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Objective: There is currently no widely accepted multidimensional health assessment questionnaire for individuals in the Chinese People Liberation Army (PLA). This study developed a multidimensional health survey questionnaire (Comprehensive Health Self-Assessment Questionnaire, CHSAQ) suitable for personnel in the PLA and conducted a preliminary examination of its reliability, validity, and discriminative ability. Methods: After 183 items from 32 dimensions were selected to form the initial version of the CHSAQ, three groups of soldiers were selected from May 2022 to April 2023 and completed three survey rounds (with 183, 131, and 55 valid items). The items were screened based on classic test theory. After screening, the final questionnaire entries were formed, the structure of the questionnaire was explored through exploratory factor analysis and confirmatory factor analysis, and its reliability, structural validity, and discriminative ability were evaluated. Results: The final questionnaire consisted of 8 dimensions and 55 items on job satisfaction, anxiety and depression, daily activities, physical function, the otolaryngology system, the integumentary system, sleep disorders, and the visual system. The total cumulative variance contribution rate was 64.648% according to exploratory factor analysis. According to the confirmatory factor analysis, the normed fit index (NFI) was 0.880, and the comparison fit index (CFI) was 0.893 (close to 0.90). The Cronbach's α coefficient of the total questionnaire was 0.970, the split half reliability coefficient was 0.937, and the retest reliability coefficient was 0.902. The results are presented as different pairwise comparisons. Conclusion: Our study developed a self-report questionnaire for evaluating the comprehensive health status of personnel in the PLA in accordance with the standard procedure for questionnaire development. Our findings also showed that the CHSAQ for individuals in the PLA has good reliability and structural validity. [ABSTRACT FROM AUTHOR]

This single-arm, multi-center clinical trial aimed to evaluate the safety, tolerability, DLT, recommended dose (RD), preliminary efficacy, and pharmacokinetics (PK) characteristics of lurbinectedin, a selective inhibitor of oncogenic transcription, in Chinese patients with advanced solid tumors, including relapsed SCLC. Patients with advanced solid tumors were recruited in the dose-escalation stage and received lurbinectedin in a 3 + 3 design (two cohorts: 2.5 mg/m2 and 3.2 mg/m2, IV, q3wk). The RD was expanded in the following dose-expansion stage, including relapsed SCLC patients after first-line platinum-based chemotherapy. The primary endpoints included safety profile, tolerability, DLT, RD, and preliminary efficacy profile, while the secondary endpoints included PK characteristics. In the dose-escalation stage, ten patients were included, while one patient had DLT in the 3.2 mg/m2 cohort, which was also the RD for the dose-expansion stage. At cutoff (May 31, 2022), 22 SCLC patients were treated in the ongoing dose-expansion stage, and the median follow-up was 8.1 months (range 3.0–11.7). The most common grade ≥ 3 treatment-related adverse events (TRAEs) included neutropenia (77.3%), leukopenia (63.6%), thrombocytopenia (40.9%), anemia (18.2%), and ALT increased (18.2%). The most common severe adverse events (SAEs) included neutropenia (27.3%), leukopenia (22.7%), thrombocytopenia (18.2%), and vomiting (9.1%). No treatment-related deaths occurred. The Independent Review Committee (IRC)-assessed ORR was 45.5% (95% CI 26.9–65.3). Lurbinectedin at the RD (3.2 mg/m2) showed manageable safety and acceptable tolerability in Chinese patients with advanced solid tumors, and demonstrates promising efficacy in Chinese patients with SCLC as second-line therapy. Trial registration: This study was registered with ClinicalTrials.gov NCT04638491, 20/11/2020. [ABSTRACT FROM AUTHOR]

• TRACES study evaluated benefits of Trilaciclib in Chinese ES-SCLC patients. • Our study demonstrated myeloprotective benefits of trilaciclib prior chemotherapy. • Trilaciclib had a well-tolerated safety profile. Trilaciclib is a transient cyclin-dependent kinase 4/6 inhibitor that decreases the incidence of chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer (ES-SCLC). TRACES study was designed to assess the safety, efficacy and pharmacokinetics (PK) of trilaciclib before chemotherapy in Chinese patients with ES-SCLC. The study included an open-label safety run-in part (Part 1) and double-blinded, placebo-controlled part (Part 2) where patients received trilaciclib or placebo before chemotherapy. Treatment-naïve or previously treated ES-SCLC patients received intravenous trilaciclib (240 mg/m2) or placebo before etoposide/carboplatin or topotecan, respectively. Primary endpoints were PK, safety and duration of severe neutropenia (DSN) in Cycle 1 in Part 1 and Part 2. Exploratory endpoints included the effect of trilaciclib on other myeloprotection endpoints, safety and antitumor efficacy. Overall, 95 Chinese patients were enrolled, of which 12 and 83 patients were in Part 1 and Part 2, respectively. In Part 1, trilaciclib was well tolerated. Non-compartmental analysis results revealed no substantial differences in the main exposure parameters. In Part 2, 41 patients received trilaciclib, and 42 received placebo. Patients in trilaciclib arm vs placebo arm had a clinically and statistically significant decrease in DSN (mean [SD]) in Cycle 1 (0 [1.7] vs 2 [3.0] days; P = 0.0003), with improvements in additional neutrophil, red blood cell, and platelet measures. After a median follow-up of 14.1 months, the median overall survival was 12.0 months in trilaciclib arm and 8.8 months in placebo arm (HR, 0.69; 95 % CI: 0.40–1.22). Median progression-free survival was 4.8 months and 4.3 months, respectively (HR, 0.86; 95 % CI: 0.53–1.39). Trilaciclib had a well-tolerated safety profile. Trilaciclib in the Chinese population demonstrated a similar PK and safety profile as seen in other global trials. There was significant reduction of DSN in Cycle 1, thereby substantiating the myeloprotective effects of trilaciclib in Chinese ES-SCLC patients. [ABSTRACT FROM AUTHOR]