Cost-Utility Analysis of Darolutamide Combined with Androgen Deprivation Therapy for Patients with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer in China.

INTRODUCTION: The increasing incidence of prostate cancer (PC) in China leads to a significant disease burden. Although three novel androgen inhibitors (darolutamide, apalutamide, and enzalutamide) have been approved for patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC), the economic evaluation of these novel treatments in China remains unknown. In this study, we aimed to evaluate the cost-utility of darolutamide combined with androgen deprivation therapy (ADT), comparing with apalutamide + ADT and enzalutamide + ADT, in patients with high-risk nmCRPC from a healthcare system perspective in China. METHODS: A partitioned survival model was developed to capture time spent by patients in three health states: nmCRPC, metastatic CRPC (mCRPC), and death. Clinical outcomes from the ARAMIS, PROSPER, and SPARTAN studies were obtained. In the absence of head-to-head studies, indirect treatment comparisons were conducted to capture the comparative effectiveness between darolutamide + ADT, apalutamide + ADT, and enzalutamide + ADT. The prices of apalutamide and enzalutamide were assumed to be the same as the initial launch price of darolutamide, since post-negotiation prices after national reimbursement drug list (NRDL) inclusion remain confidential. Other health resources costs, baseline characteristics, treatment patterns, and utility were collected through literature or clinical expert interviews. Selected sensitivity analyses were also performed. RESULTS: For a 20-year time horizon, darolutamide + ADT was associated with lower cost per quality-adjusted life years (QALYs) than apalutamide + ADT and enzalutamide + ADT (202,897 Chinese yuan (CNY)/QALY vs. 228,998 CNY/QALY and 221,409 CNY/QALY, respectively) (exchange rate, 1 USD = 6.7871 CNY). Darolutamide + ADT had better health outcomes and lower total costs compared to both apalutamide + ADT (+ 0.22 QALYs and - 72,818 CNY) and enzalutamide + ADT (+ 0.09 QALYs and - 67,451 CNY). Across the modelled sensitivity analyses (including hazard ratios and drug costs), darolutamide + ADT remained dominant or cost-effective. CONCLUSIONS: This economic evaluation suggested that, in comparison with apalutamide + ADT and enzalutamide + ADT, darolutamide + ADT was a dominant or cost-effective treatment option for patients with high-risk nmCRPC in China.

Radiomics assessment of bladder cancer grade using texture features from diffusion-weighted imaging.

PURPOSE: To 1) describe textural features from diffusion-weighted images (DWI) and apparent diffusion coefficient (ADC) maps that can distinguish low-grade bladder cancer from high-grade, and 2) propose a radiomics-based strategy for cancer grading using texture features. MATERIALS AND METHODS: In all, 61 patients with bladder cancer (29 in high- and 32 in low-grade groups) were enrolled in this retrospective study. Histogram- and gray-level co-occurrence matrix (GLCM)-based radiomics features were extracted from cancerous volumes of interest (VOIs) on DWI and corresponding ADC maps of each patient acquired from 3.0T magnetic resonance imaging (MRI). A Mann-Whitney U-test was applied to select features with significant differences between low- and high-grade groups (P < 0.05). Then support vector machine with recursive feature elimination (SVM-RFE) and classification strategy was adopted to find an optimal feature subset and then to establish a classification model for grading. RESULTS: A total 102 features were derived from each VOI and among them, 47 candidate features were selected, which showed significant intergroup differences (P < 0.05). By the SVM-RFE method, an optimal feature subset including 22 features was further selected from candidate features. The SVM classifier using the optimal feature subset achieved the best performance in bladder cancer grading, with an area under the receiver operating characteristic curve, accuracy, sensitivity, and specificity of 0.861, 82.9%, 78.4%, and 87.1%, respectively. CONCLUSION: Textural features from DWI and ADC maps can reflect the difference between low- and high-grade bladder cancer, especially those GLCM features from ADC maps. The proposed radiomics strategy using these features, combined with the SVM classifier, may better facilitate image-based bladder cancer grading preoperatively. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2017;46:1281-1288.

[Methodological quality assessment of systematic reviews correlated to traditional Chinese medicine published in China].

OBJECTIVE: To assess the methodological quality of systematic reviews or Meta-analysis of traditional Chinese medicine published in China, and to validate the applicability of OQAQ (Overview Quality Assessment Questionnaire) and AMSTAR (a measurement tool to assess systematic reviews) in traditional Chinese medicine (Chinese Medical). METHODS: Comprehensive literature retrieve was performed in CBM, CNKI, VIP as well as hand searching in Chinese Journal of Evidence-Based Medicine. The retrieve was started from January 1, 1999 and terminated by December 2008. The methodological quality of traditional Chinese medicine correlated systematic reviews was evaluated using OQAQ and AMSTAR simultaneously. RESULTS: A total of 115 systematic reviews involved 17 types of diseases, of which, the cardio-/cerebrovascular diseases was dominant (36 papers, 31.30%). The mean OQAQ score was 2.50 (95% CI: 2.22, 2.76). No significant correlation was found in OQAQ score with publication year (P = 0.35) and different disease types (P = 0.28). High consistency was observed in evaluations of systematic reviews by using OQAQ and AMSTAR (both Kappa values > 0.75). Compared with the OQAQ, AMSTAR incorporated 3 additional items: the topics, publication bias, and conflict of interest, etc. Although 98.26% of systematic reviews proposed protocols in prior, 53.04% failed to analyze the publication bias. Besides, 57.39% neglected to address the potential conflict of interest. CONCLUSIONS: Poor methodological quality in systematic reviews of Chinese Medical published in China needs to be improved and emphasized. It is necessary to integrate the special characteristics of traditional Chinese medicine itself when choosing topics of systematic reviews. It is essential to establish quality assessment tools targeting systematic reviews of traditional Chinese medicine.