Current Medical Research and Opinion最新文献

Objective: In the phase 3 RATIONALE-312 trial (ClinicalTrials.gov Identifier: NCT04005716), the addition of tislelizumab to chemotherapy as first-line treatment significantly improved overall survival and progression-free survival compared to placebo plus chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC), with an acceptable safety profile. This analysis reports the patient-reported outcomes (PROs) from RATIONALE-312.

Methods: Overall, 457 adults with ES-SCLC were randomized (1:1) to tislelizumab plus chemotherapy (n = 227) or placebo plus chemotherapy (n = 230). PROs were protocol-prespecified secondary end points that assessed health-related quality of life (HRQoL) using the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. PRO end points at Cycles 4 and 6 were analyzed using a mixed model for repeated measures. Time to deterioration (TTD) was evaluated.

Results: At Cycle 4, the tislelizumab arm demonstrated clinically meaningful improvement in coughing, hemoptysis, and chest pain. Clinically meaningful improvement was observed in the tislelizumab arm, but not in the placebo arm, for global health status (GHS)/QoL, dyspnea, and arm or shoulder pain. By Cycle 6, the tislelizumab arm achieved clinically meaningful improvement in GHS/QoL, with a statistically significant between-group difference favoring the tislelizumab arm. Clinically meaningful improvements in dyspnea, coughing, hemoptysis, and chest pain were maintained in the tislelizumab arm through Cycle 6. No between-group differences were observed in the TTD analysis.

Conclusions: Tislelizumab plus chemotherapy maintained or improved HRQoL and patient-reported symptoms compared to placebo plus chemotherapy. Along with prior efficacy and safety data, these data support tislelizumab plus chemotherapy as first-line treatment in patients with advanced ES-SCLC.

Background: Natural killer/T-cell lymphoma (NKTCL) is a highly invasive non-Hodgkin lymphoma (NHL) characterized by extranodal onset, commonly observed in the nose and nasopharynx. NHL in the female reproductive system is rare, mostly secondary, occurring in the ovaries, cervix, uterine body, and endometrium. The prognosis of this disease is extremely poor, with most patients dying within a few months of diagnosis. Owing to its rarity, the prognostic factors are difficult to ascertain. Here, we report a case of extranodal NK/T-cell lymphoma in the uterus related to pregnancy.

Case report: A 31-year-old woman sought treatment for continuous vaginal discharge after cesarean section, however, anti-inflammatory treatment had no effect. A lump was found on the anterior wall of the uterus on transvaginal ultrasonography, so uterine lesion resection was performed. Owing to pathological misdiagnosis as uterine fibroids, treatment was delayed for 10 months. After readmission with a clear diagnosis, radiotherapy, chemotherapy, and autologous stem cell transplantation were done, and the disease was put into completely remission.

Conclusion: Primary uterine NKTCL is rare, and special attention should be given to women infected with Epstein-Barr Virus (EBV) during their pregnancy and post-partum period, especially patients with abnormal uterine bleeding, vaginal discharge, fever, or high LDH.

Introduction: Topical hydrocortisones are commonly used for the self-treatment of allergic or mild inflammatory skin reactions. Post-market data analyzing usage, safety and effectiveness of hydrocortisone creams in a real-world setting are scarce.

Methods: This non-interventional, observational, pharmacy-based study analyzes the usage patterns and patient-perceived effectiveness and tolerability of Soventol Hydrocortisonacetat 0.5% (Soventol HCA) in a real-world setting. Adult participants with a moderately pronounced reddened, inflammatory or allergic skin disease for which a weak, low-concentration corticosteroid was indicated filled an online questionnaire parallel to product application for a maximum of 7 days. Severity of symptoms, frequency of application and the occurrence of adverse events were documented daily. The study was reported to the German Federal Institute for Drugs and Medical Devices (NIS-nr 7793).

Results: Data from 2,561 participants were received. Most participants used Soventol HCA for the treatment of insect bites (62.3%; N = 2,557). Almost all participants were "very satisfied" or "satisfied" with the effectiveness (97.7%; N = 2,106) and tolerability (99.1%; N = 2,106) of Soventol HCA. The vast majority of participants assessed the speed of itching relief (87.0%; N = 2,045), speed of cooling effect (90.5%; N = 2,073), pain relief (93.9%; N = 1,760), redness relief (90.2%; N = 2,033), and swelling relief (92.9%; N = 1,901) as "fast" to "very fast" or "good" to "very good." 61 non-serious adverse reactions were documented.

Conclusion: This non-interventional study provides valuable real-world insights about the patient-perceived effectiveness and tolerability of Soventol HCA in treating insect bites, but also other inflammatory or allergic skin reactions as e.g. sunburn, allergies or eczema in adults. Patient satisfaction with effectiveness and tolerability was high in all application fields, especially regarding itch reduction of insect bites.

Objective: To describe comorbidity and comedication burden among people living with HHIV(PLWH) compared with matched people without HIV and evaluate 5-year trends among PLWH from 2020-2024.

Methods: This retrospective study used administrative claims data (01/01/2016-01/31/2025) from Optum's de-identified Clinformatics Data Mart Database. The PLWH cohort included adults with ≥1 medical or pharmacy claim for an antiretroviral therapy (ART) agent in 2024 or, for those not treated with ART, an HIV diagnosis code alone (index date: earliest ART or HIV claim). People without HIV were matched 2:1 to PLWH based on age group, sex, race/ethnicity, region, and insurance type. Baseline characteristics, comorbidity burden, and comedication burden were compared between matched cohorts.

Results: 26,078 PLWH and 52,156 matched people without HIV were included (mean age: 59 years). Compared with people without HIV, PLWH had greater baseline Quan-Charlson comorbidity index scores (mean [SD]: 1.24 [1.86] vs. 0.99 [1.85]; p < 0.001) and greater numbers of comorbid conditions (3.70 [3.63] vs. 3.14 [3.79]; p < 0.001) and non-ART comedications (9.2 [7.58] vs 7.1 [7.48]; p < 0.001). Multimorbidity (≥2 comorbidities: 66.4% vs. 53.6%) and polypharmacy (≥5 non-ART drugs: 68.5% vs. 52.7%) were significantly more prevalent in PLWH (both p < 0.001). The most prevalent comorbidities were hypertension (46.9% vs. 41.2%; p < 0.001), hyperlipidemia (46.0% vs. 34.4%; p < 0.001), and type 2 diabetes (21.8% vs. 22.1%, p = 0.393).

Conclusions: PLWH have greater comorbidity and comedication burdens than people without HIV. The findings suggest clinicians should consider these factors when choosing ART to minimize drug interactions and adverse events, thereby improving the long-term health of PLWH.

Background: This study presents patient-reported outcomes (PROs) from the phase 1/2 BRUIN (NCT03740529) trial of pirtobrutinib monotherapy for the treatment of B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).

Methods: PROs were collected at each cycle using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and item library (IL) sets for CLL/SLL- and MCL-related symptoms and an Expanded Fatigue measure. Prespecified analyses included descriptive change from baseline, time to worsening (TTW) using Kaplan-Meier method, and longitudinal analyses using a mixed model for repeated measures.

Results: A total of 263 patients with CLL/SLL and 124 with non-blastoid MCL who received pirtobrutinib monotherapy after prior BTKi were included in the final PRO analysis. The proportion of patients with CLL/SLL who improved or remained stable from baseline through Cycle 31 remained above 80% for physical function (PF), CLL/SLL-related symptoms, fatigue, and global health status/quality of life (GHS/QoL). The proportion of patients with MCL who improved or remained stable through Cycle 20 remained above 70% for PF, MCL-related symptoms, fatigue, and GHS/QoL. Median TTW was not reached in either CLL or MCL. Longitudinal analyses for PF, CLL/SLL-related symptoms, fatigue, and GHS/QoL consistently met statistically significant and clinically-meaningful improvement from baseline for CLL. PRO assessments remained stable over time for MCL.

Conclusions: The final analysis from the BRUIN trial demonstrates stability in PROs throughout the duration of treatment with pirtobrutinib. Most patients with CLL/SLL and MCL reported stable or improved outcomes throughout the study.

Objective: This study explored the perspectives of people with HIV (PWH) in the United States regarding barriers and facilitators of engaging with HIV care, focusing on treatment initiation, satisfaction, adherence, and preferences.

Methods: An observational, cross-sectional, quantitative online survey was conducted from 2024 through 2025 among eligible PWH aged ≥18 years. The survey was carried out globally; we report results from PWH who reside in the United States. Survey questions assessed sociodemographic, sociobehavioral, and clinical characteristics; HIV diagnosis and linkage to care; and HIV treatments and treatment success. The survey included the validated HIV Treatment Satisfaction Questionnaire (HIVTSQ). Results were analyzed for subgroups of interest. Data were summarized descriptively; formal statistical comparisons were conducted.

Results: A total of 402 PWH participated in the survey. Rapid antiretroviral therapy (ART) initiation was deemed "important"/"very important" by 93% of participants, yet 73% of PWH ever treated did not start treatment within 7 days of diagnosis and 29% started after >30 days. Common reasons for delayed treatment included fear of side-effects, physician recommendation, and needing time to accept the diagnosis. The median HIVTSQ score for overall treatment satisfaction was 51.0/60.0, with numerically higher satisfaction observed among those aged ≥50 years (57.0), not using drugs (54.0), and on bictegravir/emtricitabine/tenofovir alafenamide (57.0). The most important features to stay on treatment were long-term tolerability and efficacy.

Conclusion: Despite the recognized importance of rapid ART initiation, almost one-third of participants ever treated started treatment >30 days after diagnosis. These findings can support tailored strategies to enhance rapid ART initiation and treatment adherence and satisfaction, thereby improving health outcomes for PWH.