bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient reported outcomes for anterior and postpectoral prosthesis implantation in single-port laparoscopic breast.
Authors: He Xiangmei , Zhang Juliang , Hou Lan , Chang Kexin , Wang Donghui , Li Danxi , Jiao Yangchi 
Published: July 2024

e12601 Background: Breast reconstruction surgery is on the rise and can significantly improve patients' quality of life, and single-port lumpectomy breast reconstruction surgery is becoming more widely used because of its minimally invasive nature, clear field of view, and aesthetics. However, patient-reported outcome studies of anterior versus posterior pectoralis muscle in this procedure are still scarce, and more evidence is needed to provide guidance to clinicians. Methods: Patients who underwent single-port laparoscopic breast reconstruction surgery at Xijing Hospital between March 2021 to December 2023 were included and divided into two groups according to the position of the prosthesis in the pectoral muscle. Patient safety was assessed for surgical safety and tumor safety. Patient Reported Outcome (PRO) was assessed using the BREAST-Q questionnaire. Results: General situation: This study was included in 58 patients with a single -hole laparoscopic breast reconstruction, and 48 patients were included in the post -pectoral muscle group. Tumor safety: 100% recurrence-free survival, 100% disease-free survival, and 100% overall survival in the follow-up patients; there was no significant difference between the anterior and posterior pectoral muscle groups in the single-port cavity. Surgical safety: there was no significant difference between the pre-pectoral and post-pectoral groups in terms of operative time, intraoperative bleeding, nipple areola complex ischemia, periosteal contracture. there were significant differences in postoperative infection, postoperative pain, and flap ischemia between the two groups, with the anterior pectoralis muscle group having a lower rate of postoperative infection, less pain, and a lower rate of flap ischemia. Patient-reported outcomes: The breast satisfaction of the breast reconstruction of the thoracic muscles under the laparoscopy, the higher social psychological health score, and the lower score in chest pain. Conclusions: In our research, the two groups of patients with single -hole laparoscopic breast reconstruction did not have a bad ending, and the single -hole laparoscopic pectoral muscle reconstruction had lower postoperative complications, and had better patient reporting ending Therefore, without considering the economic situation, we recommend the reconstruction of a single -hole laparoscopic pectoral muscles.
The predictive role of Ki67 in pathological complete response (pCR) and invasive disease-free survival (IDFS) in HER2-positive breast cancer: A retrospective study of 246 cases.
Authors: Weydandt Laura , Agabejli Saida , Lia Massimiliano , Wimberger Pauline , Aktas Bahriye , Link Theresa 
Published: July 2024

e12610 Background: While Ki67 is a routine diagnostic measure for early hormone receptor positive breast cancer, it is not integrated into the standard procedure for patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer patients, given the substantial risk linked to HER2 expression alone. Consequently, the predictive significance of Ki67 in achieving pathological complete response (pCR) or invasive disease-free survival (IDFS) in this subgroup remains uncertain. Methods: This retrospective, bi-centric analysis focused on HER2-positive early breast cancer patients undergoing neoadjuvant chemotherapy from 2015 to 2023. We assessed the correlation between Ki67 values and the achievement of pathological complete response (pCR, defined as ypT0/is, pN0). Multivariable logistic regression analyzed the independent association of various clinical parameters, including Ki67, with pCR. Ki67 values were categorized into risk groups (low <15%, intermediate 15.1-35%, high >35%) following the GepardTrio data [1]. Kaplan-Meier estimator calculated differences in overall and invasive disease-free survival. Results: The study included 246 HER2-positive early breast cancer patients with known Ki67 expression, followed for a median of 42 months. The median age was 52 years. Final nodal status was pN0 in 80.5%, pN1 in 15%, and pN2 in 3.3%. Hormone receptor positivity was observed in 66% of patients. 147 patients (60%) achieved pCR. Median Ki67 was 30. When categorized, 13% were low, 41.5% intermediate, and 45.5% high risk. No correlation between Ki67 and pCR was observed (p=0.25). HER2 IHC score 3+ significantly increased pCR compared to IHC 2+ (62.2% vs. 44.6%, p=0.023). Hormone receptor-positive tumors had a lower pCR rate (52.7% vs. 72.4%, p=0.0016. 5-year overall survival was 96.5% for pCR and 83.8% for non-pCR (p=0.008). 5-year invasive disease-free survival showed no difference between low Ki67 (89.5%), intermediate Ki67 (79.9%), and high Ki67 (80.9%) groups (p=0.77). Conclusions: In this study, Ki67 did not predict pCR in HER2-positive breast cancer, providing no additional clinical value. HER2 IHC score and hormone receptor status were predictive indicators for pCR. Ki67 expression appears to lack additional value in HER2-positive breast cancer, considering resource implications. 1. Denkert C et al: Ann Oncol. 2013 Nov;24(11):2786-93. doi: 10.1093/annonc/mdt350. Epub 2013 Aug 22. PMID: 23970015.
Prediction of pathologic complete response to chemoimmunotherapy in triple-negative breast cancer using tumor-infiltrating lymphocytes: Exploiting cutoff values.
Authors: BARROSO-SOUSA ROMUALDO , Sousa Isadora Martins de , Marin Comini Ana Carolina , Celeste Tavares Monique , Madasi Pinheiro Fernanda , Bines Jose , Dal Ponte Ferreira Rafael , Rosa Daniela Dornelles , Santos Candice Lima , Souza Zenaide Silva , Suzuki Daniele Assad , de Araujo Julio Antônio Pereira , Gagliato Debora De Melo , Dos Anjos Carlos Henrique , Zucchetti Bruna M , Ferrari Anezka Carvalho Rubin de Celis , Lopes De Brito Mayana , Monteiro Maria Marcela F. , Testa Laura , Bonadio Renata Colombo 
Published: July 2024

e12629 Background: Triple-negative breast cancer (TNBC) prognosis is significantly influenced by tumor-infiltrating lymphocytes (TILs), but the lack of validated cutoff values has limited their clinical applicability. In the era of neoadjuvant pembrolizumab plus chemotherapy (P+CT) as a new standard of care, the role of TILs as predictors of response to chemoimmunotherapy remains uncertain. Methods: This study aimed to assess TILs as predictors of pathologic complete response (pCR) within the Neo-Real study, a multicenter, real-world data investigation on neoadjuvant P+CT in TNBC. TILs were evaluated using the standardized methodology of the International TILs Working Group. Logistic regression and receiver operating characteristic (ROC) curve analysis were performed to evaluate the predictive ability of TILs expression and multivariable models for pCR. Results: The analysis included 128 patients (pts) treated with neoadjuvant P+CT (68% stage II, 26% stage III). The proportion of pts in each TILs’ category and results of ROC curve analysis are presented in the Table. A cutoff value of 10% demonstrated the highest accuracy in predicting pCR, while a high specificity was observed at a cutoff value of 50%. Thus, the probability of residual disease if TILs ≥ 50% is considerably low. Incorporating categorized clinical and pathological variables, a multivariable logistic regression model, using TILs (≥ 10% vs < 10%), Ki67 (≥ 50% vs < 50%), and tumor stage (III vs II), exhibited the highest AUC (0.688) for predicting pCR. Conclusions: Our study underscores the predictive value of TILs for pCR in TNBC following neoadjuvant P+CT. The cutoff value of ≥ 50% identified patients with a very high probability of pCR. The results reinforce TILs’ use as a biomarker for treatment de-escalation, especially for pts with TILs ≥ 50%. Further enhancement of TILs' predictive potential may be achieved through multivariable models. [Table: see text]
Adoption of decentralized trial elements in cancer clinical trials supporting FDA approvals during COVID-19.
Authors: Patel Timil , Corneli Amy , Balcazar Pamela , Lipset Craig H. , Calvert Sarah , Mervin-Blake Sabrena , Nalawade Vinit , Kluetz Paul Gustav 
Published: July 2024

e13802 Background: The COVID-19 pandemic significantly disrupted the conduct of cancer clinical trials. Facilitated by emergency FDA guidance, many sponsors integrated decentralized clinical trial (DCT) elements to prioritize patient safety and maintain access. The FDA’s Oncology Center of Excellence, in collaboration with the Clinical Trials Transformation Initiative (CTTI), assessed the adoption of DCT elements in registrational cancer clinical trials conducted during the pandemic that resulted in an FDA approval. Methods: CTTI sent trial sponsors a recruitment email with a link to an online survey and the name of the trial that resulted in an FDA approval. Sponsors were asked to select the DCT elements used in that trial prior to and in response to the pandemic, challenges faced when implementing these approaches, and the likelihood of using the approaches in the future. Data were collected from December 6, 2022 to January 17, 2023. Descriptive statistics were used to summarize sponsor responses. Results: Out of 52 eligible studies, 19 surveys were completed from 13 unique sponsors (37%; 12 pharmaceutical companies and 1 chose not to disclose). Sixty-three percent of sponsors identified as a large pharmaceutical company with a market cap of over $10 billion. The majority of cancer clinical trials (89%) occurred both in the United States and abroad, with almost all sponsors (95%) incorporating at least one DCT element during the pandemic. The most widely adopted DCT elements were remote site monitoring (89%), telemedicine (68%), remote laboratory assessments (63%), remote distribution of investigational product (58%) and local imaging assessments (47%). The main challenges in implementing DCT elements included site institutional policies (83%), site challenges with technology adoption (61%) and site regulatory restraints (56%). Many sponsors intend to incorporate some degree of decentralization in future cancer clinical trials, with remote site monitoring (95%), remote collection of patient-reported outcomes (68%), telemedicine (68%), and electronic informed consent (58%) being deemed "highly likely" or "likely" for future adoption. Conclusions: The COVID-19 pandemic accelerated the use of DCT elements in cancer clinical trials. This study represents the first systematic evaluation of the use of DCT elements in cancer clinical trials intended for regulatory submission and provides proof of concept that cancer trials with DCT elements can generate data suitable for FDA review and marketing approval. The appropriate use of DCT elements holds promise to expand clinical trial access and reduce patient burden. Further characterization and mitigation of clinical site-level challenges is warranted to encourage continued adoption of DCT elements in cancer clinical trials.
Survival implications and radiographic predictors of prognosis in patients with IDH-mutant astrocytoma with CDKN2A/b homozygous deletion: An international, multi-centered study.
Authors: Wetzel Ethan A. , Hsieh Annie Lee , Nohman Amin , Reuss David , Eyupoglus Ilker , Hua Lingyang , Youssef Gilbert , Wen Patrick Y. , Cahill Daniel P. , Jungk Christine , Juratli Tareq A. , Miller Julie J. 
Published: July 2024

e14035 Background: Isocitrate Dehydrogenase (IDH) 1 or 2 mutations are associated with improved prognosis in glioma patients. Despite their less aggressive clinical course when compared to IDH-wild type gliomas, molecularly-defined IDH-mutant glioma subtypes with poor prognosis have been identified. Among these, CDKN2A/B homozygous deletion represents the strongest negative genetic predictor of prognosis yet identified in IDH-mutant astrocytoma. With the WHO 2021 classification recognizing CDKN2A/B homozygous deletion as sufficient for the designation of astrocytoma, IDH-mutant, WHO Grade 4, the translational implications and potential for therapies targeting CDKN2A/B homozygous deletion are an area of active investigation. We sought to further characterize overall (OS) and progression-free survival (PFS) of CDKN2A/B deleted patients within a large, multi-centered, international cohort and identify clinical characteristics that predict survival for patients with CDKN2A/B deletion. Methods: Patients with IDH-mutant glioma with CDKN2A/B homozygous deletion were retrospectively identified across four institutions (Massachusetts General Hospital, USA; University Hospital Heidelberg, Germany; University Hospital Dresden, Germany, and Foudan-Shanghai, China). IDH-mutation status was determined by immunohistochemistry or next-generation sequencing. CDKN2A/B status was determined by hybridized DNA capture or FISH. Results: We identified 75 patients with IDH-mutant astrocytoma with CDKN2A/B homozygous deletion. The cohort had a median follow-up time of 5.0 years, was 56% male, and had an average age of 38.8 years. Patients were treated with chemotherapy and radiation following initial surgery in 77% of cases. Preoperative contrast enhancement and T2 FLAIR mismatch were identified in 56 and 44% of cases, respectively. Compared to a cohort of 51 patients with CDKN2A/B intact, grade 4, IDH-mutant astrocytoma, those with CDKN2A/B-deleted tumors had significantly shorter median OS and PFS (OS: 4 vs 13.5 years, HR = 6.8, HR 95% CI = 3.1, 14.6, p < 0.0001; PFS: 2.8 vs 5.9 years, HR = 3.0, HR 95% CI = 1.7, 5.2, p = 0.0001). Within the CDKN2A/B deleted cohort, preoperative contrast enhancement predicted worse OS, but not PFS (OS: HR = 2.7, 95% CI = 1.1, 7.4, p = 0.04; PFS: HR = 1.17, 95% CI = 0.7, 3.7, p = 0.24). Conclusions: These data reinforce the strong negative prognostic impact of CDKN2A/B homozygous deletion on OS and PFS and identify a novel association between preoperative contrast enhancement and shorter OS in patients with CDKN2A/Bdeleted, IDH-mutant astrocytoma.
Health state utility assessment for low-grade glioma.
Authors: Bhanja Debarati , Wilding Hannah E. , Tuohy Kyle J. , Ozair Ahmad , Hamidi Nima , Macedo Filho Leonardo , Salmi Liz , Kwan Bethany , Xie Feng , Velásquez Carlos , Glantz Michael J. , Ahluwalia Manmeet Singh , Mansouri Alireza 
Published: July 2024

e14039 Background: Low-grade gliomas (LGGs, WHO Grade II gliomas) undergo malignant transformation, portending a median survival of 5-15 years. Though resection and adjuvant therapies have significantly improved survival, there are increased risks of long-term neurological decline and treatment-related side effects. As a result, not only quantity but also quality of life (QoL) must be considered when appraising therapeutic paradigms. Health state utility assessments can quantify society’s perceptions of given health states, supporting quality-adjusted life years (QALYs) and cost-effectiveness analyses. The primary and secondary objectives were to calculate LGG health states utility values (UVs) and interpret differences between health states, respectively. Methods: Health state descriptions were developed from a comprehensive literature review, expert input, and focus groups involving neuro-oncology providers and patient advocates. Healthy, adult participants were surveyed through an online REDCap form. Two preference elicitation techniques, visual analog scale (VAS) and time trade-off (TTO), were used to derive UVs of ten LGG health states. UVs are anchored at 0 representing death and 1 for perfect health. Mann-Whitney U tests compared UVs across health states. Results: Ninety-eight participants were included. Most participants were male (52%), aged 18-29 (81.6%), and White or Asian (78%). Stable LGG had the highest UVs (Mean [SD]: VAS- 0.64 [0.21]; TTO- 0.54 [0.42]) compared to Progressive LGG (VAS- 0.44 [0.26], p<0.0001; TTO- 0.36 [0.37], p<0.0001), Stable LGG with Chemoradiation (VAS- 0.43 [0.23], p<0.0001; TTO- 0.32 [0.34], p<0.0001), and Stable LGG with Motor (VAS- 0.45 [0.23], p<0.0001; TTO- 0.23 [0.32], p<0.0001) and Language (VAS- 0.52 [0.22], p<0.0001; TTO- 0.43 [0.40], p=0.04) Deficits. Progressive LGG UVs were not statistically different from those in Progressive LGG with Motor (VAS- 0.43 [0.23], p=0.69; TTO- 0.32 [0.34], p=0.73), Language (VAS- 0.43 [0.23], p=0.62; TTO- 0.32 [0.34], p=0.60), or Visual (VAS- 0.43 [0.23], p=0.78; TTO- 0.32 [0.34], p=0.60) Deficits. Radiation negatively impacted UVs, as UVs of Stable LGG with Chemoradiation (VAS- 0.43 [0.23]; TTO- 0.32 [0.34]) were significantly lower than UVs of Stable LGG with Chemotherapy alone (VAS- 0.43 [0.23], p=0.018; TTO- 0.32 [0.34], p=0.28) on VAS. Conclusions: These are the first-ever reported LGG health state UVs. These data will enable future QALY and cost-effective analyses, which have increasing importance as new investigational therapies become available for LGG.
Hydrogenated oxide material-based hyperthermia and radiotherapy: A new treatment option for esophageal squamous carcinoma.
Authors: Yang Yuexin , Liang Jun , Jiang Jun 
Published: July 2024

e16127 Background: Radiotherapy (RT) is the mainstay of esophageal squamous carcinoma (ESCC) treatment, and hyperthemia could exert synergistic effects to refractory diseases. Hydrogenated oxide material (HMO) is a newly developed photothermal agent, featured by selectively targeting tumors, high photothermal conversion efficiency under 1064 nm near-infared (NIR) illumination and safe degradation. This study aims at investigating the combination effects of HMO-based hyperthermia and RT in ESCC. Methods: mEC25 murine ESCC cells were cultured and treated with RT alone (prescribed cumulative dose of 10Gy), HMO-based hyperthermia (incubated with 100ug/ml HMO for 20min and irradiated with 1064nm NIR continuously for 15min) or combination therapy (RT followed by HMO-based hyperthermia). FLIR-One was applied to monitor temperature alterations in HMO-based hyperthermia. Flow cytometry was performed to detect apoptosis rates 24h after treatment. Results: The temperature was increased by 21.3[19.8-23.7]℃ after NIR irradiation. The apoptosis rates were 19.4%[19.4%, 19.5%], 43.8%[43.6%, 44.0%] and 61.4%[58.5%, 61.8%] in RT alone, HMO-based hyperthermia and combination therapy group respectively. Considerably low apoptosis rates were observed in HMO-incubation and NIR-irradiation only groups, which was 6.2% and 6.6% respectively, similar to that of treatment-naive cells. Conclusions: The combination of HMO-based hyperthermia and RT provided a promising treatment modality for ESCC, while its effects in rodent models and potentials in clinical practice merit further investigations.
Efficacy and safety of donafenib as adjuvant therapy for patients with hepatocellular carcinoma undergoing curative resection: A retrospective, multicenter cohort study.
Authors: Yang Xin-Rong , Zhang Sen-Quan , Chen Zhong , Yu Zheng-Ping , Wu Sheng-dong , Fan Jia , Zhou Jian 
Published: July 2024

e16234 Background: A growing incidence of hepatocellular carcinoma and its high risk of recurrence after curative-intent treatment underscore the need for effective adjuvant treatment options. This study aimed to assess the efficacy of adjuvant donafenib in patients with hepatocellular carcinoma (HCC) following radical resection. Methods: This multicenter, real-world study retrospectively gathered clinical data of 82 patients who had undergone radical resection of HCC and received adjuvant therapy with donafenib. The primary endpoint was recurrence-free survival (RFS). The secondary endpoints included overall survival (OS) and safety. Kaplan-Meier analysis was performed to evaluate RFS and OS, while the Cox proportional-hazards model was used to estimate risk factors for tumor recurrence and death. Results: A total of 82 patients with HCC who received donafenib following surgical resection were included in the study, of which were classified as high risk for tumor recurrence (with multiple or large tumor, microvascular invasion, poor tumor differentiation). The median duration of donafenib adjuvant therapy was 10.6 months (range: 0.2–26.1 months). All patients completed follow-up as required, with a median follow-up time of 19.4 months (range: 2.8–57.6 months). During the follow-up period, a totally postoperative recurrence rate was 15.9% (13/82). 1-year recurrence rate and 2-year recurrence rate were 7.3% (6/82) and 12.2% (10/82), and 1-year survival rate and 2-year survival rate were 95.1% (78/82) and 93.9% (77/82). Kaplan-Meier analysis demonstrated that patients with higher preoperative AFP level (AFP > 400ng/mL), higher preoperative PIVKA-II level (PIVKA-II > 40mAU/mL), or poor tumor differentiation (Edmondson stage III-IV) exhibited higher rate of tumor recurrence after operation (all p value < 0.05). Multivariate analysis indicated that preoperative AFP level was an independent risk factor for tumor recurrence in patients with donafenib treatment. Treatment-related adverse events (TRAEs) occurred in 67.1% (55/82) of patients, of which the most frequent were hand-foot syndrome (25.6%, 21/82), diarrhea (20.7%, 17/82), and fatigue (17.1%, 14/82). Only 8.5% (7/82) of patients had a grade ≥3 TRAEs, with the most common being hand-foot syndrome (2.4%, 2/82) and hypertension (2.4%, 2/82). No treatment-related deaths were reported. Conclusions: This study represents the largest multicenter investigation of adjuvant therapy with donafenib to date, and the findings indicate that donafenib has the potential to be an effective treatment option for preventing postoperative recurrence in HCC. Furthermore, the preoperative AFP ≤400ng/mL can serve as an effective biomarker for postoperative administration of donafenib in HCC patients.