scholarly journals SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study

2019 ◽  
Vol 29 (4) ◽  
pp. 829-834 ◽  
Author(s):  
Fabrice R Lecuru ◽  
Mary McCormack ◽  
Peter Hillemanns ◽  
Amelie Anota ◽  
Mario Leitao ◽  
...  

BackgroundRadical hysterectomy and complete pelvic lymphadenectomies are the most commonly performed procedures for women with early-stage cervical cancer. Sentinel lymph node (SLN) mapping could be an alternative to routine pelvic lymphadenectomy, aiming to diagnose accurately nodal extension and decrease lymphatic morbidity.Primary ObjectiveTo compare 3-year disease-free survival and health-related quality of life after SLN biopsy or SLN biopsy + pelvic lymphadenectomy in early cervical cancer.Study HypothesisWe hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy.Trial DesignInternational, randomized, multicenter, single-blind trial. The study will be run by teams trained to carry out SLN biopsy, belonging to clinical research cooperative groups or recognized as experts in this field. Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section will be randomized 1:1 to SLN biopsy only or SLN biopsy + pelvic lymphadenectomy.Inclusion, Exclusion CriteriaPatients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.Primary EndpointMain endpoint will be co-primary endpoint, associating 3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24).Sample Size950 patients need to be randomized.Estimated dates for completing accrual and presenting results: study started on Q2 2018, last accrual is scheduled for Q2 2021, and last follow-up in Q2 2026.Trial registrationClinicalTrials.gov identifier: NCT03386734.

2016 ◽  
Vol 26 (4) ◽  
pp. 743-749 ◽  
Author(s):  
Mi-Kyung Kim ◽  
Jin Ah Sim ◽  
Young Ho Yun ◽  
Duk-Soo Bae ◽  
Joo Hyun Nam ◽  
...  

ObjectivesHealth-related quality-of-life (HRQOL) issues of cancer patients are considered an important clinical outcome. We aimed to investigate the prognostic value of HRQOL on long-term survival outcomes in disease-free cervical cancer survivors (CCSs).MethodsThe study sample consisted of 860 disease-free CCSs from 6 Korean cancer hospitals recruited for HRQOL survey during 2005 (median time from diagnosis, 5.9 years). Health-related quality-of-life measures included the European Organization for Research and Treatment of Cancer QLQ-C30 and its Cervical Cancer Module (CX24). Survival data were retrieved from the Korean Statistical Office after 6 years from the survey. Health-related quality-of-life domains along with sociodemographic and clinicopathologic variables were analyzed as prognostic factors for survival from the date of survey.ResultsDuring the median follow-up period of 6.3 years after the survey, 30 (3.5%) patients died from all causes. Age, time since diagnosis, and physical activity were independent prognostic factors, which constituted the baseline model along with cancer stage. When HRQOL domains were tested separately against the baseline model, functional scales (physical, role, social, and emotional functioning), global health status, symptom scales (pain and appetite loss), and cervical cancer module items (body image, sexual inactivity, and sexual worry) were significantly associated with survival (P < 0.05).ConclusionsThese findings suggest that, in addition to well-known prognostic factors, including age, time since diagnosis, and physical activity, HRQOL scores obtained from disease-free CCSs are associated with survival.


2018 ◽  
Vol 9 (2) ◽  
pp. S13
Author(s):  
Shrinivas Datar ◽  
Swapna Kulkarni ◽  
Nilambari Patil ◽  
Amruta Salunkhe ◽  
Suchita Vaidya ◽  
...  

2021 ◽  
pp. ijgc-2021-002587
Author(s):  
Felix Boria ◽  
Luis Chiva ◽  
Vanna Zanagnolo ◽  
Denis Querleu ◽  
Nerea Martin-Calvo ◽  
...  

IntroductionComprehensive updated information on cervical cancer surgical treatment in Europe is scarce.ObjectiveTo 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.MethodsThe 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.ResultsThe mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m2 (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.ConclusionsIn 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.


2019 ◽  
Vol 30 (2) ◽  
pp. 181-186 ◽  
Author(s):  
Benoit Bataille ◽  
Alexandre Escande ◽  
Florence Le Tinier ◽  
Audrey Parent ◽  
Emilie Bogart ◽  
...  

ObjectiveThe standard of care for early cervical cancer is radical hysterectomy; however, consideration of pre-operative brachytherapy has been explored. We report our experience using pre-operative brachytherapy plus Wertheim-type hysterectomy to treat early stage cervical cancer.MethodsThis single-center study evaluated consecutive patients with histologically proven node-negative early stage cervical cancer (International Federation of Gynecology and Obstetrics 2009 stage IB1–IIB) that was treated using pre-operative brachytherapy and hysterectomy. Pre-brachytherapy staging was performed using magnetic resonance imaging (MRI) and pelvic lymph node assessment was performed using lymphadenectomy. The tumor and cervical tissues were treated using brachytherapy (total dose 60 Gy) followed by Wertheim-type hysterectomy. The study included patients from January 2000 to December 2013.ResultsA total of 80 patients completed a median follow-up of 6.7 years (range 5.4–8.5). The surgical specimens revealed a pathological complete response for 61 patients (76%). Patients with incomplete responses generally had less than 1 cm residual tumor at the cervix, and only one patient had lymphovascular space involvement. The estimated 5-year rates were 88% for overall survival (95% CI 78% to 94%) and 82% for disease-free survival (95% CI 71% to 89%). Toxicities were generally mild-to-moderate, including 26 cases (33%) of grade 2 late toxicity and 10 cases (13%) of grade 3 late toxicity. Univariate analyses revealed that poor disease-free survival was associated with overweight status (≥25 kg/m2, HR 3.05, 95% CI 1.20 to 7.76, p=0.019) and MRI tumor size >3 cm (HR 3.05, 95% CI 1.23 to 7.51, p=0.016).ConclusionsPre-operative brachytherapy followed by Wertheim-type hysterectomy may be safe and effective for early stage cervical cancer, although poorer outcomes were associated with overweight status and MRI tumor size >3 cm.


Author(s):  
Larissa dos Santos ◽  
Luciana Castaneda ◽  
Suzana de Aguiar ◽  
Luiz Thuler ◽  
Rosalina Koifman ◽  
...  

Objective To analyze the factors associated with health-related quality of life (HRQoL) in women with cervical cancer (CC) in a single center in Rio de Janeiro, state of Rio de Janeiro, Brazil. Methods A cross-sectional study in women with a diagnosis of CC followed-up in the gynecology outpatient clinic of the Hospital do Câncer II (HCII, in the Portuguese acronym) of the Instituto Nacional de Câncer (INCA, in the Portuguese acronym). The data were collected from March to August 2015. Women with palliative care, communication/cognition difficulty, undergoing simultaneous treatment for other types of cancer, or undergoing chemotherapy and/or radiation therapy were excluded. For the evaluation of the HRQoL, a specific questionnaire for women with CC was used (Functional Assessment of Cancer Therapy – Cervix Cancer [FACT-Cx]). The total score of the questionnaire ranges from 0 to 168, with higher scores indicating a better HRQoL. Results A total of 115 women were included in the present study, with a mean age of 52.64 years old (standard deviation [SD] = 12.13). The domains of emotional (16.61; SD = 4.55) and functional well-being (17.63; SD = 6.15) were those which presented the worst scores. The factors that had an association with better HRQoL in women with CC were having a current occupation, a longer time since the treatment and diagnosis, and women who had undergone hysterectomy. Conclusion Considering the domains of HRQoL of the women treated for cervical cancer, a better score was observed in the domains of physical and social/family well-being. For most domains, better scores were found between those with a current occupation, with a longer time after the diagnosis and treatment, and among those who had undergone a hysterectomy.


2005 ◽  
Vol 15 (3) ◽  
pp. 498-502 ◽  
Author(s):  
P. Suprasert ◽  
J. Srisomboon ◽  
K. Charoenkwan ◽  
S. Siriaungul ◽  
S. Khunamornpong ◽  
...  

The objective of this study was to evaluate the outcomes of stages IB–IIA cervical cancer patients whose radical hysterectomy (RH) was abandoned for positive pelvic nodes detected during the operation compared with those found to have positive nodes after the operation. Among 242 patients with planned RH and pelvic lymphadenectomy (RHPL) for stages IB–IIA cervical cancer, 23 (9.5%) had grossly positive nodes. RH was abandoned, and complete pelvic lymphadenectomy was performed. Of these 23 patients, 22 received adjuvant chemoradiation, and the remaining 1 received adjuvant radiation. Four patients with positive para-aortic nodes were additionally treated with extended-field irradiation. When compared with 35 patients whose positive nodes were detected after the operation, there were significant differences regarding number of positive nodes and number of patients receiving extended-field irradiation. Complications in both groups were not significantly different, but the 2-year disease-free survival was significantly lower in the abandoned RH group compared with that of the RHPL group (58.5% versus 93.5%, P = 0.01). In conclusion, the survival of stages IB–IIA cervical cancer patients whose RH was abandoned for grossly positive pelvic nodes was significantly worse than that of patients whose node metastasis was identified after the operation. This is because the abandoned RH group had worse prognostic factors.


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