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.
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.
Foetal macrosomia is associated with high maternal and neonatal morbidity; however, obstetric management of suspected macrosomia has not been well defined. This study aimed to analyse obstetric ...management in a population of women who delivered macrosomic new-borns and assess maternal and neonatal outcomes and risk factors for complications in such cases.
This two-centre retrospective study conducted in France over a 10-year period comprised 1724 women who had delivered macrosomic new-borns (defined as those whose weight was > 90th percentile according to the Association of Users of Computerised Records in Perinatology, Obstetrics, and Gynaecology curve) from 37SA.
In this study, the caesarean section and instrumental extraction rates were 24.1% and 15.7%, respectively, and the postpartum haemorrhage rate was 7%. The rate of shoulder dystocia was 23.1% (including brachial plexus injuries, 0.4%; and clavicular fractures, 2.0%). Significant risk factors for caesarean section were maternal height < 160 cm, nulliparity, history of caesarean section, excessive uterine height, induction of labour and duration of labour > 10 h. The risk factors for shoulder dystocia were maternal height < 160 cm and instrumental extraction.
The study findings may help determine predictive factors for an unfavourable outcome at the time of delivery of a macrosomic foetus, thus allowing clinical teams to better anticipate and manage potential complications.
Vulvar cancer is a rare pathology affecting mainly elderly women. This study aims to evaluate the impact of age on tumor size in vulvar cancer.
This was a multicenter retrospective observational ...study carried out between January 1, 1998, and December 31, 2020, in patients operated on for vulvar cancer. Univariate analysis was performed according to patients' age ≥ or <65 years. Factors associated with tumor size found to be significant according to age were then included in a multiple linear regression model.
Of the 382 patients included, there were 133 patients aged <65 years and 249 ≥ 65 years. Radical total vulvectomy surgeries were more frequently performed in women ≥65 years (n = 72 (28.9 %) versus n = 20 (15 %); p = 0.004). The median histological tumor size and interquartile range was 20 mm 13–29 in the <65 years and 30 mm 15–42 in patients ≥65 years (p = 0.001). Multiple linear regression showed that age ≥65 years had a regression coefficient of 7.15 95 % CI 2.32; 11.99 (p = 0.004), constituting a risk factor for larger histological tumour size. Patients aged ≥65 years old had a higher early complication rate (n = 150 (62 %) versus n = 56 (42.7 %), p = 0.001). They also had a greater risk of recurrence (HR = 1.89 (95%CI (1.24–2.89)), p = 0.003) with a worse overall survival (HR = 5.64 (95%CI (1.70–18.68)), p = 0.005).
Age is a risk factor for larger tumor size, leading to more radical surgery and a greater risk of complications in already fragile patients, with a greater risk of recurrence and an impact on overall survival.
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.
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.
•The focus of the first menopause consultation is to address and provide answers to women's questions about menopause.•At menopause, improving lifestyle and nutrition, avoiding risk factors (notably ...smoking), and promoting physical activity could help limit the long-term impact of estrogen deficiency.•In women with moderate to severe vasomotor symptoms and in the absence of contraindications, it is recommended to prescribe menopausal hormone therapy (MHT) as first-line treatment.•For the management of genitourinary syndrome of menopause, vaginal treatment is recommended as first-line treatment.•In early postmenopausal women at low to moderate risk of fracture, it is recommended that MHT be proposed as first-line treatment to prevent osteoporosis.•To limit the excess risk of breast cancer associated with MHT, it is recommended that estradiol be combined with progesterone or dydrogesterone.•Current data do not allow the recommendation of an optimal duration of MHT, which must take into account its initial indication and its benefit–risk balance.
The aim of these recommendations is to set forth an individualized approach to the management of early postmenopausal women (i.e., within the first 10 years after natural menopause) covering all aspects of lifestyle and therapeutic management, with or without menopause hormone therapy (MHT).
Literature review and consensus of French expert opinion. Recommendations were graded according to the HAS methodology and levels of evidence derived from the international literature, except when there was no good-quality evidence.
The beginning of menopause is an ideal time for each woman to evaluate her health status by assessing her bone, cardiovascular, and cancer-related risk factors that may be amplified by postmenopausal estrogen deficiency and by reviewing her lifestyle habits. Improving lifestyle, including nutrition and physical activity, and avoiding risk factors (notably smoking), should be recommended to all women. MHT remains the most effective treatment for vasomotor symptoms but it could be also recommended as first-line treatment for the prevention of osteoporosis in early postmenopausal women at low to moderate risk for fracture. The risks of MHT differ depending on its type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used. There is reasonable evidence that using transdermal estradiol in association with micronized progesterone or dydrogesterone may limit both the venous thromboembolic risk associated with oral estrogens and the risk of breast cancer associated with synthetic progestins. Treatment should be individualized to each woman, by using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation of its benefit–risk balance. For bothersome genitourinary syndrome of menopause (GSM) symptoms, vaginal treatment with lubricants and moisturizers is recommended as first-line treatment together with low-dose vaginal estrogen therapy, depending on the clinical course. No recommendation of an optimal duration of MHT can be made, but it must take into consideration the initial indication for MHT as well as each woman's benefit–risk balance. Management of gynecological side-effects of MHT is also examined.
These recommendations are endorsed by the Groupe d'Etude sur la Ménopause et le Vieillissement hormonal (GEMVI) and the Collège National des Gynécologues-Obstétriciens Français (CNGOF).
Background
The European Society of Medical Oncology (ESMO)/European Society of Gynaecological Oncology (ESGO)/European Society for Radiotherapy & Oncology (ESTRO) classification for endometrial ...cancer (EC) now includes a high–intermediate risk (HIR) group of recurrence due to the adverse prognostic role of lymphovascular space involvement (LVSI) and grade 3 for women at intermediate risk. However, optimal surgical staging, and especially the place of lymphadenectomy, remains to be elucidated. We aimed to establish whether systematic nodal staging should be part of surgical staging for women with HIR EC.
Methods
We abstracted from a prospectively maintained multicentre database the data of 181 women with HIR EC based on uterine factors (endometrioid type 1, grade 1–2 tumors with deep (≥50%) myometrial invasion and unequivocally positive LVSI, and those with grade 3 tumors with <50% myometrial invasion regardless of LVSI status), who received primary surgical treatment between January 2001 and December 2013. We recorded frequency of lymph node (LN) metastases in those who underwent nodal staging. The secondary outcomes were overall survival and recurrence patterns.
Results
Overall, 145 (80.1%) women underwent nodal staging consisting of at least pelvic lymphadenectomy. Of these, 62 (42.7%) had LN disease (9.7% with micrometastases). The respective 5-year overall survival rates according to LN status were 85.0% (95% confidence interval CI 76.5–91.4), 71.8% (95% CI 61.9–80.4) and 36.0% (95% CI 26.6–46.2) for women with negative LN, positive LN, and unstaged (
p
= 0.047). Unstaged women were more likely to experience nodal recurrence than surgically staged/LN negative women (
p
= 0.05).
Conclusions
Systematic nodal staging should be part of surgical staging for women with apparent ESMO/ESGO/ESTRO HIR EC. Sentinel LN biopsy (SLNB) could be an option in this specific setting that may possibly substitute comprehensive staging, for the identification of patients with lymphatic dissemination.
Purpose
To define the effects of attempted external cephalic version (ECV) in a low-risk population for breech delivery in a maternity hospital where breech vaginal delivery is widely practiced.
...Materials and methods
Retrospective exposed—unexposed study including 204 patients presented with a live singleton fetus breech presentation on third-trimester ultrasound and who delivered at Reims University Hospital between January 1st, 2013 and July 1st, 2018.
Results
121 patients received ECV. Cesarean section rate was lower (OR with no adjustment 0.42 0.24–0.76
p
= 0.004) but without significant difference in the exposed patients after adjustment. This difference was significant between exposed and unexposed patients in the subgroup of 51 primiparous (OR = 0.14 0.04–0.52
p
= 0.002) and 51 multiparous (OR = 0.26 0.08–0.89
p
= 0.028) but not in the subgroup of 102 nulliparous. There was no difference in fetal impact other than neonatal management in the delivery room, which is less needed in exposed primiparous women. Attempted ECV significantly decreased the breech rate (72.5 vs 100%,
p
< 0.001). There were 7 (5.79%) complications. Three factors favored success: high uterine height (
p
= 0.011), a non-elevated BMI (
p
= 0.006) and an earlier term at ECV (
p
= 0.003).
Conclusion
The attempt of ECV in the Reims University Hospital does not significantly reduce the Cesarean section rate and has no effect on neonatal status.