Lymphovascular invasion has a significant prognostic impact in patients with early breast cancer, results from a large, national, multicenter, retrospective cohort study.

BACKGROUND: We determined the prognostic impact of lymphovascular invasion (LVI) in a large, national, multicenter, retrospective cohort of patients with early breast cancer (BC) according to numerous factors. PATIENTS AND METHODS: We collected data on 17 322 early BC patients treated in 13 French cancer centers from 1991 to 2013. Survival functions were calculated using the Kaplan-Meier method and multivariate survival analyses were carried out using the Cox proportional hazards regression model adjusted for significant variables associated with LVI or not. Two propensity score-based matching approaches were used to balance differences in known prognostic variables associated with LVI status and to assess the impact of adjuvant chemotherapy (AC) in LVI-positive luminal A-like patients. RESULTS: LVI was present in 24.3% (4205) of patients. LVI was significantly and independently associated with all clinical and pathological characteristics analyzed in the entire population and according to endocrine receptor (ER) status except for the time period in binary logistic regression. According to multivariate analyses including ER status, AC, grade, and tumor subtypes, the presence of LVI was significantly associated with a negative prognostic impact on overall (OS), disease-free (DFS), and metastasis-free survival (MFS) in all patients [hazard ratio (HR) = 1.345, HR = 1.312, and HR = 1.415, respectively; P < 0.0001], which was also observed in the propensity score-based analysis in addition to the association of AC with a significant increase in both OS and DFS in LVI-positive luminal A-like patients. LVI did not have a significant impact in either patients with ER-positive grade 3 tumors or those with AC-treated luminal A-like tumors. CONCLUSION: The presence of LVI has an independent negative prognostic impact on OS, DFS, and MFS in early BC patients, except in ER-positive grade 3 tumors and in those with luminal A-like tumors treated with AC. Therefore, LVI may indicate the existence of a subset of luminal A-like patients who may still benefit from adjuvant therapy.

Lack of prognostic impact of sentinel node micro-metastases in endocrine receptor-positive early breast cancer: results from a large multicenter cohort☆.

BACKGROUND: Prognostic impact of lymph node micro-metastases (pN1mi) has been discordantly reported in the literature. The need to clarify this point for decision-making regarding adjuvant therapy, particularly for patients with endocrine receptor (ER)-positive status and HER2-negative tumors, is further reinforced by the generalization of gene expression signatures using pN status in their recommendation algorithm. PATIENTS AND METHODS: We retrospectively analyzed 13 773 patients treated for ER-positive breast cancer in 13 French cancer centers from 1999 to 2014. Five categories of axillary lymph node (LN) status were defined: negative LN (pN0i-), isolated tumor cells [pN0(i+)], pN1mi, and pN1 divided into single (pN1 = 1) and multiple (pN1 > 1) macro-metastases (>2 mm). The effect of LN micro-metastases on outcomes was investigated both in the entire cohort of patients and in clinically relevant subgroups according to tumor subtypes. Propensity-score-based matching was used to balance differences in known prognostic variables associated with pN status. RESULTS: As determined by sentinel LN biopsy, 9427 patients were pN0 (68.4%), 546 pN0(i+) (4.0%), 1446 pN1mi (10.5%) and 2354 pN1 with macro-metastases (17.1%). With a median follow-up of 61.25 months, pN1 status, but not pN1mi, significantly impacted overall survival (OS), disease-free survival (DFS), metastasis-free survival (MFS), and breast-cancer-specific survival. In the subgroup of patients with known tumor subtype, pN1 = 1, as pN1 > 1, but not pN1mi, had a significant prognostic impact on OS. DFS and MFS were only impacted by pN1 > 1. Similar results were observed in the subgroup of patients with luminal A-like tumors (n = 7101). In the matched population analysis, pN1macro, but not pN1mi, had a statistically significant negative impact on MFS and OS. CONCLUSION: LN micro-metastases have no detectable prognostic impact and should not be considered as a determining factor in indicating adjuvant chemotherapy. The evaluation of the risk of recurrence using second-generation signatures should be calculated considering micro-metastases as pN0.

Prophylactic nipple-sparing mastectomy with immediate breast reconstruction: results of a French prospective trial.

BACKGROUND: Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is used increasingly when performing a prophylactic mastectomy. Few prospective studies have reported on complication rates. This complementary trial to the French prospective multicentre MAPAM trial aimed to evaluate the nipple-areola complex (NAC) necrosis rate in prophylactic NSM with IBR. METHODS: Patient characteristics and surgical data were recorded. Morbidity after prophylactic NSM with a focus on NAC necrosis was analysed. RESULTS: Among 59 women undergoing prophylactic NSM, 19 (32 per cent) of the incisions were partly on the NAC. Reconstructions were performed with 46 definitive implants and 13 expanders. The crude rate of postoperative complications was 25 per cent (15 patients). Complete NAC necrosis was reported in two women (3 per cent) and partial or total necrosis in nine (15 per cent). No NAC resection was necessary. Median BMI was lower in women with total or partial NAC necrosis compared with the others (20.0 versus 21.3 kg/m2 respectively; P = 0.034). CONCLUSION: Results of this prospective study confirm that prophylactic NSM with IBR is associated with a low risk of total NAC necrosis.

Breast cancer robotic nipple sparing mastectomy: evaluation of several surgical procedures and learning curve.

BACKGROUND: Few studies of robotic nipple sparing mastectomy (NSM) were reported. We report feasibility of robotic NSM and determine standard surgical procedure and learning curve threefold. METHODS: A cohort of patients with robotic NSM for breast cancer was analyzed. Complications and post-operative hospitalization stay were reported. The same technic was used for all patients except for skin and nipple areolar complex (NAC) dissection. Differences between three surgical procedures of NAC dissection were analyzed: group 1, dissection with robotic scissors using coagulation; group 2, dissection with robotic scissors without coagulation; and group 3, dissection with non-robotic scissors and then robotic dissection. We explored possible effect of learning curve among patients from group 1 with the same surgical procedure. RESULTS: Twenty-seven NSM with immediate breast reconstruction for breast cancers, 22 invasive and 5 in situ, were performed, with robotic latissimus dorsi-flap (RLDF) only in 17 cases, RLDF and breast implant in 6 cases, and implant alone in 4 cases. Repartition according to 3 surgical procedure groups was 16, 5, and 6 patients. Mean time of surgery and anesthesia decrease according to groups 1 to 3. Among 16 patients from group 1, time of surgery and anesthesia decreased with learning curve. Post-operative hospitalization decreased from group 1 to 3. We reported a total of 11 complications, with significant difference between groups (10 for group 1). Skin complications were higher for group 1 in comparison with groups 2-3 (p = 0.02). CONCLUSION: Robotic NSM can be performed with a brief learning. Standardized technique is proposed with non-robotic scissors superficial dissection and then dissection with robot.

Sentinel lymph node biopsy without axillary lymphadenectomy after neoadjuvant chemotherapy is accurate and safe for selected patients: the GANEA 2 study.

PURPOSE: GANEA2 study was designed to assess accuracy and safety of sentinel lymph node (SLN) after neo-adjuvant chemotherapy (NAC) in breast cancer patients. METHODS: Early breast cancer patients treated with NAC were included. Before NAC, patients with cytologically proven node involvement were allocated into the pN1 group, other patient were allocated into the cN0 group. After NAC, pN1 group patients underwent SLN and axillary lymph node dissection (ALND); cN0 group patients underwent SLN and ALND only in case of mapping failure or SLN involvement. The main endpoint was SLN false negative rate (FNR). Secondary endpoints were predictive factors for remaining positive ALND and survival of patients treated with SLN alone. RESULTS: From 2010 to 2014, 957 patients were included. Among the 419 patients from the cN0 group treated with SLN alone, one axillary relapse occurred during the follow-up. Among pN1 group patients, with successful mapping, 103 had a negative SLN. The FNR was 11.9% (95% CI 7.3-17.9%). Multivariate analysis showed that residual breast tumor size after NAC ≥ 5 mm and lympho-vascular invasion remained independent predictors for involved ALND. For patients with initially involved node, with negative SLN after NAC, no lympho-vascular invasion and a remaining breast tumor size 5 mm, the risk of a positive ALND is 3.7% regardless the number of SLN removed. CONCLUSION: In patients with no initial node involvement, negative SLN after NAC allows to safely avoid an ALND. Residual breast tumor and lympho-vascular invasion after NAC allow identifying patients with initially involved node with a low risk of ALND involvement.

Pelvic exenterations for gynecologic cancers: A retrospective analysis of a 30-year experience in a cancer center.

INTRODUCTION: The objective of this study was to report a 30-year experience of PE for gynecologic malignancies in a cancer center. MATERIALS AND METHODS: A retrospective study was conducted at Institut Paoli-Calmette including patients who underwent PE for gynecologic malignancies. Four periods were evaluated: P1 before 1992, P2 between 1993 and 1999, P3 between 2000 and 2006 and P4 after 2006. The study evaluated the number of PE performed during each period, the type of PE, its level, indication, location of the primary tumor, patient age, previous radiotherapy ≥45 Gy, the rate of "curative" PE and exenteration-related reconstructive techniques. 90-day post-operative mortality and morbidity using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 4.03 were reported. RESULTS: 277 PE were performed. The number of PE performed for recurrences rose during the study period (p = 0.042), PE performed for central tumors increased during P3 (64.4%) and P4 (67.4%) (p < 0.0001) and administration of radiotherapy ≥45 Gy was more frequent (p < 0.0001). The rate of "curative" PE increased (p < 0.0001). In multivariate analysis, "curative" PE were correlated with PE type, central locations and study period. Pelvic filling was progressively more frequently performed (p = 0.002). 90-day complication rate was 56.3%. In multivariate analysis there was a significant difference in distribution of CTCAE grade 3-4-5 morbidity depending on the period. Overall survival (OS) improved during the 2 last periods (p = 0.008). CONCLUSION: A better selection of eligible patients for PE, namely through improvement in imaging techniques, has enabled to raise the rate of curative PE.

Can we use robotic surgery for the treatment of pelvic recurrence and locally advanced tumors in gynecological surgery?

Over the past 20 years, feasibility of laparoscopic approaches has been validated in gynecologic surgery. This procedure has specific challenges due its longer learning curve and the limits imposed by the technique. For the surgical treatment of recurrent pelvic cancers or locally advanced tumors, open surgery remains the gold standard for most surgical teams. Robotic assistance could be an interesting alternative. The aim of this study is to present our department's robotic surgical procedures in this specific field and show its feasibility and reproducibility on several patients.

Prospective Assessment of First-Year Quality of Life After Pelvic Exenteration for Gynecologic Malignancy: A French Multicentric Study.

BACKGROUND: Pelvic exenteration remains one of the most mutilating procedures, with important postoperative morbidity, an altered body image, and long-term physical and psychosocial concerns. This study aimed to assess quality of life (QOL) during the first year after pelvic exenteration for gynecologic malignancy performed with curative intent. METHODS: A French multicentric prospective study was performed by including patients who underwent pelvic exenteration. Quality of life by measurement of functional and symptom scales was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3.0) and the EORTC QLQ-OV28 questionnaires before surgery, at baseline, and 1, 3, 6, and 12 months after the procedure. RESULTS: The study enrolled 97 patients. Quality of life including physical, personal, fatigue, and anorexia reported in the QLQ-C30 was significantly reduced 1 month postoperatively and improved at least to baseline level 1 year after the procedure. Body image also was significantly reduced 1 month postoperatively. Global health, emotional, dyspnea, and anorexia items were significantly improved 1 year after surgery compared with baseline values. Unlike younger patients, elderly patients did not regain physical and social activities after pelvic exenteration. CONCLUSIONS: Therapeutic decision on performing a pelvic exenteration can have a severe and permanent impact on all aspects of patients' QOL. Deterioration of QOL was most significant during the first 3 months after surgery. Elderly patients were the only group of patients with permanent decreased physical and social function. Preoperative evaluation and postoperative follow-up evaluation should include health-related QOL instruments, counseling by a multidisciplinary team to cover all aspects concerning stoma care, sexual function, and long-term concerns after surgery.

Adjuvant chemotherapy in pT1ab node-negative triple-negative breast carcinomas: Results of a national multi-institutional retrospective study.

BACKGROUND: Triple-negative breast cancers (TNBCs) are considered as associated with poor outcome, but prognosis of subcentimetric, node-negative disease remains controversial and evidence that adjuvant chemotherapy (CT) is effective in these small tumours remains limited. PATIENTS AND METHODS: Our objective was to investigate the impact of CT on survival in pT1abN0M0 TNBC. Patients were retrospectively identified from a cohort of 22,475 patients who underwent primary surgery in 15 French centres between 1987 and 2013. As rare pathological types may display very particular prognoses in these tumours, we retained only the invasive ductal carcinomas of no special type according to the last World Health Organisation (WHO) classification which is the most common TNBC histological type. End-points were disease-free survival (DFS) and metastasis-free survival (MFS). A propensity score for receiving CT was estimated using a logistic regression including age, tumour size, Scarff Bloom and Richardson (SBR) grade and lymphovascular invasion. RESULTS: Of a total of 284 patients with pT1abN0M0 ductal TNBC, 144 (51%) received CT and 140 (49%) did not. Patients receiving CT had more adverse prognostic features, such as tumour size, high grade, young age, and lymphovascular invasion. CT was not associated with a significant benefit for DFS (Hazard ratio, HR = 0.77 [0.40-1.46]; p = 0.419, log-rank test) or MFS (HR = 1.00 [0.46-2.19]; p = 0.997), with 5-year DFS and MFS in the group with CT versus without of 90% [81-94%] versus 84% [74-90%], and 90% [81-95%] versus 90% [83%-95%], respectively. Results were consistent in all supportive analyses including multivariate Cox model and the use of the propensity score for adjustment and as a matching factor for case-control analyses. CONCLUSIONS: This study did not identify a significant DFS or MFS advantage for CT in subcentimetric, node-negative ductal TNBC. Although current consensus guidelines recommend consideration of CT in all TNBC larger than 5 mm, clinicians should carefully discuss benefit/risk ratio with patients, given the unproven benefits.

Radio-surgical and pathologic correlations of pelvic intravenous leiomyomatosis.

Intravenous leiomyomatosis has an unusual growth pattern characterized by proliferation of smooth muscle in uterine and systemic veins. Although histologically benign, this condition could eventually have a clinically aggressive course. At an early stage, the disease is often misdiagnosed on preoperative imaging because of its low prevalence, non-specific initial clinical manifestation, and poorly known radiological characteristics. An early, accurate diagnosis is needed for appropriate surgical management that could result in a good prognosis, reducing the risk of recurrence and morbidity. Magnetic resonance imaging is a particularly valuable technique for assessing intravenous leiomyomatosis preoperatively.

Survival after breast cancer local recurrence according to therapeutic strategies.

AIMS: To compare survival outcomes after mastectomy (Mt) and lumpectomy plus interstitial brachytherapy (LpIB) in the treatment of breast cancer local recurrence (LR) occurring after conservative surgery. METHODS: Medical records of patients treated for an isolated LR from January 1, 1981 to December 31, 2009 were reviewed. To overcome the bias due to the fact that treatment choice (Mt or LpIB) was based on prognostic factors with LpIB proposed preferentially to women with good prognosis, Mt and LpIB populations were matched and compared with regard to overall survival (OS) and metastasis free survival (MFS). RESULTS: Among 348 patients analyzed, 66.7% underwent Mt, 17.8% LpIB and 15.5% Lp alone. After a median follow-up of 73.3 months, 65 patients had died (42/232 Mt, 8/62 LpIB, 15/54 Lp). Before matching, OS and MFS at 5 years were significantly better in the LpIB compared to the Mt group, due to significantly more frequent poor prognostic factors in the latter (p = 0,07 and p = 0,09 respectively, log-rank significance limit of 10%). After matching, the benefits of LpIB disappeared since MFS and OS rates were not significantly different in both groups (p = 0.68 and 0.88 respectively). After LpIB, the second LR rate was 17% at 5 years and 30% at 10 years. CONCLUSION: A second conservative breast cancer treatment associating lumpectomy and interstitial brachytherapy is possible for selected patients with LR, without decrease in neither OS nor MFS compared to mastectomy.

[Mastectomy in ambulatory hospitalization or 24hours: Feasibility, satisfaction and preferences of the patients]. / Mastectomie en hospitalisation ambulatoire ou de 24heures : faisabilité, satisfaction et préférences des patientes.

The aim of this study is to analyze the feasibility of ambulatory hospitalization or 24hours hospitalization for breast cancer treatment by mastectomy, as well as the satisfaction and the preferences of patients with regard to these ways of hospitalization. METHODS: This observational retrospective study listed the patients operated for breast cancer who had required a mastectomy at the institute Paoli-Calmettes between the 1st of January 2013 and June 30th, 2015. A questionnaire of satisfaction was proposed to the patients regarding their mode of hospitalization. RESULTS: One hundred and thirteen patients were included among which 29 were in the ambulatory group and 84 in the 24hours hospitalization group. The complications were represented by the rate of hematomas (3.5 %), which required a surgical resumption for two of the patients in the 24hours hospitalization group and for one patient in the ambulatory group (P=0.75). Patient's satisfaction rate was globally high: 72.7 % regardless of the mode of hospitalization (P=0.064). CONCLUSION: The realization of mastectomy in ambulatory hospitalization seems feasible when the organization in pre- and postoperative is anticipated with a high degree of satisfaction of the patients. The psychological impact of this radical surgery seems to be a factor to be taken into account and requires a meticulous selection of the patients.

Quality of life after mastectomy with or without immediate breast reconstruction.

BACKGROUND: Mastectomy with immediate breast reconstruction (IBR) is a surgical strategy in breast cancer when breast-conserving surgery is not an option. There is a lack of evidence showing an advantage of mastectomy plus IBR over mastectomy alone on health-related quality of life (QoL). METHODS: A large prospective multicentre survey, STIC-RMI (support of innovative and expensive techniques - immediate breast reconstruction), was undertaken to study the changes in QoL in patients treated by mastectomy with or without IBR. Patients were recruited between 2007 and 2009. European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 instruments were used to assess QoL before operation, and at 6 and 12 months after surgery. A propensity score was used to compare QoL between mastectomy alone and mastectomy plus IBR, with limited bias. RESULTS: A total of 595 patients were included from 22 French academic hospitals, of whom 407 (68·4 per cent) underwent IBR. One-year data were available for 71·1 per cent of patients. Factors associated with IBR were age, histological tumour type, palpable nodes and an attempt at breast-conserving surgery. At inclusion, QoL was significantly better in the IBR group (P < 0·001) and there was no significant change in either group during 1 year compared with baseline. Results for the QLQ-BR23 functional dimension varied according to propensity score quartiles; IBR had no influence in the lowest quartile. In the upper quartiles, QoL increased slightly over the year among patients who had IBR, whereas it decreased among those who had mastectomy alone (P = 0·037). Satisfaction with the cosmetic outcome strongly influenced QoL, especially in upper quartiles (P < 0·001). However, an unsatisfactory outcome after IBR was still considered a better condition than simple mastectomy. CONCLUSION: The QoL benefit provided by IBR depends on patients' life status at inclusion; young active women with an in situ tumour are more likely to preserve their QoL after IBR.

Impact of age on surgical staging and approaches (laparotomy, laparoscopy and robotic surgery) in endometrial cancer management.

OBJECTIVE: This study aims to evaluate the different surgical approaches, perioperative morbidity and surgical staging according to age in patients with endometrial cancer. METHODS: Multicentre retrospective study. Cancer characteristics and perioperative data were collected for patients surgically treated for endometrial cancer. The patients were divided into 2 groups according to their age: younger or older than 75 years. RESULTS: Surgery was performed on 270 women <75 years old and on 74 ≥ 75 years old. Minimally invasive surgery was performed less often in the elderly compared with their younger counterparts (58.2% vs. 74.8%; p = 0.006). Independently of the surgical approach, the rate of pelvic and para-aortic lymphadenectomy was lower in women older than 75 years old than their younger counterparts (52.7% vs. 74.8%; p < 0.001; 8.1% vs. 21.8%; p = 0.007 respectively). According to the guidelines, more frequent surgical understaging was seen in the elderly compared with the younger (37% vs. 15.2%; p = 0.002). In the comparison of complications for each surgical approach, there was no statistical difference in the ≥75-year-old age group in terms of intra- or postoperative complications between the laparotomy, laparoscopy or robotic surgery group. We found a shorter length of hospital stay for the women who underwent laparoscopy or robotic surgery compared with laparotomy (p < 0.0001). CONCLUSION: Elderly women with endometrial cancer are often surgically understaged whereas there is no evidence of greater perioperative complications than for their younger counterparts. They should benefit from minimally invasive surgery and optimal surgical staging to the same extent as younger women.

Pathological complete response in invasive breast cancer treated by skin sparing mastectomy and immediate reconstruction following neoadjuvant chemotherapy and radiation therapy: Comparison between immunohistochemical subtypes.

CONTEXT: Even if neoadjuvant chemotherapy (NACT) and oncoplastic techniques have increased the breast conserving surgery rate, mastectomy is still a standard for multifocal or extensive breast cancers (BC). In the prospect of increasing breast reconstruction, an alternative therapeutic protocol was developed combining NACT with neoadjuvant radiation therapy (NART), followed by mastectomy with immediate breast reconstruction (IBR). The oncological safety of this therapeutic plan still needs further exploration. We assessed pathological complete response (pCR) as a surrogate endpoint for disease free survival. METHODS: Between 2010 and 2016, 103 patients undergoing mastectomy after NACT and NART were recruited. After CT and RT were administrated, a completion mastectomy with IBR by latissimus dorsi flap was achieved 6 to 8 weeks later. pCR was defined by the absence of residual invasive disease in both nodes and breast. Histologic response was analyzed for each immunohistochemical subset. RESULTS: pCR was obtained for 53.4% of the patients. This pCR rate was higher in hormonal receptor negative (HER2 and triple negative) patients when compared to luminal tumours (69.7% vs 45.7%, p=0.023). DISCUSSION: The pCR rate found in this study is higher than those published in studies analyzing NACT (12.5%-27.1%). This can be explained by the combination of anthracycline and taxane, the use of trastuzumab when HER2 was overexpressed but also by RT associated to NACT. CONCLUSION: Inverting the sequence protocol for BC, requiring both CT and RT, allows more IBR without diminishing pCR and should therefore be considered as an acceptable therapeutic option.

[Single-port versus mini-laparoscopy in benign adnexal surgery: Results of a not randomized pilot study]. / Cœlioscopie monotrocart versus micro-cœlioscopie dans la chirurgie annexielle bénigne : résultats d'une étude pilote non randomisée.

OBJECTIVE: Carry out a preliminary study comparing postoperative pain and intraoperative and postoperative complications between micro-laparoscopy and laparoscopic monotrocart non-oncological adnexal surgery. METHODS: All patients should benefit from a benign adnexal surgery were included prospectively from February to May 2014. The insufflation pressure, infiltration of trocar holes with a local anesthetic, postoperative analgesics were prescribed standardized. Operative and postoperative complications, type and length of hospital stay as well as EVA and analgesic consumption were recorded. RESULTS: Nine patients were included in monotrocart group versus 7 in the micro-laparoscopy group. There were no differences in operative and postoperative complications, the type and length of hospital stay, as well as cosmetics satisfaction. However, there was a significant difference in the VAS to D2 (2.15 vs. 4.08, P=0.04) and analgesic consumption at D0 (P=0.04), D1 (P=0.04), D2 (P=0.02) and D3 (P=0.01), for the benefit of micro-laparoscopy. DISCUSSION AND CONCLUSION: Despite an enrollment of patients low, micro-laparoscopy appears to have a significant advantage over the monotrocart laparoscopy for postoperative pain in benign adnexal surgery.

Axillary lymph node micrometastases decrease triple-negative early breast cancer survival.

BACKGROUND: Triple-negative breast cancers (TNBCs) are the most deadly form of breast cancer (BC) subtypes. Axillary lymph node involvement (ALNI) has been described to be prognostic in BC taken as a whole, but its prognostic value in each subtype is unclear. We explored the prognostic impact of ALNI and especially of small size axillary metastases in early TNBCs. METHODS: We analysed in this multicentre study all patients treated for early TNBC in 12 French cancer centres. We explored the correlation between clinicopathological data and ALNI, with a specific focus on the dichotomisation between macrometastases and occult metastases, which is defined as the presence of isolated tumour cells or micrometastases. The prognostic value of ALNI both in terms of disease-free survival (DFS) and overall survival (OS) was also explored. RESULTS: We included 1237 TNBC patients. Five-year DFS and OS were 83.7% and 88.5%, respectively. The identified independent prognostic features for DFS were tumour size >20 mm (hazard ratio (HR)=1.86; 95% CI: 1.11-3.10, P=0.018), lymphovascular invasion (HR=1.69; 95% CI: 1.21-2.34, P=0.002) and ALNI both in case of macrometastases (HR=1.97; 95% CI: 1.38-2.81, P<0.0001) and occult metastases (HR=1.72; 95% CI: 1.1-2.71, P=0.019). DFS and OS were similar between tumours with occult metastases and macrometastases. Tumours presenting at least two pejorative features (out of ALNI, lymphovascular invasion and large tumour size) displayed a significantly poorer DFS in both the training set and validation set, independently of chemotherapy administration. Tumours with no more than one of the above-cited pejorative features had a 5-year OS of ⩾90% vs 70% for other cases (P<0.0001). CONCLUSIONS: Axillary lymph node involvement is a key prognostic feature for early TNBC when isolated tumour cells were identified in lymph nodes. This impact is independent of chemotherapy use.

Impact of completion axillary lymph node dissection in patients with breast cancer and isolated tumour cells or micrometastases in sentinel nodes.

BACKGROUND: Omission of completion axillary lymph node dissection (ALND) is a standard practice in patients with breast cancer (BC) and negative sentinel nodes (SNs) but has shown insufficient evidence to be recommended in those with SN invasion. METHODS: A retrospective analysis of a cohort of patients with BC and micrometastases (Mic) or isolated tumour cells (ITCs) in SN. Factors associated with ALND were identified, and patients with ALND were matched to patients without ALND. Overall survival (OS) and recurrence-free survival (RFS) were estimated in the overall population, in Mic and in ITC cohorts. FINDINGS: Among 2009 patients analysed, 1390 and 619 had Mic and ITC in SN, respectively. Factors significantly associated with ALND were SN status, histological type, age, number of SN harvested and absence of adjuvant chemotherapy. After a median follow-up of 60.4 months, ALND omission was independently associated with reduced OS (hazard ratio [HR] 2.41, 90 confidence interval [CI] 1.36-4.27, p = 0.0102), but not with increased RFS (HR 1.21, 90 CI 0.74-2.0, p = 0.52) in the overall population. In matched patients, the increased risk of death in case of ALND omission was found only in the Mic cohort (HR 2.88, 90 CI 1.46-5.69), not in the ITC cohort. The risk of recurrence was also significantly increased in the subgroup of matched Mic patients (HR 1.56, 90 CI 0.90-2.73). INTERPRETATION: A separate analysis of Mic and ITC groups, matched for the determinants of ALND, suggested that patients with Mic had increased recurrence rates and shorter OS when ALND was not performed. Our results are consistent with those of previous studies for patients with ITC but not for those with Mic. Randomised controlled clinical trials are still warranted to show with a high level of evidence if ALND can be safely omitted in patients with micrometastatic disease in SN.