ABSTRACT
OBJECTIVE: To report urinary bother, urinalysis changes, disease-free survival (DFS), and overall survival (OS) over 2 years for subjects enrolled in a phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab for recurrent or persistent high-grade non-muscle invasive bladder cancer (HGNMIBC). METHODS: Eighteen patients consented to the study. Five were screen failures. Clinical activity was determined using cystoscopy and cytology with a biopsy of suspicious lesions. Urinalysis and International Prostate symptom score were assessed at pre-treatment, Week 10 (during combined BCG and pembrolizumab treatment), and 3 and 6 months from treatment completion. IPSS was analyzed using a mixed-model repeated measures analysis. A Chi-square test was used to compare urinalysis results at each interval. RESULTS: The pathologic disease stage after restaging transurethral resection and before treatment was pTa in 6 (46.2%), CIS in 6 (46.2%), and pT1 in 1 (7.7%). There was no increase in reported urinary bother throughout treatment. Quality of life measurements demonstrated no change in subjective burden. On urinalysis, we did not observe significant differences at 3 months compared to baseline evaluation. At 12 months, the DFS and OS were 69.23% and 92.31%, respectively. At 24 months, the DFS and OS were 38.46% and 92.31%, respectively. CONCLUSIONS: Treatment with BCG combined with intravenous pembrolizumab is not showing increased urinary bother or adverse urinalysis changes. Two-year response data is promising and await confirmation in the phase III study (Keynote 676).
Subject(s)
Antibodies, Monoclonal, Humanized , BCG Vaccine , Neoplasm Recurrence, Local , Urinary Bladder Neoplasms , Humans , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/pathology , BCG Vaccine/administration & dosage , BCG Vaccine/therapeutic use , Male , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/adverse effects , Administration, Intravesical , Middle Aged , Female , Neoplasm Recurrence, Local/drug therapy , Follow-Up Studies , Treatment Outcome , Urinalysis , Aged, 80 and over , Disease-Free Survival , Non-Muscle Invasive Bladder NeoplasmsABSTRACT
INTRODUCTION AND HYPOTHESIS: The annual cost of prolapse surgeries is expected to grow at twice the rate of population growth. Understanding the economic impact of apical prolapse procedures, including sacrospinous fixation (SSF), abdominal sacrocolpopexy (ASC), and laparoscopic sacrocolpopexy (LSC), is crucial. We aimed to compare overall cost of SSF versus ASC and LSC, as well as health resource utilization, up to 90-day follow-up. METHODS: Truven Marketscan Commercial Claims and Encounter databases 2008-2012 were used to calculate index and 90-day follow-up costs for SSF, ASC, and LSC with/without hysterectomy. Rates of inpatient readmissions, outpatient visits, and emergency room (ER) visits were also calculated during the follow-up period. Statistical analyses were performed using SAS 9.3. RESULTS: There were 17,549 SSF, 6126 ASC, and 10,708 LSC procedures. Mean index cost was lower for SSF (US$10,993) than ASC ($12,763, p < 0.0001) and LSC ($13,647, p < 0.0001). Concurrent hysterectomy impacted costs. Follow-up costs were likewise lower for SSF ($13,916) than ASC ($15,716, p < 0.0001) and LSC ($16,838, p < 0.0001). Lower rates of readmission were reported in SSF (4.22%) than ASC (5.40%, p = 0.0001) and LSC (4.64%, p = 0.0411). The rate of at least one ER visit was also lower for SSF (10.9%) than for ASC (12.0%, p = 0.0170) and comparable with LSC (10.6%, p = 0.0302). CONCLUSIONS: Overall mean costs are significantly lower for SSF than ASC/LSC, as are those for health resource utilization. Besides lower morbidity rates being associated with vaginal procedures, our results demonstrate another reason to consider the increased use of SSF over sacrocolpopexies in apical prolapse surgery.
