Non-neonatal tetanus continues to pose a public health challenge in low- and middle-income regions. This study aimed to describe the decade-long profile of non-neonatal tetanus in Guangdong, China, from 2011 to 2021—a period marked by rapid economic development and healthcare system strengthening. Multicenter, retrospective study. The study was conducted across 159 hospitals in Guangdong, China. We included patients with a clinical diagnosis of tetanus admitted between 2011 and 2021. A total of 2,567 cases (median age 53 years; 62.1
LBA6003 Background: This study aimed to assess the efficacy and safety of toripalimab combined with induction chemotherapy and radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma (LANPC). Methods: Patients with non-metastatic T4N1 or N2–3 (AJCC 8 th edition) NPC were recruited from 13 centers in China from Aug 2021 to Jul 2022 and randomly assigned (1:1) to receive either toripalimab plus gemcitabine-cisplatin induction chemotherapy and concurrent cisplatin-radiotherapy ( standard arm) or standard therapy sparing concurrent cisplatin ( cisplatin-free arm). Toripalimab was administered at a dosage of 240 mg once every 3 wks for up to 17 cycles (1.06 year), covering the induction (×3 cycles), radiotherapy (×3), and adjuvant (×11) phases. The trial would be considered positive if both coprimary endpoints, failure-free survival (FFS; non-inferiority) and the incidence of all-grade vomiting (superiority), were significantly met, maintaining a 1-sided type I error of 5% without α splitting. A total of 532 patients were needed to achieve 80% power to detect a HR of 1.74, with non-inferiority defined as the lower limit of the 1-sided 95% CI for the difference in 3-year FFS greater than -8%. Quality of life (QoL) was assessed based on EORTC and FACT systems. Tolerability was measured by PRO-CTCAE questionnaires. Results: After a median follow-up of 36 mo, intention-to-treat analysis in 532 patients (266 vs 266) showed that the estimated 3-year FFS was 88.3% in the cisplatin-free arm and 87.6% in the standard arm, with a difference of 0.7% (1-sided 95% CI, -4.8% to ∞; p non-inferiority = 0.002); the stratified HR was 0.92 (95% CI, 0.66 to 1.79; log-rank p = 0.731). The incidence of all-grade vomiting in safety dataset was 25.6% (68/260) in cisplatin-free arm and 69.0% (156/261) in standard arm (χ 2 p < 0.001); the incidence of grade 3–4 vomiting, 3.8% vs 10.3%. Acute grade 3–4 adverse events (AEs) occurred in 136 (52.3%) and 166 (63.6%) patients, including immune-related AEs in 13 (5.0%) and 22 (8.4%) patients, in the cisplatin-free and standard arms, respectively. No treatment-related death was observed. Compared to standard arm, cisplatin-free arm had significantly better QoL in global health status, physical function, role function, nausea/vomiting, constipation, swallowing, sexuality, and H&N total score, as well as higher tolerability to nausea, vomiting, constipation, and fatigue during radiotherapy. Conclusions: Removing concurrent cisplatin from toripalimab plus chemoradiotherapy provides comparable survival, lower toxicity, and better QoL and tolerability for patients with LANPC. Clinical trial information: NCT04907370 . 3-yr survival (%) Cisplatin-free arm ( n = 266) Standard arm ( n = 266) p non-inferiority OS 96.1 96.5 < 0.001 LRRFS 92.9 93.6 0.001 DMFS 93.2 91.6 < 0.001
e13120 Background: Accumulating data demonstrate both overall and intracranial activity of Trastuzumab deruxtecan (T-DXd) in HER2 positive breast cancer brain metastasis (BCBM). Limited data available regarding its efficacy on HER2 low BCBM, as well as patients who have symptomatic active BM, leptomeningeal disease (LMD), and poor performance status. Methods: This multicenter, retrospective, real-world study enrolled patients who were diagnosed with HER2 positive or low BCBM, and received T-DXd treatment. Progression-free survival (PFS), overall survival (OS), intracranial progression survival (IC-PFS), objective response rate (ORR), disease control rate (DCR), IC-ORR, IC-DCR and adverse events (AEs) were evaluated. Results: From January 2021 toNovember 2024, 58 HER2 positive patients and 30 HER2 low patients were enrolled in the study. In the HER2 positive cohort, the median PFS, IC-PFS, and OS were 12, 15, and 46 months, respectively. The ORR, DCR, IC-ORR, and IC-DCR based on RECIST 1.1 were 65.2%, 91.3%, 61.0%, and 90.2%, respectively. According to RANO-BM, IC-ORR and IC-DCR were 59.5% and 88.1%. HR expression showed no impact on efficacy. In HER2-low cohort, the median PFS, IC-PFS, and OS were 5, 18, and 26 months, respectively. The ORR, DCR, IC-ORR, and IC-DCR based on RECIST 1.1 were 38.1%, 85.7%, 44.4%, and 85.7%, with no CNS progression at data cutoff. According to RANO-BM criteria, IC-ORR and IC-DCR were 44.4% and IC-DCR 94.4%. HR positive subgroup showed significantly better survival outcomes than HR negative subgroup, the overall PFS, and CNS PFS, with 15 months vs. 4 months (P = 0.0027) and 18 months vs. 4 months (P = 0.012), respectively. 4 patients had isolated LMD and 12 had both brain metastases and LMD, the median IC-PFS was 16 months. T-DXd was well tolerated, the most common AEs included fatigue (45.9%), nausea (11.4%) and appetite loss (25.2%). Interstitail lung disease (ILD) occurred in 6 (6.7%) patients, with only 1 patients diagnosed with grade 3 ILD, and discontinued T-DXd. Conclusions: In conclusion, the present study strongly confirmed the robust intracranial efficacy of T-DXd BCBM with both HER2 positive and low expression, patients with stable and active disease, with significant symptoms and LMD.
6085 Background: In the era of intensity-modulated radiotherapy (IMRT), the precision of radiotherapy has been greatly enhanced, allowing for more precise targeting of tumor tissue while minimizing damage to surrounding normal tissues. Therefore, whether radiotherapy alone can replace the traditional chemoradiotherapy regimen, which may cause substantial side effects, particularly hematologic toxicity, gastrointestinal adverse reactions, and immune suppression, has become a key focus of current clinical research. This investigation explores the potential benefits of IMRT as a standalone treatment, particularly its ability to offer similar efficacy in terms of overall survival and disease control while sparing patients from the added toxicities associated with chemotherapy. Methods: In a parallel-group, multicenter, randomized, controlled phase III trial, we compared cisplatin-based concurrent chemoradiotherapy with radiotherapy alone. Stage II NPC patients (2010 UICC staging) were randomly assigned in a 1:1 ratio to receive concurrent chemoradiotherapy (IMRT combined with cisplatin, 100 mg/m² every 3 weeks for 3 cycles) or IMRT alone. The primary endpoint was overall survival in the intention-to-treat population. Secondary endpoints included progression-free survival, locoregional relapse-free survival, distant metastasis-free survival, and safety. Results: A total of 211 patients were enrolled (106 in the IMRT alone group, 105 in the concurrent chemoradiotherapy group). The median follow-up time was 37 months. The 3-year overall survival rate was 96.3% for the IMRT alone group and 98.2% for the concurrent chemoradiotherapy group (HR = 0.650, 95% CI: 0.109-3.889; p-value = 0.637). No significant differences were observed between the groups in progression-free survival, locoregional recurrence, or distant metastasis (all p-values > 0.05). The incidence of grade 3-4 adverse events was significantly lower in the IMRT alone group (p-value < 0.05), including hematologic toxicity (leukopenia) and non-hematologic toxicity (hypokalemia). Conclusions: In stage II NPC patients, IMRT alone can achieve comparable 3-year overall survival to concurrent chemoradiotherapy, while significantly reducing side effects, which may provide a feasible treatment option for these patients, particularly for those with early-stage II nasopharyngeal carcinoma, where radiotherapy alone offers high therapeutic potential and lower treatment risks. Clinical trial information: NCT02610010 .
Approximately 20% to 30% of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) experience disease relapse despite definitive chemoradiotherapy. The programmed cell death 1 (PD-1) blockade camrelizumab has demonstrated considerable value in recurrent or metastatic NPC, while its role in locoregionally advanced NPC is unclear. To evaluate the efficacy and safety of adjuvant camrelizumab for patients with locoregionally advanced NPC. Randomized, open-label, multicenter, phase 3 clinical trial conducted from August 2018 to November 2021 at 11 centers in China and enrolling 450 patients with T4N1M0 or T1-4N2-3M0 NPC who had completed induction-concurrent chemoradiotherapy. The final date of follow-up was March 20, 2024. Patients were randomized (1:1) to receive adjuvant camrelizumab (200 mg intravenously once every 3 weeks for 12 cycles; n = 226) or observation (standard therapy group; n = 224). The primary end point was event-free survival (freedom from distant metastasis, locoregional relapse, or death due to any cause). Secondary end points included distant metastasis–free survival, locoregional relapse–free survival, overall survival, safety, and health-related quality of life. Among the 450 participants (mean age, 45 [SD, 10] years; 24% women), after a median follow-up of 39 (IQR, 33-50) months, the camrelizumab group had a 3-year event-free survival rate of 86.9%, whereas the standard therapy group had a rate of 77.3% (stratified hazard ratio, 0.56; 95% CI, 0.36-0.89; P = .01). Grade 3 or 4 adverse events were reported in 23 patients (11.2%) in the camrelizumab and 7 (3.2%) in the standard therapy group. Reactive capillary endothelial proliferation was the most common adverse event related to camrelizumab, occurring in 85.8% of patients at grade 1 or 2, while 2% of patients had grade 3 or 4 events. There was no significant deterioration in quality of life associated with camrelizumab treatment. Adjuvant PD-1 blockade with camrelizumab significantly improved event-free survival with manageable toxicities, highlighting its potential role in the management of locoregionally advanced NPC. ClinicalTrials.gov Identifier: NCT03427827
