Pelvic lymph node dissection has been the standard of care for patients with early cervical cancer. Sentinel node (SN) mapping is safe and feasible and may increase the detection of metastatic ...disease, but benefits of omitting pelvic lymph node dissection in terms of decreased morbidity have not been demonstrated.
In an open-label study, patients with early cervical carcinoma (FIGO 2009 stage IA2 to IIA1) were randomly assigned to SN resection alone (SN arm) or SN and pelvic lymph node dissection (SN + PLND arm). SN resection was followed by radical surgery of the tumour (radical hysterectomy or radical trachelectomy). The primary end-point was morbidity related to the lymph node dissection; 3-year recurrence-free survival was a secondary end-point.
A total of 206 patients were eligible and randomly assigned to the SN arm (105 patients) or SN + PLND arm (101 patients). Most patients had stage IB1 lesion (87.4%). No false-negative case was observed in SN + PLND arm. Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the SN + PLND arm (51.5%; p = 0.0046), as was the rate of postoperative neurological symptoms (7.8% vs. 20.6%, p = 0.01, respectively). However, there was no significant difference in the proportion of patients with significant lymphoedema between the two groups. During the 6-month postoperative period, the difference in morbidity decreased over time. The 3-year recurrence-free survival was not significantly different (92.0% in SN arm and 94.4% in SN + PLND arm).
SN resection alone is associated with early decreased lymphatic morbidity when compared with SN + PLND in early cervical cancer.
•Randomised study comparing sentinel node biopsy and pelvic lymph node dissection.•Sentinel node biopsy alone is associated with decreased minor lymphatic morbidity.•No increased risk of recurrence while omitting pelvic lymph node dissection.
Background: Laparoscopy in the management of women with borderline ovarian tumors remains controversial. We therefore evaluated the adequacy of initial laparoscopic staging according to FIGO ...guidelines, by comparison with laparotomy. Patients and methods: In a French retrospective multicenter study of 358 women with borderline ovarian tumors, we compared epidemiological characteristics, sonographic findings, serum tumor marker levels, and surgical and histological parameters between women undergoing laparoscopy and women undergoing laparotomy. Results: One hundred and forty-nine (41.6%) of the 358 women underwent laparoscopy. Mean age, mean gestity and parity, and mean tumor size were higher in the laparotomy group. Forty-two women (28.2%) underwent laparoconversion, mainly for suspected ovarian cancer or large tumor volume. Conservative treatment and cyst rupture were more frequent in the laparoscopy group than in the laparoconversion and laparotomy groups (P <0.0001). The rate of complete staging was lower in the laparoscopy group than in the laparoconversion and laparotomy groups (P <0.0001), with no difference between these latter two groups. No difference in the recurrence rate was noted between the groups, but a higher recurrence rate was observed after conservative treatment (P <0.001). Conclusions: Laparoscopic management of borderline ovarian tumors is associated with a higher rate of cyst rupture and incomplete staging. Recurrence was more frequent after conservative treatment. Whatever the surgical route, the rate of complete initial staging was low, emphasizing the need to respect treatment guidelines for borderline ovarian tumors.
To compare the accuracy of five major risk stratification systems (RSS) in classifying the risk of recurrence and nodal metastases in early-stage endometrial cancer (EC).
Data of 553 patients with ...early-stage EC were abstracted from a prospective multicentre database between January 2001 and December 2012. The following RSS were identified in a PubMed literature search and included the Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC-1), the Gynecologic Oncology Group (GOG)-99, the Survival effect of para-aortic lymphadenectomy (SEPAL), the ESMO and the ESMO-modified classifications. The accuracy of each RSS was evaluated in terms of recurrence-free survival (RFS) and nodal metastases according to discrimination.
Overall, the ESMO -modified RSS provided the highest discrimination for both RFS and for nodal metastases with a concordance index (C-index) of 0.73 (95% CI, 0.70-0.76) and an area under the curve (AUC) of 0.80 (0.78-0.72), respectively. The other RSS performed as follows: the PORTEC1, GOG-99, SEPAL, ESMO classifications gave a C-index of 0.68 (0.66-0.70), 0.65 (0.63-0.67), 0.66 (0.63-0.69), 0.71 (0.68-0.74), respectively, for RFS and an AUC of 0.69 (0.66-0.72), 0.69 (0.67-0.71), 0.68 (0.66-0.70), 0.70 (0.68-0.72), respectively, for node metastases.
None of the five major RSS showed high accuracy in stratifying the risk of recurrence or nodal metastases in patients with early-stage EC, although the ESMO-modified classification emerged as having the highest power of discrimination for both parameters. Therefore, there is a need to revisit existing RSS using additional tools such as biological markers to better stratify risk for these patients.
Lymphovascular space invasion (LVSI) is one of the most important predictors of nodal involvement and recurrence in early stage endometrial cancer (EC). Despite its demonstrated prognostic value, ...LVSI has not been incorporated into the European Society of Medical Oncology (ESMO) classification. The aim of this prospective multicentre database study is to investigate whether it may improve the accuracy of the ESMO classification in predicting the recurrence risk.
Data of 496 patients with apparent early-stage EC who received primary surgical treatment between January 2001 and December 2012 were abstracted from prospective multicentre database. A modified ESMO classification including six risk groups was created after inclusion of the LVSI status in the ESMO classification. The primary end point was the recurrence accuracy comparison between the ESMO and the modified ESMO classifications with respect to the area under the receiver operating characteristic curve (AUC).
The recurrence rate in the whole population was 16.1%. The median follow-up and recurrence time were 31 (range: 1-152) and 27 (range: 1-134) months, respectively. Considering the ESMO modified classification, the recurrence rates were 8.2% (8 out of 98), 23.1% (15 out of 65), 25.9% (15 out of 58), and 45.1% (28 out of 62) for intermediate risk/LVSI-, intermediate risk/LVSI+, high risk/LVSI-, and high risk/LVSI+, respectively (P<0.001). In the low risk group, LVSI status was not discriminant as only 7.0% (14 out of 213) had LVSI+. The staging accuracy according to AUC criteria for ESMO and ESMO modified classifications were of 0.71 (95% CI: 0.68-0.74) and 0.74 (95% CI: 0.71-0.77), respectively.
The current modified classification could be helpful to better define indications for nodal staging and adjuvant therapy, especially for patients with intermediate risk EC.
Bacterial vaginosis (BV) is a recurrent disease in women despite treatment by antibiotics. This study investigated the impact of a vaginal probiotic, Lactobacillus crispatus IP174178* (Lc), on the ...rate of recurrence and time to recurrence.
A prospective, multi-centre, double blind, randomised phase III trial in women with at least two documented episodes of BV in the previous year (diagnosis confirmed by presence of three Amsel criteria and a Nugent score≥7), and who had been clinically cured (i.e., no Amsel criteria) after oral metronidazole treatment (1g/day×7 days). The patients were randomised to receive vaginal capsules of either Lc or placebo, once a day, for 14 days over the first two menstrual cycles and another 14 days of the same treatment for the following two menstrual cycles. The primary efficacy endpoint was the number of patients with at least one bacteriologically confirmed recurrence of BV.
Out of 98 assessable patients (mean age 35.7 years), 78 women were evaluated (20 patients had missing data). During the treatment period, 16/39 patients (41%) had at least one recurrence in the placebo group versus 8/39 patients (20.5%) in the Lc group (P=0.0497). The time to recurrence was longer by 28% in the Lc group (3.75±0.16 months) vs. the placebo group (2.93±0.18 months) (P=0.0298). Tolerability and safety were good in both groups.
In women with recurrent BV after antibiotics, treatment with Lc IP 174178 administered over four menstrual cycles, could significantly reduce the rate of recurrence and increase the time to recurrence.
In vulvar cancer, it is admitted that tumor-free margin distance is one of the most important element for locoregional control. It is currently recommended to surgically remove the tumor with at ...least an 8 mm tumor-free margin. The aim of this study was to evaluate the impact of tumor-free margin distance on recurrence and survival in vulvar cancer.
From 2005 to 2016, 112 patients surgically treated for a vulvar squamous cell cancer were included in a retrospective multicenter study. Overall, disease-free and metastasis-free survivals were analyzed according to tumor-free margin distance.
Patients were divided into three groups: group 1 (margin <3 mm, n = 47); group 2 (margin ≥3 mm to < 8 mm, n = 48) and group 3 (margin ≥8 mm, n = 17). During the study, 26,8% patients developed recurrence (n = 30) after a median of 8 months (1-69). Analysis of 5-year overall survival, as well as disease-free and metastasis-free survivals, did not reveal a difference between groups. We performed a subgroup analysis in patients with a tumor-free margin <8 mm (group 1 and 2). It showed that histological lesions observed closest to the edge of the specimen were more often invasive or in situ carcinoma lesions in group 1 than in group 2, in which VIN lesions were mainly observed at this location. After re-excision, no patients in group 1 and 50% (n = 2) patients in group 2 developed recurrence.
This study did not reveal a significant impact of tumor-free margin distance on recurrence and survival in vulvar cancer. Moreover, the benefit of re-excision seems stronger when tumor-free margins are positive or very close (<3 mm), cases in which invasive or in situ lesions are often present closest to the edge of the specimen.
It is recommended to classify Borderline Ovarian Tumors (BOTs) according to the WHO classification. Transvaginal and suprapubic ultrasonography are recommended for the analysis of an ovarian mass ...(Grade A). In case of an undetermined ovarian lesion on ultrasonography, it is recommended to perform a pelvic MRI (Grade A) with a score for malignancy (ADNEX MR/O-RADS) (Grade C) included in the report and to formulate a histological hypothesis (Grade C). Pelvic MRI is recommended to characterize a tumor suspected of being BOT (Grade C). It is recommended to evaluate serum levels of HE4 and CA125 and to use the ROMA score for the diagnosis of indeterminate ovarian mass on imaging (grade A). If there is a suspicion of a mucinous BOT on imaging, serum levels of CA 19−9 may be proposed (Grade C). For Early Stages (ES) of BOT, if surgery without risk of tumor rupture is possible, laparoscopy with protected extraction is recommended over laparotomy (Grade C). For treatment of a bilateral serous ES BOT with a strategy to preserve fertility and/or endocrine function, bilateral cystectomy is recommended where possible (Grade B). For mucinous BOTs with a treatment strategy of fertility and/or endocrine function preservation, unilateral salpingo-oophorectomy is recommended (grade C). For mucinous BOTs treated by initial cystectomy, unilateral salpingo-oophorectomy is recommended (grade C). For serous or mucinous ES BOTs, routine hysterectomy is not recommended (Grade C). For ES BOTs, lymphadenectomy is not recommended (Grade C). For ES BOTs, appendectomy is recommended only in case of a macroscopically pathological appendix (Grade C). Restaging surgery is recommended in cases of serous BOTs with micropapillary architecture and an incomplete abdominal cavity inspection during initial surgery (Grade C). Restaging surgery is recommended for mucinous BOTs after initial cystectomy or in cases where the appendix was not examined (Grade C). If restaging surgery is decided for ES BOTs, the following procedures should be performed: peritoneal washing (grade C), omentectomy (grade B), complete exploration of the abdominal cavity with peritoneal biopsies (grade C), visualization of the appendix and appendectomy in case of a pathological macroscopic appearance (grade C) as well as unilateral salpingo-oophorectomy in case of a mucinous BOT initially treated by cystectomy (grade C). In advanced stages (AS) of BOT, it is not recommended to perform a lymphadenectomy as a routine procedure (Grade C). For AS BOT in a patient with a desire to fall pregnant, conservative treatment involving preservation of the uterus and all or part of the ovary may be proposed (Grade C). Restaging surgery aimed at removing all lesions, not performed initially, is recommended for AS BOTs (Grade C). After treatment, follow-up for a duration greater than 5 years is recommended due to the median recurrence time of BOTs (Grade B). It is recommended that a systematic clinical examination be carried out during follow-up of a treated BOT (Grade B). If the determination of tumor markers is normal preoperatively, the routine dosage of tumor markers in BOT follow-up is not recommended (Grade C). In case of an initial elevation in serum CA 125 levels, it is recommended to monitor CA 125 during follow up (Grade B). In case of conservative treatment, it is recommended to use transvaginal and transabdominal ultrasound during follow up of a treated BOT (Grade B). In the event of a BOT recurrence in a woman of childbearing age, a second conservative treatment may be proposed (Grade C). A consultation with a physician specialized in Assisted Reproductive Technique (ART) should be offered in the case of BOTs in women of childbearing age (Grade C). When possible, a conservative surgical strategy is recommended to preserve fertility in women of childbearing age (Grade C). In the case of optimally treated BOT, there is no evidence to contraindicate the use of ART. The use of hormonal contraception after serous or mucinous BOT is not contraindicated (Grade C). After management of mucinous BOT, for women under 45 years, given the benefit of Hormonal Replacement Therapy (HRT) on cardiovascular and bone risks, and the lack of hormone sensitivity of mucinous BOTs, it is recommended to offer HRT (Grade C). Over 45 years of age, HRT can be prescribed in case of a climacteric syndrome after individual benefit to risk assessment (Grade C).
Objective
To evaluate delivery and neonatal outcomes in women with resected or in situ bowel endometriosis.
Design
Retrospective cohort study.
Setting
France.
Population and sample
Analysis of 72 ...pregnancies from 67 women followed for colorectal endometriosis from 2001 to 2014 in six centres including two university expert centres for endometriosis.
Methods
Univariate analysis of maternal and neonatal outcomes.
Main outcome measures
Routes for delivery and rate of complications.
Results
The colorectal surgery group comprised 41 women and the in situ colorectal group, 26 women. Overall, half of the women underwent caesarean section. A high incidence of postoperative complications (39%) was observed after caesarean section with no difference between the groups. Surgical difficulties at newborn extraction (22%) and postoperative complications (39%) occurred more often in women with anterior deep infiltrating endometriosis (respectively 63 versus 11%, P = 0.007 and 67% versus 26%, P = 0.046) independently of prior surgery for endometriosis. In the remaining half, vaginal delivery required an operative procedure in 28% of the women with a significant increase in postpartum complications compared with those who did not require a procedure (P = 0.001). Overall, the incidence of postpartum complications was lower after vaginal delivery (14%) than after caesarean section (39%) (P = 0.03).
Conclusion
Pregnant women with colorectal endometriosis, irrespective of prior surgery, should be informed of the high risk of delivery by caesarean section. Vaginal delivery is preferrable in this setting because of the lower incidence of postpartum complications.
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Due to the incidence of postpartum complications whatever the route of delivery, women should receive level III maternal care.
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Due to the incidence of postpartum complications whatever the route of delivery, women should receive level III maternal care.
The purpose of the current study was to evaluate the characteristics of borderline ovarian tumors (BOTs) diagnosed during pregnancy.
We conducted a retrospective multicenter study of 40 patients with ...BOTs diagnosed during pregnancy between 1997 and 2009 at five tertiary universitary departments of Gynecology and Obstetrics and one French cancer center. The medical records were reviewed to determine surgical procedure, histology, restaging surgery and recurrence.
Mean patient age was 30.2±5.4 years. Most BOTs were diagnosed during the first trimester of pregnancy (62%). Salpingo-oophorectomy (N = 24) was more frequently performed than cystectomy (N = 11) during pregnancy (P = 0.01). Only two patients had an initial complete staging. BOTs were mucinous, serous and mixed in 48%, 42% and 10% of patients, respectively. Twenty-one percent of mucinous BOTs exhibited intraepithelial carcinoma or microinvasion. Forty-seven percent of serous BOTs exhibited micropapillary features, noninvasive implants or microinvasion. Restaging surgery performed in 52% patients resulted in upstaging in 24% of cases. Recurrence rate in patients with serous BOT with micropapillary features or peritoneal implants was 7.5%.
BOTs diagnosed during pregnancy exhibit a high incidence of aggressive features and are rarely completely staged initially. Given this setting, up-front salpingo-oophorectomy should be considered and restaging planned.