Oncologic Outcomes Research Articles

What are the true benefits of robotic pancreaticoduodenectomy for patients with pancreatic cancer?

Pancreatic ductal adenocarcinoma (PDAC) is a devastating disease, and multimodal treatment including high quality surgery can improve survival outcomes. Pancreaticoduodenectomy (PD) has evolved with minimally-invasive approaches including the implementation of robotic PD (RPD). In this key paper evaluation, we discuss the findings of Kalabin et al. whilst evaluating the 'true benefits' of RPD compared to the open approach for the treatment of PDAC. We have performed a mini-review of studies assessing PD approaches and compared intraoperative characteristics, perioperative outcomes, post-operative complications and oncological outcomes. RPD was associated with similar or longer operative times, and reduced intra-operative blood loss. Perioperative pain scores were significantly lower with shorter lengths of stay with the robotic approach. With regards to post-operative complications, post-operative pancreatic fistula rates were similar, with lower rates of clinically relevant fistulas after RPD. Oncological outcomes were comparable or superior in terms of margin status, lymph node harvest, time to chemotherapy and survival between RPD and OPD.In conclusion, RPD allows safe implementation of minimally-invasive PD. The current literature shows that RPD is either equivalent, or superior in certain aspects to OPD. Once more centers gain sufficient experience, RPD is likely to demonstrate clear superiority over alternative approaches.

Robotic-assisted radical resection versus open surgery for cholangiocarcinoma: a systematic review and meta-analysis.

To compare the clinical efficacy and safety of robot-assisted resection and open surgery for cholangiocarcinoma (CCA). We conducted a comprehensive search of PubMed, the Cochrane Library, and Embase databases for studies comparing treatment for CCA, covering the period from database inception to January 30, 2024. Two researchers will independently screen literature and extract data, followed by meta-analysis using Review Manager 5.3 software. A total of 5 articles with 513 patients were finally included. Among them, 231 in the robotic group, and 282 in the open group. The Meta-analysis revealed that the robotic group had a significant advantage in terms of intraoperative blood loss (MD =  -101.44, 95% CI -135.73 to -67.15, P < 0.05), lymph node harvest(MD = 1.03, 95% CI 0.30-1.76, P < 0.05) and length of hospital stay(MD =  -1.92, 95% CI -2.87 to-0.97, P < 0.05). However, there were no statistically significant differences between the two groups in terms of transfusion rate (OR = 0.62, 95% CI 0.31-1.23, P > 0.05), R0 resection (OR = 1.49, 95% CI 0.89- 2.50, P > 0.05), 30-day mortality (OR = 1.68, 95% CI 0.43-6.65, P > 0.05) and complications (OR = 0.76, 95% CI 0.30- 1.95, P > 0.05). Robotic-assisted radical resection for CCA is feasible and safe, and its long-term efficacy and oncological outcomes need to be confirmed by further studies.

Oncologic Safety of Immediate Oncoplastic Surgery Compared with Standard Breast-Conserving Surgery for Patients with Invasive Lobular Carcinoma.

Invasive lobular carcinoma (ILC) of the breast grows in a diffuse pattern, resulting in a high risk of positive margins at surgical resection. Oncoplastic approaches have been shown to reduce this risk, but concerns persist around the safety of immediate oncoplastic surgery for those with ILC. This study evaluated the short- and long-term oncologic outcomes of immediate oncoplastic surgery for patients with ILC. This study retrospectively analyzed an institutional database of stages I to III ILC patients who underwent breast-conserving surgery (BCS) with or without immediate oncoplastic surgery (oncoplastic closure or oncoplastic reduction mammoplasty [ORM]). The study compared positive margin rates, rates of successful BCS, and recurrence-free survival (RFS) by type of surgery. For 494 patients the findings showed that the use of immediate ORM was associated with significantly lower odds of positive margins (odds ratio [OR], 0.34; 95 % confidence interval [CI], 0.17-0.66; p = 0.002). Both lumpectomy with oncoplastic closure and ORM were significantly associated with higher rates of successful BCS than standard lumpectomy (94.2 %, 87.8 %, and 73.9 %, respectively; p < 0.001). No difference in RFS was observed between those undergoing immediate oncoplastic surgery and those undergoing standard lumpectomy alone. The patients with stages I to III ILC who underwent immediate oncoplastic surgery had significant benefits including lower odds of positive margins and higher rates of successful BCS, with both types of immediate oncoplastic surgery showing similar RFS compared with lumpectomy alone. This supports the oncologic safety of immediate oncoplastic surgery for diffusely growing tumors such as ILC, providing it an ideal option for patients desiring BCS.

Robotic transanal minimally invasive surgery (r-TAMIS): perioperative and short-term outcomes for local excision of rectal cancers.

Transanal minimally invasive surgery (TAMIS) is an advanced technique for excision of early rectal cancers. Robotic TAMIS (r-TAMIS) has been introduced as technical improvement and potential alternative to total mesorectal excision (TME) in early rectal cancers and in frail patients. This study reports the perioperative and short-term oncological outcomes of r-TAMIS for local excision of early-stage rectal cancers. Retrospective analysis of a prospectively collected r-TAMIS database (July 2021-July 2023). Demographics, clinicopathological features, short-term outcomes, recurrences, and survival were investigated. Twenty patients were included. Median age and body mass index were 69.5 (62.0-77.7) years and 31.0 (21.0-36.5) kg/m2. Male sex was prevalent (n = 12, 60.0%). ASA III accounted for 66.7%. Median distance from anal verge was 7.5 (5.0-11.7) cm. Median operation time was 90.0 (60.0-112.5) minutes. Blood loss was minimal. There were no conversions. Median postoperative stay was 2.0 (1.0-3.0) days. Minor and major complication rates were 25.0% and 0%, respectively. Seventeen (85.0%) patients had an adenocarcinoma whilst three patients had an adenoma. R0 rate was 90.0%. Most tumours were pT1 (55.0%), followed by pT2 (25.0%). One patient (5.0%) had a pT3 tumour. Specimen and tumour maximal median diameter were 51.0 (41.0-62.0) mm and 21.5 (17.2-42.0) mm, respectively. Median specimen area was 193.1 (134.3-323.3) cm2. Median follow-up was 15.5 (10.0-24.0) months. One patient developed local recurrence (5.0%). r-TAMIS, with strict postoperative surveillance, is a safe and feasible approach for local excision of early rectal cancer and may have a role in surgically unfit and elderly patients who refuse or cannot undergo TME surgery. Future prospective multicentre large-scale studies are needed to report the long-term oncological outcomes.

Enhancing Lymph Node Yield in Gastric Cancer Resection: Impact of Back Table Dissection on Number of Lymph Node Examined.

During gastric cancer resection, back table dissection (BTD) involves examination and separation of lymph node (LN) packets from the surgical specimen based on LN stations, which are sent to pathology as separately labeled specimens. With potential impact on clinical outcomes, we aimed to explore how BTD affects number of LNs examined. A retrospective review of a gastric cancer database was performed, including all cases of gastrectomy with D2 lymphadenectomy from January 2009 to March 2022. Back table dissection and conventional groups were compared using Mann-Whitney U and Fisher's exact tests. Multiple linear regression modeling was used to identify potential predictors of number of LN examined. A total of 174 patients were identified: 39 (22%) BTD and 135 (78%) conventional. More patients in the BTD group underwent neoadjuvant chemotherapy (62% vs 29%, P < .05). Compared to the conventional group, the BTD group had a greater number of LNs examined (42 [26-59] vs 21[15-33], median [IQR], P < .001), lower LN positivity ratio (.01 vs .07, P = .013), and greater number of LNs in patients with BMI >35 (32.5[27.5-39] vs 22[13-27], P = .041). A multiple linear regression model controlling for age, BMI, preoperative N stage, neoadjuvant chemotherapy, surgeon experience, and operative approach identified BTD as a significant positive predictor of number of LN examined (β = 19.7, P = .001). Back table dissection resulted in improved LN yield during gastric cancer resection. As a simple technical addition, BTD helps enhance pathology examination and improve surgeon awareness, which may ultimately translate to improve oncologic outcomes.

Oncologic Outcomes for Different Axillary Staging Techniques in Patients with Nodal-Positive Breast Cancer Undergoing Neoadjuvant Systematic Treatment: A Cancer Registry Study.

Targeted approaches such as targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB) showed false-negative rates of < 10% compared with axillary lymph node dissection (ALND) in patients with nodal-positive breast cancer undergoing neoadjuvant systemic treatment (NAST). We aimed to evaluate real-world oncologic outcomes for different axillary staging techniques. We identified nodal-positive breast cancer patients undergoing NAST from 2016 to 2021 from the state cancer registry of Baden-Wuerttemberg, Germany. Invasive disease-free survival (iDFS) was assessed using Kaplan-Meier statistics and multivariate Cox regression models (adjusted for age, ypN stage, ypT stage, and tumor biologic subtype). A total of 2698 patients with a median follow-up of 24.7 months were identified: 2204 underwent ALND, 460 underwent SLNB (255 with ≥ 3 sentinel lymph nodes [SLNs] removed, 205 with 1-2 SLNs removed), and 34 underwent TAD. iDFS 3 years after surgery was 69.7% (ALND), 76.6% (SLNB with ≥ 3 SLNs removed), 76.7% (SLNB with < 3 SLNs removed), and 78.7% (TAD). Multivariate Cox regression analysis showed no significant influence of different axillary staging techniques on iDFS (hazard ratio [HR] for SLNB with < 3 SLNs removed 0.96, 95% confidence interval [CI] 0.62-1.50; HR for SLNB with ≥ 3 SLNs removed 0.86, 95% CI 0.56-1.3; HR for TAD 0.23, 95% CI 0.03-1.64; ALND reference), and for ypN+ (HR 1.92, 95% CI 1.49-2.49), triple-negative breast cancer (HR 2.35, 95% CI 1.80-3.06), and ypT3-4 (HR 2.93, 95% CI 2.02-4.24). These real-world data provide evidence that patient selection for de-escalated axillary surgery for patients with nodal-positive breast cancer undergoing NAST was successfully adopted and no early alarm signals of iDFS detriment were detected.

Current role and perspectives of living donor liver transplantation for hepatocellular carcinoma: systematic review of the past 20years.

Hepatocellular carcinoma (HCC) poses a significant global health challenge, and liver transplantation (LT) remains the best curative option. Living donor liver transplantation (LDLT) emerged as a potential solution to organ scarcity, reducing waitlist times. This comprehensive review explores LDLT practices, focusing on patient selection criteria and oncologic outcomes. A systematic review following PRISMA guidelines included 50 studies (2004-2023) with 8062 patients. Data encompassed baseline characteristics, HCC features, and oncologic outcomes. Further analysis categorized results by geography and publication year. Heterogeneity in patient demographics, tumor burden, and transplant characteristics was observed. Recent LDLT series demonstrated a shift towards refined selection criteria, increased neoadjuvant treatment, and improved oncologic outcomes. Geographic disparities revealed unique challenges in Eastern and Western practices. LDLT proves effective for HCC, addressing donor shortages. Evolving practices highlight the importance of refining inclusion criteria and optimizing tumor management. While geographic differences exist, LDLT, when judiciously applied, offers promising outcomes.

Effect of young age (below 40 years) on oncologic outcomes in Lebanese patients with breast cancer: a matched cohort study

BackgroundDeveloping countries have a significantly higher incidence of breast cancer in patients younger than 40 years as compared to developed countries. This study aimed to examine if young age at diagnosis is an independent prognostic factor for worse survival outcomes in breast cancer as well as the effect of age on Disease-free survival (DFS) and local recurrence free survival (LRFS) after adjusting for various tumor characteristics, local and systemic treatments.MethodsThis is a secondary analysis of prospective cohort of patients from two existing databases. We identified patients with breast cancer aged 40 years or less and we matched them to those older than 40 years. We also matched based on stage and molecular subtypes. In cohort 1, we matched at a ratio of 1:1, while in cohort 2 we matched at a ratio of 1:3.ResultsIn cohort 1, Disease-free survival (DFS) at 5 years was significantly shorter for those younger than 40 years (75.6% and 92.7% respectively; p < 0.03). On multivariate analysis, only chemotherapy was found to be significant, while age was not found to be an independent predictor of prognosis. Local recurrence free survival at 5 years was similar between both age categories. Only hormonal therapy is a significant predictor for LRFS at 5 years. In the second cohort, DFS and LRFS at 3 years were similar between those younger and those older than 40 years. On multivariate analysis, no factor including age was found to be an independent predictor of prognosis.ConclusionData in the literature is controversial on the effect of young age on breast cancer prognosis. Our findings could not demonstrate that age is an independent prognostic factor in our population. There is a need for outcomes from larger, prospective series that have longer follow-ups and more data from our region.

A Comprehensive Review of the Current State of Robot-assisted Laparoscopic Salvage Prostatectomy.

Salvage robot assisted radical prostatectomy (sRARP) is performed for patients with biochemical or biopsy proven, localized prostate cancer recurrences after radiation or ablative therapies. Traditionally, sRARP has been avoided by lower volume surgeons due to technical demand and high complication rates. Post-radiation sRARP outcomes studies exist but remain few in number. With increasing use of whole gland and focal ablative therapies, updates on sRARP in this setting are needed. The aim of this narrative review is to provide an overview of recently reviewed studies on the oncologic outcomes, functional outcomes, and complications after post-radiation and post-ablative sRARP. Tips and tricks are provided to guide surgeons who may perform sRARP. We performed a non-systematic literature search of PubMed and MEDLINE for the most relevant articles pertaining to the outlined topics from 2010-2022 without limitation on study design. Only case reports, editorial comments, letters, and manuscripts in non-English languages were excluded. Key Content and Findings: Salvage robotic radical prostatectomy is performed in cases of biochemical recurrence after radiation or ablative therapies. Oncologic outcomes after sRARP are worse compared to primary surgery (pRARP) though improvements have been made with the robotic approach when compared to open salvage prostatectomy. Higher pre-sRARP PSA levels and more advanced pathologic stage portend worse oncologic outcomes. Patients meeting low-risk, EAU-biochemical recurrence criteria have improved oncologic outcomes compared to those with high-risk BCR. While complication rates in sRARP are higher compared to pRARP, Retzius sparing approaches may reduce complication rates, particularly rectal injuries. In comparison to the traditional open approach, sRARP is associated with a lower rate of bladder neck contracture. In terms of functional outcomes, potency rates after sRARP are poor and continence rates are low, though Retzius sparing approaches demonstrate acceptable recovery of urinary continence by 1 year, post-operatively. Advances in the robotic platform and improvement in robotic experience have resulted in acceptable complication rates after sRARP. However, oncologic and functional outcomes after sRARP in both the post-radiation and post-ablation settings are worse compared to pRARP. Thus, when engaging in shared decision making with patients regarding the initial management of localized prostate cancer, patients should be educated regarding oncologic and functional outcomes and complications in the case of biochemically recurrent prostate cancer that may require sRARP.

Single Institution Experience in the Management of Locally Advanced (pT4) Differentiated Thyroid Carcinomas.

Locally infiltrating (T4) differentiated thyroid carcinomas (DTC) represent a challenge. Surgical strategy and adjuvant therapy should be planned balancing morbidity and oncologic outcome. A series of patients with T4 DTC who underwent multidisciplinary evaluation and treatment is reported. The main study endpoints were the oncologic outcome, complication rates, and risk factors for tumor recurrence. All DTC cases operated between 2009 and 2021 were reviewed and T4 DTC cases were identified. En bloc resection of inferior laryngeal nerve (ILN), tracheal, and/or internal jugular vein (IJV) was performed in cases of massive infiltration. In cases of pharyngoesophageal junction (PEJ) invasion, the shaving technique was always applied. Among 4775 DTC cases, 60 were T4. ILN infiltration was documented in 45 cases (en bloc resection in 9), tracheal infiltration in 14 (tracheal resection in 2), PEJ invasion in 11 (R0 resection in 7 cases and < 1 cm residual tissue in 4 cases), IJV resection in 6, and laryngeal in 2. In total, 11 postoperative ILN palsy, 23 transient hypoparathyroidisms, and 2 hematomas requiring reoperation were registered. Final histology showed 7 pN0, 22 pN1a, and 31 pN1b tumors. Aggressive variants were observed in 47 patients. All but 1 patient underwent radioiodine treatment, 12 underwent adjuvant external beam radiation therapy (EBRT), and 2 underwent chemotherapy. At a median follow-up of 58 months, no tumor-related death was registered, and seven patients required reoperation for recurrence. Tracheal invasion was the only significant factor negatively impacting recurrence (p = 0.045). A multidisciplinary approach is essential for the management of T4 DTC. Individualized and balanced surgical strategy and adjuvant treatments, in particular EBRT, ensure control of locally advanced disease with acceptable morbidity.

Conversion surgery intervention versus continued systemic therapy in patients with a response after PD-1/PD-L1 inhibitor-based combination therapy for initially unresectable biliary tract cancer: a retrospective cohort study.

The role of conversion surgery in patients with unresectable biliary tract cancer (BTC) who responded positively to PD-1/PD-L1 inhibitor-based therapy remains unclear. This study aimed to assess the outcomes in patients with or without conversion surgery. In this cohort study, patients with advanced BTC who received combination therapy with PD-1/PD-L1 inhibitors from July 2019 to January 2023 were retrospectively. Patients who exhibited positive responses and met the criteria for conversion surgery were enrolled, and their surgical and oncological outcomes were analyzed. Out of 475 patients, 34 who met the conversion resection criteria were enrolled. The median follow-up was 40.5 months post-initiation of systemic therapy. Ultimately, 13 patients underwent conversion surgery, while 21 received continuation of systemic treatment alone (non-surgical group). The median interval from the initial antitumor therapy to surgery was 6.7 (interquartile range [IQR] 4.9-9.2) months. Survival with conversion surgery was significantly longer than the non-surgical cohort, with a median progression-free survival (PFS) (unreached vs. 12.4mo; hazard ratio 0.17 [95% CI 0.06-0.48]; P=0.001) and overall survival (OS) (unreached vs. 22.4mo; hazard ratio 0.28 [95% CI 0.09-0.84]; P=0.02), respectively. After a median postoperative follow-up of 32.2 months in the surgical cohort, 8 patients survived without recurrence. The estimated 3-year OS, PFS and recurrence-free survival rate in the surgical cohort were 59.9%, 59.2% and 60.6%, respectively. The R0 resection rate reached 92.3%, with 2 achieving a pathological complete response. One patient experienced a Clavien-Dindo grade 3 complication without surgery-related mortality. No serious adverse events or surgical delays were observed. Multivariate analysis indicated that conversion surgery was independently associated with OS (P=0.03) and PFS survival (P=0.003). Conversion surgery appears safe and offers survival benefits to patients responding to immune checkpoint inhibitors (ICIs)-based combinations. However, further studies are required to validate this strategy in the era of immunotherapy.

Top Peritoneal Surface Malignancy Articles from 2022 to Inform your Cancer Practice.

Over the last few decades, the role of cytoreductive surgery (CRS) with or without regional-based peritoneal therapies such as hyperthermic intraperitoneal chemotherapy (HIPEC) has evolved in the management of patients with peritoneal surface malignances (PSMs). Despite the benefit of CRS in improving oncologic outcomes, significant challenges remain in the treatment of patients with advanced PSMs, and the role of HIPEC continues to be questioned. Additionally, while there has been improvement in perioperative outcomes, long-term survival remains poor. As a result, there is much need to improve our understanding of the processes that drive tumor biology, thereby improving patient selection for various treatment approaches. Additionally, newer therapies are needed for patients who remain poor surgical candidates and who progress on systemic therapy. This article highlights recently published studies that we consider impactful in the care of patients with PSMs.

Liver Resection in Synchronous Bilobar versus Unilobar Colorectal Liver Metastases: A Retrospective Analysis of Oncological Outcomes and Patient Survival.

Resection of colorectal liver metastasis has emerged as the standard treatment. Our study compares oncological outcomes of patients with resected synchronous bilobar versus unilobar colorectal liver metastasis. This retrospective study presents long-term follow-up data of 105 consecutive patients with primary colorectal cancer and synchronous liver metastasis. All patients underwent primary tumor and metastasis resections between 2007 and 2019. Fifty-five patients with bilobar and 50 patients with unilobar colorectal liver metastases were included. No significant difference in overall, tumor-specific, or recurrence-free survival was observed between patients with bilobar and unilobar metastases. After case-control matching, the results were confirmed in patients with similar tumor burdens. In the multivariate analysis, chemotherapy following liver metastasis resection was a significant prognostic factor associated with improved overall survival (hazard ratio 0.518, 95% confidence interval: 0.302-0.888, p = 0.017). Overall survival, as well as tumor-specific and recurrence-free survival, did not differ between patients with unilobar and bilobar liver metastasis. These findings contribute to the understanding that primary tumor and metastasis resection in eligible patients improve long-term outcomes.

Abstract PO5-19-10: First oncological outcomes of HypoG-01: a UNICANCER phase III trial comparing loco-regional hypo vs normo fractionated radiation therapy in early breast cancer patients

Abstract Objective Normofractionated (NF) radiation therapy (RT) is still standard for loco-regional early breast cancer (EBC) in many countries. HypoG-01, a UNICANCER, non-inferiority, open-label, multicenter, randomized phase III trial (NCT03127995), conducted in parallel with the DBCG Skagen trial 1 (NCT02384733), evaluated hypofractionated (HF) RT with 40 Gy/15 fr (2.67 Gy/fr) versus NF RT 50 Gy/25 fr (2.0 Gy/fr). This is the first report of oncological outcomes, secondary endpoints of the trial. Methods Patients (pts) ≥18 years old were operated for T1-3, N0-3, M0 breast cancer. All pts received nodal and thoracic wall or breast RT. Tumor-bed boost (sequential or simultaneous) and nodal levels treated were decided according to local guidelines. Target volumes were delineated according to the ESTRO consensus. RT technique was left at the investigator’s discretion. Stratification factors included treating center, type of surgery, number of positive nodes and body mass index. The primary endpoint, reported previously, was time to occurrence of arm lymphedema. Oncological outcomes included locoregional relapse free survival (LRFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer specific survival (BCSS) and overall survival (OS) as defined per DATECAN guidelines. All time to cancer related endpoints were defined as starting from the date of randomization until the event. The primary statistic test was stratified one-sided logrank test: 5% significance level in per-protocol population (PPP) with a pre-specified non-inferiority margin of 1.545. Stratified Cox model was used for calculating hazard ratios of oncological outcomes. Results In total, 1265 pts were randomized to HF versus NF RT from Sep 2016 to Mar 2020 with 1221 in the PPP (HF group 614 pts (50.3%); NF group 607 (49.7%)), 5 consent withdrawn and 39 major deviations. Median age was 58 years (range 23-91), surgery included mastectomy (501 pts; 45%) and axillary clearance (921 pts; 82.8%). Sequential (67.8%) or simultaneous integrated (32.2%) tumor-bed boost was used in 596 pts (48.8%). With a median follow-up for OS in PP analysis of 3.8 years (95% CI 3.3 to 3.9), HF was non-inferior to NF RT in terms of lymphedema (HR=1.07; 90% CI 0.86-1.34, non-inferiority p=0.003). Table 1 reports the hazard ratio and 3-year survival rates for the oncological endpoints LRFS, IDFS, DDFS, BCCS and OS. There was no sign of disadvantage for any of these endpoints comparing HF to NF. Additional analyses will be presented at the meeting. Conclusion Moderately HF loco-regional RT is non-inferior to NF RT in terms of lymphedema risk in EBC and does not show a disadvantage in terms of LRFS, IDFS, DDFS, BCCS and OS with a median follow-up of 3.8 years. Together with the Skagen 1 trial, this study provides level 1A evidence supporting the use of 40 Gy/15 fr for loco-regional radiation therapy in EBC with respect to arm lymphedema risk; Table 1: Oncological outcomes according to treatment arm in the per protocol analysis HF: Moderately hypofractionated radiation therapy; NF: Normofractionated radiation therapy; n:number of patients; N: number of events Citation Format: Sofia Rivera, Eleni Karamouza, Youlia Kirova, Séverine Racadot, Mohamed Benchalal, Jean-Baptiste Clavier, Claire Charra-Brunaud, Marie-Eve Chand-Fouche, Delphine Argo-Leignel, Karine Peignaux, Ahmed Benyoucef, David Pasquier, Philippe Guilbert, Julien Blanchecotte, Agnès Tallet, Adeline Petit, Guillemette Bernadou, Xavier Zasadny, Claire Lemanski, Jacques Fourquet, Emmanuelle Malaurie, Honorine Kouto, Carole Massabeau, Alexandre Henni, Pauline Regnault, Aurélie Belliere, Yazid Belkacemi, Magali Le Blanc-Onfroy, Julien Geffrelot, Jean-Briac Prevost, Marie Bergeaud, Assia Lamrani-Ghaouti, Amandine Ruffier, Naima Bonnet, Stephanie Wong, Christine Rossier, Thomas Brion, Pierre Maroun, Claire Petit, Guillaume Auzac, Stefan Michiels. First oncological outcomes of HypoG-01: a UNICANCER phase III trial comparing loco-regional hypo vs normo fractionated radiation therapy in early breast cancer patients [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 PO5-19-10.

Abstract PO4-22-08: Ten-Year Oncologic Outcomes in T1-3N1 Breast Cancer After Targeted Axillary Sampling: A Retrospective Study

Abstract Background Targeted axillary sampling (TAS) is a new surgical concept for the assessment of axillary lymph node status in breast cancer that is hypothesized to be more effective at minimizing postoperative morbidities than axillary lymph node dissection (ALND), provided the metastatic axillary lymph node can be accurately detected without missing data; however, the oncologic outcomes over long-term follow-up have not been sufficiently investigated. This was a retrospective analysis to evaluate the 10-year oncologic outcomes in T1-3N1 breast cancer after TAS. Methods Clinically, we defined TAS as removal of a bunch of ALNs located around SLNs and targeted LNs, but without full exposure of the axillary vein, long thoracic nerve and thoracodorsal nerve. Between 2008 and 2013, 230 female patients with cT1-3N1 breast cancer underwent breast and axillary surgery (ALND, n = 171; TAS, n = 59) at our institute. After TAS was applied, additional axillary radiotherapy was performed. Various postoperative complications, including postoperative seroma, lymphedema, and 10-year oncological outcomes, were evaluated and compared between the ALND and TAS groups. Results Although overall survival during the 10-year follow-up period was better in the TAS group, there was no statistically significant difference in oncologic outcomes, including locoregional recurrence, distant metastasis, and overall survival (p = 0.395, 0.818, and 0.555, respectively). Furthermore, the incidence of lymphedema on the ipsilateral arm was significantly higher in the ALND group (p &amp;lt; 0.001). Conclusions The 10-year oncological outcomes of TAS were not inferior to those of conventional ALND in T1-3N1 breast cancers; however, the incidence of lymphedema was significantly higher in the ALND group. Citation Format: Byeongju Kang, Jeeyeon Lee, Yee Soo Chae, Ho Yong PARK, Jin Hyang Jung. Ten-Year Oncologic Outcomes in T1-3N1 Breast Cancer After Targeted Axillary Sampling: A Retrospective Study [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 PO4-22-08.

Abstract PO4-22-03: Intensity Modulated Proton Therapy (IMPT) for the Definitive Adjuvant Management of Women with Breast Cancer: A Single Institutional Experience of 5-Year Oncologic Outcomes

Abstract Purpose: There is limited data reporting the oncologic outcomes of breast cancer patients treated definitively with adjuvant proton beam therapy. Here we report a single institutional experience of oncologic outcomes, treating a predominantly vulnerable breast cancer patient population and compare these to historical standards primarily utilizing photon therapy. Materials and Methods: Unver IRB approval, we retrospectively reviewed 453 definitively treated breast cancer patients from 2016 – 2023 using adjuvant IMPT as part of their cancer care. Patients with recurrent disease, receiving re-irradiation, and those with less than 1-year of follow up were excluded from this analysis. Patients were treated with surgery and systemic therapies as per standards of care. Radiation therapy was administered using pencil beam scanning IMPT with daily image guidance. χ2 and Mann-Whitney U tests were performed to determine differences between select variables. Kaplan-Meier analysis and Cox proportional hazard models were used to analyze overall survival (OS). Results: With a median follow up of 22 months for the entire cohort, 453 patients were treated at XXXX as part of definitive adjuvant management for their breast cancer. Nearly 30% of patients self-identified as black (n=135), average patient age was 54 and 56% (n=255) self-identified as being married with approximately 25% (n=109) of patients having Medicare/Medicaid insurance. 198 patients (43.8%) had an intact breast and the remainder mastectomy of which 37.4% had reconstruction at the time of their radiation. 229 patients (50.7%) received neoadjuvant chemotherapy while 55 patients (12%) received concurrent chemotherapy which was either her2+ directed or Xeloda. The number of patients (%) corresponding to the AJCC 8th edition anatomical staging is as follows: Stage 0: 12 (2.7%); Stage I: 91 (20.1%); Stage 2: 197 (43.6%); Stage 3: 152 (33.6%). Median RT dose delivered for patients receiving comprehensive treatment was 50.4 Gy with 81% of patients receiving a boost to either scar, lumpectomy cavity and/or LN regions. Median RT dose delivered for patients receiving whole breast radiation was 42.56 Gy with a 10 Gy lumpectomy cavity boost. 5-yr OS by stage was 0: 100%; stage I: 98.8%; stage 2: 93.5%; stage 3: 90.8%. Five-year OS for black, white and other race patients were 85.3%, 95.8% and 96%, respectively (White as Ref: HR 3.176, 95% CI: 1.313-7.681, p=0.010 for black patients). For the entire cohort, patients with triple negative disease had a 5-yr OS of 80.4% (HR: 4.33, 95% CI 1.87-10.04, p&amp;lt; 0.001) and there was no difference in OS when insurance status was considered (p=0.378). Conclusions: To the best of our knowledge this represents the largest series of definitively treated breast cancer patients utilizing adjuvant proton therapy and the 5-year OS rates in our analysis coincide with published standards1. Results from the on-going randomized RADCOMP study will provide further guidance as to which patients benefit the most from proton therapy and will further support equivalent oncological outcomes when compared to photon therapy. 1. Weiss A, Chavez-MacGregor M, Lichtensztajn DY, et al. Validation study of the American Joint Committee on Cancer eighth edition prognostic stage compared with the anatomic stage in breast cancer. JAMA Oncol. 4(2):203-209, 2018. Citation Format: Elizabeth Nichols, Gurbani Singh, Desiree Lejano, Sarah McAvoy, Mark Mishra, Melissa Vyfhuis. Intensity Modulated Proton Therapy (IMPT) for the Definitive Adjuvant Management of Women with Breast Cancer: A Single Institutional Experience of 5-Year Oncologic Outcomes [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 PO4-22-03.

Abstract PO3-02-11: Impact of Tumor Volume on Oncologic Outcomes in Patients with T1 Breast Cancer: A Retrospective Analysis

Abstract Backgrounds: Measuring the extent of tumor cell accretion in the primary organ typically involves assessing the longest diameter, an important component of the widely employed TNM staging system. The largest tumor diameter is considered indicative of the risk of cancer metastasis and the likelihood of distant recurrences. However, relying solely on the unidimensional diameter to determine the degree of cancer cell accretion can be inadequate since each tumor has a unique three-dimensional shape, thus leading to different tumor volumes. Purpose: The aim of this study was to investigate the impact of tumor volume on oncologic outcomes in patients with T1-2 breast cancer. Method: We retrospectively reviewed the medical records of 1,018 patients diagnosed with invasive breast cancer who underwent breast-conserving surgery at Seoul National University Bundang Hospital from 2010 to 2015. Patients with multiple tumors, positive margins leading to mastectomy, or those who received neoadjuvant chemotherapy were excluded. Tumor volume was defined as the product of the length of the three axes to simplify the calculation. Recurrence-free survival (RFS) was estimated by the Kaplan-Meier analysis. Result: The median value for tumor volume was 7.502 cm³. Out of 1,018 patients, 124 patients exhibited tumor volumes greater than the median value. Higher tumor volume was associated with pathologic T stage (P &amp;lt; 0.001), pathologic N stage (P = 0.004), histologic grade (P &amp;lt; 0.001), and luminal B subtype (P = 0.008). In multivariable logistic regression analyses for recurrence, higher tumor volume (OR 3.532, 95% CI 1.708-7.303, P = 0.001), CEA elevation (OR 6.129, 95% CI 1.497-25.092, P = 0.012), pN stage (OR 2.038, 95% CI 1.005-4.132, P = 0.048), and luminal B subtype (OR 2.407, 95% CI 1.060-5.470, P = 0.036) were shown to be predictive factors for recurrence, while completion of radiation therapy (OR 0.142, 95% CI 0.050-0.402, P &amp;lt; 0.001) and completion of hormone therapy (OR 0.200, 95% CI 0.047-0.849, P = 0.029) were identified as protective factors. The 5-year RFS was significantly lower in patients with higher tumor volume compared to those with lower volume (97.4% vs. 91.9%; p &amp;lt; 0.001). In multivariable Cox regression analysis, tumor volume (HR 3.056, 95% CI 1.572-5.940, P = 0.001), CEA elevation (HR 4.934, 95% CI 1.437-16.935, P = 0.011), luminal B subtype (HR 2.336, 95% CI 1.076-5.073, P = 0.032), completion of RT (HR 0.131, 95% CI 0.053-0.325, P &amp;lt; 0.001), and completion of HTx (HR 0.199, 95% CI 0.060-0.655, P = 0.008) were identified as independent prognostic factors for RFS. Conclusion: In the current study, we showed higher tumor volume results in poorer oncologic outcomes in patients with T1-2 breast cancer. Therefore, the T stage based on tumor volume, which includes all three-dimensional measurements, can better predict the prognosis in breast cancer patients than the traditional T stage that is solely dependent on the unidimensional longest tumor diameter. Citation Format: Hyoung Won Koh, Eun-Kyu Kim, Hee-Chul Shin. Impact of Tumor Volume on Oncologic Outcomes in Patients with T1 Breast Cancer: A Retrospective Analysis [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 PO3-02-11.

Abstract PO1-22-06: Pre-operative radiotherapy followed by mastectomy and breast reconstruction – a systematic review of oncological and reconstructive outcomes

Abstract Background Pre-operative radiotherapy (PRT) followed by mastectomy and autologous breast reconstruction for locally advanced breast cancer has the potential to reduce the deleterious impact of radiotherapy on the reconstructed breast and expedite treatment without impact on oncologic control. The PRADA feasibility study (Lancet Oncol 2022; 23: 682-90) has previously demonstrated the technique is technically feasible and safe in modern breast oncology practice, however, there is a clear necessity for longer term outcome data to precisely determine clinical efficacy. In order to understand and appraise this evidence gap, we performed a systematic review focused on oncologic and reconstructive outcomes of PRT followed by mastectomy and breast reconstruction. Methods A prospectively registered search (PROSPERO ID: CRD42023349524) of Medline (Ovid), EMBASE (Ovid), EMCARE (Ovid) and CINAHL (EBSCO) databases was performed in August 2022 for studies reporting NART prior to mastectomy and breast reconstruction. Oncological and aesthetic outcomes were extracted with risk of bias (ROBINS-I) and methodological quality assessed (STROBE checklist) for each study. Results Twenty one published articles (18 papers and 3 abstracts) were identified reporting the outcomes of 1,126 patients with median follow-up between 19.0-212.4 months. Seventeen studies were non randomised single-centre cohort studies (12 retrospective and 5 prospective). Patients received neoadjuvant chemotherapy in 18 studies. The majority of studies were of low methodological quality and at serious risk of bias. Rates of locoregional recurrence and overall survival ranged between 0-21.7% and 79.8%-98.3% respectively. Rates of flap loss or necrosis ranged from 0-12.0%. Rates of revisional procedures ranged between 0-35.3%. Patient-reported outcomes were reported in 8 studies and were mostly ‘good’ or ‘excellent’. Conclusion The published literature described a heterogeneity of outcome for patients undergoing NART prior to mastectomy and breast reconstruction. This reflects a large number of small retrospective single-centre cohort studies of low methodological quality at risk of bias. There is a clear need for a prospective randomised controlled trial appraising the outcomes of PRT in the context of autologous breast reconstruction. Citation Format: Ken Ho, Joseph Ward, Chiugo Ike, Paul Thiruchelvam, Aadil Khan, Daniel Leff. Pre-operative radiotherapy followed by mastectomy and breast reconstruction – a systematic review of oncological and reconstructive outcomes [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 PO1-22-06.

Abstract PS01-02: Long-term outcomes of sentinel lymph node biopsy following neoadjuvant chemotherapy for initially node-positive breast cancer: A systematic review and meta-analysis

Abstract Background: Sentinel lymph node biopsy (SLNB) alone is now frequently offered to women with initially node-positive breast cancer who convert to pathologically node negative (nodal pCR) following neoadjuvant chemotherapy (NAC), despite limited long-term data regarding the oncologic safety of this approach. The aim of this meta-analysis was to evaluate the long-term oncologic outcomes associated with SLNB alone following NAC for initially node-positive breast cancer. Methods: A systematic review and meta-analysis was conducted according to PRISMA guidelines. Medline (Ovid), Embase, and Cochrane Central Registry were systematically searched for studies comparing women undergoing SLNB or ALND following NAC for initially clinically node-positive breast cancer. Included studies reported one of the following outcomes: axillary recurrence (AR), locoregional recurrence (LRR), disease-free survival (DFS) or overall survival. A random effects meta-analysis was used to calculate weighted pooled effect estimates (risk ratios, RR) for all outcomes. Variability across studies due to heterogeneity was estimated using I2 statistics. Subgroup analysis was performed by length of follow-up for each study. Risk of bias within studies was assessed using the Newcastle-Ottawa Scale (NOS). Results: Data for participants undergoing treatment between 2004 and 2022 was captured across studies. The median age of women treated with NAC for initially node-positive breast cancer ranged from 46 to 60 years. The median follow-up time ranged from 19.5 to 108 months across included studies. Nine observational studies were eligible for meta-analysis. No studies were excluded from the analysis on the basis of quality: Newcastle-Ottawa Scale scores ranged from 6 to 9 (maximum possible score of 9). Rates of axillary recurrence (AR) were low across all included studies (range 0.0% to 5.6%). For AR, data for 2,882 patients from 7 studies was quantitatively synthesized (SLNB=1,964; ALND=917). For LRR, data for 2,629 patients from 7 studies was quantitatively synthesized (SLNB=1,857; ALND=771). No significant differences were observed in AR between patients undergoing SLNB alone versus ALND following NAC for initially node-positive breast cancer: pooled RR 1.02 (95% CI: 0.46-2.29, I2=0.0%). Similarly, no significant differences were observed in LRR (RR 0.70, 95% CI: 0.45-1.10, I2=0.0%), DFS (RR 0.77, 95% CI: 0.55-1.08, I2=0.0%), nor overall mortality (RR 0.66, 95% CI: 0.33-1.33, I2=0.0%) between the SLNB and ALND groups. Conclusions: Among patients who convert to node-negative following NAC, this meta-analysis suggests that SLNB alone does not result in significantly different oncologic outcomes compared to ALND, and that de-escalation of axillary surgery to SLNB alone in this context may be safely considered in this patient population. Citation Format: Mariam Rana, Anna Weiss, Alison Laws, Carol Mita, Tari King. Long-term outcomes of sentinel lymph node biopsy following neoadjuvant chemotherapy for initially node-positive breast cancer: A systematic review and meta-analysis [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 PS01-02.

Abstract PO3-22-12: Clinical feasibility of nipple sparing mastectomy (NSM) followed by immediate reconstruction based on direct-to-implant technique

Abstract [Background] The development of NSM approach combined with immediate implant-based breast reconstruction (IBBR) for patients with earlystage breast cancer (BC) preserve the natural skin envelope including nipple-areolar complex (NAC) to able to immediately reconstruct the breast with a permanent implant and simultaneously omit the skin expansion with a tissue expander. We retrospectively analyzed the clinical results of NSM+IBBR and compared the complication rate, outcome of patients who underwent immediate (one-stage) or delayed (two-stage) IBBR followed by standard TM or NSM. [Patients and Results] A total of 108 patients who underwent a TM that included SSM or NSM followed by one- or two-stage IBBR between January 2013 and April 2022. 53 patients underwent a total mastectomy (TM) and 32 patients underwent an NSM followed by two-stage IBBR, and 24 patients underwent an NSM followed by one-stage IBBR. The operation times were 236, 247.2, and 321 min, and the mean surgical bleeding was 60.4, 88.8, and 138 ml, respectively. The complications in the three groups included infection (2.7%, 11.1%, and 6.3%), seroma/hematoma (0%, 5.6%, and 6.3%), flap necrosis (2.7%, 11.1%, and 12.5%), and loss of tissue expander or implant (2.7%, 5.6%, and 6.3%), respectively. At the median 62-month follow-up after the NSM + IBBR, one patient was diagnosed with distant lymph node metastases at the 24-month follow-up and one patient had new primary breast cancer within the reconstructed breast at the 38-month follow-up. But no loco-regional recurrence at the NAC or other distant recurrence were detected in the patients undergone regardless TM or NSM + one-stage or two-stage IBBR. [Summary] Our results suggested that the use of one-stage IBRR tended to increase the operating time and the amount of bleeding compared to two-stage IBRR and the complication rate might be higher in cases in which an NSM is followed by IBBR. Oncological outcome was consistent with the studies showing that loco-regional recurrence is less likely at the NAC regardless of whether the patients underwent one-stage or two-stage IBBR following an NSM. Citation Format: Uhi Toh, Yuko Takao, Yuriko Katagiri, Rie Sugihara, Hidetaka Watanabe. Clinical feasibility of nipple sparing mastectomy (NSM) followed by immediate reconstruction based on direct-to-implant technique [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 PO3-22-12.