Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial.

BACKGROUND: Neoadjuvant short-course radiotherapy (SCRT) followed by CAPOX and camrelizumab (a programmed cell death protein 1 monoclonal antibody) has shown potential clinical activity for locally advanced rectal cancer (LARC) in a phase II trial. This study aimed to further confirm the efficacy and safety of SCRT followed by CAPOX and camrelizumab compared to long-course chemoradiotherapy (LCRT) followed by CAPOX alone as neoadjuvant treatment for LARC. PATIENTS AND METHODS: In this randomized, phase III trial, patients with T3-4/N+ rectal adenocarcinoma were randomly assigned (1 : 1) to receive SCRT or long-course chemoradiotherapy (LCRT), followed by two cycles of camrelizumab and CAPOX or CAPOX alone, respectively. After surgery, each arm underwent either six cycles of camrelizumab and CAPOX, followed by up to 17 doses of camrelizumab, or six cycles of CAPOX. The primary endpoint was pathological complete response (pCR) rate (ypT0N0) assessed by a blinded independent review committee. Key secondary endpoints tested hierarchically were 3-year event-free survival (EFS) rate and overall survival (OS). RESULTS: Between July 2021 and March 2023, the intention-to-treat population comprised 113 patients in the experimental arm and 118 patients in the control arm, with surgery carried out in 92% and 83.9%, respectively. At data cut-off (11 July 2023), the pCR rates were 39.8% [95% confidence interval (CI) 30.7% to 49.5%] in the experimental arm compared to 15.3% (95% CI 9.3% to 23.0%) in the control arm (difference, 24.6%; odds ratio, 3.7; 95% CI 2.0-6.9; P < 0.001). In each arm, surgical complication rates were 40.0% and 40.8%, and grade ≥3 treatment-related adverse events were 29.2% and 27.2%. Three-year EFS rate and OS continue to mature. CONCLUSIONS: In LARC patients, neoadjuvant SCRT followed by camrelizumab plus CAPOX demonstrated a significantly higher pCR rate than LCRT followed by CAPOX, with a well-tolerated safety profile. SCRT followed by camrelizumab and chemotherapy can be recommended as a neoadjuvant treatment modality for these patients.

[Development and validation of a persistent postural-perceptual dizziness screening questionnaire].

Objective: To develop a simple screening questionnaire for persistent postural-perceptual dizziness (PPPD) and evaluate its screening ability. Methods: A convenience sample of 296 individuals who met the inclusion criteria between November 2021 and January 2023 were prospectively selected for three rounds of screening at the Vertigo Specialty Clinic of the Department of Otorhinolaryngology-Head and Neck Surgery in the First Hospital of Shanxi Medical University. In conjunction with expert opinion and statistical analysis, the first and second rounds of screening were used to modify and finalize the questionnaire entries, and the third round of screening was used to evaluate the questionnaire's screening ability. Independent sample t-test was used for inter group comparison, reliability and validity indicators were employed to screen and evaluate questionnaire entries, and the receiver operating characteristic (ROC) curve was plotted to determine the optimal cut-off value and corresponding sensitivity and specificity. Results: The final PPPD screening questionnaire entries included 21 items. In evaluating the reliability of this questionnaire, the Cronbach's alpha coefficient was 0.831, the half folding coefficient was 0.742, the content validity was 0.86, and the Kaiser-Meyer-Olkin (KMO) value in the structural validity was 0.811. Additionally, there were six factors with characteristic root>1 and a cumulative contribution rate of 62.62%. The area under the ROC curve of the screening questionnaire was 0.935 (95%CI: 0.877-0.992), and the optimal cut-off value was 8.5, with a sensitivity of 85.0%, a specificity of 85.5%, and a Kappa value of 0.653. Conclusion: The PPPD simple screening questionnaire designed in this study has a high sensitivity and specificity, making it a useful tool for identifying PPPD patients.

[The application of setting tube voltage and iodine delivery rate in weight-grouped for reducing the radiation and contrast medium dose in coronary CT angiography].

Objective: To evaluate the application value of reducing tube voltage and iodine delivery rate according to body weight in coronary CT angiography (CCTA). Methods: A prospective randomized controlled study. A total of 297 subjects, 172 males and 125 females, aged [M (Q1, Q3)]60.0 (50.0, 68.0) years, who underwent CCTA examination in Peking University Third Hospital due to clinically suspected coronary heart disease from May to December 2022 were included. According to the odd or even visit dates, the subjects were randomly divided into test group (n=156) and control group (n=141). The subjects in both groups were divided into four sub-groups according to body weight: 50-59 group, 60-69 kg group, 70-79 kg group and 80-89 kg group, respectively. The CCTA images were reconstructed with hybrid iterative algorithm(KARL 3D) with levels of 6 and 8, respectively. 100 kVp and iodine flow rate 1.1, 1.3, 1.4 and 1.5 gI/s recommended by the domestic CCTA application guidelines were used in the control group, while the tube voltage and iodine flow rate were reduced in the test group based on the guidelines and body weight:70 kVp and 0.8 g I/s in 50~59 kg group, 80 kVp and 1.0 gI/s in 60~69 kg group, 80 kVp and 1.1 gI/s in70~79 kg group, and 100 kVp and 1.5 gI/s in 80~89 kg group, respectively. The CT values and standard deviation (SD) of aortic root, proximal left anterior descending branch (LAD) and distal right coronary artery (RCA) luminal CCTA, the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of coronary artery CT images, subjective coronary scores and effective radiation dose (ED) were compared between the both groups. One-way ANOVA or Wilcoxon test was used to analyze the differences of above indicators between the groups to evaluate the application value of low voltage and low iodine flow rate based on weight in coronary CCTA. Results: CT values of aortic root, LAD proximal CT values and SD values of aortic root [411.4 (377.2, 439.8) HU, (366.3±42.9) HU, 26.5±2.3] in the test group were all higher than those in the control group [379.00 (335.2, 415.9) HU, (355.0±46.9) HU and 24.8±2.3]. The differences were statistically significant (all P<0.05), and the other parameters were not statistically significant (all P>0.05). The total subjective image quality score in test group were superior to those in the control group (all P<0.05). The total ED and contrast agent dosage [2.07 (1.52, 3.28) mSv and (38.28±9.68) ml] in CCTA examination in the test group were lower than those in the control group [3.30(2.32, 4.44) mSv and (45.31±5.63) ml], and the differences were statistically significant (all P<0.05). The dosage of ED and contrast agent in the test group was decreased by 37.3% and 15.5%, respectively. Conclusion: Combined with KARL 3D,it is feasible to reduce contrast medium and ED by setting the tube voltage and iodine flow rate of CCTA according to the weight of the subject, which can further reduce the radiation dose and contrast agent dosage of CCTA.