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Background: This study aimed to investigate the prognostic value of the Gustave Roussy Immune score (GRIm-score) in platinum-refractory metastatic urothelial carcinoma (UC) treated with pembrolizumab. Methods: This multicenter retrospective study (YUSHIMA study) evaluated 331 patients with metastatic UC treated with pembrolizumab after platinum-based chemotherapy between January 2018 and June 2023 at 13 institutions. We collected pretreatment variables, including the GRIm-score based on serum albumin, lactate dehydrogenase, and neutrophil-to-lymphocyte ratio. The patients were divided into low and high GRIm-score groups. Prognostic factors for overall survival (OS) and progression-free survival (PFS) were determined using the multivariate Cox proportional hazard model. Results: During the median follow-up period of 7.3 months, 278 (84%) patients showed disease progression, and 223 (67%) died from any cause. Multivariate analysis revealed that the high GRIm-score group was an independent and significant adverse prognostic factor of both OS and PFS (hazard ratio, 1.65 and 1.82, respectively; both p < 0.001) along with Eastern Cooperative Oncology Group Performance Status of ≥ 2 (both p < 0.001), presence of visceral metastasis (both p < 0.001), and hemoglobin of < 9.2 g/dL (p = 0.030 and p = 0.038). C-reactive protein of > 42 mg/L was a significant prognostic factor for OS (p = 0.001). Conclusion: The GRIm-score is an independent prognostic marker for survival outcomes in patients with platinum-refractory metastatic UC treated with pembrolizumab. [ABSTRACT FROM AUTHOR]

In this study, to assess the utility of whole-body DWI (WB-DWI) as an imaging biomarker for metastatic hormone-naïve prostate cancer (mHNPC), we evaluated tumor diffusion volume based on apparent diffusion coefficient (ADC) values. WB-DWI results obtained from 62 mHNPC patients were evaluated in this retrospective analysis. The association with castration resistant–free survival (CFS) was evaluated for both prostate and metastatic tumor diffusion volume (pDV and mDV, respectively) based on WB-DWI. The usefulness of pDV and mDV based on ADC values to predict CFS was also examined. During the follow-up period, 22 patients progressed to castration-resistant prostate cancer, and the median CFS was 42.6 months. The median mDV and pDV were 6.7 and 12.6 mL, respectively. mDV was a significant predictor of CFS (hazard ratio [HR]: 2.75; p = 0.022), while pDV was not significant. When DV was divided into groups by ADC values (× 10− 3 mm2/s) of 0.4–1.0 and 1.0–1.8 (× 10− 3 mm2/s), mDV with ADC values (× 10− 3 mm2/s) of 0.4–1.0 (mDV0.4−1.0) showed a more favorable association with CFS compared to total mDV. On multivariate analysis, mDV0.4−1.0 and Gleason grade group had a statistically significant association with CFS (HR: 4.0; p = 0.004, and HR: 3.4; p = 0.006, respectively), while pDV with ADC values (× 10− 3 mm2/s) of 0.4–1.0 did not have a significant association. mDV is useful for predicting CFS in mHNPC patients. mDV may be a better imaging biomarker when based on ADC values. [ABSTRACT FROM AUTHOR]

Background: In this study, we investigated the association between the early response of serum and hematological variables and the outcome of cabazitaxel therapy. Patients and methods: The medical records of 59 consecutive patients who had previously received docetaxel chemotherapy for the treatment of metastatic castration-resistant prostate cancer (CRPC) and who received cabazitaxel at our hospital between January 2011 and March 2020 were retrospectively reviewed and statistically analyzed. Results: The median follow-up period after cabazitaxel initiation was 15.2 months. The 30% prostate-specific antigen (PSA) response rate, median PSA progression-free survival period, and overall survival (OS) period were 45.8%, 4.3 months, and 22.6 months, respectively. Within 1 to 2 cycles of cabazitaxel, we were unable to identify hematological or serum kinetics that had a relationship with OS. Analysis of the variables after 3 cycles of cabazitaxel, however, revealed two factors, PSA decline > 30% (p = 0.016) and neutrophil–lymphocyte ratio (NLR) decline > 30% (p = 0.044), as the predictors of favorable outcome for OS. We established a prognostic model for predicting the OS period composed of these two factors, which exhibited distinctly separated OS curves (p = 0.004). The C-index of a model incorporating these two factors was 0.703. Conclusions: This is the first study to demonstrate that PSA and NLR decline 3 cycles after the initiation of cabazitaxel were associated with favorable outcome in patients with CRPC. Also, 3 cycles of cabazitaxel might be necessary to assess the efficacy of cabazitaxel therapy. [ABSTRACT FROM AUTHOR]

Background: We aimed to establish an external validation of the Briganti 2019 nomogram in a Japanese cohort to preoperatively evaluate the probability of lymph node invasion in patients with high-risk, clinically localized prostate cancer. Methods: The cohort consisted of 278 patients with prostate cancer diagnosed using magnetic resonance imaging-targeted biopsy who underwent radical prostatectomy and extended pelvic lymph node dissection from 2012 to 2020. Patients were rated using the Briganti 2019 nomogram, which evaluates the probability of lymph node invasion. We used the area under curve of the receiver operating characteristic analysis to quantify the accuracy of the nomogram. Results: Nineteen (6.8%) patients had lymph node invasion. The median number of lymph nodes removed was 18. The area under the curve for the Briganti 2019 was 0.71. When the cutoff was set at 7%, 84 (30.2%) patients with extended pelvic lymph node dissection could be omitted, and only 1 (1.2%) patient with lymph node invasion would be missed. Sensitivity, specificity, and negative predictive values at the 7% cutoff were 94.7, 32.0, and 98.8%, respectively. Conclusion: This external validation showed that the Briganti 2019 nomogram was accurate, although there may still be scope for individual adjustments. [ABSTRACT FROM AUTHOR]

Background: Enzalutamide is a novel, non-steroidal anti-androgen that has demonstrated excellent anti-tumor activity for both non-metastatic and metastatic castration-resistant prostate cancer (nmCRPC and mCRPC) patients, and that is being rapidly introduced into clinical practice in Japan. Objective: We retrospectively investigated the treatment efficacy, safety profile, and prognostic factors of enzalutamide over a relatively long observation period in Japanese patients with nmCRPC and mCRPC. Patients and methods: The medical records of 184 consecutive Japanese patients with nmCRPC and mCRPC who started enzalutamide treatment in our institution between January 2012 and April 2018 were reviewed. Efficacy and safety profiles were assessed and statistically analyzed. Results: Among these 184 patients, 44 (23.9%) nmCRPC patients, 89 (48.4%) docetaxel-naïve mCRPC patients, and 51 docetaxel-pretreated (27.7%) mCRPC patients underwent enzalutamide therapy. The median prostate-specific antigen progression-free survival (PSA-PFS) and overall survival (OS) periods for nmCRPC patients were 39.2 months and not reached; those for docetaxel-naïve mCRPC patients were 16.5 months and 59.8 months; and those for docetaxel-pretreated mCRPC patients were 7.0 months and 30.4 months, respectively. Multivariate analysis identified performance status ≥ 2, PSA > 8.89 ng/mL (median value), hemoglobin < lower limit of normal range, neutrophil to lymphocyte ratio > 3.0, and 4-week PSA decline < 50% as the predictive factors for shorter OS. Our respective prognostic models using these factors successfully demonstrated distinctly separated survival curves (p < 0.001). In addition, among these patients, 30 (16.3%) experienced adverse events and 16 (8.7%) experienced adverse events resulting in the discontinuation of therapy. Fatigue (14%) and appetite loss (7%) were the most common such events. Conclusions: Both the survival period and risk factors were extracted from a relatively long-term observation period. Since enzalutamide was approved for administration to patients with castration-sensitive prostate cancer earlier this year (2020), we believe that the data presented here will be useful for both physicians and patients in clinical practice. [ABSTRACT FROM AUTHOR]