Pub Date : 2024-12-01Epub Date: 2024-09-25DOI: 10.1245/s10434-024-16260-2
Heather G Lyu, Christina L Roland, Christopher P Scally
{"title":"ASO Author Reflections: The Optimal Timing for Resection in Patients with Small GISTs: Balancing Risks and Benefits.","authors":"Heather G Lyu, Christina L Roland, Christopher P Scally","doi":"10.1245/s10434-024-16260-2","DOIUrl":"10.1245/s10434-024-16260-2","url":null,"abstract":"","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"9285-9286"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: This study aimed to show the association between tumor location and laterality of positive lymph nodes by evaluating biopsy and magnetic resonance imaging (MRI) findings, and to optimize the extended pelvic lymph node dissection (ePLND) side for prostate cancer.
Methods: The study enrolled patients who underwent robot-assisted radical prostatectomy with ePLND. Tumor locations were determined according to International Society of Urological Pathology grade group 4/5 in biopsies and Prostate Imaging-Reporting and Data System category 4/5 in MRI results. The concordance of tumor location lobe and positive lymph node side with the performance of tumor location-guided ePLND for positive lymph node detection was evaluated.
Results: For 301 patients who underwent ePLND at Kyushu University Hospital, tumor locations determined by biopsy and MRI findings showed no lesion in 8 (2.7%) patients, unilateral lobe in 223 (74.1%) patients, and bilateral lobe in 70 (23.3%) patients. The accuracies for detection of any and all positive lymph nodes by tumor location-guided unilateral ePLND were 99.6% and 97.3%, respectively. Among the patients at St. Luke's International Hospital, the accuracies for detection of any and all positive lymph nodes by tumor location-guided unilateral ePLND were estimated to be 99.0% and 97.3%, respectively.
Conclusions: This study proposed tumor location-guided ePLND according to biopsy and MRI findings. This novel strategy is expected to reduce the burden of bilateral ePLND at the cost of acceptable risk of failing to detect positive lymph nodes.
{"title":"Optimization of Extended Pelvic Lymph Node Dissection Side for Prostate Cancer.","authors":"Masaki Shiota, Masaki Shimbo, Shigehiro Tsukahara, Tokiyoshi Tanegashima, Jun Mutaguchi, Shunsuke Goto, Satoshi Kobayashi, Takashi Matsumoto, Kazunori Hattori, Fumiyasu Endo, Masatoshi Eto","doi":"10.1245/s10434-024-16294-6","DOIUrl":"10.1245/s10434-024-16294-6","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to show the association between tumor location and laterality of positive lymph nodes by evaluating biopsy and magnetic resonance imaging (MRI) findings, and to optimize the extended pelvic lymph node dissection (ePLND) side for prostate cancer.</p><p><strong>Methods: </strong>The study enrolled patients who underwent robot-assisted radical prostatectomy with ePLND. Tumor locations were determined according to International Society of Urological Pathology grade group 4/5 in biopsies and Prostate Imaging-Reporting and Data System category 4/5 in MRI results. The concordance of tumor location lobe and positive lymph node side with the performance of tumor location-guided ePLND for positive lymph node detection was evaluated.</p><p><strong>Results: </strong>For 301 patients who underwent ePLND at Kyushu University Hospital, tumor locations determined by biopsy and MRI findings showed no lesion in 8 (2.7%) patients, unilateral lobe in 223 (74.1%) patients, and bilateral lobe in 70 (23.3%) patients. The accuracies for detection of any and all positive lymph nodes by tumor location-guided unilateral ePLND were 99.6% and 97.3%, respectively. Among the patients at St. Luke's International Hospital, the accuracies for detection of any and all positive lymph nodes by tumor location-guided unilateral ePLND were estimated to be 99.0% and 97.3%, respectively.</p><p><strong>Conclusions: </strong>This study proposed tumor location-guided ePLND according to biopsy and MRI findings. This novel strategy is expected to reduce the burden of bilateral ePLND at the cost of acceptable risk of failing to detect positive lymph nodes.</p>","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"8986-8992"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-09-25DOI: 10.1245/s10434-024-16156-1
Megan C Saucke, Nora Jacobson, Grace McKinney, Heather B Neuman
Background: Patient engagement in decision making can improve satisfaction with care. Studies demonstrate that patients' emotional states can be significant barriers to engaging in shared decision making.
Objective: We sought to examine how emotion associated with a breast cancer diagnosis impacts patient experiences during the surgical consultation, and explore opportunities for surgeons to mitigate the impact of emotion.
Methods: We conducted 30 semi-structured interviews with patients who participated in the decision aid arm of Alliance A231701CD, had low engagement, and experienced barriers to engagement. We used qualitative content analysis to analyze the interview data and organize it into overarching themes.
Results: Participants recalled strong emotions with their diagnosis, describing it as devastating and shocking. Although several participants said that their emotional reaction to the diagnosis lessened over time, others expressed still feeling very anxious. Participants described ways in which their surgeon helped to de-escalate their emotional state, beginning with the establishment of rapport and continuing through treatment planning. Participants valued surgeons who they perceived to be personable and compassionate, treated them as an individual, provided reassuring and matter-of-fact information about their cancer, and efficiently communicated plans for next steps.
Conclusions: Patients with breast cancer are often emotionally overwhelmed during their surgical consults, which impedes their ability to listen and participate in decision making. However, surgeon behaviors can help de-escalate emotions. Addressing emotion is critical to support patients in reaching a decision for breast cancer surgery and is likely to improve patient satisfaction with the decision process.
{"title":"Role of the Surgeon in De-Escalating Emotion During a Breast Cancer Surgery Consultation: A Qualitative Study of Patients' Experiences in Alliance A231701CD.","authors":"Megan C Saucke, Nora Jacobson, Grace McKinney, Heather B Neuman","doi":"10.1245/s10434-024-16156-1","DOIUrl":"10.1245/s10434-024-16156-1","url":null,"abstract":"<p><strong>Background: </strong>Patient engagement in decision making can improve satisfaction with care. Studies demonstrate that patients' emotional states can be significant barriers to engaging in shared decision making.</p><p><strong>Objective: </strong>We sought to examine how emotion associated with a breast cancer diagnosis impacts patient experiences during the surgical consultation, and explore opportunities for surgeons to mitigate the impact of emotion.</p><p><strong>Methods: </strong>We conducted 30 semi-structured interviews with patients who participated in the decision aid arm of Alliance A231701CD, had low engagement, and experienced barriers to engagement. We used qualitative content analysis to analyze the interview data and organize it into overarching themes.</p><p><strong>Results: </strong>Participants recalled strong emotions with their diagnosis, describing it as devastating and shocking. Although several participants said that their emotional reaction to the diagnosis lessened over time, others expressed still feeling very anxious. Participants described ways in which their surgeon helped to de-escalate their emotional state, beginning with the establishment of rapport and continuing through treatment planning. Participants valued surgeons who they perceived to be personable and compassionate, treated them as an individual, provided reassuring and matter-of-fact information about their cancer, and efficiently communicated plans for next steps.</p><p><strong>Conclusions: </strong>Patients with breast cancer are often emotionally overwhelmed during their surgical consults, which impedes their ability to listen and participate in decision making. However, surgeon behaviors can help de-escalate emotions. Addressing emotion is critical to support patients in reaching a decision for breast cancer surgery and is likely to improve patient satisfaction with the decision process.</p><p><strong>Clinical trials registration: </strong>ClinicalTrials.gov identifier: NCT03766009.</p>","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"8873-8881"},"PeriodicalIF":4.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-09-27DOI: 10.1245/s10434-024-16243-3
Mahtab Vasigh, Ahmed Mohamed, Lisa Jacobs, Julie Lange, Melissa Camp, Bonnie Sun, Pamela Wright, Maureen O'Donnell, Hanh-Tam Tran, Olutayo Sogunro, Mehran Habibi, Fabian Johnston, David Euhus
Background: Breast-conserving surgery is often discouraged in BRCA gene carriers with early onset breast cancer. The genetic variant carrier breast cancers are more likely to be multifocal or multicentric (MFMC).
Patients and method: This retrospective study includes newly diagnosed patients with breast cancer undergoing genetic testing between 2010 and 2021 within the Johns Hopkins Regional Health System. After excluding patients who received neoadjuvant chemotherapy or stage IV breast cancers, patients were divided into two groups: those who tested positive for a variant recognized by the National Comprehensive Cancer Network as predisposing the patient to breast cancer (ATM, BRCA1, BRCA2, CHEK2, NF1, PALB2, RAD51C, RAD51D, and TP53) and those who tested negative. Pathologic features of the tumors were compared, focusing on evidence for MFMC disease, defined as more than one malignant foci more than 5 mm apart.
Results: Among the 282 eligible cases, 69 (24%) were positive for a genetic variant. The variant carriers were younger at diagnosis (p < 0.001), more likely to have invasive ductal carcinoma (p = 0.03), more likely to have undergone mastectomy (p = 0.03), and more likely to have a grade 3 cancer (p = 0.003). Variant carriers were not more likely to have MFMC disease (28% vs. 22%, p = 0.4). A positive genetic variant was not a predictor of MFMC within the entire cohort [odds ratio (OR):1.3, 95% confidence interval (CI) 0.6-2.6, p = 0.5).
Conclusion: Genetic variant carrier cancers are not more likely to be MCMF than sporadic cancers.
{"title":"The Association Between Breast Cancer Predisposing Genetic Variants and Multifocal, Multicentric Breast Cancer.","authors":"Mahtab Vasigh, Ahmed Mohamed, Lisa Jacobs, Julie Lange, Melissa Camp, Bonnie Sun, Pamela Wright, Maureen O'Donnell, Hanh-Tam Tran, Olutayo Sogunro, Mehran Habibi, Fabian Johnston, David Euhus","doi":"10.1245/s10434-024-16243-3","DOIUrl":"10.1245/s10434-024-16243-3","url":null,"abstract":"<p><strong>Background: </strong>Breast-conserving surgery is often discouraged in BRCA gene carriers with early onset breast cancer. The genetic variant carrier breast cancers are more likely to be multifocal or multicentric (MFMC).</p><p><strong>Patients and method: </strong>This retrospective study includes newly diagnosed patients with breast cancer undergoing genetic testing between 2010 and 2021 within the Johns Hopkins Regional Health System. After excluding patients who received neoadjuvant chemotherapy or stage IV breast cancers, patients were divided into two groups: those who tested positive for a variant recognized by the National Comprehensive Cancer Network as predisposing the patient to breast cancer (ATM, BRCA1, BRCA2, CHEK2, NF1, PALB2, RAD51C, RAD51D, and TP53) and those who tested negative. Pathologic features of the tumors were compared, focusing on evidence for MFMC disease, defined as more than one malignant foci more than 5 mm apart.</p><p><strong>Results: </strong>Among the 282 eligible cases, 69 (24%) were positive for a genetic variant. The variant carriers were younger at diagnosis (p < 0.001), more likely to have invasive ductal carcinoma (p = 0.03), more likely to have undergone mastectomy (p = 0.03), and more likely to have a grade 3 cancer (p = 0.003). Variant carriers were not more likely to have MFMC disease (28% vs. 22%, p = 0.4). A positive genetic variant was not a predictor of MFMC within the entire cohort [odds ratio (OR):1.3, 95% confidence interval (CI) 0.6-2.6, p = 0.5).</p><p><strong>Conclusion: </strong>Genetic variant carrier cancers are not more likely to be MCMF than sporadic cancers.</p>","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"8891-8899"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The purpose of this study was to provide a detailed evaluation of the oncological advantages of surgery following neoadjuvant chemotherapy (NAC) for patients with borderline resectable (BR) or unresectable (UR) pancreatic ductal adenocarcinoma (PDAC), with a focus on minimizing biases. Recently, NAC has become the standard care for BR or UR locally advanced (UR-LA) PDAC, however, many studies have assessed survival benefits and favorable variables without consideration for biases, particularly immortal time bias.
Patients and methods: This study included patients diagnosed with BR or UR-LA PDAC at Juntendo University Hospital from 2019 to 2022. To mitigate bias, we applied methods such as propensity score matching (PSM), time-dependent covariate Cox proportional hazard regression analysis (TDC), landmark analysis, and multivariable Cox proportional hazards regression model.
Results: The study analyzed 124 patients, dividing them into a surgery group (n = 57) and a chemotherapy-only group (n = 67). After PSM, there were 21 matched pairs. Survival analysis using TDC analysis showed that the surgery group had significantly better overall survival compared with the chemotherapy-only group in both the entire cohort and the matched pairs. Cox regression analysis of the entire cohort also revealed a similar superiority of surgery, while the landmark analysis showed varying results depending on the landmark setting.
Conclusions: After careful adjustment for selection and immortal time biases, surgery following NAC appears to significantly extend survival in patients with BR or UR PDAC.
{"title":"Survival Analysis of Conversion Surgery in Borderline Resectable and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma Addressing Selection and Immortal Time Bias: A Retrospective Single-Center Study.","authors":"Ryota Ito, Ryuji Yoshioka, Naotake Yanagisawa, Shigeto Ishii, Jun Sugitani, Ryoji Furuya, Masahiro Fujisawa, Hiroshi Imamura, Yoshihiro Mise, Hiroyuki Isayama, Akio Saiura","doi":"10.1245/s10434-024-16203-x","DOIUrl":"10.1245/s10434-024-16203-x","url":null,"abstract":"<p><strong>Background: </strong>The purpose of this study was to provide a detailed evaluation of the oncological advantages of surgery following neoadjuvant chemotherapy (NAC) for patients with borderline resectable (BR) or unresectable (UR) pancreatic ductal adenocarcinoma (PDAC), with a focus on minimizing biases. Recently, NAC has become the standard care for BR or UR locally advanced (UR-LA) PDAC, however, many studies have assessed survival benefits and favorable variables without consideration for biases, particularly immortal time bias.</p><p><strong>Patients and methods: </strong>This study included patients diagnosed with BR or UR-LA PDAC at Juntendo University Hospital from 2019 to 2022. To mitigate bias, we applied methods such as propensity score matching (PSM), time-dependent covariate Cox proportional hazard regression analysis (TDC), landmark analysis, and multivariable Cox proportional hazards regression model.</p><p><strong>Results: </strong>The study analyzed 124 patients, dividing them into a surgery group (n = 57) and a chemotherapy-only group (n = 67). After PSM, there were 21 matched pairs. Survival analysis using TDC analysis showed that the surgery group had significantly better overall survival compared with the chemotherapy-only group in both the entire cohort and the matched pairs. Cox regression analysis of the entire cohort also revealed a similar superiority of surgery, while the landmark analysis showed varying results depending on the landmark setting.</p><p><strong>Conclusions: </strong>After careful adjustment for selection and immortal time biases, surgery following NAC appears to significantly extend survival in patients with BR or UR PDAC.</p>","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"8744-8755"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-10-10DOI: 10.1245/s10434-024-16308-3
Emily E Stroobant, Aravind Sreeram, Vivian E Strong
{"title":"ASO Author Reflections: Unraveling the Disappearance of Signet Ring Cell Gastric Cancer: Surveillance and Biological Insights.","authors":"Emily E Stroobant, Aravind Sreeram, Vivian E Strong","doi":"10.1245/s10434-024-16308-3","DOIUrl":"10.1245/s10434-024-16308-3","url":null,"abstract":"","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"9048-9049"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-31DOI: 10.1245/s10434-024-16127-6
Shiho Kobayashi, Takashi Miki, Kentaro Kamiya
{"title":"ASO Author Reflections: Impact of 1-Year Changes in Skeletal Muscle Quality on Prognosis in Postoperative Patients with Early Gastric Cancer.","authors":"Shiho Kobayashi, Takashi Miki, Kentaro Kamiya","doi":"10.1245/s10434-024-16127-6","DOIUrl":"10.1245/s10434-024-16127-6","url":null,"abstract":"","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"9057-9058"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-07-27DOI: 10.1245/s10434-024-15940-3
Olivia Cheng, Lauren M Postlewait
{"title":"ASO Author Reflections: Defining the Need for Services for Patients at High Risk of Breast Cancer at a Safety-Net Hospital: An Approach to Narrowing the Disparities Gap.","authors":"Olivia Cheng, Lauren M Postlewait","doi":"10.1245/s10434-024-15940-3","DOIUrl":"10.1245/s10434-024-15940-3","url":null,"abstract":"","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"8910-8911"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-20DOI: 10.1245/s10434-024-16075-1
Gurudutt P Varty, Shraddha Patkar, Mahesh Goel
{"title":"ASO Author Reflections: Transition to Robotic Radical Cholecystectomy: Building the Future on Strong Fundamentals.","authors":"Gurudutt P Varty, Shraddha Patkar, Mahesh Goel","doi":"10.1245/s10434-024-16075-1","DOIUrl":"10.1245/s10434-024-16075-1","url":null,"abstract":"","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"9225-9226"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549180/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: This study reported the safety and efficacy of a phase 2, open-label, single-arm, exploratory clinical trial of induction immunochemotherapy in patients with initially unresectable advanced esophageal squamous cell carcinoma (ESCC).
Patients and methods: Patients underwent three cycles of induction therapy with tislelizumab, cisplatin, and 5-fluorouracil. The primary endpoints were the safety, major pathological response (MPR), and pathological complete response (pCR). Secondary endpoints included the R0 resection rate, disease-free survival (DFS), and overall survival (OS). Genomic data and immune microenvironment data were analyzed exploratively.
Results: The treatment was safe, with a grade 3 or higher adverse event rate of 14.9% (7/47). Of the total 47 patients enrolled in the study, 19 (40.4%) achieved MPR, 12 (25.5%) achieved pCR, 4 (8.5%) achieved complete clinical response (cCR) and declined surgery, and 23 (48.94%) underwent successful resection. Median follow-up was 18 months, with a median DFS of 24 months, a median OS of 36 months. A high tumor mutation burden was associated with a better prognosis for patients who underwent surgery. Patients who achieved pCR had higher levels of immune cell infiltration and a greater proportion and concentration of tertiary lymphoid structures compared with those who experienced a major pathological response.
Conclusions: Tislelizumab combined with chemotherapy is effective for ESCC, yielding high cCR, pCR, surgical conversion, and R0 resection rates, and tolerable adverse events.
{"title":"Induction Therapy of Tislelizumab Combined with Cisplatin and 5-Fluorouracil and Subsequent Conversion Surgery in Patients with Unresectable Advanced Esophageal Squamous Cell Carcinoma: A Phase 2, Single Center Study.","authors":"Tongpeng Xu, Jianan Bai, Kun Zhao, Xiaofeng Chen, Shuhui Wang, Shusheng Zhu, Chongqi Sun, Chenhui Zhao, Ting Wang, Ling Zhu, Meizhen Hu, Fei Pang, Junling Zhang, Wei Wang, Yongqian Shu, Fang Li, Yue Zhou","doi":"10.1245/s10434-024-16033-x","DOIUrl":"10.1245/s10434-024-16033-x","url":null,"abstract":"<p><strong>Background: </strong>This study reported the safety and efficacy of a phase 2, open-label, single-arm, exploratory clinical trial of induction immunochemotherapy in patients with initially unresectable advanced esophageal squamous cell carcinoma (ESCC).</p><p><strong>Patients and methods: </strong>Patients underwent three cycles of induction therapy with tislelizumab, cisplatin, and 5-fluorouracil. The primary endpoints were the safety, major pathological response (MPR), and pathological complete response (pCR). Secondary endpoints included the R0 resection rate, disease-free survival (DFS), and overall survival (OS). Genomic data and immune microenvironment data were analyzed exploratively.</p><p><strong>Results: </strong>The treatment was safe, with a grade 3 or higher adverse event rate of 14.9% (7/47). Of the total 47 patients enrolled in the study, 19 (40.4%) achieved MPR, 12 (25.5%) achieved pCR, 4 (8.5%) achieved complete clinical response (cCR) and declined surgery, and 23 (48.94%) underwent successful resection. Median follow-up was 18 months, with a median DFS of 24 months, a median OS of 36 months. A high tumor mutation burden was associated with a better prognosis for patients who underwent surgery. Patients who achieved pCR had higher levels of immune cell infiltration and a greater proportion and concentration of tertiary lymphoid structures compared with those who experienced a major pathological response.</p><p><strong>Conclusions: </strong>Tislelizumab combined with chemotherapy is effective for ESCC, yielding high cCR, pCR, surgical conversion, and R0 resection rates, and tolerable adverse events.</p><p><strong>Trial registration: </strong>NCT05469061.</p>","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":"9321-9331"},"PeriodicalIF":3.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}