Nicolas Pouget

Impact of axillary dissection in women with invasive breast cancer who do not fit the Z0011 ACOSOG trial because of three or more metastatic sentinel lymph nodes

AIM The objective of this study was to determine the effects of axillary lymph node dissection (ALND) versus sentinel lymph node biopsy alone (SLNB) on the survival of patients with 3 or more metastatic lymph nodes (MLN) in invasive breast cancer. METHODS Data of 9521 patients with invasive T1-2M0 breast carcinoma and initial treatment with SLNB completed or not by ALND and 3 or more MLN were extracted from the SEER database. Univariate and multivariate analyses were performed. RESULTS Overall, 9521 patients were included in the study. SLNB-alone compared with ALND did not result in different overall survival (OS) or specific survival (SS) for patients with 3 or more MLN (p = 0.46 and 0.58, respectively). In subgroup analyses, OS was comparable between SLNB-alone and ALND when patients had only 3 or more than 3 MLN. When patients had 3 MLN, the 5-year SS was significantly better for patients with ALND compared with SLNB-alone: 91.5% and 85.1%, respectively (p = 0.02). The Hazard Ratio (HR) for OS comparing SLNB-alone with ALND adjusting for age, adjuvant radiotherapy, tumor size, estrogen receptor status, grade and tumor type resulted in an HR of 1.05 (95% CI, 0.72-1.54, p = 0.77). CONCLUSION In conclusion, patients with a T1-T2 invasive breast cancer and at least 3 MLN do not benefit from ALND after SLNB for specific and overall survival, thus limiting ALND to a staging procedure. A subgroup of patients with 3 MLN had a better SS with ALND, possibly due to an under-staging of the SLNB-alone group.

Multicenter prospective evaluation of the reliability of the combined use of two models to predict non-sentinel lymph node status in breast cancer patients with metastatic sentinel lymph nodes: the MSKCC nomogram and the Tenon score. Results of the NOTEGS study

Background:The purpose of this study was to prospectively evaluate the combined use of The Memorial Sloan Kettering Cancer Center nomogram and Tenon score to select, in patients with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN for whom additional axillary lymph node dissection (ALND) could be avoided.Methods:From January 2011 to July 2012, a prospective non-interventional nationwide study was conducted (NCT01509963). We sought to identify the false reassurance rate (FRR, a negative test result is false) in patients with both a ⩽10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ⩽3.5 (low risk): the proportion of patients with metastatic non-SN at additional ALND. Our hypothesis was that these patients would have a FRR⩽5%.Results:Data on 2822 patients with breast cancer from 53 institutions were prospectively recorded. At least one SN was metastatic (isolated tumour cells, micro- or macrometastases) in 696 patients (24.7%). Among patients with ALND and complete data to calculate combined risk (n=504), 67 and 437 patients had low and high combined risk, respectively. Patients at low risk had less ALND (47%) compared to patients at high risk (P<0.001). This study did not meet its primary objective because the FRR in patients with low risk was 16.4% (11 out of 67) (95% confidence interval (CI): 9.7–23.1%). In the high-risk group, 33.9% (148 out of 437) (95% CI: 29.6–38.4%) had non-SN metastases (P=0.004).Conclusions:In this controlled prospective study, metastatic SN patients with both a ⩽10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ⩽3.5 failed to identify patients at low risk of metastatic non-SN when completion ALND was not systematic.

Age impact on human papillomavirus vaccination in France in 2014: A study from the National Health Insurance Database.

INTRODUCTION Human papillomavirus (HPV) is the main cause of cervical cancer. In France, since March 2007, HPV vaccination has been recommended for girls aged 14, in addition to a catch-up program for girls aged 15 to 23. In October 2012, the target population was changed to 11- to 14-year-old girls. The main objective of the present study was to evaluate the impact of the recommendation change on HPV vaccination coverage and compliance. METHODS We conducted a descriptive study of the Échantillon Généraliste des Bénéficiaires (EGB), which is a random 1/97 permanent sample from the French National Health Insurance Database. We focused our analyses on girls aged 11 to 17 years who were covered by the main insurance scheme (which covers 77% of the French population). RESULTS We included 16,195 girls in this analysis. At the last update of the database (06/15/2014), 42% of 17-year-old girls had been vaccinated, with more than 50% of them having been vaccinated at age 14. Between January 2012 and June 2014, patients were reimbursed for a total of 7698 doses of the HPV vaccine. During the first trimester of 2013, the number of vaccinated 11- to 13-year-old girls increased, growing by more than 20-fold between the last trimester of 2012 (n=8) and the last trimester of 2013 (n=178). Less than 60% of the vaccinated patients received 3 injections. DISCUSSION Implementation of the new recommendations was rapid but had only a slight impact on vaccination coverage.

The role of neoadjuvant chemotherapy in ovarian cancer

ABSTRACT Introduction: Ovarian cancer is mostly diagnosed at advanced stage. Better survival is achieved through complete debulking surgery and chemotherapy. Historically, neoadjuvant chemotherapy (NAC) has been introduced for unresectable disease to decrease tumor load and perform a unique complete surgery. Four randomized control trials have compared primary debulking surgery to NAC, but there is still controversy about the use of neoadjuvant chemotherapy and questions about its modalities. Areas covered: We made a review of knowledge on benefits of NAC compared to primary debulking chemotherapy, in terms of survival and morbidity, methods of administration, new drugs in early and late phase trials, the selection of patients. Similar survival was observed after NAC and interval debulking surgery or primary debulking surgery. Morbidity of surgery was decreased after interval debulking compared primary debulking surgery. Conventional drugs are carboplatin and paclitaxel. Safety of bevacizumab was evaluated in phase 2 trials associated with conventional drugs. Immunotherapy trials are enrolling patients in phase 1 study. Expert commentary: NAC followed by debulking surgery is the best treatment for patients with advanced ovarian cancer.

Synthèse des recommandations nationales et internationales concernant les indications de la technique du ganglion sentinelle et du curage axillaire complémentaire après ganglion sentinelle positif dans la prise en charge des cancers du sein

Management of breast cancer is based on national and international guidelines. These are defined on evidence-based medicine. The main purpose of this review is to compare the different guidelines for sentinel lymph node biopsy and completion axillary dissection after positive sentinel lymph node biopsy. This review of breast cancer guidelines led to identify consensus, but in some specific situations, they differ. The guidelines cannot be applied to all clinical cases, mandatoring multidisciplinary meetings are essential.

Abstract P2-01-11: Prospective evaluation of the reliability of the combined use of two models to predict non-sentinel lymph node status in breast cancer patients with metastatic sentinel lymph nodes: The MSKCC nomogram and the Tenon score – PHRC-NOTEGS study

Background: Several mathematical models have been developed to predict non-SN status in patients with breast cancer with SN metastasis. The Memorial Sloan-Kettering Cancer Center nomogram and Tenon score outperform other methods in academic studies but their exportability at multiple geographic locations and practice settings has never been reported. The purpose of this study was to prospectively evaluate the combined use of the MSKCC nomogram (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom additional axillary lymph node dissection (ALND) could be avoided. Material and methods: From January 2011 to July 2012, data on 3157 patients with breast cancer from 65 institutions (university affiliated, general, regional hospital, nonprofit private hospital and private practice) were prospectively recorded (NCT01509963). Selection criteria were patients aged over 18 years old with untreated invasive T1-2 breast cancer with an indication of SN procedure. The primary outcome measure was the false negative rate in patients with both a ≤10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ≤3.5 (i.e. low risk): proportion of patients with metastatic non-SN at additional ALND. The hypothesis was a 5%±5% rate in this group of patients. Other patients were considered at high risk. Because of the results of the Z011 and IBCSG 23-01 trials, additional ALND was not mandatory.in case of metastatic SN. Results: Among the 2936 patients, at least one SN was metastatic (isolated tumor cells, micro- or macrometastasis) in 696 patients (23.7%). Among them, 178 did not have completion ALND. Among patients with completion ALND (n=518, 74.4%), 67 (13%), 437 (84%) and 14 (3%) patients were at low, high and undetermined combined risk while 47.5% were at low risk in patients without completion ALND (p Conclusion: In this controlled prospective trial, metastatic SN patients with both a ≤ 10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ≤ 3.5 had completion axillary dissection in 47% of cases: in these patients, the false negative rate was statistically over 5% and did not reach the primary endpoint. Further evaluation is warranted to determine the outcome of patients with and without axillary dissection. Citation Format: Roman Rouzier, Catherine Uzan, Alexandra Rousseau, Eugenie Guillot, Sonia Zilberman, Charles Meyer, Pablo Estevez, Pierre-Francois Dupre, David Kere, Virginie Doridot, Gauthier D9halluin, Xavier Fritel, Nicolas Pouget, Chafika Mazouni, Tabassome Simon, Charles Coutant. Prospective evaluation of the reliability of the combined use of two models to predict non-sentinel lymph node status in breast cancer patients with metastatic sentinel lymph nodes: The MSKCC nomogram and the Tenon score – PHRC-NOTEGS study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-01-11.

Actualités sur l’assistance robotisée en chirurgie oncogynécologique

Laparoscopic approach, over the past 20 years, has become, in gynoncologic surgery, a gold standard for several teams. Introduced 10 years ago, robotic-assisted laparoscopy is increasingly used in the gynecologic surgical field. For the surgeon, advantages of this intuitive robotic surgery are the three-dimensional approaches, the precision of the dissection with robotic instrument articulation, and a shorter learning curve compared with conventional laparoscopy. For the patients, a quicker postoperative recovery, less postoperative pain, and lower blood loss compared with laparoscopy seem to emerge. This review summarizes all the published results of robotic assistance used in cervical and endometrial cancer surgical management.RésuméDepuis 20 ans, la coelioscopie est devenue une voie d’abord chirurgicale incontournable, particulièrement en gynécologie. Introduite depuis une dizaine d’années, l’assistance robotisée est de plus en plus utilisée, la chirurgie gynécologique oncologique constituant un éventail d’indications privilégié. Pour le chirurgien, ses avantages sont la restitution d’une vision en trois dimensions, l’absence de tout tremblement et donc une précision du geste plus grande (les instruments sont voués de sept degrés de libertéet permettant des mouvements à 360°), et enfin un apprentissage plus rapide que la coelioscopie conventionnelle. Pour nos patientes, les publications actuelles semblent en faveur d’une diminution de la morbidité (réduction des hémorragies peropératoires, diminution des douleurs postopératoires, durée d’hospitalisation plus courte). Dans cette revue de la littérature, nous faisons un état des lieux des résultats de l’assistance robotisée appliquée à la prise en charge des cancers pelviens.