E.; Aa, M.A. van der; Gorp, T. van; Vos, M.C.; ... ; Kruitwagen, R.F.P.M. 2021
Background: Incomplete surgical staging of patients with early-stage epithelial ovarian cancer (EOC) has been reported in up to 98% of cases, when based on the International Federation of... Show moreBackground: Incomplete surgical staging of patients with early-stage epithelial ovarian cancer (EOC) has been reported in up to 98% of cases, when based on the International Federation of Obstetrics and Gynecology (FIGO) staging procedure. The aim of the present retrospective study was to clarify the reasons for incomplete staging.Methods: The PRISMA (Prevention Recovery Information System for Monitoring and Analysis) technique was used to evaluate cases with FIGO I-IIa EOC based on incomplete staging from five gynecologic oncologic center hospitals in the Netherlands in the period 2010-2014.Results: Fifty cases with an incomplete surgical staging of EOC according to national guidelines were included. The most common reasons for incomplete staging were insufficient random biopsies of the peritoneum (n = 34, 68%), and less than ten lymph nodes being resected and/or found at pathology (n = 16, 32%). The most mentioned reason for not performing biopsies was, besides forgetting to do so, believing that after careful inspection and palpation, taking biopsies is irrelevant and/or already are being taken while performing a hysterectomy (peritoneum of cul-de-sac, bladder). The value of contralateral pelvic lymph node dissection in case of a unilateral ovarian malignancy was also doubted, influencing the number of lymph nodes resected.Conclusions: The most important reasons for incomplete staging in EOC are, besides omitting elements by accident, questioning the importance of obligatory elements of the staging procedure. A structured list of staging steps during surgery and more evidence-based consensus concerning these obligatory elements might increase the number of complete staging procedures in EOC. (C) 2021 Published by Elsevier Inc. Show less
Introduction Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. Objective To evaluate baseline characteristics of women with early cervical cancer and to... Show moreIntroduction Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. Objective To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. Methods The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. Results The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m(2) (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0-84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation. Conclusions In this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations. Show less
Kaba, M.; Fouw, M. de; Deribe, K.S.; Abathun, E.; Peters, A.A.W.; Beltman, J.J. 2021
AbstractIntroductionIn Ethiopia there is an extensive unmet need for palliative care, while the burden of non-communicable diseases and cancer is increasing. This study aimed to explore palliative... Show moreAbstractIntroductionIn Ethiopia there is an extensive unmet need for palliative care, while the burden of non-communicable diseases and cancer is increasing. This study aimed to explore palliative care needs and preferences of patients, their caregivers, and the perspective of stakeholders on service provision in palliative programs for women, mostly affected by cervical cancer and breast cancer.MethodsA rapid program evaluation using a qualitative study approach was conducted in three home-based palliative care programs in Addis Ababa and Yirgalem town, Ethiopia. Female patients enrolled in the programs, and their primary caregivers were interviewed on palliative care needs, preferences and service provision. We explored the views of purposely selected stakeholders on the organization of palliative care and its challenges. Audio-taped data was transcribed verbatim and translated into English and an inductive thematic analysis was applied. Descriptive analyses were used to label physical signs and symptoms using palliative outcome scale score.ResultsA total of 77 interviews (34 patients, 12 primary caregivers, 15 voluntary caregivers, 16 stakeholders) were conducted. The main physical complaints were moderate to severe pain (70.6%), followed by anorexia (50.0%), insomnia, nausea and vomiting (41.2%). Social interaction and daily activities were hampered by the patients’ condition. Both patients and caregivers reported that programs focus most on treatment of symptoms, with limited psychosocial, emotional, spiritual and economic support. Lack of organizational structures and policy directions limit the collaboration between stakeholders and the availability of holistic home-based palliative care services.ConclusionsAlthough female patients and caregivers appreciated the palliative care and support provided, the existing services did not cover all needs. Pain management and all other needed supports were lacking. Multi-sectorial collaboration with active involvement of community-based structures is needed to improve quality of care and access to holistic palliative care services. Show less
Kaba, M.; Fouw, M. de; Deribe, K.S.; Abathun, E.; Peters, A.A.W.; Beltman, J.J. 2021
IntroductionIn Ethiopia there is an extensive unmet need for palliative care, while the burden of non-communicable diseases and cancer is increasing. This study aimed to explore palliative care... Show moreIntroductionIn Ethiopia there is an extensive unmet need for palliative care, while the burden of non-communicable diseases and cancer is increasing. This study aimed to explore palliative care needs and preferences of patients, their caregivers, and the perspective of stakeholders on service provision in palliative programs for women, mostly affected by cervical cancer and breast cancer.MethodsA rapid program evaluation using a qualitative study approach was conducted in three home-based palliative care programs in Addis Ababa and Yirgalem town, Ethiopia. Female patients enrolled in the programs, and their primary caregivers were interviewed on palliative care needs, preferences and service provision. We explored the views of purposely selected stakeholders on the organization of palliative care and its challenges. Audio-taped data was transcribed verbatim and translated into English and an inductive thematic analysis was applied. Descriptive analyses were used to label physical signs and symptoms using palliative outcome scale score.ResultsA total of 77 interviews (34 patients, 12 primary caregivers, 15 voluntary caregivers, 16 stakeholders) were conducted. The main physical complaints were moderate to severe pain (70.6%), followed by anorexia (50.0%), insomnia, nausea and vomiting (41.2%). Social interaction and daily activities were hampered by the patients' condition. Both patients and caregivers reported that programs focus most on treatment of symptoms, with limited psychosocial, emotional, spiritual and economic support. Lack of organizational structures and policy directions limit the collaboration between stakeholders and the availability of holistic home-based palliative care services.ConclusionsAlthough female patients and caregivers appreciated the palliative care and support provided, the existing services did not cover all needs. Pain management and all other needed supports were lacking. Multi-sectorial collaboration with active involvement of community-based structures is needed to improve quality of care and access to holistic palliative care services. Show less
Objective. The aim of this study was to assess the superiority of ICG-Tc-99m-nanocolloid for the intraoperative visual detection of sentinel lymph nodes (SLNs) in vulvar squamous cell carcinoma ... Show moreObjective. The aim of this study was to assess the superiority of ICG-Tc-99m-nanocolloid for the intraoperative visual detection of sentinel lymph nodes (SLNs) in vulvar squamous cell carcinoma (VSCC) patients compared to standard SLN detection using Tc-99m-nanocolloid with blue dye.Methods. In this multicenter, randomized controlled trial, VSCC patients underwent either the standard SLN procedure or with the hybrid tracer ICG-Tc-99m-nanocolloid. The primary endpoint was the percentage of fluorescent SLNs compared to blue SLNs. Secondary endpoints were successful SLN procedures, surgical outcomes and postoperative complications.Results. Forty-eight patients were randomized to the standard (n = 24) or fluorescence imaging group (n = 24) using ICG-Tc-99m-nanocolloid. The percentage of blue SLNs was 65.3% compared to 92.5% fluorescent SLNs (p < 0.001). A successful SLN procedure was obtained in 92.1% of the groins in the standard group and 97.2% of the groins in the fluorescence imaging group (p = 0.33). Groups did not differ in surgical outcome, although more short-term postoperative complications were documented in the standard group (p = 0.041).Conclusions. Intraoperative visual detection of SLNs in patients with VSCC using ICG-Tc-99m-nanocolloid was superior compared to Tc-99m-nanocolloid and blue dye. The rate of successful SLN procedures between both groups was not significantly different. Fluorescence imaging has potential to be used routinely in the SLN procedure in VSCC patients to facilitate the search by direct visualization. Clinical Trial Registration: Netherlands Trial Register (Trial ID NL7443). (C) 2020 The Author(s). Published by Elsevier Inc. Show less
ObjectiveThe aim of this study was to assess the impact of the evolving role of the addition of chemotherapy to postoperative radiotherapy on oncological outcomes and toxicity in patients with... Show moreObjectiveThe aim of this study was to assess the impact of the evolving role of the addition of chemotherapy to postoperative radiotherapy on oncological outcomes and toxicity in patients with early-stage cervical cancer after radical hysterectomy.MethodsRetrospective cohort study of patients with stage IB1-IIB FIGO 2009 cervical cancer treated from November 1999 to May 2015 by primary surgery and radiotherapy (46-50.4 Gy in 1.8-2.0 Gy fractions) with or without concurrent cisplatin (40 mg/m(2), 5-6 weekly cycles) with or without a brachytherapy boost. Chemotherapy was allocated depending on the risk factors for recurrence. Incidences of all outcomes were calculated using Kaplan-Meier's methodology and compared by log-rank tests. Risk factors for recurrence and survival were identified using Cox's proportional hazards models.ResultsA total of 154 patients were included, median follow-up was 9.6 years (IQR: 6.1-12.8). Five-year pelvic recurrence-free survival was 75.3%; 74.7% in patients with high-risk factors treated with radiotherapy; and 77.3% in those treated with chemoradiation (P=0.43). Distant metastasis-free survival at 5 years was 63.4%; 63.6% in high-risk patients after radiotherapy; and 57.1% after chemoradiation (P=0.36). Five-year overall survival was 63.9%: 66.8% and 51.6% after radiotherapy and after chemoradiation in patients with high-risk factors (P=0.37), respectively. Large tumor size was a risk factor for vaginal and pelvic recurrence, >= 2 involved lymph nodes was a significant risk factor for para-aortic recurrence and death. Mild treatment-related late toxicity was observed in 53.9% of the patients. Five-year severe (grade 3-5) late rectal, bladder, bowel, and vaginal toxicities were, respectively, 1.3%, 0%, 3.4%, and 0.9%. Any late severe toxicity was observed in 5.5% of patients treated with radiotherapy and in 15.3% of those treated with chemoradiation (P=0.07).ConclusionPostoperative (chemo)radiation for early-stage cervical cancer patients with risk factors for recurrence yields adequate pelvic tumor control, but overall survival is limited due to distant metastasis. Show less
Background Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter... Show moreBackground Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. Methods We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. Results Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m(2)(range; 15-49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07; 95% CI, 1.35 to 3.15; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76; 95% CI, 1.75 to 4.33; P<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective vaginal closure had similar rates of relapse to those who underwent open surgery (HR, 0.63; 95% CI, 0.15 to 2.59; P<0.52). Conclusions Minimally invasive surgery in cervical cancer increased the risk of relapse and death compared with open surgery. In this study, avoiding the uterine manipulator and using maneuvers to avoid tumor spread at the time of colpotomy in minimally invasive surgery was associated with similar outcomes to open surgery. Further prospective studies are warranted. Show less
Both cryotherapy and thermal ablation are treatment methods for cervical precancerous lesions in screening programs in resource constrained settings. However, for thermal ablation the World Health... Show moreBoth cryotherapy and thermal ablation are treatment methods for cervical precancerous lesions in screening programs in resource constrained settings. However, for thermal ablation the World Health Organization stated that there is insufficient data to define a standard treatment protocol. This study used an ex-vivo model to compare the tissue interaction of both cryotherapy and thermal ablation to contribute to a treatment protocol. We used porcine tissue to measure the temperature profile over time at 0, 2, 4 and 6 mm depth. For cryotherapy the standard double freeze method was used, thermal ablation was applied for one cycle of 60 s with 100 degrees C. Based on literature search we used 4 mm depth as landmark for the depth of precancerous lesions, and -10 degrees C for cryotherapy and 46 degrees C for thermal ablation as critical temperature to induce cell necrosis. Cryotherapy achieved the critical temperature for tissue necrosis (-10 degrees C) in 3 out of 6 experiments at 4 mm depth, median minimum temperature was -9.6 degrees C (IQR 25-75 -15.8 degrees C to -4.9 degrees C). Thermal ablation achieved the critical temperature for tissue necrosis (46 degrees C) in 3 out of 7 experiments at 4 mm depth, median maximum temperature was 43.1 degrees C (IQR 25-75 42.3 degrees C to 49.9 degrees C). Both treatment modalities achieved tissue necrosis at 4 mm depth in our ex-vivo model. For cryotherapy the double freeze technique should be used. For thermal ablation a single application less than 60 s might not be sufficient and multiple applications should be considered. Show less
Wenzel, H.H.B.; Smolders, R.G.V.; Beltman, J.J.; Lambrechts, S.; Trum, H.W.; Yigit, R.; ... ; Aa, M.A. van der 2020
Aim: Recently, the safety of laparoscopic radical hysterectomy (LRH) has been called into question in early-stage cervical cancer. This study aimed to evaluate overall survival (OS) and disease... Show moreAim: Recently, the safety of laparoscopic radical hysterectomy (LRH) has been called into question in early-stage cervical cancer. This study aimed to evaluate overall survival (OS) and disease-free survival (DFS) in patients treated with abdominal radical hysterectomy (ARH) and LRH for early-stage cervical cancer and to provide a literature review.Methods: Patients diagnosed between 2010 and 2017 with International Federation of Gynaecology and Obstetrics (2009) stage IA2 with lymphovascular space invasion, IB1 and IIA1, were identified from the Netherlands Cancer Registry. Cox regression with propensity score, based on inverse probability treatment weighting, was applied to examine the effect of surgical approach on 5-year survival and calculate hazard ratios (HR) and 95% confidence intervals (CIs). Literature review included observational studies with (i) analysis on tumours <4 cm (ii) median follow-up >= 30 months (iii) >= 5 events per predictor parameter in multivariable analysis or a propensity score.Results: Of the 1109 patients, LRH was performed in 33%. Higher mortality (9.4% vs. 4.6%) and recurrence (13.1% vs. 7.3%) were observed in ARH than LRH. However, adjusted analyses showed similar DFS (89.4% vs. 90.2%), HR 0.92 [95% CI: 0.52-1.60]) and OS (95.2% vs. 95.5%), HR 0.94 [95% CI: 0.43-2.04]). Analyses on tumour size (<2/>2 cm) also gave similar survival rates. Review of nine studies showed no distinct advantage of ARH, especially in tumours <2 cm.Conclusion: After adjustment, our retrospective study showed equal oncological outcomes between ARH and LRH for early-stage cervical cancer - also in tumours <2 cm. This is in correspondence with results from our literature review. (C) 2020 The Authors. Published by Elsevier Ltd. Show less
Tesfai, F.M.; Kroep, J.R.; Gaarenstroom, K.; Kroon, C. de; Loenhout, R. van; Smit, V.; ... ; Beltman, J.J. 2020
Objective To assess the feasibility, safety, oncological, and obstetric outcomes in patients with cervical tumors >2 cm treated with neoadjuvant chemotherapy in preparation for abdominal radical... Show moreObjective To assess the feasibility, safety, oncological, and obstetric outcomes in patients with cervical tumors >2 cm treated with neoadjuvant chemotherapy in preparation for abdominal radical trachelectomy. Methods A retrospective analysis of patients with cervical cancer >2 cm (up to 6 cm) was conducted in patients who were selected to receive neoadjuvant chemotherapy before abdominal radical trachelectomy. Surgical and clinical outcomes were examined in relation to radiological and pathological results. In addition, obstetric outcomes were described. The Mann-Whitney U test and Fisher's exact test were performed to compare radiological findings between successful and unsuccessful abdominal radical trachelectomy procedures. International Federation of Gynecology and Obstetrics (FIGO) 2009 staging classification was used for this study. Results A total of 19 women were treated with neoadjuvant chemotherapy for cervical tumors >2 cm at our institution between May 2006 and July 2018. The median age was 28 years (range 19-36). The distribution of FIGO stages was seven patients stage IB1 (37%), 10 patients stage IB2 (53%), and two patients (10%) stage IIA. Mean clinical tumor size was 4.4 cm (range 3.5-6.0). Histology revealed 74% cases of squamous cell carcinoma. The remaining patients had adenocarcinoma (21%) and only one patient had clear cell adenocarcinoma (5%). Chemotherapy consisted of six weekly cycles of cisplatin (70 mg/m(2)) and paclitaxel (70 mg/m(2)). In 15 of the 19 patients (74%) fertility was successfully preserved. In the four patients in whom fertility preservation failed, one patient had stable disease after three cycles and did not meet the criteria for fertility-sparing surgery and three patients had intra- or post-operative indications for adjuvant therapy. Three of the 19 patients (15.7%) had a relapse, two of whom died. One case was in the group of successful abdominal radical trachelectomy. Conclusion Neoadjuvant chemotherapy followed by fertility-sparing surgery may be a feasible and safe option in select patients with cervical tumors >2 cm. Unfavorable prognostic factors are defined as non-responsiveness and non-squamous pathology, which can help in patient selection for fertility-sparing surgery. Show less
