Background: Reliably predicting brain metastasis (BM) and brain metastasis‑free survival (BMFS) in patients with primary small cell carcinoma of the esophagus (PSCCE) remains a clinical challenge. Objectives: To develop and externally validate predictive nomograms for assessing BM probability and BMFS in patients with PSCCE. Design: A retrospective model development and external validation study. Methods: Using a training cohort, we constructed two separate nomograms. The first was developed using univariable and multivariable logistic regression to predict the probability of BM. The second was built using a Fine‑Gray competing-risk model to estimate BMFS, treating death without BM as a competing event. The performance of both nomograms was evaluated using the area under the receiver operating characteristic (ROC) curve/time-dependent ROC curve, calibration plots, and decision curve analysis (DCA). External validation was subsequently performed using an independent validation cohort. Results: The study sample included 492 patients in the training cohort (mean age at diagnosis 61.97 ± 8.86 years; 133 (27%) female) and 344 patients in the external validation cohort (mean age at diagnosis 62.97 ± 8.14 years; 108 (31%) female). Age, N stage, and M stage emerged as independent predictors and were included in a nomogram to estimate BM risk. Adding lesion length and initial treatments (radiotherapy, chemotherapy, and surgery) to these three factors allowed the model to predict BMFS. Both nomograms showed strong predictive performance in the training cohort, with area under the ROC curve values of 0.76 and 0.843, respectively, supported by calibration plots and DCA. These results were confirmed in the external validation cohort. The logistic regression‑based nomogram accurately predicted BM probability, while the Fine–Gray model provided reliable estimates of BMFS. Conclusion: We successfully developed and externally validated two complementary nomograms that reliably predict BM probability and BMFS in patients with PSCCE. These tools may aid in risk stratification and inform personalized surveillance strategies.
Concurrent chemoradiotherapy is the standard treatment for inoperable, locally advanced esophageal cancer. However, older patients often have reduced tolerance to radiotherapy and concurrent intravenous chemotherapy due to declining physical function and multiple comorbidities. This prospective, single-center, phase II study assessed the efficacy and safety of nimotuzumab, an epidermal growth factor receptor antagonist, combined with concurrent radiotherapy and S-1 in patients 75 years and older. A total of 56 patients were enrolled, with the primary endpoint being progression-free survival (PFS), while secondary endpoints included overall survival (OS), objective response rate, disease control rate, treatment-related adverse events, nutritional indicators, and quality of life (QOL). Most nutritional indicators remained stable after treatment. As of June 2024, the median follow-up duration was 24.1 months (8.8-34.1). Eleven patients achieved complete response, 39 achieved partial response, five had stable disease, and one experienced progressive disease. The median PFS was 25.3 months (95% CI, 16.5-34.1), while the median OS was 28.2 months (95% CI, 24.1-32.3). Most adverse events were grade 1-2 (85.7%). Among survivors, 45.5% reported high satisfaction with their QOL, and 84.8% did not experience weight loss. This combination therapy demonstrated promising efficacy and safety, suggesting it may be a viable treatment option for this patient population.
4027 Background: Concurrent chemoradiotherapy is the standard treatment method for inoperable and locally advanced esophageal cancer. Nevertheless, due to decreased physical function and the presence of multiple complications, older patients often have reduced tolerance to radiotherapy and chemotherapy. Methods: We conducted this prospective, single-center, phase II study to evaluate the efficacy and safety of nimotuzumab (an epidermal growth factor receptor antibody) plus concurrent radiotherapy and S-1 in 75 years and older patients with stage II-IVB esophageal squamous cell carcinoma (ESCC). The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, nutritional indicators, and quality of life (QOL). Most nutritional indicators remained stable after treatment. Results: As of June 2024, a total of 56 patients were enrolled in this study. The median follow-up was 24.1 months (95% CI: 8.8, 34.1). 11 patients had complete response, 39 patients had partial response, 5 patients had stable disease, and 1 patient had progressive disease. The ORR was 89.2%, and the DCR was 98.1%. The 1- and 3-year PFS rates were 67.8% (95% CI: 55.5%, 80.1%) and 35.8% (95% CI: 17.6%, 54.0%), with the median PFS was 25.3 months (95% CI: 16.5, 34.1). The 1- and 3-year OS rates were 79.6% (95% CI: 68.8%, 90.4%) and 40.1% (95% CI: 21.1%, 59.1%), with the median OS was 28.2 months (95% CI: 24.1, 32.3). Most adverse events were grade 1-2 (85.7%). Among survivors, 45.5% patients reported high satisfaction with their QOL, and 84.8% patients did not experience weight loss. Conclusions: Our treatment combination of nimotuzumab plus S-1 and concurrent radiotherapy indicated favorable efficacy and safety profile. This might be an underlying treatment choice for older patients with ESCC. Clinical trial information: NCT06048913 .
BACKGROUND:This phase II trial prospectively assessed the efficacy and safety of induction chemoimmunotherapy followed by sequential concurrent chemoradiotherapy plus immunotherapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC) who were ineligible for surgery. METHODS:Forty-four patients received 2 cycles of induction therapy (paclitaxel plus carboplatin/nedaplatin combined with a PD-1 inhibitor), followed by concurrent radiotherapy with two additional cycles of chemoimmunotherapy and subsequent immune maintenance therapy for up to 1 year. The primary endpoint was progression-free survival (PFS); the secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and quality of life (QoL). RESULTS:At the data cut-off point (median follow-up: 25.5 months), both the ORR and DCR were 95.5%. The median PFS was 26 months (95% CI, 14.8-37.2), and the median OS was 29 months (95% CI, 23.0-35.0). The 1-, 2-, and 3-year PFS rates were 75.0%, 51.9%, and 40.4%, respectively, and the OS rates were 81.8%, 63.1%, and 42.0%, respectively. Distant metastasis represented the main failure mode (64.0%). Treatment-related adverse events were generally mild; moreover, 17 patients (38.6%) experienced grade ≥3 events, primarily involving hematologic toxicity (14/17). Severe immune-related adverse events were rarely observed. QoL assessment in surviving patients (n = 21) indicated favorable overall function and well-being. CONCLUSIONS:This regimen of induction chemoimmunotherapy followed by concurrent chemoradiotherapy and maintenance immunotherapy demonstrated promising survival outcomes, a manageable safety profile, and a preserved QoL, thereby offering a viable nonsurgical alternative for patients with locally advanced ESCC.
Radiation-induced skin toxicity, resulting from ionizing or nonionizing radiation, is a common skin disorder. However, the underlying relationship between skin microbiota and radiation-induced skin toxicity remains largely unexplored. Herein, we uncover the microbiota–skin interaction based on a genome-wide association study (GWAS) featuring 150 skin microbiota and three types of skin microenvironment. Summary datasets of human skin microbiota were extracted from the GWAS catalog database, and summary datasets of radiation-induced skin toxicity from the FinnGen biobank. Mendelian Randomization (MR) analysis was leveraged to sort out the causal link between skin microbiota and radiation-induced skin toxicity. We identified 33 causal connections between human skin microbiota and radiation-induced skin toxicity, including 19 positive and 14 negative causative directions. Among these potential associations, the genus Staphylococcus could serve as a common risk factor for radiation-induced skin toxicity, especially for radiodermatitis. And Streptococcus salivarius was identified as a potential protective factor against radiation-induced skin toxicity. Additional analysis indicated no pleiotropy, heterogeneity, or reverse causal relationship in the results. We comprehensively assessed potential associations of skin microbiota with radiation-induced skin toxicity and identified several suggestive links. Our results provide promising targets for the prevention and treatment of radiation-induced skin toxicity.
Background and purpose:To integrate clinical characteristics, radiomics, and dosiomics to provide accurate and individualized prediction of radiation pneumonitis (RP) in elderly patients aged 70 and over with esophageal cancer receiving radiotherapy. Materials and methods:Based on a phase III clinical study (NCT02979691) that included elderly patients with esophageal squamous cell carcinoma (ESCC) who received definitive radiotherapy, we selected a total of 229 patients with available computed tomography (CT) and dose images. Radiomic and dosiomics features were extracted from both lungs. The patients were randomly assigned to either the training group (N = 161) or the test group (N = 68) in a 7:3 ratio. In the training set, logistic regression (LR) was applied to calculate the radiomic score (R score) and dosiomic score (D score). The constructed multivariate LR and ridge regression prediction models were evaluated using the test set. The endpoint of the predictive model is defined as a grade ≥ 2 RP. Discrimination and prediction were assessed by calculating the area under curve (AUC) of the receiver operating characteristic curve and plotting calibration and decision curve analyses (DCA). Results:The hybrid LR model integrating R score, D score and clinical characteristics had the best clinical applicability. The hybrid model demonstrated superior predictive performance on the test set, achieving an area under the curve (AUC) of 0.76, while the combined clinical and DVH model achieved an AUC of 0.70. Conclusions:A hybrid model combining radiomics and dosiomics with clinical characteristics showed the best performance for predicting RP.
Abstract Background The standard treatment for elderly patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is definitive chemoradiotherapy with S-1. However, the 3-year overall survival (OS) is limited to approximately 40%. Tislelizumab is the first- and second-line standard treatment for advanced ESCC with tolerable toxicity. In this study, we aimed to explore a new curative strategy for locally advanced unresectable ESCC in the elderly by combining tislelizumab with chemoradiotherapy. Methods This study is an open-label, multicenter, investigator-initiated phase II clinical trial in older patients with inoperable locally advanced ESCC evaluating tislelizumab plus concurrent chemoradiotherapy compared with concurrent chemoradiotherapy. The main inclusion criteria were pathological confirmation of locally advanced inoperable ESCC at clinical cT1N2-3M0 or cT2-4bN0-3M0 (stage II–IVA), age ≥ 70 years, absence of previous systemic anti-tumor therapy, and adequate organ function. A total of 136 patients will be recruited from approximately seven centers (in Tianjin, Chengdu, Taiyuan, Zhengzhou, Shijiazhuang, Changsha, Nanjing) over a period of 18 months and randomized in a 1:1 ratio to receive tislelizumab in combination with concurrent chemoradiotherapy (tislelizumab + S-1 + radiotherapy) or concurrent chemoradiotherapy (S-1 + radiotherapy). The efficacy and safety of the treatment will be evaluated during the therapy and follow-up period until disease progression, death, or the end of the trial. The primary study endpoint was investigator-assessed progression-free survival (PFS), and secondary study endpoints were OS, objective response rate (ORR), duration of remission (DOR), and safety. Fresh or archival tumor tissues and peripheral blood samples will be used in exploratory studies. Discussion This study is the first “programmed death-1 (PD-1) inhibitor combined with concurrent chemoradiotherapy” for elderly patients with inoperable locally advanced ESCC (NCT06061146). The synergistic efficacy of combined definitive concurrent chemoradiotherapy with tislelizumab is expected to result in survival benefits for elderly patients with inoperable locally advanced ESCC. Because S-1 plus concurrent radiotherapy is the standard treatment option for locally advanced ESCC in older patients, the combination of definitive concurrent chemoradiotherapy and tislelizumab has the potential to change the standard ESCC therapeutic strategy with comparable safety. Trial registration ClinicalTrials.gov NCT06061146.Registered 9/10/2023.
This study aims to evaluate the clinical effectiveness of trilaciclib in preventing myelosuppression in patients with esophageal cancer undergoing chemotherapy. Based on the use of trilaciclib, 81 patients were divided into a primary prevention group (PP group, n = 49) and a secondary prevention group (SP group, n = 32). The incidence of myelosuppression, antibiotic usage rate, survival outcomes, and other treatment-related toxicities were analyzed using chi-square tests and Kaplan–Meier survival curves. The incidence of chemotherapy-induced myelosuppression in the SP group was significantly higher than that in the PP group (96.9% vs. 79.6%), with a significantly higher proportion of grade III and above events (37.6% vs. 8.2%, p < 0.05). For chemotherapy-induced neutropenia, the incidence of grade III/IV events in the SP group was significantly higher than in the PP group (28.1% vs. 8.2%, p = 0.017). Additionally, the SP group experienced higher rates and severity of chemotherapy-induced anemia and thrombocytopenia. The PP group provided better protection against grade III/IV leukopenia and neutropenia (p < 0.05). Non-hematological toxicities and efficacy outcomes were similar between groups (p > 0.05). The study is the first to demonstrate that trilaciclib is a safe and effective option for the prevention of myelosuppression in esophageal cancer patients.
The optimal radiotherapy dose for cervical and upper thoracic esophageal cancer (ESCA) remains controversial, with limited evidence supporting dose escalation. This study aims to evaluate the survival impact of varying radiotherapy doses and explore potential benefits in specific patient subgroups using multicenter real-world data.Data from 2,527 inoperable cervical and upper thoracic ESCA patients treated with IMRT/3DCRT across eight medical centers in China during 1st June 2004 and 1st June 2020 were retrospectively analyzed. Patients were divided into low-dose (50–<60 Gy) and high-dose (≥ 60 Gy) groups. Subgroup analyses were conducted to identify populations that might benefit from higher doses.High-dose radiotherapy (≥ 60 Gy) improved overall survival (OS) in cervical ESCA patients before and after propensity score matching (P = 0.026 and P = 0.047). For upper thoracic ESCA, high-dose radiotherapy showed a survival advantage before matching (P = 0.008), though not after (P = 0.680). Subgroup analysis revealed survival benefits in upper thoracic ESCA patients with poor performance status (KPS < 90), those not receiving chemotherapy (P = 0.043 and P = 0.013), and borderline improvement in patients with smaller gross tumor volumes (< 35.1 cm³, P = 0.057). Radiation doses exceeding 63 Gy provided no additional survival benefit compared to 60–63 Gy.High-dose radiotherapy (≥ 60 Gy) significantly improves survival in cervical ESCA patients. Subgroup analysis highlights its potential benefits for upper thoracic ESCA patients with KPS < 90, those not receiving chemotherapy, and those with smaller tumor volumes (< 35.1 cm³).
PURPOSE:This study reports the long-term outcomes of simultaneous integrated boost radiotherapy (SIB-RT) combined with oral S-1 chemotherapy (CRTCT) in inoperable patients aged ≥ 70 years with inoperable esophageal squamous cell carcinoma (ESCC). METHODS:In this multicenter, phase III randomized trial, patients with inoperable, locally advanced stage II-IV ESCC were randomized to receive either CRTCT or RT alone. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), restricted mean survival time (RMST), and patterns of failure. RESULTS:After a median follow-up of 75 months, patients in the CRTCT group had longer OS than those in the RT group (hazard ratio (HR), 0.74; 95 % confidence interval (CI), 0.57-0.95; P = 0.02), with better 5-year OS rates (34.1 % vs. 23.6 %,P = 0.02), PFS (31.1 % vs. 20.9 %,P = 0.02), and RMST (33.0 vs. 27.0 months,P = 0.02). CRTCT's effect on OS stabilized over 5 years. Locoregional failure was lower in the CRTCT group (HR, 0.64; 95 % CI, 0.45-0.92; P = 0.02), with similar distant and mixed failure risks. CONCLUSIONS:SIB-RT combined with oral S-1 chemotherapy significantly improved long-term survival and therefore might be considered a standard of care for elderly patients with inoperable ESCC. TRIAL REGISTRATION Clinical Trials.gov Identifier: NCT0297969.
BACKGROUND:The treatment strategy for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) is immunotherapy-based systemic treatment. The effect of local radiotherapy on the survival of recurrent or metastatic ESCC patients is unclear. This work is aimed to investigate the efficacy of local radiotherapy in combination with immunotherapy-based systemic therapy. METHODS:In this retrospective observational study, data were collected from recurrent or metastatic ESCC patients treated at the Radiotherapy Department of Jiangsu Province Hospital between March 2019 and December 2022. This study enrolled a total of 73 patients with recurrent or metastatic ESCC. The overall survival (OS) of all patients and OS stratified by different treatment patterns were analyzed. Prognostic factors influencing OS were examined using uni- and multi-variate Cox tests. RESULTS:The median OS of the study population was 21.4 (95%CI: 13.7-29.1) months. The median OS of patients who received radiotherapy in additional to systemic therapy was 31.5 (13.5-49.5) months, while the patients who received systemic therapy alone had a significantly shorter median OS of 10.7 (95%CI: 8.0-13.4) months. OS was also significantly different among patients receiving different cycles of immunotherapy. The median OS of patients after 1-6 cycles of immunotherapy was 14.6 (95%CI: 11.3-18.0) months, that after 7-12 cycles was 21.1 (95%CI: 0-43.8) months, and that after more than 12 cycle was 52.1 (25.6-78.6) months. CONCLUSIONS:In the first-line therapy of recurrent or metastatic ESCC based on immunotherapy, the addition of local radiotherapy significantly improves patient survival. As the number of immunotherapy cycles increases, the survival benefits become more pronounced.
This study systematically analyzes the current situation of tumor radiotherapy education and reveals the core contradictions it faces: lagging curriculum content, weak practical teaching, and insufficient interdisciplinary knowledge leading to deviations in clinical competence cultivation. Based on the current situation analysis, propose an innovative training model: (1) Curriculum reconstruction: Integrating OBE concept and ADDIE model, constructing a three-level curriculum system of “basic clinical frontier”; (2) Advanced Practice: Establishing a five level capability ladder using the EPA model (basic operations → conventional design → precise implementation → multidisciplinary integration → technological innovation), with supporting dynamic monitoring mechanisms; (3) Technological empowerment: Realizing clinical scene visualization training through digital twins, AI personalized learning systems, and VR/AR technology. The implementation path emphasizes the deep integration of intelligent technology, the incubation of clinical research projects, and the construction of a collaborative ecosystem between industry, academia, and research. The conclusion indicates that this model solves the lack of linkage between educational ecological elements, promotes the transformation of radiotherapy education towards “intelligence, personalization, and globalization,” and provides a systematic solution for the strategic delivery of composite radiotherapy talents for a healthy China.
The prognosis for patients with esophageal squamous cell carcinoma (ESCC) is poor, with a 5-year survival rate of approximately 30%. There are significant differences in prognosis among patients, and some patients experience local recurrence and distant metastasis within 1 year after comprehensive treatment. Therefore, there is an urgent need for highly sensitive and specific biomarkers to assess the therapeutic risks and prognosis of patients with inoperable esophageal cancer. This study aimed to investigate the predictive value of the LabBM score in the survival of patients with inoperable ESCC. A single-center retrospective study was conducted, including 150 and 155 patients with unresectable ESCC who received concurrent chemoradiotherapy at our hospital between January 1, 2013, and June 30, 2018, and between July 1, 2018, and March 1, 2020, respectively, as the training and validation cohorts. Laboratory parameters, including lactate dehydrogenase, platelet count, C-reactive protein, and albumin, were collected 1 week prior to concurrent chemoradiotherapy. The LabBM score was calculated, and survival differences were analyzed across patients with different LabBM scores. Cox regression and Kaplan-Meier analyses were used to assess factors influencing progression-free survival (PFS) and overall survival (OS), aiming to clarify the prognostic value of the LabBM score for PFS and OS. In the training group, of the 150 patients enrolled, 123 were in the low LabBM group (0-1), 23 in the medium LabBM group (1.5-2), and 4 in the high LabBM group (2.5-3.5). The median survival was 33 months in the low LabBM group, 11 months in the medium LabBM group, and 6.5 months in the high LabBM group, with a significant difference in survival between the 3 groups (P = .000). Univariate Cox analysis showed that a higher LabBM score was associated with worse OS (P < .05). Multivariate Cox regression analysis revealed that a higher LabBM score (hazard ratios: 2.75, 95% CI: 1.08-7.03, P = .034) was an independent influencing factor for OS. In receiver operating characteristic analysis, the AUC area for OS and PFS predicted by the LabBM-based risk model was 0.92 (95% CI: 0.86-0.97, P = .00) and 0.956 (95% CI: 0.88-0.98, P = .000), respectively. The AUC for LabBM scores predicting OS and PFS were 0.63 (95% CI: 0.54-0.72, P = .011) and 0.61 (95% CI: 0.52-0.70, P = .039), respectively. The AUC area of the risk model was significantly higher than that of other single parameters. Subsequently, we re-enrolled 155 patients with inoperable esophageal cancer in different time periods for the above analysis, and the results were consistent with the experimental group. In inoperable ESCC patients, the LabBM score-based risk model is a novel and effective prognostic indicator.
PURPOSE:To compare the efficacy of dCRT versus dCRT plus consolidation ICIs (dCRT + cICIs) in LA-ESCC and to evaluate the safety of dCRT + cICIs. METHODS:Patients with LA-ESCC who received dCRT or dCRT + cICIs were included. sIPTW adjusted for sex, age, clinical TNM stage, smoking, and alcohol consumption between the two groups. The study analyzed overall survival (OS) and progression-free survival (PFS) between the two groups, and evaluated immune-related adverse events (irAEs) within the dCRT + cICIs cohort. RESULTS:We retrospectively identified 176 ESCC patients, with 123 in the dCRT group and 53 in the dCRT + cICIs group. Pre-sIPTW analysis showed significantly improved OS in the dCRT + cICIs group (median, 46.4 vs. 20.9 months; P = 0.02). The dCRT + cICIs group had a better PFS than the dCRT group (median, 27.4 vs. 12.9 months; P = 0.02). After sIPTW, the OS was numerically better in the dCRT + cICIs group than in the dCRT group (median, 42.9 vs. 21.6 months; P = 0.1), with improvement in 1- and 2-year OS rates. There was no significant difference in PFS between dCRT + cICIs group and dCRT group (median, 23.0 vs. 13.0 months; P = 0.2), with numerically better 1- and 2-year PFS in the dCRT + cICIs group. In the dCRT + cICIs group, approximately 43.4 % of patients experienced irAEs, and grade 3-4 irAEs occurred in 13.2 % of patients. The most common was hypothyroidism in 11.3 % of patients. CONCLUSIONS:Our preliminary findings suggested that consolidation immunotherapy following dCRT might trend toward prolonged OS and PFS in patients with LA-ESCC, and that irAEs are generally tolerated.
The potential benefits of adding immune checkpoint inhibitors (ICIs) to definitive chemoradiotherapy (dCRT) for inoperable esophageal squamous cell carcinoma (ESCC) remain unclear, different timing for immunotherapy intervention during the peri-dCRT period on survival outcomes is worth exploring. Patients with inoperable ESCC receiving dCRT combined with ICIs between April 2018 and April 2022 were recruited from five hospitals in China. A historical control group treated with dCRT alone was used for comparison. Stabilized inverse probability of treatment weights (sIPTW) analyses were conducted to compare survival. The survival outcomes and treatment-related adverse effects were analyzed. A total of 290 patients with inoperable ESCC who received dCRT+ICI treatment were analyzed. The median follow-up was 35.7 months. The 1-year and 2-year overall survival (OS) rates were 86.7% and 66.9%, respectively, and the 1-year and 2-year progression-free survival (PFS) rates were 66.7% and 47.3%, respectively. The median PFS was 22.4 months, and the median OS was not reached. The dCRT+ICI group had significantly longer OS than the historical control group (2-year OS: 66.9% vs. 56.5%, for sIPTW-adjusted data: HR = 0.62, p < .001). After sIPTW, no differences in OS were found among the induction, concurrent, and consolidation groups. The sIPTW-adjusted analysis showed that both the induction and concurrent groups had significantly longer PFS than the consolidation group. Combining immunotherapy with dCRT improved survival outcomes and demonstrated a favorable safety profile in patients with inoperable ESCC. Induction or concurrent immunotherapy may provide superior survival benefits compared to consolidation immunotherapy.Trial registration Trial no. NCT04821778 registered in ClinicalTrials.gov
BACKGROUND:Chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of esophageal cancer treatment, often necessitating reductions or delays in chemotherapy. Current treatments target specific blood cells, causing adverse effects. Trilaciclib, a novel CDK4/6 inhibitor with myeloprotective effects, has not yet been evaluated for its use in esophageal cancer treatment. We aimed to investigate the efficacy and safety of trilaciclib in preventing CIM. METHODS:Clinical data were retrospectively collected from 203 patients with esophageal cancer who underwent concurrent radiotherapy at the Department of Radiotherapy of Jiangsu Province People's Hospital between January 2022 and January 2024. Patients were divided into the trilaciclib group (34 patients) and control group (169 patients). Propensity score matching (PSM) was performed to balance the baseline characteristics, and the incidence of myelosuppression and adverse events was compared. RESULTS:Following PSM, 34 patients were included in each group, with no significant differences in baseline characteristics. The trilaciclib group exhibited significantly higher leukocyte, neutrophil, hemoglobin, and platelet levels (p < 0.05). The trilaciclib group exhibited a lower incidence of grade III-IV neutropenia and leukopenia, and none developed febrile neutropenia. Objective remission and disease control rates were comparable between the groups, with 1-year overall survival and progression-free survival rates of 82.0% and 73.4% in the trilaciclib group and 78.9% and 72.7% in the control group (not significant). The incidence of non-hematological toxic events was similar between the groups (p > 0.05). CONCLUSION:Trilaciclib prevented myelosuppression in patients with esophageal cancer undergoing concurrent chemoradiotherapy, demonstrating good safety and efficacy.
Purpose: We constructed a prediction model to predict a 2-year locoregional recurrence based on the clinical features and radiomic features extracted from the machine learning method using computed tomography (CT) before definite chemoradiotherapy (dCRT) in locally advanced esophageal cancer. Patients and methods: A total of 264 patients (156 in Beijing, 87 in Tianjin, and 21 in Jiangsu) were included in this study. All those locally advanced esophageal cancer patients received definite radiotherapy and were randomly divided into five subgroups with a similar number and divided into training groups and validation groups by five cross-validations. The esophageal tumor and extratumoral esophagus were segmented to extract radiomic features from the gross tumor volume (GTV) drawn by radiation therapists before radiotherapy, and six clinical features associated with prognosis were added. T stage, N stage, M stage, total TNM stage, GTV, and GTVnd volume were included to construct a prediction model to predict the 2-year locoregional recurrence of patients after definitive radiotherapy. Results: A total of 264 patients were enrolled from August 2012 to April 2018, with a median age of 62 years and 81% were males. The 2-year locoregional recurrence rate was 52.6%, and the 2-year overall survival rate was 45.6%. About 66% of patients received concurrent chemotherapy. In total, we extracted 786 radiomic features from CT images and the Principal Component Analysis (PCA) method was used to screen out the maximum 30 features. Finally, the Support Vector Machine (SVM) method was used to construct the integrated prediction model combining radiomics and clinical features. In the five training groups for predicting locoregional recurrence, the mean value of C-index was 0.9841 (95%CI, 0.9809–0.9873), and in the five validation groups, the mean value was 0.744 (95%CI, 0.7437–0.7443). Conclusions: The integrated radiomics model could predict the 2-year locoregional recurrence after dCRT. The model showed promising results and could help guide treatment decisions by identifying high-risk patients and enabling strategies to prevent early recurrence.
BACKGROUND:The optimal radiation dose for the treatment of small cell carcinoma of the esophagus (SCEC) has not been established. This study aimed to investigate the treatment outcomes and toxicities in patients with limited-stage SCEC (LS-SCEC) treated by radiotherapy. METHODS:Patients with LS-SCEC from 14 institutions were retrospectively identified between December 2000 and October 2021. The primary endpoints of the study included overall survival (OS), progression-free survival (PFS), and local regional control (LRC), and the secondary endpoints were treatment-related toxicity parameters. Patients were categorized into a high-dose (HD, ≥ 60 Gy) group and low-dose (LD, <60 Gy) group based on the radiation dose. Additionally, they were classified into two groups based on the treatment sequence: concurrent chemoradiotherapy (CCRT) and sequential chemoradiotherapy (SCRT). A 1:1 propensity score matching (PSM) approach was applied to balance the observable potential confounding factors between the groups. RESULTS:Of the 150 patients included in the study, 56 received LD, and 94 received HD radiotherapy. After 1:1 PSM, the OS, PFS, and LRC in the HD group were higher than those in the LD group; however, the difference was not statistically significant (P > 0.05). No significant differences in survival and the occurrence of treatment-related toxicity were observed between the CCRT and SCRT groups. CONCLUSIONS:Neither CCRT nor SCRT was significantly associated with longer survival in LS-SCEC when a higher radiation dose was selected. A lower radiation dose might be a preferable time-dose fraction scheme; however, additional studies are required to validate these findings.
Background:Against the backdrop of esophageal cancer's high global incidence, the dominant role of esophageal squamous cell carcinoma (ESCC) with poor prognosis, limited surgical opportunities, and the American Joint Committee on Cancer (AJCC) staging system's insufficiency, there is an urgent need to develop a prognostic nomogram for ESCC patients undergoing chemoradiotherapy. The purpose of this study was to establish a clinical nomogram for effectively predicting overall survival (OS) for patients with non-operated ESCC after definitive chemoradiotherapy. Methods:A total of 869 patients diagnosed with ESCC from 2010 to 2015 were retrieved from the Surveillance, Epidemiology, and End Results database. The nomogram was developed based on independent predictors determined by multivariate Cox regression analyses. Additional external validation was conducted on 318 ESCC patients enrolled from The First Affiliated Hospital of Nanjing Medical University. The receiver operating characteristic curve analysis and calibration plot were utilized to assess the predictive discriminative ability and reliability of the nomogram in both the training cohort and external validation cohort. The clinical practicability was evaluated by decision curve analysis and further comparing the novel model and the eighth edition of the American Joint Committee on Cancer (AJCC) staging system. Results:The multivariate analysis of the training cohort suggested that age, sex, tumor site, tumor size, clinical T stage, clinical N stage were significantly associated with OS and were all incorporated into the nomogram. The results suggested that the novel nomogram performed well with good discrimination and agreement and exhibited more optimal clinical benefits than AJCC 8th staging system. Meanwhile, an online web-server based on the new nomogram was developed for convenient clinical practice. Conclusions:The prognostic nomogram developed in this study demonstrates favorable predictive performance for survival outcomes in ESCC patients receiving definitive chemoradiotherapy. Its discriminative ability, consistency, and clinical benefits surpass those of the AJCC 8th Edition staging system. Additionally, a convenient online tool for the nomogram has been developed. This model can objectively quantify patients' survival risks, providing critical reference for the formulation of individualized treatment strategies and possessing clinical application value.