Difference of oncological efficacy between two immune checkpoint inhibitors following first-line platinum-based chemotherapy in patients with unresectable, metastatic, advanced urothelial carcinoma: a multicenter real-world Japanese cohort.

BACKGROUND: Maintenance avelumab is currently recommended for patients with unresectable and/or metastatic (mUC) achieving at least stable disease (SD) on first-line platinum-based chemotherapy (1L-CT). Pembrolizumab is an alternative therapeutic avenue for this patient cohort in clinical practice. We investigated real-world data, focusing on the correlation between response to 1L-CT and oncological efficacy of subsequent immune checkpoint inhibitor (ICI) therapy with avelumab or pembrolizumab. METHODS: A multicenter database registered 626 patients with mUC diagnosed from 2008-2023; among these, 175 receiving 2-6 cycles of 1L-CT followed by ICI therapy. Patients were categorized based on response to 1L-CT using the Response Evaluation Criteria in Solid Tumors (v1.1). Objective response rate on ICI, progression to ICI-free survival (ICI-PFS), and overall survival from start of 1L-CT were compared between avelumab-treated and pembrolizumab-treated patients in each response subgroup. RESULTS: ICI-PFS was significantly longer in patients achieving partial response on 1L-CT and subsequently receiving pembrolizumab compared to those receiving avelumab. Notably, patients achieving SD on 1L-CT and subsequently receiving pembrolizumab manifested significantly higher objective response rate (14% and 41%, respectively) and prolonged ICI-PFS relative to those receiving avelumab. In contrast, overall survival did not delineate difference between patients treated with avelumab versus pembrolizumab. Similar findings were discerned in the subanalysis of patients having favorable SD (tumor shrinkage, from - 29 to 0%) and unfavorable SD (tumor enlargement, from + 1 to + 19%) on 1L-CT. CONCLUSIONS: Our study provides real-world evidence regarding difference of oncological efficacy between maintenance avelumab and subsequent pembrolizumab in patients with mUC who achieved partial response or SD on 1L-CT.

First-line pembrolizumab for patients with early relapsing urothelial carcinoma after perioperative chemotherapy: a retrospective analysis of bladder cancer and upper urinary tract cancer.

BACKGROUND: First-line pembrolizumab is available for recurrent disease within 12 months after the receipt of platinum-based perioperative chemotherapy. However, the benefit of first-line pembrolizumab is unclear. This study evaluated the oncological outcome of patients treated with pembrolizumab compared with chemotherapy as first-line therapy for early relapsing disease after the receipt of platinum-based perioperative chemotherapy. METHODS: Data from a multicenter study included 454 patients diagnosed with unresectable or metastatic UC from November 2006 to July 2021. We identified patients with early and non-early relapsing disease. Oncological outcomes were evaluated using progression-free survival, overall survival, and survival with disease control. RESULTS: Fifty-three patients with early relapsing disease and 15 patients with non-early relapsing disease were identified. Of 53 patients with early relapsing disease, 26 (49.1%) were treated with pembrolizumab and 27 (50.9%) were treated with chemotherapy as first-line therapy. Fifteen patients with non-early relapsing disease were treated with chemotherapy. Early relapsing disease was associated with shorter progression-free survival and overall survival than non-early relapsing disease. Pembrolizumab was associated with longer progression-free survival and survival with disease control than chemotherapy in patients with early relapsing disease. There was no significant difference in overall survival between pembrolizumab and chemotherapy, but overall survival plateau with a long tail was observed in pembrolizumab. CONCLUSIONS: First-line pembrolizumab in earlier clinical settings for highly malignant tumors might improve the prognosis of patients with early relapsing disease after the receipt of platinum-based perioperative chemotherapy.

Effect of Prolonged Duration of Transrectal Ultrasound-Guided Biopsy of the Prostate and Pre-Procedure Anxiety on Pain in Patients without Anesthesia.

OBJECTIVE: To evaluate factors correlated with pain during prostate biopsy and willingness to undergo transrectal ultrasound-guided prostate biopsy (TR-PBx) again without anesthesia in patients undergoing TR-PBx without anesthesia. METHODS: This retrospective, single-center study evaluated 624 patients who underwent TR-PBx without anesthesia. Based on a nomogram using patient age and prostate volume, 6-12 core biopsy samples were allocated. Anxiety was evaluated using the Faces Anxiety Scale before the TR-PBx. Pain was evaluated using the Faces Pain Scale at each puncture and immediately after confirmation of cessation of bleeding from the rectum after the transrectal probe was pulled out. The question "If this operation must be repeated, would you agree to undergo it again under same conditions?" was asked after the procedure was completed. The change in pain at each puncture and factors correlated with post-procedural pain were calculated using multiple regression analysis, and factors predicting an answer of "yes" to the question using binary logistic analysis were evaluated. RESULTS: Scores on the Faces Pain Scale significantly increased from the first core sample to last as the number of samples increased. However, the number of samples did not show significant correlation with pain evaluated after the procedure was complete. Time during the biopsy and the anxiety score had a significant correlation with the pain scale score for the completed procedure. Short duration of TR-biopsy and a low anxiety score predicted a reply of "Yes" to the question. CONCLUSION: A long operative time during the TR-PBx procedure and strong pre-procedure anxiety can increase pain for patients undergoing the procedure without anesthesia and cause patients to be unwilling to undergo TR-PBx again without anesthesia.