Surgery For Stage Research Articles

Disparities in patients with HER2-positive breast cancer receiving optimal treatment: Analysis of the real-world ASCO CancerLinQ dataset.

e13739 Background: Racial/ethnic disparities in locoregional second breast cancer events (SBCE) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) are not well defined. We examined rates of SBCE and overall survival (OS) by race and ethnicity in the ASCO CancerLinQ Discovery (CLQD) real-world dataset in HER+ BC pts receiving optimal and not-optimal treatment. Methods: CLQD was used to identify pts undergoing surgery for stage I-III HER2+ BC from 2005-2022. Race/ethnicity were self-reported. Optimal treatment was defined as HER2-directed therapy for stage II-III HER2+ BC starting in 2008, adjuvant endocrine therapy for hormone-receptor positive (HR+) HER2+ BC, radiation after lumpectomy, and regional nodal irradiation for N2-N3 disease. The primary endpoint was SBCE defined as a second event in the ipsilateral or contralateral breast or axilla, with OS as a secondary endpoint. Kaplan-Meier analysis was used to estimate SBCE-free survival and OS. Results: Of 8,795 stage I-III HER2+ BC pts, 5,487 (62.4%) were Non-Hispanic White (NHW), 1,083 (12.3%) Non-Hispanic Black (NHB), 418 (4.7%) Hispanic, 323 (3.7%) Asian or Pacific Islander (API), and 1,484 (16.9%) other/unknown. Overall, 39.2% had HR-HER2+ and 60.7% had HR+HER2- BC. NHW pts were the most likely to present with stage I disease (40.2% vs 31.9%, 29.0%, and 30.3% of NHB, Hispanic, and API pts, respectively, p<0.01) and less likely to be age <50 at diagnosis (26.1% vs 32.3%, 41.0%, and 36.6% in NHB, Hispanic, and API, p<0.01). Overall, 54.2% of HER2+ BC pts received optimal treatment: 54.1%, 60.2%, 60.5%, and 58.8% of NHW, NHB, Hispanic, and API pts (p<0.01). Neoadjuvant HER2-therapy was given in 42.4%, 46.3%, 53.8%, and 51.2% of NHW, NHB, Hispanic, and API pts (p<0.01) and endocrine therapy in 64.7%, 56.8%, 59.3%, and 54.7%, respectively (p<0.01). 5-yr SBCE-free survival and OS are shown (Table). SBCE-free survival was not statistically different by race and ethnicity in optimally or non-optimally treated pts. Optimal treatment increased OS by 4.1% and 0.9% in NHW and NHB pts with HR-HER2+ BC and 2.4% and 8.9% in NHW and NHB pts with HR+HER2+ BC. Conclusions: Differences in OS, but not SBCE, were seen by race/ethnicity in HER2+ BC. OS differences were not completely mitigated by receipt of optimal treatment. [Table: see text]

NRG-BR007: A phase III trial evaluating de-escalation of breast radiation (DEBRA) following breast-conserving surgery of stage 1, HR+, HER2-, RS ≤18 breast cancer.

TPS622 Background: Approximately 50% of newly diagnosed invasive breast cancers are stage 1, with the majority being ER/PR-positive, HER2-negative. Genomic assays such as the Oncotype DX have identified patients (pts) with reduced risk of distant metastasis and without benefit from chemotherapy added to endocrine therapy, freeing them from excess toxicity. Genomic assays are also recognized as prognostic for in-breast recurrence (IBR) after BCS and could similarly allow de-escalation of adjuvant radiotherapy (RT). Reducing overtreatment is of interest to pts, providers, and payers. Methods: We hypothesize that breast-conserving surgery (BCS) alone is non-inferior to BCS plus RT for IBR and breast preservation in women intending endocrine therapy (ET) for stage 1 invasive breast cancer (ER and/or PR-positive, HER2-negative with an Oncotype DX Recurrence Score [RS] of ≤18). Stratification is by age (<60; ≥60), tumor size (≤1 cm; >1-2cm), and RS (≤11, >11-18/MammaPrint Low). Pts are randomized post-BCS to Arm 1 with breast RT using standard methods (moderate or ultra hypo- or conventional-fractionated whole breast RT with/without boost, or APBI) with ≥5 yrs of ET (tamoxifen or AI) or Arm 2 with ≥5 yrs of ET (tamoxifen or AI) alone. The specific regimen of ET in both arms is at the treating physician’s discretion. Eligible pts are stage 1: pT1 (≤2 cm), pN0, age ≥50 to <70 yrs, s/p BCS with negative margins (no ink on tumor), s/p axillary nodal staging (SNB or ALND), ER and/or PR-positive (ASCO/CAP), HER2-negative (ASCO/CAP), and Oncotype DX RS ≤18 (diagnostic core biopsy or resected specimen); (a “low risk” MammaPrint is permissible if completed as part of usual care prior to screening). Primary endpoint is IBR (invasive breast cancer or DCIS). Secondary endpoints are breast conservation rate, invasive in-breast recurrence, relapse-free interval, distant disease-free survival, overall survival, patient-reported breast pain, patient-reported worry about recurrence, and adherence to ET. We assume a clinically acceptable difference in IBR of 4% at 10 yrs to judge omission of RT as non-inferior (10-yr event-free survival for RT group is 95.6% v 91.6% for the omission-of-RT group). BR007 is powered to detect non-inferiority with 80% power and a one-sided α=0.025, assuming that there would be a ramp-up in accrual in the first two years (leveling off in yrs 3-5); 1,670 pts (835 per arm) are required for randomization. Conservative loss to follow-up is 1%/yr. Some T1a pts screened may have Oncotype DX scores >18, making them ineligible for the study. In the accrual process, 1,714 pts will be required to register to ensure that our final randomized cohort is 1,670 pts. Current accrual (02-05-2024) is 805 screened and 716 randomly assigned. Clinical trial information: NCT04852887 .

Induction immunotherapy-based regimens followed by palliative CCRT may lead to conversion surgery in selected patients and boost survival for stage IV ESCC.

e16059 Background: ESCC is still a health burden in Taiwan; besides, double cancers easily occur in Taiwan, like HypoCa & ESCC or OSCC and ESCC. ESCC is still an immunogenic cancer type. Nivolumab with chemotherapy or nivolumab with ipilimumab in CM648 study and pembrolizumab with chemotherapy in KN590 study have also won survival benefits compared with chemotherapy alone in frontline treatment for R/M ESCC, esp. for PDL1+ patients. In our previous study, EGFR TKI, such as afatinib, have multiple immuno-modulatory effects and may help to increase immunotherapy benefits in the 1st line(67% ORR) of CT-unfit advanced ESCC. Following KN590 or chemotherapy failure, good rescue efficacy(70% ORR) was also seen in subsequent afatinib with anti-PD1.(ASCO-GI2022). Methods: We try to analyze the treatment options and final survivals of 72 patients with stage IV ESCC from 2010 to 2019 in my institution from National Taiwan University Hospital, Yun-lin Branch. Results: See Table. Conclusions: In this 10-year experience in one institution, we suggested induction Immuno-chemotherapy, Bio-immunochemotherapy, & Bio-immunotherapy may lead to coversion chemoradiation, even to final surgery for stage IV ESCC with well systemic control in selected fit patients to boost further survival. Maintenance metronomic UFUR with anti-PD1 may also be beneficial. Afatinib with anti-PD1 could be a good option for (1)frontline treatment for double cancers or CT-unfit patients; (2)salvage treatment in later lines, even failing KN590 or CM648. [Table: see text]

Closing the RCT Gap-A Large Meta-Analysis on the Role of Surgery in Stage I-III Small Cell Lung Cancer Patients.

Despite clear guideline recommendations, surgery is not consistently carried out as part of multimodal therapy in stage I small cell lung cancer (SCLC) patients. The role of surgery in stages II and III is even more controversial. In the absence of current randomized control trials (RCT), we performed a meta-analysis comparing surgery versus non-surgical treatment in stage I to III SCLC patients. A systematic review of the literature was conducted on 1 July 2023, focusing on studies pertaining to the impact of surgery on small cell lung cancer (SCLC). These studies were evaluated using the ROBINS-I tool. Statistical analyses, including I² tests, Q-statistics, DerSimonian-Laird tests, and Egger regression, were performed to assess the data. In addition, 5-year survival rates were analyzed. The meta-analysis was conducted according to PRISMA standards. Among the 6826 records identified, 10 original studies encompassing a collective cohort of 95,323 patients were incorporated into this meta-analysis. Heterogeneity was observed across the included studies, with no discernible indication of publication bias. Analysis of patient characteristics revealed no significant differences between the two groups (p-value > 0.05). The 5-year survival rates in a combined analysis of patients in stages I-III were 39.6 ± 15.3% for the 'surgery group' and 16.7 ± 12.7% for the 'non-surgery group' (p-value < 0.0001). SCLC patients in stages II and III treated outside the guideline with surgery had a significantly better 5-year survival compared to non-surgery controls (36.3 ± 20.2% vs. 20.2 ± 17.0%; p-value = 0.043). In the absence of current RCTs, this meta-analysis provides robust suggestions that surgery might significantly improve survival in all SCLC stages. Non-surgical therapy could lead to a shortening of life. The feasibility of surgery in non-metastatic SCLC should always be evaluated as part of a multimodal treatment.

Analysis of sequential chemotherapy efficacy in ovarian epithelial carcinoma, fallopian tube carcinoma and primary peritoneal carcinoma

Objective: To explore the sequential chemotherapy efficacy of different chemotherapeutic regimens in ovarian epithelial carcinoma, fallopian tube carcinoma, and primary peritoneal carcinoma. Methods: A retrospective analysis was conducted on clinical and pathological data of 100 patients with platinum-sensitive ovarian epithelial carcinoma, fallopian tube carcinoma, and primary peritoneal carcinoma treated at Peking University Peopel's Hospital from January 1992 to January 2019. All patients underwent staging surgery or cytoreductive surgery followed by adjuvant chemotherapy. Based on different postoperative adjuvant chemotherapy regimens, patients were divided into the sequential chemotherapy group (70 cases) and the conventional chemotherapy group (30 cases). Clinical and pathological characteristics, chemotherapy efficacy, adverse reactions, and prognosis were compared between the two groups. Results: (1) Clinical and pathological characteristics: the age, tumor types (including ovarian epithelial carcinoma, fallopian tube carcinoma, and primary peritoneal carcinoma), pathological types, International Federation of Gynecology and Obstetrics (FIGO) stage, postoperative residual disease size, presence of neoadjuvant chemotherapy, and total number of chemotherapy cycles were compared between the sequential chemotherapy group and the conventional chemotherapy group. There were no statistically significant differences observed in these characteristics between the two groups (all P>0.05). (2) Chemotherapy efficacy: the median sum of complete response (CR)+partial response (PR) duration in the sequential chemotherapy group was 80.0 months (range: 39 to 369 months), whereas in the conventional chemotherapy group, it was 28.0 months (range: 13 to 52 months). A statistically significant difference was observed between the two groups (Z=-7.82, P<0.001). (3) Chemotherapy adverse reactions: in the sequential chemotherapy group, 55 cases (79%, 55/70) experienced bone marrow suppression and 20 cases (29%, 20/70) had neurological symptoms. In the conventional chemotherapy group, these adverse reactions occurred in 11 cases (37%, 11/30) and 2 cases (7%, 2/30), respectively. Statistically significant differences were observed between the two groups for both bone marrow suppression and neurological symptoms (all P<0.05). For the other chemotherapy adverse reactions compared between the two groups, no statistically significant differences were observed (all P>0.05). (4) Prognosis: during the follow-up period, the recurrence rate in the sequential chemotherapy group was 73% (51/70) and in the conventional chemotherapy group was 100% (30/30). The median sum of recurrence-free interval was 70.5 months (range: 19 to 330 months) in the sequential chemotherapy group and 15.0 months (range: 6 to 40 months) in the conventional chemotherapy group. Statistically significant differences were observed between the two groups for both recurrence rate and median recurrence-free interval (all P<0.01).In the sequential chemotherapy group, the median progression-free survival (PFS) time was 84.0 months (range: 34 to 373 months), and the median overall survival (OS) time was 87.0 months (range: 45 to 377 months). In contrast, in the conventional chemotherapy group, the median PFS time was 30.5 months (range: 14 to 60 months), and the median OS time was 37.5 months (range: 18 to 67 months). Statistically significant differences were observed between the two groups for both PFS and OS (all P<0.001). In the sequential chemotherapy group, the 3-year, 5-year, and 10-year OS rates were 100% (70/70), 93% (65/70), and 21% (15/70), respectively. In contrast, in the conventional chemotherapy group, the OS rates were 50% (15/30) at 3 years, 3% (1/30) at 5 years, and 0 at 10 years, respectively. The two groups were compared respectively, and the differences were statistically significant (all P<0.05). Conclusions: Sequential chemotherapy significantly prolongs PFS and OS in patients with ovarian epithelial carcinoma, fallopian tube carcinoma, and primary peritoneal carcinoma. The efficacy is superior to that of the conventional chemotherapy, with manageable adverse reactions. The use of sequential chemotherapy as first-line treatment for patients with ovarian epithelial carcinoma, fallopian tube carcinoma, and primary peritoneal carcinoma is recommended.

Prognostic implication of methylation-based circulating tumor DNA detection prior to surgery in stage I non-small cell lung cancer

BackgroundCirculating tumor DNA (ctDNA) positivity at diagnosis, which is associated with worse outcomes in multiple solid tumors including stage I–III non-small cell lung cancer (NSCLC), may have utility to guide (neo)adjuvant therapy. MethodsIn this retrospective study, 260 patients with clinical stage I NSCLC (180 adenocarcinoma, 80 squamous cell carcinoma) were allocated (2:1) to high- and low-risk groups based on relapse versus disease-free status ≤5 years post-surgery. We evaluated the association of preoperative ctDNA detection by a plasma-only targeted methylation-based multi-cancer early detection (MCED) test with NSCLC relapse ≤5 years post-surgery in the overall population, followed by histology-specific subgroup analyses. ResultsAcross clinical stage I patients, preoperative ctDNA detection did not associate with relapse within 5 years post-surgery. Sub-analyses confined to lung adenocarcinoma suggested a histology-specific association between ctDNA detection and outcome. In this group, ctDNA positivity tended to associate with relapse within 2 years, suggesting prognostic implications of MCED test positivity may be histology- and time-dependent in stage I NSCLC. Preoperative ctDNA detection was associated with upstaging of clinical stage I to pathological stage II–III NSCLC. ConclusionsOur findings suggest preoperative ctDNA detection in patients with resectable clinical stage I NSCLC using MCED, a pan-cancer screening test developed for use in an asymptomatic population, has no detectable prognostic value for relapse ≤5 years post-surgery. MCED detection may be associated with early adenocarcinoma relapse and increased pathological upstaging rates in stage I NSCLC. However, given the exploratory nature of these findings, independent validation is required.

Comparison of Clinical Outcomes Between Laparoscopic and Open Surgery in Colorectal Cancer Patients.

Our research compares the clinical results of open surgery versus laparoscopic surgery for colorectal malignancies. Our analysis focused on a database that included data on patients with colorectal cancer who had laparoscopic or open surgery for stages I to III at a prestigious healthcare institute in India. Two groups of 50 patients underwent laparoscopic and 50 underwent conventional open colorectal surgery (OCRS and LCRS, respectively) throughout the same time. Patient demographics, operation data, initial postoperative outcomes, follow-up appointments, pathology results, and cancer stages were examined. The LCRS group had a much longer operation time compared to the OCRS. Subjects in the LCRS group experienced a notably accelerated recovery after surgery. The hospital stay for the OCRS group was considerably longer compared to that in the LCRS group. Laparoscopic colorectal surgery is a reliable and convenient alternative to the traditional open approach, providing comparable oncological efficacy.

Fertility-Sparing Surgery for Stage I Epithelial Ovarian Cancer.

To describe population-level utilization of fertility-sparing surgery and outcome of reproductive-aged patients with early epithelial ovarian cancer who underwent fertility-sparing surgery in the United States. This retrospective study queried the National Cancer Institute's Surveillance, Epidemiology, and End Result Program. The study included 3,027 patients younger than age 50 years with stage I epithelial ovarian cancer receiving primary surgical therapy from 2007 to 2020. Fertility-sparing surgery was defined as preservation of one ovary and the uterus for unilateral lesion and preservation of the uterus for bilateral lesions. Temporal trend of fertility-sparing surgery was assessed with linear segmented regression with log-transformation. Overall survival associated with fertility-sparing surgery was assessed with Cox proportional hazard regression model. A total of 534 patients (17.6%) underwent fertility-sparing surgery. At the cohort level, the utilization of fertility-sparing surgery was 13.4% in 2007 and 21.8% in 2020 (P for trend=.009). Non-Hispanic White individuals (2.8-fold), those with high-grade serous histology (2.2-fold), and individuals with stage IC disease (2.3-fold) had a more than twofold increase in fertility-sparing surgery utilization during the study period (all P for trend<.05). After controlling for the measured clinicopathologic characteristics, patients who received fertility-sparing surgery had overall survival comparable with that of patients who had nonsparing surgery (5-year rates 93.6% vs 92.1%, adjusted hazard ratio 0.87, 95% CI, 0.57-1.35). This survival association was consistent in high-grade serous (5-year rates 92.9% vs 92.4%), low-grade serous (100% vs 92.2%), clear cell (97.5% vs 86.1%), mucinous (92.1% vs 86.6%), low-grade endometrioid (95.7% vs 97.7%), and mixed (93.3% vs 83.7%) histology (all P>.05). In high-grade endometrioid tumor, fertility-sparing surgery was associated with decreased overall survival (5-year rates 71.9% vs 93.8%, adjusted hazard ratio 2.90, 95% CI, 1.09-7.67). Among bilateral ovarian lesions, fertility-sparing surgery was not associated with overall survival (5-year rates 95.8% vs 92.5%, P=.364). Among 41,914 patients who had epithelial ovarian cancer with any age and stage, those younger than age 50 years with stage I disease increased from 8.6% to 10.9% during the study period (P for trend=.002). Nearly one in five reproductive-aged patients with stage I epithelial ovarian cancer underwent fertility-sparing surgery in recent years in the United States. More than 90% of reproductive-aged patients with stage I epithelial ovarian cancer who underwent fertility-sparing surgery were alive at the 5-year timepoint, except for those with high-grade endometrioid tumors.

Arthrodesis for Eaton-Littler stage III degenerative trapeziometacarpal arthritis: a retrospective comparative study of fixation methods

Purpose: This study compared clinical outcomes depending on the fixation modality in patients who underwent arthrodesis surgery for Eaton-Littler stage III trapeziometacarpal (TM) joint arthritis between 2009 and 2022. Methods: In total, 39 patients with 44 hands (five patients had surgery on both hands) were selected. Depending on the operative fixation instruments, patients were divided into two groups: group 1, surgery with 25-gauge interosseous wiring and Kirschner wire or headless screw fixation; group 2, surgery with only multiple headless screws for fixation. Bone union was achieved at 62 days after surgery in group 1 and 75 days in group 2 (p=0.165). Results: The preoperative mean visual analogue scores improved during the postoperative outpatient follow-up period in both groups (group 1, from 4.0 preoperatively to 1.0 at the final follow-up; group 2, from 5.0 preoperatively to 2.0 at the final follow-up). Mean grip strength and pinch strength increased after surgery. One patient (4.8%) experienced nonunion in group 1, whereas nonunion occurred in four patients (17.4%) in group 2. This difference was not statistically significant. Four patients in group 1 and no patients in group 2 underwent fixation instrument removal after sound union. Conclusion: Adequate stability can be achieved during arthrodesis by combining interosseous wiring and other implants or multiple headless compression screws, resulting in successful outcomes for patients with Eaton-Littler stage III degenerative TM arthritis.

The ASCENT Trial: a phase 2 study of induction and consolidation afatinib and chemoradiation with or without surgery in stage III EGFR-mutant NSCLC.

The role of tyrosine kinase inhibitors (TKIs) in early-stage and metastatic oncogene-driven non-small cell lung cancer (NSCLC) is established, but it remains unknown how best to integrate TKIs with concurrent chemoradiotherapy (cCRT) in locally advanced disease. The phase 2 ASCENT trial assessed the efficacy and safety of afatinib and cCRT with or without surgery in locally advanced epidermal growth factor receptor (EGFR)-mutant NSCLC. Adults ≥18 years with histologically confirmed stage III (AJCC 7th edition) NSCLC with activating EGFR mutations were enrolled at Mass General and Dana-Farber/Brigham Cancer Centers, Boston, Massachusetts. Patients received induction afatinib 40 mg daily for 2 months, then cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 IV every 3 weeks during RT (definitive or neoadjuvant dosing). Patients with resectable disease underwent surgery. All patients were offered consolidation afatinib for 2 years. The primary endpoint was the objective response rate (ORR) to induction TKI. Secondary endpoints were safety, conversion to operability, progression-free survival (PFS), and overall survival (OS). Analyses were performed on the intention-to-treat population. Nineteen patients (median age 56 years; 74% female) were enrolled. ORR to induction afatinib was 63%. Seventeen patients received cCRT; 2/9 previously unresectable became resectable. Ten underwent surgery; 6 had a major or complete pathological response. Thirteen received consolidation afatinib. With a median follow-up of 5.0 years, median PFS and OS were 2.6 (95% CI, 1.4-3.1) and 5.8 years (2.9-NR), respectively. Sixteen recurred or died; 6 recurrences were isolated to CNS. The median time to progression after stopping consolidation TKI was 2.9 months (95% CI, 1.1-7.2). Four developed grade 2 pneumonitis. There were no treatment-related deaths. We explored the efficacy of combining TKI with cCRT in oncogene-driven NSCLC. Induction TKI did not compromise subsequent receipt of multimodality therapy. PFS was promising, but the prevalence of CNS-only recurrences and rapid progression after TKI discontinuation speak to unmet needs in measuring and eradicating micrometastatic disease.

The Effect of Neoadjuvant Systemic Therapy on Surgical Outcomes After Lymph Node Dissections for Stage III Melanoma; An Australian Cohort

BackgroundNeoadjuvant systemic therapy (NAST) for patients with stage III melanoma achieves high major pathologic response rates and high recurrence-free survival rates. This study aimed to determine how NAST with targeted therapies (TTs) and immune checkpoint inhibitors (ICIs) influences surgical outcomes after lymph node dissection in terms of complications, morbidity, and textbook outcomes.MethodsPatients who underwent a lymph node dissection after either NAST in a clinical trial or upfront surgery for stage III melanoma between 2014 and 2022 were identified from an institutional research database.ResultsThe study included 89 NAST-treated patients and 79 upfront surgery-treated patients. The rate of postoperative complications did not differ between the NAST- and upfront surgery-treated patients (55% vs. 51%; p = 0.643), and steroid treatment for drug toxicity did not influence the complication rate (odds ratio [OR], 1.1; 95% confidence interval [CI], 0.4–3; p = 0.826). No significant differences in postoperative morbidity were observed in terms of seroma (23% vs. 11%; p = 0.570) or lymphedema (36% vs. 51%; p = 0.550). The rate of achieving a textbook outcome was comparable for the two groups (61% vs. 57%; p = 0.641).ConclusionsThe surgical outcomes after lymph node dissections were comparable between the patients who received NAST and those who had upfront surgery, indicating that surgery can be safely performed after NAST with TT or ICI for stage III melanoma.

Laparoscopic Ultrasound-Guided Transcystic Approach for the Treatment of Common Bile Duct Stones.

Background: The treatment of choledocholithiasis with nondilated common bile duct (CBD) is a challenge for surgeons who often choose endoscopic retrograde cholangiopancreatography with laparoscopic cholecystectomy (LC) staging surgery instead of simultaneous laparoscopic CBD exploration with LC because of the small CBD diameter. This study aims to introduce and assess the clinical applicability of a technique we developed to identify and extract CBD stones using laparoscopic ultrasound (LUS). Methods: We retrospectively reviewed surgical procedures and clinical data of 13 patients who underwent LC and CBD exploration using LUS between May 2022 and August 2023. The cystic duct was used for CBD stone removal. Results: Ten patients were successfully treated; 2 patients with residual stones were treated with ursodeoxycholic acid, whereas 1 patient required a microincision near the CBD and choledochoscopy because of stone incarceration in the duodenal papilla. The CBD diameter was 6 mm (5-9 mm). There were less than three CBD stones, with diameters of 2-6 mm; the median operative time was 105 minutes (range, 52-155 minutes). One patient developed postoperative cholangitis. The median postoperative hospital stay was 6 days (3-8 days). The stone clearance rate was 76.9%, and the CBD stone detection rate was 100%. No intraoperative complications, postoperative bile leakage, and mortality occurred. Conclusions: CBD exploration and transcystic stone extraction under LUS guidance are safe and effective approaches for patients with choledocholithiasis; strict control over surgical indications is necessary. This study could provide new strategies for effectively treating choledocholithiasis.

Chemoradiotherapy versus surgery after neoadjuvant chemoimmunotherapy in patients with stage III NSCLC: a real-world multicenter retrospective study

PurposeThe optimal treatment after neoadjuvant chemoimmunotherapy for patients with stage III non-small cell lung cancer (NSCLC) is unclear. This study aimed at comparing the efficacy and safety of chemoradiotherapy and surgery after neoadjuvant chemoimmunotherapy in stage III NSCLC.Materials and methodsWe conducted a real-world multicenter retrospective study on patients with stage III NSCLC who received surgery or chemoradiotherapy after neoadjuvant chemoimmunotherapy between October 2018 and December 2022. Progression-free survival (PFS) and overall survival (OS) were assessed from the initiation of neoadjuvant treatment and estimated by the Kaplan‒Meier method. Univariate and multivariate Cox regression models were used to examine potential prognostic factors. One-to-one propensity score matching (PSM) was used to further minimize confounding.ResultsA total of 239 eligible patients were enrolled, with 104 (43.5%) receiving surgery and 135 (56.5%) receiving CRT. After 1:1 PSM, 1- and 2-year PFS rates in patients receiving radical surgery (rSurgery group) vs. patients receiving definitive cCRT (dCCRT group) were 80.0% vs. 79.2% and 67.2% vs. 53.1%, respectively (P = 0.774). One- and 2-year OS rates were 97.5% vs. 97.4% and 87.3% vs. 89.9%, respectively (P = 0.558). Patients in the dCCRT group had a numerically lower incidence of distant metastases compared to those in the rSurgery group (42.9% vs. 70.6%, P = 0.119). The incidence of treatment-related adverse events was similar in both groups, except that the incidence of grade 3/4 hematological toxicity was significantly higher in the dCCRT group (30.0% vs. 10.0%, P = 0.025).ConclusionFollowing neoadjuvant chemoimmunotherapy, definitive concurrent chemoradiotherapy may achieve noninferior outcomes to radical surgery in stage III NSCLC.

Residual cancer burden in two-stage nipple sparing mastectomy after first stage lumpectomy and devascularization of the nipple areolar complex.

Ischemic complications after nipple-sparing mastectomy (NSM) can be ameliorated by 2-stage procedures wherein devascularization of the nipple-areolar complex (NAC) and lumpectomy with or without nodal staging surgery is performed first (1S), weeks prior to a completion NSM (2S). We report the time interval between procedures in relation to the presence of residual carcinoma at 2S NSM. Women with breast cancer who received 2S NSM from 2015 to 2022 were identified. Both patient level and breast level analyses were conducted. Clinical staging at presentation, pathologic staging at 1S and residual disease at 2S pathology are noted. Residual disease was classified as microscopic (1-2mm), minimal (3-10mm), and moderate (> 10mm). 59 patients (108 breasts) underwent 2S NSM. The median time interval between 1 and 2S for all patients was 34days: 31days for upfront surgery invasive cancer, 41days for upfront DCIS surgery and 31days for those receiving neoadjuvant therapy. Completion NSM was performed within 6weeks for 72% of the breasts analyzed. Of the 53 breasts with invasive cancer on 1S pathology, 35% (19/53) had no residual invasive disease and 24.5% (13/53) had neither residual invasive nor in situ carcinoma on final 2S. Among the 50 women who had upfront surgery, 16 (32%) had residual invasive cancer found at 2S NSM, 9 of which had less than or equal to 1cm disease. Invasive cancers were completely resected during 1S procedure in 65% of breasts. Residual disease was minimal and there was only one case of upstaging at 2S. Added time of two-stage surgery is offset by a reduction in ischemic mastectomy flap complications.

Nongestational ovarian choriocarcinoma with bilateral teratoma: A rare case report and literature review.

Trophoblastic neoplasms are often associated with pregnancy, and nongestational trophoblastic neoplasms are extremely rare. Nongestational ovarian choriocarcinoma (NGCO) is a highly aggressive germ cell-derived tumor frequently presenting with early hematogenous metastasis. Herein, we report a case of a 28-year-old unmarried woman with regular menstruation who experienced vaginal bleeding 1 week after her last menstrual cycle. Doppler ultrasound revealed bilateral adnexal masses and elevated serum human chorionic gonadotropin (hCG) levels. The patient was initially misdiagnosed as presenting an ectopic pregnancy. The final pathology confirmed an International Federation of Gynecology and Obstetrics stage IA NGCO with bilateral mature teratoma of the ovary. This is an extraordinary instance of ovarian choriocarcinoma which emerged without any prior gestation, and the patient's lack of a history of pregnancy made the diagnosis ignored. After initial surgery and 1 cycle of bleomycin, etoposide, and cisplatin (BEP) chemotherapy, a laparoscopic fertility-preserving comprehensive staging surgery was performed. Two cycles of chemotherapy with BEP were administered as supplemental therapy postsurgery, and leuprorelin was administered to protect ovarian function. Menstruation resumed 4 months after chemotherapy completion, and tumor indicators were within the normal range. No signs of recurrence were observed at the 36-month follow-up. NGCO should be considered if a female patient exhibits irregular vaginal bleeding and masses in the adnexal area. The present case and our literature review also highlighted that fertility-sparing surgery and multidrug chemotherapy are effective methods for treating NGCO.

Abstract PO1-19-02: A phase III trial evaluating De-escalation of Breast Radiation (DEBRA) following breast-conserving surgery (BCS) of stage 1, HR+, HER2-, RS ≤18 breast cancer: NRG-BR007

Abstract Background: Approximately 50% of newly diagnosed invasive breast cancers are stage 1, with the majority being ER/PR-positive, HER2-negative. Genomic assays such as the Oncotype DX® have identified patients (pts) with reduced risk of distant metastasis and without benefit from chemotherapy added to endocrine therapy, freeing them from excess toxicity. Genomic assays are also recognized as prognostic for in-breast recurrence (IBR) after BCS and could similarly allow de-escalation of adjuvant radiotherapy (RT). Reducing overtreatment is of interest to pts, providers, and payers. Methods: We hypothesize that BCS alone is non-inferior to BCS plus RT for in-breast recurrence and breast preservation in women intending endocrine therapy (ET) for stage 1 invasive breast cancer (ER &amp;/or PR positive, HER2-negative with an Oncotype DX Recurrence Score [RS] of ≤18). Stratification is by age (&amp;lt; 60; ≥60), tumor size (≤1 cm; &amp;gt;1-2cm), and RS (&amp;lt; 11, 11-18). Pts are randomized post-BCS to Arm 1 with breast RT using standard methods (hypo- or conventional-fractionated whole breast RT with/without boost, or APBI) with ≥5 yrs of ET (tamoxifen or AI) or Arm 2 with ≥5 yrs of ET (tamoxifen or AI) alone. The specific regimen of ET in both arms is at the treating physician’s discretion. Eligible pts are stage 1: pT1 (≤2 cm), pN0, age ≥50 to &amp;lt; 70 yrs, s/p BCS with negative margins (no ink on tumor), s/p axillary nodal staging (SNB or ALND), ER &amp;/or PR positive (ASCO/CAP), HER2-negative (ASCO/CAP), and Oncotype DX RS of ≤18 (diagnostic core biopsy or resected specimen). Primary endpoint is in-breast recurrence (invasive breast cancer or DCIS). Secondary endpoints are breast conservation rate, invasive in-breast recurrence, relapse-free interval, distant disease-free survival, overall survival, patient-reported breast pain, patient-reported worry about recurrence, and adherence to ET. We assume a clinically acceptable difference in IBR of 4% at 10 yrs to judge omission of RT as non-inferior (10-yr event-free survival for RT group is 95.6% vs 91.6% for the omission of RT group). BR007 is powered to detect non-inferiority with 80% power and a one-sided α=0.025, assuming that there would be a ramp-up in accrual in the first two years (leveling off in Yrs 3-5); 1,670 pts (835 per arm) are required for randomization. Conservative loss to follow-up is 1% per yr. Some of the T1a pts screened may have Oncotype DX scores &amp;gt;18, making them ineligible for the study. In the accrual process, 1,714 pts will be required to register to ensure that our final randomized cohort is 1,670 pts. Current accrual (07-07-2023) is 555 screened and 488 randomized (~96% of predicted accrual). Support: U10CA180868, -180822, UG1CA189867, UG1CA189867; Susan G. Komen Foundation (JRW). NCT: 04852887. Citation Format: Julia White, Reena Cecchini, Eleanor Harris, Eleftherios Mamounas, Daniel Stover, Patricia Ganz, Reshma Jagsi, Stewart Anderson, Carmen Bergom, Valérie Théberge, Mahmoud El-Tamer, Richard Zellars, Dean Shumway, Guang-Pei Chen, Thomas Julian, Norman Wolmark. A phase III trial evaluating De-escalation of Breast Radiation (DEBRA) following breast-conserving surgery (BCS) of stage 1, HR+, HER2-, RS ≤18 breast cancer: NRG-BR007 [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 PO1-19-02.

Abstract PO5-22-09: Positive pegulicianine fluorescence rate in the lumpectomy cavity correlates with tumor distance to margins in excised tissue

Abstract Title: Positive pegulicianine fluorescence rate in the lumpectomy cavity correlates with tumor distance to margins in excised tissue Background: A randomized, two-arm pivotal study of pegulicianine fluorescence guided surgery (pFGS) at 14 US sites was conducted using the Lumicell Direct Visualization System (DVS) to identify residual cancer in the lumpectomy cavity after the standard of care (SoC) tumor excision. We reported that the Lumicell DVS detects residual cancer in the lumpectomy cavity, including in orientations pathologically negative on the SoC specimen. In addition, 15% (9 of 62) of patients with positive SoC margins were converted to final negative margins by taking Lumicell DVS directed cavity margins, avoiding a second unnecessary surgery. Interestingly, 8 of these 9 patients had no tumor found in the Lumicell DVS guided specimens. We hypothesize that fluorescence decreases as the distance from the tumor boundary increases. We analyzed data from the pivotal study (NCT03686215) to assess correlation of pegulicianine signal with tumor-to-margin distance, and its potential clinical value. Methods: The pivotal study enrolled 406 patients undergoing breast conserving surgery (BCS) for stage 0-III breast cancers. Patients received an IV injection of pegulicianine 2-6 hours prior to surgery. After the standard of care lumpectomy was completed, additional Lumicell DVS-guided cavity margins were excised at sites of positive pegulicianine fluorescence signal in the lumpectomy cavity walls using a hand-held imaging device and patient-calibrated cancer detection software. The positive fluorescence rate, that is, the rate at which the Lumicell DVS indicates areas suspected to contain cancer, was calculated as the ratio of orientations with positive pegulicianine signal to the total number of orientations with (1) negative margins, (2) positive margins and (3) positive margins with ink on tumor, on the initial SoC lumpectomy specimen. Calculations were made on a per-margin basis. Positive margins were defined as ink on tumor for invasive cancer and tumor less than 2 mm from the margin for ductal carcinoma in situ (DCIS) alone. Results: Results are presented in Table 1. We found a statistically significant higher positive fluorescence rate in orientations with positive margins (p=0.044). The positive fluorescence rate was even higher (21.1%) when only considering cases with ink on tumor (a subset of the positive margin group). Discussion: By design, pegulicianine is activated by enzymes within the tumor and in stromal cells at the invasive front surrounding the tumor. Thus, when tumor is closer to the edge of the lumpectomy specimen, the rate of positive pegulicianine fluorescence in the cavity increases, being highest when there is tumor present at the inked margin. This feature of pegulicianine fluorescence guides the surgeon to resect more tissue in these areas in order to achieve a negative margin of the required width. The conversion of positive margins after the SoC lumpectomy to appropriately wide final negative margins prevents a second surgery, even when there is no tumor in the DVS guided margins. These findings have strengthened our understanding of the utility of this technology. Table 1 Positive cavity wall fluorescence rate for SoC lumpectomy positive margins, SoC lumpectomy negative margins and SoC lumpectomy ink on tumor margins Citation Format: Irene Wapnir, E Shelley Hwang, Kelly Hunt, David Carr, Peter Blumencranz, Manna Chang, Kate Smith, Jorge Ferrer, Barbara Smith. Positive pegulicianine fluorescence rate in the lumpectomy cavity correlates with tumor distance to margins in excised tissue [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 PO5-22-09.

Abstract PO2-17-07: Risk analysis of the differences in eligibility criteria between monarchE and POTENT clinical trials

Abstract Background Luminal subtype recurrence risk classifications for breast cancer have been updated and put into practice with the development of treatment. Despite this, it is noteworthy that from 2008 to 2016, early breast cancer (EBC) of luminal subtype has been reported to have little improvement in survival probability. For early-stage luminal breast cancer, several clinical trials, such as monarchE, NATALEE (which is not available in Japan) or POTENT, were being conducted. In order to avoid overtreating individuals who might not benefit from adjuvant therapy, those at high risk of recurrence ought to be accurately picked up. In monarchE and POTENT trials, abemaciclib and S-1 have shown to be effective in adjuvant therapies for luminal breast cancer although it is unrevealed if the eligible patients for each criterion are at higher risk of recurrence than ineligible patients. Besides, some of the eligibility for POTENT overlaps with those for monarchE, the patients who met POTENT but did not meet monarchE criteria at how much risk of recurrence still remains unknown. Here, we investigated recurrence risk according to the criteria of each trial in Japanese patients in real world. Methods We reviewed the records of 1209 patients who received surgery for stage I–III breast cancer from January 2016 to May 2022 and selected 637 analytic cohort patients and retrospectively analyzed the recurrence-free survival (RFS) of the patients using the Kaplan–Meier method. High-recurrence-risk was defined according to monarchE trial and POTENT trial. Patients’ RFS was the primary endpoint. Results The 5-year RFS for all luminal breast cancer patients was 94.87% at Chiba University Hospital. Among monarchE eligible patients, the 5-year RFS was 82.49% and cohort 1 and cohort 2 eligible patients was 78.62% and 92.18% respectively, which were statistically lower than monarchE non-eligible patients (98.58%) (p &amp;lt; 0.0001, p = 0.0216, respectively). Even though the 5-year RFS rate for POTENT eligible patients (91.16%) was lower than POTENT non-eligible patients (99.13%) (p &amp;lt; 0.0001), while excluding those who met the monarchE criteria, the prognosis of POTENT eligible patients (5-year RFS rate 97.76%) had no significant differences from the patients with POTENT non-eligible breast cancer (p =0.0660). Our results suggested that the eligible patients of both monarchE and POTENT were associated with poor prognoses so the criteria set are considered to be appropriate. However, although POTENT criteria suggested a reasonable capacity for recurrence prediction, there was no dramatic difference in recurrence between POTENT non-eligible patients and the patients who are POTENT eligible but are not monarchE eligible. This might offer justification for reconsidering the use of S-1 in monarchE non-eligible patients. With the use of clinicopathological factors, it may assist in identifying individuals with high recurrence risk who would benefit from lengthier adjuvant chemotherapy regimens. Conclusion MonarchE criteria accurately identifies patients at high risk of relapse but the relapse in the patients who only qualified for POTENT is statistically almost the same as that in POTENT non-eligible patients. Citation Format: Muhan Yu, Mamoru Takada, Hideyuki Yamada, Hiroshi Fujimoto, Junta Sakakibara, Hiroto Yamamoto, Takeshi Nagashima, Masayuki Otsuka. Risk analysis of the differences in eligibility criteria between monarchE and POTENT clinical trials [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 PO2-17-07.

Abstract PO4-11-12: Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS)

Abstract Background: In pegulicianine fluorescence guided surgery (pFGS), a standard of care lumpectomy procedure is performed, and additional tissue is taken from cavity walls at sites of high pFGS signal. This approach been shown to reduce 2nd surgeries and remove additional tumor left by standard surgery, but may remove more tissue, potentially worsening cosmetic outcomes. Patient breast satisfaction surveys were used to assess cosmesis after pFGS. Methods: A prospective Pivotal trial of pFGS in women undergoing lumpectomy surgery for stage 0-III breast cancer was conducted at 14 US sites (NCT03686215). We assessed the safety and efficacy of the Lumicell DVS in identifying and removing residual cancer from the lumpectomy cavity in real time. Patient Reported Outcome Measures (PROM) data was collected as an exploratory endpoint. The BREAST-Q, a validated tool that measures patient perspectives after different breast procedures, was used to collect PROM data. An 11-question BREAST-Q survey was used to measure patients’ breast satisfaction at baseline (pre-surgery) and at multiple timepoints through 6-months post lumpectomy. Descriptive statistics of participating patients’ responses were collected and analyzed. Survey results were analyzed by the distribution of patient ratings for each question and the change in the distribution of ratings over time, with comparison of baseline to post-lumpectomy. Comparison of patient satisfaction with or without additional pFGS-directed tissue removal was performed with Item Response Theory assuming all items equally discriminative of responding patients. For each timeframe, responses to BREAST-Q items were used to create a response score for each patient. Scaled factor scores (0-100) were compared between groups with and without additional tissue removed during pFGS. Results: Of the 357 patients evaluated for efficacy in the primary Pivotal study analysis, 255 patients agreed to participate in the PROM surveys (71%). Approximately 60% of the participating respondents completed a pre- and initial post-lumpectomy survey while only 34% of the participating patients completed a pre- and 6-month post-lumpectomy survey. Most patients responded either “Very Satisfied” or “Somewhat Satisfied” across all surveyed timeframes. No significant difference in patient breast satisfaction was found at any time point between the groups with and without additional pFGS-guided shaves removed (p &amp;gt;0.05). There were 4 patients with scores of 3 or higher pre-surgery but 2 or lower post-surgery. Among these, 1 had no pFGS-guided shaves taken. The remaining 3 had had pFGS-guided shaves taken, but 2 required a second lumpectomy surgery and 1 underwent mastectomy, these additional surgeries likely accounting for decreased cosmetic outcomes. Discussion: Patient perspective of breast satisfaction was not decreased by the amount of extra tissue removed by pFGS. These data suggest that pFGS using the Lumicell DVS does not significantly decrease breast cosmesis. Three of 4 patients with decreased satisfaction had 2nd surgeries, confirming the importance of finding approaches to decrease 2nd surgeries. This data was collected during the COVID-19 pandemic, which may have adversely impacted the compliance rate of survey completion. Studies in larger cohorts with longer follow up are required to better assess the relative impact of 2nd surgeries, radiation, and systemic therapy on breast satisfaction PROM scores after lumpectomy. Citation Format: Kelly Hunt, Irene Wapnir, E Shelley Hwang, David Carr, Peter Blumencranz, Kate Smith, Manna Chang, Jorge Ferrer, Barbara Smith. Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS) [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 PO4-11-12.

AB041. SOH24AB_105. Evaluating the use of pre-operative colonoscopy prior to combined colorectal/gynaecological surgery for stage IV endometriosis

AB041. SOH24AB_105. Evaluating the use of pre-operative colonoscopy prior to combined colorectal/gynaecological surgery for stage IV endometriosis