Sentinel node biopsy for the management of early stage endometrial cancer: long-term results of the SENTI-ENDO study.

OBJECTIVE: We report the long-term results of the SENTI-ENDO study evaluating the impact of sentinel lymph node (SLN) biopsy on management and survival in patients with early stages of endometrial cancer (EC). METHODS: Patients with FIGO stage I-II EC underwent pelvic SLN biopsy after cervical dual injection (technetium and patent blue) and systematic pelvic node dissection. This study is a secondary endpoint reporting the long-term recurrence free survival (RFS) and the impact of the SLN procedure on adjuvant therapies. RESULTS: The median follow-up was 50 months (range: 3-77 months). Eighteen of the 125 patients (14.4%) experienced a recurrence. The 50-month recurrence-free survival (RFS) was 84.7% with no difference between patients with and without detected SLN (p = 0.09). Among patients with detected SLN (111), no difference in RFS was observed between those with and without positive SLN (p = 0.5). In the whole population, adjuvant therapy was performed in low-, intermediate- and high-risk groups in 31 of 64 patients (48.4%), 28 of 37 patients (75.7%) and 14 of 17 patients (82.3%), respectively (p = 0.0001). For the 111 patients with detected SLN, EBRT was performed in 27 of the 89 with negative SLN and in 11 of the 14 with positive SLN (p = 0.001). Chemotherapy was performed more frequently in patients with positive SLN (6/12, 50%) than in patients with negative SLN (7/56, 12.5%) (p = 0.009). CONCLUSIONS: Our results support the impact of SLN biopsy on surgical management and indications for adjuvant therapies. Further studies are required to assess the clinical impact of the SLN biopsy in early stage EC.

Comparison of diagnostic accuracy of frozen section with imprint cytology for intraoperative examination of sentinel lymph node in early-stage endometrial cancer: results of Senti-Endo study.

BACKGROUND: In early-stage endometrial cancer, intraoperative examination of sentinel lymph nodes (SLNs) can predict nodal involvement and avoid a second surgical procedure. Our goal was to determine the diagnostic accuracy (DA) of intraoperative examination in diagnosing metastatic pelvic SLNs. METHODS: This was a retrospective study, including 125 patients with early stage endometrial cancer. Results of intraoperative examination by frozen section (FS) or imprint cytology (IC) were compared with final histology (serial sectioning and immunohistochemistry (IHC)). The diagnostic value of intraoperative examination was calculated. RESULTS: Of the 111 patients with SLNs detected (89%), 87 (78.5%) had an intraoperative examination (30 with FS and 57 with IC). Intraoperative examination detected SLN metastases in 9 of 16 patients with metastatic SLN at definitive histology (sensitivity = 56.3%): macrometastasis in 8 and micrometastasis in 1. Seven false-negative cases were found (43.7%; micrometastases in 6 and isolated tumor cells in 1). The DA of intraoperative examination was 92% (95% confidence interval (CI), 84-96.7). For FS and IC, DA was 97.3% (95% CI, 85.8-99.9) and 88% (95% CI, 75.7-95.5), respectively. CONCLUSIONS: FS has better DA than IC for intraoperative examination of SLNs in endometrial cancer. The main limitation of both techniques is in detecting micrometastasis and isolated tumor cells.

Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO).

BACKGROUND: Retrospective single-centre series have shown the feasibility of sentinel lymph-node (SLN) identification in endometrial cancer. We did a prospective, multicentre cohort study to assess the detection rate and diagnostic accuracy of the SLN procedure in predicting the pathological pelvic-node status in patients with early stage endometrial cancer. METHODS: Patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-II endometrial cancer had pelvic SLN assessment via cervical dual injection (with technetium and patent blue), and systematic pelvic-node dissection. All lymph nodes were histopathologically examined and SLNs were serial sectioned and examined by immunochemistry. The primary endpoint was estimation of the negative predictive value (NPV) of sentinel-node biopsy per hemipelvis. This is an ongoing study for which recruitment has ended. The study is registered with ClinicalTrials.gov, number NCT00987051. FINDINGS: From July 5, 2007, to Aug 4, 2009, 133 patients were enrolled at nine centres in France. No complications occurred after injection of technetium colloid and no anaphylactic reactions were noted after patent blue injection. No surgical complications were reported during SLN biopsy, including procedures that involved conversion to open surgery. At least one SLN was detected in 111 of the 125 eligible patients. 19 of 111 (17%) had pelvic-lymph-node metastases. Five of 111 patients (5%) had an associated SLN in the para-aortic area. Considering the hemipelvis as the unit of analysis, NPV was 100% (95% CI 95-100) and sensitivity 100% (63-100). Considering the patient as the unit of analysis, three patients had false-negative results (two had metastatic nodes in the contralateral pelvic area and one in the para-aortic area), giving an NPV of 97% (95% CI 91-99) and sensitivity of 84% (62-95). All three of these patients had type 2 endometrial cancer. Immunohistochemistry and serial sectioning detected metastases undiagnosed by conventional histology in nine of 111 (8%) patients with detected SLNs, representing nine of the 19 patients (47%) with metastases. SLN biopsy upstaged 10% of patients with low-risk and 15% of those with intermediate-risk endometrial cancer. INTERPRETATION: SLN biopsy with cervical dual labelling could be a trade-off between systematic lymphadenectomy and no dissection at all in patients with endometrial cancer of low or intermediate risk. Moreover, our study suggests that SLN biopsy could provide important data to tailor adjuvant therapy. FUNDING: Direction Interrégionale de Recherche Clinique, Ile-de-France, Assistance Publique-Hôpitaux de Paris.

Reexcision for positive margins in breast cancer: A predictive score of residual disease.

BACKGROUND: Guidelines recommend re-excision if resection margins are positive in lumpectomy for breast cancer. However, residual disease (RD) is not always found. The aim of our study was to develop a score to predict RD in re-excision specimens. MATERIALS AND METHODS: We carried out a multicenter, retrospective study with two population groups. The 'modeling' group was composed of 148 patients treated in the Centre Hospitalier Poissy-St-Germain or the Georges Pompidou European Hospital and the 'validation' group was composed of 67 patients treated in Curie Institute. The score was built with a logistic regression model. RESULTS: Factors independently associated with RD were: a cumulative length of all positive margins>5 mm, invasion by ductal carcinoma in situ only, a pathological tumor size>30 mm and a pathological tumor size<30 mm with a discrepancy of >50% between pathological and radiological tumor size. The 7-point score allowed the classification of patients into three risk groups for RD: low (16% of patients experienced RD), moderate (65%) and high (100%). The areas under the ROC curve of the score and the logistic model were 0.72(95%CI:0.68-0.75,p = 0.60). The proportion of RD in each group of the validation population (25%, 48%, and 100% in the low, moderate and high group, respectively) confirmed the accuracy of the score in an independent population. CONCLUSIONS: This score enables the identification of patients at high risk of RD but it cannot provide guidance for the decision to undertake re-excision surgery in the low-risk group. Further studies are needed to test the score in extensive datasets and better identify low-risk patients.

Combined vaginal and abdominal approach to sleeve gastrectomy for morbid obesity in women: a preliminary experience.

BACKGROUND: Natural orifice translumenal endoscopic surgery is an emerging surgical phenomenon. Although the development of "pure" natural orifice translumenal endoscopic surgical techniques in humans has been slowed by major technical hurdles, "hybrid" or combined variants have been increasingly reported. Laparoscopic sleeve gastrectomy (SG) is a commonly performed treatment of morbid obesity. We have developed a combined variant of SG for patients with morbid obesity. Our aim was to assess the feasibility and safety of such an approach, which could eventually reduce the postoperative pain, preserve the abdominal wall, and enhance cosmesis. METHODS: Combined, transvaginal and abdominal SG was attempted in 20 patients. The inclusion criteria were morbid obesity (body mass index <50 kg/m(2)), female gender, an absence of gynecologic disorders, and the absence of major previous abdominal surgery. The local ethical committee approved the present study. The technique was performed using a vaginal incision with 1 or 2 abdominal ports. RESULTS: The procedure was a success in 14 patients (70%). In 6 patients, conversion to a more conventional laparoscopic SG was required, with ≥ 1 abdominal ports added. The mean operative time was 116 minutes (range 54-231). The postoperative complication rate was 5% (1 patient developed pneumonia). No hemorrhage, surgical site infection, or fistula was encountered. The mean length of hospital stay was 72 hours (range 24-144). CONCLUSION: Our combined, transvaginal and abdominal variant of laparoscopic SG was sure and feasible in a small series of selected patients with morbid obesity.

Five-millimeter trocar site small bowel eviscerations after gynecologic laparoscopic surgery.

Trocar site hernia is a known complication after laparoscopic surgery, especially at 10-mm and larger port sites. Only a few cases of herniation through 5-mm port sites are reported in the literature. We describe 2 cases of bowel herniation and bowel obstruction through 5-mm port sites. The patients were 63 and 74 years old; both had endometrial cancer and underwent an uncomplicated hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy with peritoneal drains left at the lateral 5-mm port sites. Each patient presented symptoms of small bowel obstruction after which the drains were removed and were found to have evisceration through a laterally placed 5-mm port site. The bowel was reduced locally, and a segmental bowel resection was needed in 1 case. Bowel herniation can occur through the fascial defect after placement of a 5-mm port, especially if drains have been placed at the port site.

Macroscopic quality control improves the reliability of blue dye-only sentinel lymph node biopsy in breast cancer.

BACKGROUND: One of the problems of sentinel lymph node (SLN) biopsy is the risk of false negatives. At the Institut Curie, to reduce the false-negative rate, we have developed a histological quality control of the SLN performed by blue dye alone, which consists of verification of the SLN blue stain by the pathologist. METHODS: A total of 324 patients underwent an SLN biopsy procedure with patent blue dye only followed by an immediate axillary dissection. Initially, SLNs were checked to ensure that they were blue by macroscopic examination. Finally, a search for immunohistochemistry micrometastasis was performed. RESULTS: In 277 (85.5%) of 324 patients, an SLN was identified by the surgeon. After standard examination, the false-negative rate was 11.1% (10 of 90). After macroscopic checking of the 197 negative SLNs, 167 of the 197 were confirmed blue, and there were 5 false negatives, which brought the false-negative rate down to 5.6% (5 of 90). Sixty SLNs out of the 167 confirmed blue SLNs were then proved to be immunohistochemically micrometastatic, and there were 3 false negatives, giving a final false-negative rate of 2.2% (2 of 90; P =.002). CONCLUSIONS: In this series, the procedure of pathologic analysis of the SLN has resulted in a significant reduction of the false-negative rate.