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643 citation(s) found for "Go, Lucas T".

Use of calcium phosphate bone cement in retrosigmoid craniotomies to reduce rates of pseudomeningocele and craniotomy-site CSF leakage: a cohort study and meta-analysis
Webb, Kevin L. , Michaelcheck, Charlotte E., Link, Michael J. , Celda, María Peris, Carlstrom, Lucas P. , Peris Celda, Maria, Bauman, Megan M. J. , Morshed, Ramin A. , Gompel, Jamie J. Van

Mayo Clinic

Journal of Neurosurgery | June 6, 2025 | Volume: 143 | Issue: 4 | Pages: 1027-1036

10.3171/2025.1.jns241076 | PMID 40479821 Get It

OBJECTIVE Calcium phosphate cement (CPC) use has been previously described as a strategy to reduce the rates of pseudomeningocele and CSF leakage following skull base surgery. The authors aimed to present their institutional experience with CPC in retrosigmoid craniotomy and perform a systematic review of the literature to determine the effectiveness of CPC in reducing postoperative complications, including pseudomeningocele and craniotomy-site CSF leakage. METHODS A retrospective single-institution cohort study of patients who underwent retrosigmoid craniotomy with and without CPC cranioplasty from January 2017 to April 2024 was performed. A systematic literature review and meta-analysis of CPC use in retrosigmoid craniotomy was also performed. RESULTS Of 336 patients who underwent retrosigmoid craniotomy, 193 (57%) were female and the median age at surgery was 55 years (range 18–81 years). The median follow-up duration was 23 months (range 3–80 months). CPC was used to seal the edge of the craniotomy in 66 patients (20%). Among all patients, 50 (15%) experienced a postoperative complication, and 28 (8%) were wound-specific complications. Patients in the non-CPC group experienced significantly more postoperative wound-specific complications than those in the CPC group (10% vs 0%, p = 0.002). Specifically, pseudomeningocele occurred in 0 patients (0%) in the CPC group compared with 24 patients (9%) in the non-CPC group (p = 0.006), which progressed to CSF leaks at the craniotomy site in 6 patients (p = 0.60). Additionally, no patients (0%) in the CPC group experienced wound infection, dehiscence, or breakdown compared with 10 patients (4%) in the non-CPC group (p = 0.22). Five patients (8%) in the CPC group reported prolonged mild incisional pain at the craniotomy site, and there were no instances of major complications related to the CPC. In the meta-analysis, 10 studies met the inclusion criteria, yielding a total of 2166 patients (including the current study), 1101 of whom received CPC. In the pooled analysis, CPC was significantly associated with lower risk of CSF leakage at the craniotomy site (OR 0.23, 95% CI 0.13–0.42; p < 0.01) and lower risk of infection (OR 0.17, 95% CI 0.08–0.38; p < 0.01). CONCLUSIONS CPC use in retrosigmoid craniotomies could be a safe and effective strategy to reduce the incidence of pseudomeningocele and craniotomy-site CSF leakage, leading to lower rates of wound-related complications and infection.
Single-Fraction Stereotactic Radiosurgery as Primary Management of Sporadic Meningiomas: A 25-Year Cohort Study
Kumar, Rahul , Carlstrom, Lucas P. , Morshed, Ramin A. , Brown, Paul D. , Mahajan, Anita , Graffeo, Christopher S. , Link, Michael J. , Pollock, Bruce E. , Morshed, Ramin , Graffeo, Christopher Salvatore , Kumar, Rahul , Laack, Nadia N.

Mayo Clinic

Neurosurgery | June 6, 2025 | Volume: 97 | Issue: 6 | Pages: 1267-1274

10.1227/neu.0000000000003528 | PMID 40476726 Get It

BACKGROUND AND OBJECTIVES: Stereotactic radiosurgery (SRS) is increasingly used as a primary treatment modality for intracranial meningiomas. We aim to describe clinical outcomes after single-fraction SRS for sporadic intracranial meningiomas. METHODS: A prospectively maintained database was reviewed for patients with sporadic meningiomas who underwent SRS (Gamma Knife) as primary treatment modality from April 1997 to February 2022. Primary outcomes included progression-free survival (PFS) and treatment-related complications. RESULTS: Six hundred sixteen patients (653 tumors) underwent SRS with median follow-up of 6.3 years (interquartile range [IQR] 3.1-10.5 years). The median tumor volume was 4.5 cm 3 (IQR 2.0-8.0 cm 3 ). The median margin dose was 15.0 Gy (IQR 14.0-16.0). In-field progression was noted in 7 tumors (1.1%) and marginal progression in 2 tumors (0.3%) for a raw failure rate of 1.4%. PFS estimates at 5, 10, and 15 years were 99.8%, 99.0%, and 93.2%, respectively. Factors associated with reduced PFS on univariable analysis included older age (hazards ratio [HR] 1.14, 95% CI, 1.05-1.22, P < .001), male sex (HR 5.44, 95% CI, 1.45-20.4, P = .010), increasing tumor volume (HR 1.06, 95% CI, 0.99-1.13, P = .028), and lower tumor margin dose (HR 0.65, 95% CI, 0.43-0.97, P = .006). Treatment-related complications were noted in 56 patients (9.1%), of which 45 (7.3%) were temporary, 5 (0.8%) were minor, and 6 (1.0%) were permanent and/or required intervention. Radiosurgical parameters associated with treatment-related complications included increased number of isocenters (odds ratio [OR] 1.09, 95% CI, 1.04-1.14, P < .001), higher 12-Gy volume (OR 1.06, 95% CI, 1.03-1.09, P < .001), larger tumor volume (OR 1.06, 95% CI, 1.02-1.10, P < .001), and lower maximal dose (OR 0.90, 95% CI, 0.82-0.98, P = .11). CONCLUSION: SRS is effective as a primary treatment modality for sporadic, small-volume to medium-volume intracranial meningiomas. Pre-emptive SRS should be discussed as a safe management strategy compared with observation alone for incidentally discovered meningiomas.
The 6 Pillars of Lifestyle Medicine and Prevalence of Cardiovascular and Cardiometabolic Diseases in Brazil: A Cross-Sectional, Population-Based Study Involving 88,531 Adults
Oliveira, Arão Belitardo , Woldeamanuel, Yohannes W. , Pereira, Larissa Karen, Oliveira, Lucas Alves de Brito , Peres, Mário Fernando Prieto , Goulart, Alessandra C. , Woldeamanuel, Yohannes Woubishet , Pereira, Larissa Karen , Rozen, Todd D. , Mota, Jorge Augusto Pinto Silva

Mayo Clinic

American Journal of Lifestyle Medicine | June 5, 2025 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1177/15598276251348170 | PMID 40485745 Get It

Objective: We aimed to estimate the prevalence of cardiovascular diseases (CVDs) and cardiometabolic diseases (CMB) in Brazil, and their relationship with a healthy lifestyle score based on the six pillars of lifestyle medicine proposed by the American College of Lifestyle Medicine. Methods: Data were derived from the 2019 Brazilian National Health Survey, a nationwide cross-sectional study. The prevalence of CVDs/CMB was based on medical-endorsed, self-reported diagnoses and weighted for sample strata. A healthy lifestyle score (0-14 points; the higher the score, the better) incorporates physical activity, diet, sleep, mental health, risky substance use, and social connections. Results: Among 88,531 adults included in the analysis (mean age: 47.1 years; 52.9% female), the weighted prevalence of CVDs/CMB ranged from 1.9% (stroke) to 25.9% (hypertension). Weighted Poisson regression models, adjusted for age, sex, socioeconomic status, and geographic disparities, showed an inverse linear relationship between lifestyle score and CVDs/CMB prevalence. Participants in the highest lifestyle score quartile exhibited lower prevalence for heart diseases [0.48 (95% CI: 0.43, 0.53)], stroke [0.35 (95% CI: 0.29, 0.43)], hypertension [0.85 (95% CI: 0.80, 0.90)], diabetes [0.80 (95% CI: 0.70, 0.91)], dyslipidemia [0.73 (95% CI: 0.66, 0.80)], and obesity [0.81 (95% CI: 0.74, 0.88)], compared to the lowest quartile ( P < 0.001 for all). Conclusions: Higher scores on the six pillars of lifestyle medicine are associated with a lower prevalence of major CVDs/CMB in Brazil.
Variation in Complete Blood Count Reports Across US Hospitals
Go, Lewis T , Go, Lucas T, Gunaratne, Madugodaralalage D. S. K. , Abeykoon, Jithma P.

Mayo Clinic

JAMA Network Open | June 5, 2025 | Volume: 8 | Issue: 6 | Pages: e2514050

10.1001/jamanetworkopen.2025.14050 | PMID 40471583 Get It

This cross-sectional study of laboratory test records from US hospitals compares the total types of complete blood count results recorded in academic and community settings.
Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on Surgical Resection for the Treatment of Patients With Vestibular Schwannomas: Update
Hadjipanayis, Constantinos G., Graffeo, Christopher S. , Patel, Neil S. , Carlson, Matthew L. , Jacob, Jeffrey T. , Carlstrom, Lucas P. , Gompel, Jamie J. Van , Olson, Jeffrey J.

Mayo Clinic

Neurosurgery | June 5, 2025 | Volume: 98 | Issue: 2 | Pages: 272-277

10.1227/neu.0000000000003473 | PMID 40470965 Get It

BACKGROUND: Surgical intervention remains an important option in the management of vestibular schwannoma (VSs). Development of a systematic approach to choose the most appropriate route for this intervention, based on existing published evidence, is an important goal. OBJECTIVE: To review the literature published since the 2018 Congress of Neurological Surgeons Guideline on surgical intervention for patients with sporadic VSs and use this information to update that set of recommendations. METHODS: The literature in the PubMed and MEDLINE databases from January 2015 through May 20, 2022, was searched for manuscripts pertaining to surgical intervention for VSs. Those manuscripts meeting inclusion criteria were then analyzed for creation of recommendations in response to a set of updated questions. RESULTS: The resultant findings included a considerable amount of data that did not alter the recommendations form the 2018 publication on this topic. Thus, recommendations stating hearing preservation surgery through the middle fossa or retrosigmoid approach may be considered in individuals with good preoperative hearing as an alternative to simple observation remain. In addition, if microsurgical resection is necessary after stereotactic radiosurgery, it is recommended that patients be counseled that there is an increased likelihood of a subtotal resection and decreased facial nerve function. In some questions, insufficient data were present to create an answer and that is stated. CONCLUSION: This guideline demonstrates surgical intervention for VSs and represents a range of options, and the choice of the intervention depends on the specific aspects of the lesion and the individual that harbors them. Objective refinement of those choices will require thoughtful research design by investigations that wish to address those items for which we still have insufficient information. The full guideline can be seen online at https://www.cns.org/guidelines/treatment-adults-vestibular-schwannoma/7-surgical-resection-treatment-of-patients-with-ve-2
Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines Update for the Role of Imaging in the Management of Patients With Vestibular Schwannomas
Graffeo, Christopher S. , Tavakol, Sherwin , Dunn, Ian F., Sivakumar, Walavan , Carlstrom, Lucas P. , Gompel, Jamie J. Van , Olson, Jeffrey J.

Mayo Clinic

Neurosurgery | June 5, 2025 | Volume: 98 | Issue: 2 | Pages: 283-287

10.1227/neu.0000000000003419 | PMID 40470931 Get It

BACKGROUND: Imaging is a critical aspect of vestibular schwannoma (VS) management, influencing essentially every aspect of care including diagnosis, surveillance, treatment decision making, and follow-up after either resection or stereotactic radiosurgery. Despite this, treatment protocols are heterogeneous, and frequently based on historical practices, or low-quality evidence. OBJECTIVE: To update evidence-based guidelines for the use of imaging in the clinical management of patients with VS published by the Congress of Neurological Surgeons in 2018. METHODS: Systematic review of the literature published from 1/1/2015 to 5/20/2022 regarding imaging protocols for VS management. Salient questions were identified by a writing group of diverse individuals with topic-specific expertise. Questions were validated by the Congress of Neurological Surgeons Guidelines Committee. Following systematic review, literature tables and summary statements pertinent to the study questions were generated by the writing group, which underwent subsequent evaluation and revision by the task force before formalization. RESULTS: Seven questions were formulated; adequate literature was identified to formulate updated recommendations for 6 of these. Search strategy identified 1143 unique records, of which 109 underwent full-text review, and 57 were included in this study. Most studies provided level III evidence, with rare level II studies noted, yielding level III recommendations. CONCLUSION: The current evidence base for imaging protocols in VS clinical management is broad, diverse, low certainty, and low quality. This in part reflects a heterogeneous disease, although variability in treatment philosophies may also influence local decision making. Key areas for future study include the clinical utility of advanced imaging techniques and head-to-head comparisons of imaging protocols for patients in common initial VS management pathways (eg, observation, resection, or stereotactic radiosurgery). The full guideline can be seen online at https://www.cns.org/guidelines/treatment-adults-vestibular-schwannoma/5-role-of-imaging-in-management-of-patients-with-v
Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study
Babiker, Hani M. , Picozzi, Vincent J. , Chandana, Sreenivasa R , Melichar, Bohuslav, Kasi, Anup , Gang, Jin, Gállego, Javier , Bullock, Andrea J. , Chunyi, Hao, Hitre, Erika, Osipov, Arsen , Alés, Inmaculada, Dragovich, Tomislav, Lee, Woo Jin , Feeney, Kynan, Ueno, Makoto , Seufferlein, Thomas , Investigators, on behalf of the PANOVA-3 Study, Osipov, Arsen, Matrana, Marc , Blondin, Nicholas, Shroff, Rachna T. , Orr, Douglas, Anderson, Michael J. , Shields, Anthony F. , Hamm, John , Bullock, Andrea, Nagireddy, Sumana, Kolodney, Joanna, Dragovich, Tomislav, Maniam, Ajit, Sears, Judith D., Stilwill, Joseph, Cusnir, Mike , Niewiaroska, Anna, Small, William, Kasi, Anup, Tache, Jason, Ross, Sharona, Shihabi, Samer, Gandhi, Sunil, Reeves, J. N. , Green, Garrett , Feinstein, Trevor, Huyck, Timothy K., Ramdin, Nadia, Marsh, Robert , Jiang, Yixing , Hatoum, Hassan , Manda, Sudhir, Kochenderfer, Mark D., Illum, Henrik, Richards, Donald , Valilis, P., Wong, Lucas, Newton, Herbert B. , Abdelrahim, Maen, Einspahr, David, Siegel, Richard, McKenney, Scott, Narang, Mohit , Cárdenes, Higinia R. , Thanikachalam, Kannan , Raff, Joshua P. , Ye, Joseph , Behl, Deepti , Kam, Audrey E., DeRose, Paul, Tasneem, A. , Brenner, Warren, Santos, Jennifer De Los , Rausch, D C, Trikha, Gaurav, Gabrail, Nashat , Mowat, Rex B., Jahangir, Khawaja, Schumaker, Robert P. , Soffen, Edward , Bravin, Eric, Gupta, Mukul Kumar , Bedoya-Apraez, Ivan Dario, Kang, Tyler Y., Lemay, Frédéric , Vincent, Mark , Létourneau, Richard, Doehring, Christine, Haberkorn, Mike, Rußwurm, Karen, Chater, Jack, Küng, Marc , Schacher, Sabine, Passhak, Maria , Geva, Ravit , Hubert, Ayala, Golan, Talia , Senellart, Hélène, Trouilloud, Isabelle , Blan, Jean-Frederic, Dourthe, Luis-Marie, Roy, Florence Le, Martin-Babau, J., Greil, Richard , Schreil, Georg, Gerger, Armin , Eisterer, Wolfgang , Mercadé, T. Macarulla, Cubillo, Antonio , Pons, Francesc Valladares, Díaz, Inmaculada Alés, Rivera, Fernando , Sarvise, Mariano Ponz, Airoldi, Mario , Bellotti, Giovanna, Corsi, Domenico , Antonuzzo, Lorenzo , Melichar, Bohuslav, Holečková, Petra , Kotasek, Rostislav, Němeček, Radim , Cutsem, Eric van, Laethem, Jean‐Luc Van , Sym, Sun Jin , Kim, Jin Young , Oh, Sang Cheul , Park, Joon Oh, Kim, Jin Won , Lee, Myung Ah , Choi, Hye Jin, Kang, Seok Yun , Mruk, Andrzej, Freier, Beata, Kosakowska, Ewa Anna, Kocsis, Judit, Csőszi, Tibor , Hitre, Erika, Al-Farhat, Yousuf, Cang, Shundong , Jin, Gang , Zuo, Changzeng, Song, Lijie, Wu, Zheng , Gao, Jie , Zhang, Tao� , Wang, Yusheng , Yuan, Xin , Li, Zhi-Hua , Chen, Rufu , Cai, Xiujun , Zhu, Zhizhen, Bai, Yuxian , Bai, Chunmei, Yau, Thomas, Joubert, Warren , Wong, Ka Yeung Mark, Harris, Marion , Mišir, Ana, Faccio, Adilson , Cruz, Felipe Melo , Azevedo, Srergio De, Victorino, Ana Paula , Paiva, Tadeu Ferreira, Franke, Fábio , Tiscoski, Katsuki Arima , Parolla, Gabriel, Lilno, Flora, Siqueira, Mariana Bruno , Lyra, Marcos, Lira, Jose Luis Martinez, Oliva, Dolores Mendoza, Vazquez, Arturo, Luviano, Jesus Elvis Cabrera, Gutiérrez, Erika Castillo , Camargo, Vanessa Rosas, Guerra, Cristian Chavez, Flores, Osvaldo Hernandez, Contreras, Jessica Reyes, Villanueva, Ángel Gómez, Villanueva, Omar Zayas, Bullock, Andrea , Wyrwicz, Lucjan , Osipov, Arsen , De La Fouchardiere, Christelle , Lee, Woojin , Ueno, Makoto , Van Cutsem, Eric , Macarulla, Teresa , Babiker, Hani , Antonuzzo, Lorenzo , Melichar, Bohuslav, Kasi, Anup , Gang, Jin, Gallego, Javier , Hitre, Erika, Fouchardière, Christelle de la , Dragovich, Tomislav, Philip, Philip A. , Cutsem, Eric Van , Macarulla, Teresa , Investigators, on behalf of the PANOVA-3 Study, Spigel, David R. , Osipov, Arsen, Lou, Emil , Bullock, Andrea, Dragovich, Tomislav, Coveler, Andrew L. , Arena, Francis P. , Kasi, Anup, Ross, Sharona , Reeves, James, Green, Garrett, Uemura, Marc Isamu , Ye, Joseph, Wang, James Z. , Rausch, Daniel, Park, Jae‐Hyun , Schumaker, Robert, Gupta, Mukul, Letourneau, Richard, Fuchs, Martin , Vogel, Arndt , Chater, Jack, Schacher, Sabine, Stemmer, Salomon M. , Dourthe, Luis-Marie, Abdelghani, Méher Ben , Pons, Francesc Valladares, Guillén‐Ponce, Carmen , Yayá, Ricardo , Ponz‐Sarvisé, Mariano , Vincenzi, Bruno , Melichar, Bohuslav, Petruzelka, Lubos B. , Cutsem, Eric van, Borbath, Ivan , Hwang, Jun‐Eul , Oh, Sung Yong , Lee, Moon Hee , Choi, Hye Jin , Chon, Hong Jae , Ramlau, Rodryg , Mruk, Andrzej, Hitre, Erika, Bassam, Ali, Hao, Chunyi , Liang, Bo , Li, Wei , Bai, Chunmei , Joubert, Warren, Marx, Gavin M. , Azevedo, Srergio De, Hoff, Paulo M. , Vazquez, Arturo, Guerra, Cristian Chavez, Cortez, David Orta, Campos-Gómez, Saúl , Espinoza, Iván Romarico González

Mayo Clinic

Journal of Clinical Oncology | May 31, 2025 | Volume: 43 | Issue: 21 | Pages: 2350-2360

10.1200/jco-25-00746 | PMID 40448572 Get It

PURPOSE Tumor treating fields (TTFields) use alternating electric fields to disrupt cancer cell proliferation. Feasibility of TTFields therapy with gemcitabine/nab-paclitaxel was previously demonstrated in patients with advanced pancreatic adenocarcinoma. PANOVA-3 was designed to confirm safety and efficacy of TTFields in patients with unresectable locally advanced pancreatic adenocarcinoma (LA-PAC). METHODS In this global phase III trial, 571 patients with newly diagnosed LA-PAC were randomly assigned to receive gemcitabine 1,000 mg/m 2 and nab-paclitaxel 125 mg/m 2 by intravenous infusion once a day on days 1, 8, and 15 of a 28-day cycle with or without TTFields. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), local PFS, pain-free survival, and overall response rate (ORR). Distant PFS was analyzed post hoc. RESULTS OS was significantly prolonged using TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel (median, 16.2 months [95% CI, 15.0 to 18.0] v 14.2 months [95% CI, 12.8 to 15.4]; hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.99]; P = .039). PFS, local PFS, and ORR were not improved. Pain-free survival was significantly prolonged with TTFields with gemcitabine/nab-paclitaxel (median, 15.2 months [95% CI, 10.3 to 22.8] v 9.1 months [95% CI, 7.4 to 12.7]; HR, 0.74 [95% CI, 0.56 to 0.97]; P = .027), as was distant PFS (median, 13.9 months [95% CI, 12.2 to 16.8] v 11.5 months [95% CI, 10.4 to 12.9]; HR, 0.74 [95% CI, 0.57 to 0.96]; P = .022). Device-related skin adverse events (AEs) were experienced by 76.3% of patients. Most device-related skin AEs were mild to moderate, with 7.7% of patients reporting a grade 3 AE. CONCLUSION This study demonstrated significant OS, pain-free survival, and distant PFS benefits for TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in patients with unresectable LA-PAC, with no additive systemic toxicity.
Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008.
Guan, Yu, Puhalla, Shannon L. , Deming, Dustin A. , Philip, Philip Agop, Hong, Theodore S. , Rojas-Khalil, Yesenia, Dasari, Arvind , Kopetz, Scott , Lucas, Peter C. , Şahin, İbrahim Halil , Loree, Jonathan M. , Wolmark, Norman , Yothers, Greg , George, Thomas J. , Lieu, Christopher H.

Mayo Clinic

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2025.43.16_suppl.tps3644 Get It

TPS3644 Background: Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer (CC) to determine need for adjuvant chemotherapy (AC). However, circulating tumor DNA (ctDNA) represents a highly specific and sensitive approach (especially with serial monitoring) for identifying minimal/molecular residual disease (MRD) post-surgery in CC patients (pts), and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. CC pts who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may be spared the toxicities associated with AC. Furthermore, for CC pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal AC regimen has not been established. We hypothesize that for pts whose CC has been resected, ctDNA status may be used to risk-stratify for making decisions about AC. Methods: In this prospective phase II/III trial, up to 1,912 pts with resected stage IIB, IIC, and III CC will be enrolled. Based on the post-operative ctDNA status using personalized and tumor-informed assay (Signatera™, bespoke assay), those who are ctDNA- (Cohort A) will be randomized to immediate AC with fluoropyrimidine (FP)+oxaliplatin (Ox) for 3-6 mos per established guidelines v serial ctDNA monitoring. Patients who are ctDNA+ post-operatively, or with serial monitoring (Cohort B), will be randomized to FP+Ox v more intensive AC with addition of irinotecan (I) for 6 mos. One cycle of chemotherapy is allowed while awaiting ctDNA testing results for cohort assignment. The primary endpoints for Cohort A are time to ctDNA+ status (phase II) and disease-free survival (DFS) (phase III) in the immediate v delayed AC arms. The primary endpoint for Cohort B is DFS in the FP+Ox v FP+Ox+I arms for both phase II and phase III portions of the trial. Secondary endpoints include prevalence of detectable ctDNA post-operatively, time-to-event outcomes (overall survival and time to recurrence) by ctDNA status, and the assessment of compliance to adjuvant therapy. Biospecimens including archival tumor tissue, as well as post-operative plus serial matched/normal blood samples, will be collected for exploratory correlative research. Active enrollment across the NCTN started in June 2022 with CCTG sites joining in August 2023. Current accrual (as of 1-27-2025): 647/1,912. NCT: 05174169. Support: U10 CA180868, -180822; -180888; UG1 CA189867; Natera, Inc. Clinical trial information: NCT05174169 .
Clinical outcomes of patients with stage I triple-negative breast cancer (TNBC) treated with or without chemotherapy: The Mayo Clinic experience.
Yadav, Sumeet Kumar, Reed, Sarah K., Zahrieh, David M. , Idossa, Damé , Leon‐Ferre, Roberto A. , Reed, Sarah K., Hillman, David W. , Boughey, Judy C. , Giridhar, Karthik V. , Kalari, Krishna R. , Lucas, Peter C. , Couch, Fergus J. , Ingle, James N. , Goetz, Matthew P.

Mayo Clinic

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 548-548

10.1200/jco.2025.43.16_suppl.548 Get It

548 Background: TNBC is associated with higher risk of recurrence and poorer survival rates than other breast cancer subtypes. For node-positive TNBC or tumors larger than 0.5 cm, chemotherapy is generally recommended. For stage I TNBC, the benefit from chemotherapy, the optimal regimen, and whether to administer it in the neoadjuvant versus adjuvant setting remain controversial. Here, we report the treatment patterns and clinical outcomes of patients with stage I TNBC treated at Mayo Clinic. Methods: Using the Mayo Clinic Tumor Registry data, we identified patients with stage I TNBC treated between 2010 and 2021. We used the pathologic tumor (T) category for patients treated with upfront surgery and the clinical T category for patients receiving neoadjuvant chemotherapy. We used the Kaplan-Meier method and log-rank test to compare recurrence-free survival (RFS) according to treatment groups, measured from the day of surgery. RFS was reported at a median follow-up of 3.9, 6.2, and 7.3 years for patients who received chemotherapy neoadjuvantly, adjuvantly, and surgery alone with no chemotherapy, respectively. Results: A total of 602 patients with Stage I TNBC were included, with a median age of 62 years. 290 (48%) underwent upfront surgery followed by adjuvant chemotherapy (pT1a: 2%, pT1b: 25%, pT1c: 74%), 127 (21%) received neoadjuvant chemotherapy followed by surgery (cT1a: 2%, cT1b: 11%, cT1c: 87%), and 185 (31%) underwent primary surgery without any chemotherapy (pT1mi/T1a: 33%, pT1b: 32%, pT1c: 35%). Most patients treated with neoadjuvant therapy received anthracycline/cyclophosphamide + taxane (70%), while most patients treated in the adjuvant setting received a non-anthracycline containing regimen (60%). The 5-year RFS was 96% (95% CI: 93-100%) for patients who received chemotherapy neoadjuvantly, 95% (95% CI: 92-98%) for those who received chemotherapy adjuvantly, and 85% (95% CI: 80-91%) for those treated with surgery alone and no chemotherapy ( P < 0.0001). 71 (56%) of the 127 patients who received neoadjuvant therapy achieved a pCR, with only 1 RFS event (at 14 months) in that group, compared to 4 RFS events among those not achieving pCR (at 12, 20, 28 and 75 months, respectively). Among patients not receiving chemotherapy (either adjuvantly or neoadjuvantly), the 5-year RFS rates were 94% for pT1mi/T1a, 92% for pT1b and 72% for pT1c (T1mi/a/b vs T1c, P = 0.009). Conclusions: In this large cohort of stage I TNBC, patients who received chemotherapy (adjuvantly or neoadjuvantly) had better 5-year RFS compared with those treated with locoregional therapy only. Among patients receiving chemotherapy, 5-year RFS was nearly identical regardless of whether chemotherapy was administered before or after surgery. Interestingly, patients undergoing upfront surgery were more likely to receive an anthracycline-sparing chemotherapy regimen.