INTRODUCTION:Bilobectomy is an uncommon but sometimes necessary procedure in selected patients with non-small cell lung cancer (NSCLC). However, whether outcomes are influenced by resection type or underlying surgical indication remains unclear. MATERIALS AND METHODS:This single-center study included consecutive patients undergoing bilobectomy for NSCLC between 2010 and 2024. Upper and lower bilobectomies were analyzed separately and stratified by surgical indication (trans-fissural invasion, N1 disease, or endobronchial involvement). Endpoints included major postoperative complications, overall survival (OS), and disease-free survival (DFS). Multivariable analyses identified independent predictors of outcomes. RESULTS:A total of 153 patients were included, of whom 27 (17.6%) underwent upper and 126 (82.4%) lower bilobectomy. The overall complication rate was 36.4%, higher after lower bilobectomy (p = 0.020), while no differences were observed according to surgical indication (p = 0.550). Five-year DFS and OS were 41.9% and 55.3%, with no significant differences by indication or resection type (all p > 0.05). At multivariable analysis, lower bilobectomy (OR 4.89, p = 0.011) and neoadjuvant therapy (OR 2.92, p = 0.010) were associated with postoperative complications. FEV1 independently predicted both DFS (HR 0.61, p = 0.018) and OS (HR 0.57, p = 0.015), whereas neither indication nor bilobectomy type influenced survival. CONCLUSION:Bilobectomy provides acceptable perioperative and oncologic outcomes in selected NSCLC patients. Long-term survival is primarily driven by tumor biology and functional status rather than surgical factors. While lower bilobectomy is associated with increased postoperative morbidity, resection type and indication do not independently affect survival.
The role of surgery in malignant pleural mesothelioma (MPM) remains controversial, particularly after the negative results of the MARS 1 and 2 trials. Lung-sparing cytoreductive procedures such as extended pleurectomy/decortication (eP/D) are increasingly adopted in high-volume centers, but real-world outcomes within multimodality pathways vary widely. This study analyzes our Institutional experience with parenchyma-sparing surgery in a trimodal strategy, focusing on perioperative outcomes, recurrence patterns, and survival, with particular attention to the prognostic impact of nodal status. We conducted a retrospective observational study including consecutive patients with epithelioid MPM who underwent eP/D with curative intent between 2010 and 2022 at a single tertiary Center. All patients were evaluated within a multidisciplinary framework and routinely received platinum–pemetrexed induction chemotherapy. Clinical, pathological, perioperative, and follow-up data were prospectively recorded. Survival was analyzed using Kaplan–Meier curves and Cox regression. A total of 102 patients were included. Median age was 65.9 years, and 75
Malignant pleural mesothelioma (MPM) poses an imaging challenge that requires special attention, especially in patients who have undergone talc pleurodesis. [18F]FDG PET/CT (FDG PET) is a validated imaging modality in oncology that has proven useful for detecting malignant pleural lesions. However, the inflammatory reaction induced by pleurodesis renders its interpretation unreliable. In this study, we assessed in parallel the role of [11C]Methionine PET/CT (MET PET) and FDG PET in MPM patients before and after talc pleurodesis. We prospectively enrolled 30 consecutive patients with clinical suspicion of MPM who were referred to our Institution from September 2014 to February 2016 for talc pleurodesis. The study was approved and registered at ClinicalTrials.gov (NCT02519049). Patients underwent assessment at baseline and after pleurodesis with two consecutive scans: FDG PET (standard imaging) and MET PET (experimental imaging). Semi-quantitative parameters were defined for both scans and statistically compared to pathological findings from video-assisted thoracoscopy (VATS), including SUVmax, SUVmean, metabolic tumor volume (MTV) and total lesion glycolysis for FDG PET or metabolic tumor burden (TLG or MTB = MTV x SUVmean) for MET PET. Twenty patients (M:F = 18:2; median age, 72 years) with MPM (18 epithelioid, 2 non-epithelioid) completed all study investigations. All tumors showed increased uptake of both FDG and MET PET. After talc pleurodesis, FDG PET showed a significant increase in mean and median MTV (P = 0.0005 and 0.0003, respectively) and mean and median TLG (P = 0.0172 and 0.0028, respectively). In contrast, MET PET parameters showed significant increases in mean and median SUVmax (P = 0.0208 and 0.0209, respectively) and SUVmean (P = 0.0106 and 0.0109, respectively) compared to baseline. There was a significant negative correlation between SUVmax, MTV and MTB/TLG and the percentage change at the early assessment post-pleurodesis for both MET PET (rho = -0.645, P < 0.01; rho = -0.517, P = 0.013; rho = -0.528, P = 0.011, respectively) and FDG PET (rho = -0.808, P < 0.01; rho = -0.781, P < 0.01; rho = -0.888, P < 0.01, respectively). The percentage change in SUVmax was significantly greater in FDG PET than for MET PET (+ 19 https://www.clinicaltrials.gov/ ).
Background:Postoperative pneumonia (PoP) is a significant complication that can arise after lung resection surgery, affecting between 1.5% and 12% of patients. This condition can result in serious consequences, including respiratory failure, extended hospital stays, and increased mortality rates. This study aimed to identify clinical and surgical risk factors for PoP and characterize the microbiological profile of infections in patients undergoing lung cancer surgery. Methods:A retrospective observational study was carried out involving 750 adult patients who underwent lung cancer surgery from 2017 to 2019 at the Thoracic Surgery Unit of IRCCS Humanitas Research Hospital. The study analyzed data on patient demographics, comorbidities, preoperative lung function, surgical details, and postoperative outcomes. The primary endpoint was the occurrence of PoP, which was defined based on radiological and clinical criteria occurring between 72 hours and postoperative day 7. Results:PoP was observed in 79 patients, representing 10.7% of the cohort. Identified risk factors for PoP included smoking, low preoperative lung function [measured by forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO)], chronic obstructive pulmonary disease (COPD), asthma, diabetes, a high American Society of Anesthesiologists (ASA) score, advanced cancer stages (III-IV), squamous cell carcinoma, and the use of neoadjuvant chemotherapy. Surgical risk factors included the use of open thoracotomy and the conversion from video-assisted thoracoscopic surgery (VATS)/robotic-assisted thoracoscopic surgery (RATS) to open thoracotomy. Patients who developed PoP experienced significantly worse postoperative outcomes, including higher rates of respiratory failure, longer hospital stays, and extended chest tube duration. In 87.3% of PoP cases, bronchoscopy with bronchoalveolar lavage was performed, revealing Escherichia coli (E. coli) and Pseudomonas aeruginosa as the most frequently identified pathogens. Conclusions:PoP is a common and clinically impactful complication after lung cancer surgery. Independent risk factors identified include asthma, higher ASA score, and conversion to thoracotomy. Endoscopic evaluation with microbiological sampling proved valuable for early diagnosis and targeted therapy. These findings support the implementation of optimized preoperative assessment, surgical planning, and multidisciplinary management strategies to reduce PoP incidence and improve clinical outcomes.
Background/objectives: Pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer (BC) is a solid indicator of favourable prognosis, potentially also being useful for more conservative patient management. We aim to explore the potential of [18F]FDG PET/CT as a non-invasive method to predict response to NAC. Methods: In this prospective, observational cohort study, we enrolled BC patient candidates for NAC who underwent baseline and preoperative [18F]FDG PET/CT. NAC response was determined using final histopathology. PET images were assessed qualitatively and semi-quantitatively, and the findings correlated with NAC response. Results: In total, 133 BC patients were included. The visual analysis of preoperative PET/CT detected residual disease (RD) with high specificity (>93%) and moderate sensitivity, based on pCR/RD classification and RCB index. Semiquantitative measures (SUVmax, TBR) were significantly higher in non-responders across the classification methods (p < 0.001 for all). Conclusions: These findings highlight the potential of preoperative [18F]FDG PET/CT as a complementary tool for identifying excellent responders to NAC across BC subtypes or response criteria. This could inform personalised treatment and potentially allow for surgery to be omitted in selected patients.
Video assisted thoracic surgery (VATS) lobectomy is the treatment of choice for early-stage lung cancer. It is safe and effective compared to open surgery, as demonstrated by a large body of scientific evidence over the last few decades. VATS lobectomy’s evolution was driven by the need to decrease post-operative pain by reducing the extent of surgical accesses, maintaining the same oncological efficacy of open lobectomy with less invasiveness. VATS lobectomy just turned 30 years old, evolving and changing significantly from its origins. The aim of this mini review is to retrace the history, starting from a multiport approach to a single port approach. At the end of this mini review, we will discuss the advanced and the future challenges of the technique that has revolutionized thoracic surgery.
Abstract Objectives The role of axillary surgery in the management of breast cancer (BC) has evolved considerably over the past decades, with only a few routine indications for axillary lymph node dissection (ALND) remaining in clinical practice. However, de-escalation of axillary surgery, especially in BC patients with 1-3 positive sentinel lymph nodes (SLNs) challenges the recently established criteria for adjuvant treatment (i.e., combination therapy with abemaciclib, endocrine therapy, and chemotherapy in patients with ≥ 4 positive nodes). The question remains as to whether these patients should undergo further ALND to determine whether ≥ 4 nodes are positive. To further investigate the latest controversies in axillary management of BC patients and predict the presence of ≥ 4 axillary lymph node metastasis, we evaluated and compared patients ≥ 4 positive nodes in the per-protocol population of the SINODAR-ONE clinical trial. Patients in the standard arm (ALND) of the per-protocol population were evaluated, and a comparison of characteristics between patients with ≥ 4 metastatic lymph nodes versus patients with 1-3 metastatic lymph nodes was performed. Categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate. Multivariable analysis was performed using a logistic regression model to identify independent predictors of ≥4 axillary lymph node metastasis. Results: Overall, 403 cN0 T1-2 BC patients in the per-protocol population were randomized to receive ALND. Of these, 65 and 338 patients presented with ≥ 4 or 1-3 axillary lymph node metastasis, respectively. Invasive lobular BC (26.2% versus 14.5% if other histology, odds ratio (OR)=4.185, 95% confidence interval (95%CI)= 1.284-1.443, p= 0.041), G3 (38.5% versus 21.3% if G1-2, OR=5.930, 95%CI= 2.134-2.289, p= 0.015), pT2 (46.2% versus 30.5% if pT1, OR=5.260, 95%CI= 15.330-16.346, p= 0.022), and 2 positive SLNs (32.3% versus 13.6% if 1 positive SLN, OR=13.188, 95%CI= 1.179-1.280, p< 0.0001) were found to significantly increase the probability to present ≥4 axillary lymph node metastasis at definitive histopathological evaluation. Conclusions: The introduction of abemaciclib and other combination therapies has the potential to impact the surgical management of the axilla. Our results suggest that a minority of cN0 T1-2 BC patients may be understaged if ALND is not performed. However, the improvements and increasing effectiveness of combination therapies may sufficiently control and treat the axillary tumor-burden left behind, potentially reducing the need for extensive axillary surgery, as demonstrated by the promising 3-year oncological outcomes of the SINODAR-ONE trial. Although ALND may still be considered, after multidisciplinary team discussion, in individual patients presenting with specific risk factors for additional axillary disease (lobular, G3, pT2 BC with 2 positive SLNs), our suggestion is that routine ALND is not indicated for systemic therapy decision-making in the upfront surgical setting. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Bottini, Alberto Testori, Valentina Errico, Simone Di Maria Grimaldi, Giulia Caraceni, Shadya Darwish, Giuseppe Canavese, Corrado Tinterri. To dissect or not to dissect? The surgeon’s perspective on the prediction of ≥ 4 axillary lymph node metastasis in cN0 T1-2 breast cancer: A comparative analysis of the per-protocol population of the SINODAR-ONE clinical trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS01-04.
BackgroundPostoperative seroma is most frequent after mastectomy (ME) in combination with axillary lymph node dissection (ALND), and its reported incidence varies from 15.5% up to 90%. Seromas can be responsible for discomfort, infections and can lead to reconstruction failure. Therefore, many ways of seroma prevention have been studied, although from a recent overview it has become clear that no single method is reliably successful. Mechanical closure of the dead space, however, was consistently found to be significantly effective. The aim of our study is to evaluate if quilting of the axilla, in patients undergoing ME, immediate prosthetic breast reconstruction and ALND reduces the duration of drain maintenance, the incidence of seromas that require aspiration (clinically significant seromas, CSS) and reconstruction failure rate.Materials and methodsIn our study population we analyzed a total of 81 patients divided into two groups: 27 consecutive patients undergoing mastectomy, axillary lymph node dissection (ALND), breast reconstruction and quilting of the axilla. We subsequently randomly picked up a double number of patients (54) undergoing the same oncological and reconstructive procedures without undergoing axillary quilting, matched for clinical characteristics in order to analyze efficacy of the procedure while reducing any bias. Our observational retrospective data was collected from October 2016 to July 2020 in one single high-volume center. Our median follow-up time was of 40.6 months.ResultsIn the case group we observed a reduced time of drain maintenance: 16 vs. 20 days observed in the non-quilted group (p < 0.05). Incidence of seromas that required aspiration was 11% in the control group, while 3,7% in the case group. In addition to that, we observed 6 cases of implant removal in the control group, while in the quilted group we only observed a single case.ConclusionPrevious literature and our results confirm that quilting of the axilla with flap fixation significantly decreases time of drain maintenance, allowing the earlier removal of the drains as well as decreasing the incidence of seroma, its eventual associated complications and related social costs. Moreover, our work suggests how quilting sutures decrease the incidence of seroma in patients undergoing immediate reconstruction, probably reducing the risk for implant removal.
Background: Despite the implementation of enhanced recovery programs, the reported average postoperative length of stay after robotic lobectomy remains as 4 days. In this prospective study, we present the outcomes of early discharge (on day 2) with telehealth home monitoring device after robotic lobectomy for lung cancer in selected patients. Methods: All patients with a caregiver were discharged on postoperative day 2 (POD 2) with a telemonitoring device provided they met the specific discharge criteria. Inclusion criteria: <75 years old, stage I-II NSCLC, with caregiver, ECOG 0–2, scheduled for lobectomy, logistic proximity to hospital (<60 km); intra-postoperative exclusion criteria: conversion to open surgery, early complications needing hospital monitoring or redo-operation, difficult pain management, <92 HbO2% saturation on room air or need for O2 supplementation, altered vital or laboratory parameters. Teleconsultations were scheduled as follows: the first one in afternoon of POD2, two on POD3, then once a day until chest tube removal. After discharge, patients recorded their vital signs at least four times a day using the device, which allowed two surgeons to monitor them via a mobile application. In the event of sudden changes in vital signs or the occurrence of adverse events, patients had access to a direct phone line and a dedicated re-hospitalization pathway. The primary outcome was safety, assessed by the occurrence of post-discharge complications or readmissions, as well as feasibility. Secondary outcomes: comparison of safety profile with a matched control group in which the standard of care and the evaluation of resource optimization were maintained and economic evaluation. Results: Between July 2022 and February 2024, 48 patients were enrolled in the present study. Six patients (12.5%) dropped out due to unsatisfied discharge criteria on POD2. Exclusion causes were: significant air leaks (n:2) requiring monitoring and the use of suction device, uncontrolled pain (n:2), atrial fibrillation, and occurrence of cerebral ischemia (n:1 each). The adherence rate to vital signs monitoring by patients was 100%. A mean number of four measurements per day was performed by each patient. During telehealth home monitoring, a total of 71/2163 (1.4%) vital sign measurements violated the established acceptable threshold in 22 (52%) patients. All critical violations were managed at home. During the surveillance period (defined as the time from POD 2 to the day of chest tube removal), a persistent air leak was recorded in one patient requiring readmission to the hospital (on POD 13) and re-intervention with placement of a second thoracic drainage due to unsatisfactory lung expansion. No other postoperative complication occurred nor was there any readmission needed. Compared to the control group, the discharge gain was 2.5 days, with an economic benefit of 528 €/day (55.440 € on the total enrolled population). Conclusions: Our results confirm that the adoption of telehealth home monitoring is feasible and allows a safe discharge on postoperative day two after robotic surgery for stage I-II NSCLC in selected patients. A potential economic benefit (141 days of hospitalizations avoided) for the healthcare system could result from the adoption of this protocol.
Background: The role of axillary surgery in the management of breast cancer (BC) has evolved considerably over the past decades, with only a few routine indications for axillary lymph node dissection (ALND) remaining in clinical practice. However, de-escalation of axillary surgery, especially in BC patients with 1-3 positive sentinel lymph nodes (SLNs) challenges the recently established criteria for adjuvant treatment (i.e., combination therapy with abemaciclib, endocrine therapy, and chemotherapy in patients with ≥4 positive nodes).
This record contains raw data related to article “Percutaneous Computed Tomography (CT)-Guided Localization with Indocyanine Green for the Thoracoscopic Resection of Small Pulmonary Nodules" Abstract Background: The identification of small lung nodules is challenging during mini-invasive thoracic surgery. Unable to palpate them directly, surgeons have developed several methods to preoperatively localize pulmonary nodules, including the computed tomography-guided positioning of coils or metallic landmarks (hook wire) or bronchoscopic marking. Methods: We present a series of patients scheduled for the video-assisted thoracoscopic sublobar resection of small pulmonary nodules, in which we performed preoperative percutaneous computed tomography (CT)-guided nodule localization through the injection of a mixture of indocyanine green and human albumin. Results: A total of 40 patients underwent a preoperative CT-guided injection of indocyanine green followed by VATS resection within 24 h. Patients tolerated the procedure well, no pain medication was administrated, and no complications were observed during the marking procedure. All pulmonary nodules were easily detected and successfully resected. Conclusion: the near-infrared dye marking solution of indocyanine green (ICG) with diluted human albumin was safe, effective, and easy to perform. The ICG solution has the potential to facilitate the accurate localization and resection of pulmonary nodules during VATS surgery, avoiding the risk of marker displacement/migration.
Background: The identification of small lung nodules is challenging during mini-invasive thoracic surgery. Unable to palpate them directly, surgeons have developed several methods to preoperatively localize pulmonary nodules, including the computed tomography-guided positioning of coils or metallic landmarks (hook wire) or bronchoscopic marking. Methods: We present a series of patients scheduled for the video-assisted thoracoscopic sublobar resection of small pulmonary nodules, in which we performed preoperative percutaneous computed tomography (CT)-guided nodule localization through the injection of a mixture of indocyanine green and human albumin. Results: A total of 40 patients underwent a preoperative CT-guided injection of indocyanine green followed by VATS resection within 24 h. Patients tolerated the procedure well, no pain medication was administrated, and no complications were observed during the marking procedure. All pulmonary nodules were easily detected and successfully resected. Conclusion: the near-infrared dye marking solution of indocyanine green (ICG) with diluted human albumin was safe, effective, and easy to perform. The ICG solution has the potential to facilitate the accurate localization and resection of pulmonary nodules during VATS surgery, avoiding the risk of marker displacement/migration.
Purpose. In modern breast cancer treatment, a growing role has been observed for breast reconstruction together with an increase in clinical indications for postmastectomy radiotherapy (PMRT). Choosing the optimum type of reconstructive technique is a clinical challenge. We therefore conducted a national multicenter study to analyze the impact of PMRT on breast reconstruction. Methods. We conducted a retrospective case-control multicenter study on women undergoing breast reconstruction. Data were collected from 18 Italian Breast Centres and stored in a cumulative database which included the following: autologous reconstruction, direct-to-implant (DTI), and tissue expander/immediate (TE/I). For all patients, we described complications and surgical endpoints to complications such as reconstruction failure, explant, change in type of reconstruction, and reintervention. Results. From 2001 to April 2020, 3116 patients were evaluated. The risk for any complication was significantly increased in patients receiving PMRT (aOR, 1.73; 95% CI, 1.33–2.24; p<0.001). PMRT was associated with a significant increase in the risk of capsular contracture in the DTI and TE/I groups (aOR, 2.24; 95% CI, 1.57–3.20; p<0.001). Comparing type of procedures, the risk of failure (aOR, 1.82; 95% CI, 1.06–3.12, p=0.030), explant (aOR, 3.34; 95% CI, 3.85–7.83, p<0.001), and severe complications (aOR, 2.54; 95% CI, 1.88–3.43, p<0.001) were significantly higher in the group undergoing DTI reconstruction as compared to TE/I reconstruction. Conclusion. Our study confirms that autologous reconstruction is the procedure least impacted by PMRT, while DTI appears to be the most impacted by PMRT, when compared with TE/I which shows a lower rate of explant and reconstruction failure. The trial is registered with NCT04783818, and the date of registration is 1 March, 2021, retrospectively registered.
Abstract Background The initial results of the SINODAR-ONE randomized clinical trial reported that patients with T1–2 breast cancer and one to two macrometastatic sentinel lymph nodes treated with breast-conserving surgery, sentinel lymph node biopsy only, and adjuvant therapy did not present worse 3-year survival, regional recurrence, or distant recurrence rates compared with those treated with axillary lymph node dissection. To extend the recommendation of axillary lymph node dissection omission even in patients treated with mastectomy, a sub-analysis of the SINODAR-ONE trial is presented here. Methods Patients with T1–2 breast cancer and no more than two metastatic sentinel lymph nodes undergoing mastectomy were analysed. After sentinel lymph node biopsy, patients were randomly assigned to receive either axillary lymph node dissection followed by adjuvant treatment (standard arm) or adjuvant treatment alone (experimental arm). The primary endpoint was overall survival. The secondary endpoint was recurrence-free survival. Results A total of 218 patients were treated with mastectomy; 111 were randomly assigned to the axillary lymph node dissection group and 107 to the sentinel lymph node biopsy-only group. At a median follow-up of 33.0 months, there were three deaths (two deaths in the axillary lymph node dissection group and one death in the sentinel lymph node biopsy-only group). There were five recurrences in each treatment arm. No axillary lymph node recurrence was observed. The 5-year overall survival rates were 97.8 and 98.7 per cent in the axillary lymph node dissection treatment arm and the sentinel lymph node biopsy-only treatment arm, respectively (P = 0.597). The 5-year recurrence-free survival rates were 95.7 and 94.1 per cent in the axillary lymph node dissection treatment arm and the sentinel lymph node biopsy treatment arm, respectively (P = 0.821). Conclusion In patients with T1–2 breast cancer and one to two macrometastatic sentinel lymph nodes treated with mastectomy, the overall survival and recurrence-free survival rates of patients treated with sentinel lymph node biopsy only were not inferior to those treated with axillary lymph node dissection. To strengthen the conclusion of the trial, the enrolment of patients treated with mastectomy was reopened as a single-arm experimental study. Registration number NCT05160324 (http://www.clinicaltrials.gov)
This record contains raw data related to article “Immediate direct-to-implant breast reconstruction: A single center comparison between different procedures" Background: The increased incidence of conservative mastectomy operations (nipple- and skin- sparing) has increased the frequency of immediate breast reconstructions (IBR). In order to guarantee patients the best possible aesthetic outcome, the least chance of complications and moreover, the least postoperative pain, the technique with prepectoral prosthetic pocket was recently reconsidered with the use of ADM. This is the first study using Fortiva® in prepectoral breast reconstruction, and it compares the outcomes of three different patient populations (undergoing retromuscular, prepectoral and prepectoral reconstruction with ADM). The authors suggest that prepectoral breast reconstruction with ADM may bring benefits compared to the current standard technique (retromuscular) as well as compared to the prepectoral reconstruction without ADM. Methods: Retrospective data analysis of patients who underwent mastectomy followed by immediate breast reconstruction with silicone implants (DTI), performed by a team of breast surgeons and plastic surgeons. Logistic factor regressions were performed in order to investigate the effects of the three different intervention techniques on the incidence of complications. Fisher's exact test was used to analyze the differences in the occurrence of each complication. Mann Whitney test was used to compare the averages of referred pain. A p value <0.05 was considered significant. Results: A total of 67 patients underwent DTI reconstruction, of which 43 with retromuscular prosthesis, 13 prepectoral and 11 prepectoral with ADM. We found a significantly lower incidence of surgical complications with ADM, exclusively in comparison with retromuscular reconstruction (p = 0.028). It emerges prepectoral reconstruction with ADM involves significantly less visibility of the implant than both the prepectoral surgery without ADM (p = 0.013) and the retromuscular technique (p = 0.029). Finally, postoperative pain referred at twelfth month is significantly less relevant in the group with prepectoral prosthesis and ADM, both in the group with retromuscular (p < 0.001) and prepectoral without ADM (p = 0.001). Conclusions: This study demonstrates that immediate prepectoral breast reconstruction with ADM is a safe and reliable technique, able to exceed some type of limits imposed by prepectoral reconstruction. Moreover, it provides benefits if compared to the current standard technique. In the future, this technique could also be added to it, after a proper selection of patients in pre- and intraoperative time.
BACKGROUND:Intraoperative localisation of nodal disease in non-small cell lung cancer (NSCLC) can be challenging. Lymph node localisation via radiopharmaceuticals is used in many conditions; we tested the feasibility of this approach in NSCLC.METHODS:NSCLC patients were prospectively recruited. Intraoperative peri-tumoral injections of [99mTc]Tc-albumin nanocolloids were performed, followed by removing the tumour and locoregional lymph nodes. These were examined ex vivo with a gamma probe and labelled sentinel lymph nodes (SLNs) if they showed any activity or non-sentinel lymph nodes (nSLNs) if they did not. Thereafter, the surgical field was scanned with the probe; any further radioactive lymph node was removed and labelled as "extra" SLNs (eSLNs). All specimens were sent to histology, and metastatic status was recorded.RESULTS:48 patients were enrolled, and 290 nodal stations were identified: 179 SLNs, 87 nSLNs, and 24 eSLNs. A total of 44 nodal metastases were identified in 22 patients, with 36 of them (82%) located within SLNs. Patients with nSLNs metastases had at least a co-existing positive SLN. No metastases were found in eSLNs.CONCLUSIONS:The technique shows high sensitivity for intraoperative nodal metastases identification. This information could allow selective lymphadenectomies in low-risk patients or more aggressive approaches in high-risk patients.
Abstract Introduction: Axillary lymph node dissection (ALND) has always been part of breast cancer (BC) treatment. However, during the past 25 years, the surgical management of the axilla has shifted towards a more conservative approach. Until now, ALND has remained the standard surgical technique when the sentinel lymph node (SLN) is macrometastatic. However, ALND may now be considered overtreatment for early-stage BC. The SINODAR-ONE trial is a prospective non-inferiority multicenter randomized study aimed at assessing the role of ALND in patients undergoing either breast-conserving surgery (BCS) or mastectomy for T1-2 BC presenting 1-2 macrometastatic SLNs. Objectives: The primary endpoint was to evaluate whether sentinel lymph node biopsy (SLNB) only was associated with clinically relevant worsening of the prognosis compared with ALND in terms of overall survival (OS). The secondary endpoint was to evaluate whether there was increased regional (lymph node recurrence) or distant recurrence in terms of recurrence-free survival (RFS) in patients with macrometastatic SLN who did not undergo ALND. Methods: Patients were randomly assigned (1:1 ratio) to either removal of ≥10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). Results: The trial started in April 2015 and ceased in April 2020, involving 889 patients. The majority of the patients (75.2%) underwent BCS; 328 of 439 patients (74.7%) in the standard treatment arm, and 333 of 440 patients (75.7%) in the experimental treatment arm. 218 patients (24.8%) underwent mastectomy. SLN status at randomization was comparable between the two groups of treatment, with a median number of two SLNs removed and a median number of one positive SLN in both arms. The median number of non-SLNs identified at definitive histopathological evaluation was 16 (interquartile range [IQR] 12–21) in the ALND group. Overall, 193 of 439 patients (44.0%) in the standard treatment arm had additional macrometastases in the removed axillary lymph nodes. However, the median number of positive non SLNs was 0 (IQR 0–1) in the ALND group. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with a 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with a 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB only arm, respectively (p = 0.936). Conclusion: The 3-year survival and relapse rates of T1-2 BC patients with 1-2 macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND in patients undergoing BCS. However, given the low number of patients treated with mastectomy, there is no certainty that ALND omission can be extended also to this sub-group. In order to collect further evidence regarding the safety of the experimental treatment in patients candidates for mastectomy, the reopening of the enrollment of these patients as part of a single-arm experimental study started in June 2022. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Testori, Valentina Errico, Alberto Bottini, Simone Di Maria Grimaldi, Giulia Caraceni, Luca Boni, Paolo Bruzzi, Bethania Fernandes, Davide Franceschini, Ruggero Spoto, Rosalba Torrisi, Marta Scorsetti, Armando Santoro, Giuseppe Canavese, Corrado Tinterri. Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-06-01.
EDITORIAL article Front. Surg., 10 January 2023Sec. Surgical Oncology Volume 9 - 2022 | https://doi.org/10.3389/fsurg.2022.1081959
Despite the adoption of enhanced recovery programs, the reported postoperative length of stay after robotic surgery is 4 days even in highly specialized centers. We report preliminary results of a pilot study for a new protocol of early discharge (on day 2) with telehealth home monitoring after robotic lobectomy for lung cancer. All patients with a caregiver were discharged on postoperative day 2 with a telemonitoring device if they satisfied specific discharge criteria. Teleconsultations were scheduled once in the afternoon of post-operative day 2, twice on postoperative day 3, and then once a day until the chest tube removal. Post-discharge vital signs were recorded by patients at least four times daily through the device and were available for consultation by two surgeons through phone application. In case of sudden variation of vital signs or occurrence of adverse events, a direct telephone line was available for patients as well as a protected re-hospitalization path. Primary outcome was the safety evaluated by the occurrence of post-discharge complications and readmissions. Secondary outcome was the evaluation of resources optimization (hospitalization days) maintaining the standard of care. During the study period, twelve patients satisfied all preoperative clinical criteria to be enrolled in our protocol. Two of twelve enrolled patients were successively excluded because they did not satisfy discharge criteria on postoperative day 2. During telehealth home monitoring a total of 27/427 vital-sign measurements violated the threshold in seven patients. Among the threshold violations, only 1 out of 27 was a critical violation and was managed at home. No postoperative complication occurred neither readmission was needed. A mean number of three hospitalization days was avoided and an estimated economic benefit of about EUR 500 for a single patient was obtained if compared with patients submitted to VATS lobectomy in the same period. These preliminary results confirm that adoption of telemonitoring allows, in selected patients, a safe discharge on postoperative day 2 after robotic surgery for early-stage NSCLC. A potential economic benefit could derive from this protocol if this data will be confirmed in larger sample.