ABSTRACT
PURPOSE: Neoadjuvant gemcitabine and cisplatin (GC) followed by radical cystectomy (RC) is standard for patients with muscle-invasive bladder cancer (MIBC). On the basis of the activity of atezolizumab (A) in metastatic BC, we tested neoadjuvant GC plus A for MIBC. METHODS: Eligible patients with MIBC (cT2-T4aN0M0) received a dose of A, followed 2 weeks later by GC plus A every 21 days for four cycles followed 3 weeks later by a dose of A before RC. The primary end point was non-muscle-invasive downstaging to < pT2N0. RESULTS: Of 44 enrolled patients, 39 were evaluable. The primary end point was met, with 27 of 39 patients (69%) < pT2N0, including 16 (41%) pT0N0. No patient with < pT2N0 relapsed and four (11%) with ≥ pT2N0 relapsed with a median follow-up of 16.5 months (range: 7.0-33.7 months). One patient refused RC and two developed metastatic disease before RC; all were considered nonresponders. The most common grade 3-4 adverse event (AE) was neutropenia (n = 16; 36%). Grade 3 immune-related AEs occurred in five (11%) patients with two (5%) requiring systemic steroids. The median time from last dose of chemotherapy to surgery was 7.8 weeks (range: 5.1-17 weeks), and no patient failed to undergo RC because of AEs. Four of 39 (10%) patients had programmed death-ligand 1 (PD-L1)-positive tumors and were all < pT2N0. Of the patients with PD-L1 low or negative tumors, 23 of 34 (68%) achieved < pT2N0 and 11 of 34 (32%) were ≥ pT2N0 (P = .3 for association between PD-L1 and < pT2N0). CONCLUSION: Neoadjuvant GC plus A is a promising regimen for MIBC and warrants further study. Patients with < pT2N0 experienced improved relapse-free survival. The PD-L1 positivity rate was low compared with published data, which limits conclusions regarding PD-L1 as a predictive biomarker.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Neoadjuvant Therapy , Urinary Bladder Neoplasms , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , B7-H1 Antigen/therapeutic use , Cisplatin/therapeutic use , Cystectomy , Deoxycytidine/analogs & derivatives , Deoxycytidine/therapeutic use , Female , Humans , Male , Muscles , Neoadjuvant Therapy/adverse effects , Neoplasm Invasiveness , Neoplasm Recurrence, Local/drug therapy , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgery , GemcitabineABSTRACT
INTRODUCTION: Return for unplanned postoperative care is an important quality metric in the United States. Most of our postoperative return visits occur after ureteroscopy. Routine preoperative ureteral stenting is not recommended by the American Urological Association due to its impact on the quality of life, despite its proposed operative advantages. We evaluated the association between preoperative ureteral stenting and the resulting perioperative outcomes in the context of quality measures such as return to the emergency department (ED) and readmission rates. MATERIALS AND METHODS: After the Institutional Review Board approval, a retrospective review of patients undergoing ureteroscopy from February 2014 to present was conducted. Patient's demographics and perioperative outcomes were compared based on the presence or absence of a ureteral stent before ureteroscopy. Details and rates of nurse calls, returns to the ED, and readmissions within 90 days were also compared. RESULTS: A total of 421 instances of ureteroscopy, 278 prestented ureteroscopy (psURS), and 143 direct ureteroscopy (dURS) were included for analysis. Preoperative demographics were similar. The psURS cohort was more likely to undergo flexible ureteroscopy, utilized an access sheath more often (P < 0.0001), and had less ureteral dilation (P < 0.0001). Prestenting did not influence operative time (P = 0.8534) or stone-free rates (P = 0.2241). dURS patients were more likely to call the nurse; however, psURS versus dURS yielded no difference in return to the ED or readmission within 90 days. CONCLUSIONS: In this study, preoperative stenting offered few operative advantages and did not meaningfully influence returns to the ED and readmissions within 90 days after ureteroscopy.
ABSTRACT
For chronic malignant and benign ureteral obstruction, the metal construction of the Resonance ureteral stent has been developed to maintain ureteral patency for up to 12 months, obviating the need for the frequent exchange required for conventional plastic ureteral stents. We report our experience placing tandem Resonance stents (TRS) in a single ureter of patients who failed management with a single Resonance stent. A retrospective review of patients who had TRS for management of ureteral obstruction between February 2014 and May 2017 was performed. Seven renal units from four patients with a median age of 62 years were managed with TRS. All but one renal unit was successfully managed with TRS initially. Hydronephrosis resolved in 80% of renal units at a median of 33 days, and creatinine reached its nadir a median of 38 days after placement, with a median improvement of 0.68 ng/mL. However, the median length of management with TRS was only 123.5 days with one exchange, and there was an overall success rate of 28.5% at 1 year. TRS placement is a feasible option for short-term management in a challenging population that would like to avoid nephrostomy and has failed other modalities.