Impact of neoadjuvant pembrolizumab adherence on pathologic complete response in triple-negative breast cancer: a real-world analysis.

BACKGROUND: The addition of pembrolizumab (pembro) to neoadjuvant chemotherapy (NAC) is standard of care for the treatment of early triple-negative breast cancer (TNBC) after KEYNOTE-522 trial demonstrated improved pathologic complete response (pCR) rates with the combination. However, the optimal treatment strategy for TNBC remains uncertain as questions persist about which patients benefit from pembro and the best treatment schedule and regimen. We identified real-world clinical characteristics and treatment variables associated with response to NAC plus pembro. METHODS: Patients with early TNBC treated with NAC plus pembro between February 2020 and September 2023 were identified. Univariate and multivariate analysis was performed using logistic regression to identify factors associated with pCR. Cox proportional hazard prediction models were used to identify predictors of invasive disease-free survival and overall survival in this cohort. RESULTS: A pCR was achieved in 75 (63.6%) of 118 patients. Age at diagnosis (P = .04), Ki-67 (P = .004), duration from start of pembro to surgery (P = .006) and NAC to surgery (P = .01), number of cycles of pembro (P = .04) and NAC (P = .02), and completion of at least 8 cycles of pembro (P = .015) and NAC (P = .015) were each significantly associated with pCR in univariate analysis. In multivariate analysis, patients younger than 55 years at time of diagnosis (vs age > 55 years) and those completing at least 8 cycles of pembro remained predictive of pCR (OR's 2.50, 2.49, P = .035 and .037, respectively). CONCLUSIONS: In this real-world analysis of patients with TNBC treated with NAC plus pembro, younger age and the completion of at least 8 cycles of pembrolizumab were associated with pCR.

Impact of PIPAC-Oxaliplatin on Functional Recovery, Good Days, and Survival in a Refractory Colorectal and Appendiceal Carcinomatosis: Secondary Analysis of the US PIPAC Collaborative Phase 1 Trial.

BACKGROUND: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel, minimally invasive, safe, and repeatable method to treat carcinomatosis. Evidence regarding the clinical benefit (quality of life and survival) of PIPAC compared with that of conventional standard therapy (ST) is lacking. METHODS: This is the secondary analysis of the phase 1 US-PIPAC trial for refractory colorectal and appendiceal carcinomatosis. A PIPAC cohort was compared with a retrospective cohort of consecutive patients receiving ST. The primary outcome was number of good days (number of days alive and out of the hospital). The secondary outcomes were overall survival (OS), progression-free survival (PFS), health-related quality of life (HRQoL), and objective functional recovery (daily step count). RESULTS: The study included 32 patients (PIPAC, 12; ST, 20) with similar baseline characteristics. Compared with the ST cohort, the PIPAC cohort had lower median inpatient hospital stays (> 24 h) within 6 months (0 vs 1; p = 0.015) and 1 year (1 vs 2; p = 0.052) and higher median good days at 6 months (181 vs 131 days; p = 0.042) and 1 year (323 vs 131 days; p = 0.032). There was no worsening of HRQoL after repeated PIPACs. Step counts diminished immediately after PIPAC but returned to baseline within 2-4 weeks. Kaplan-Meier analysis demonstrated a favorable association between receipt of PIPAC and OS (median, 11.3 vs 5.1 months; p = 0.036). CONCLUSION: Compared with ST, PIPAC was associated with higher number of good days, reduced hospitalization burden, and longer OS without a negative impact on HRQoL with repeated PIPACs. These findings are foundational for evaluation of PIPAC in a randomized clinical trial.

Atezolizumab combined with immunogenic salvage chemoimmunotherapy in patients with transformed diffuse large B-cell lymphoma.

Patients with relapsed/refractory (R/R) transformed diffuse large B-cell lymphoma (DLBCL) from indolent B-cell lymphomas, including Richter transformation (RT), have a poor prognosis. PD-1/PD-L1 antibodies produce modest objective and complete response rates (ORR and CRR) in B-NHL as monotherapy but may synergize with immunogenic chemotherapies like gemcitabine and oxaliplatin (GemOx). Thus, we evaluated the safety and efficacy of atezolizumab plus rituximab and GemOx (R-GemOx+Atezo) in R/R transformed DLBCL, including RT. We conducted a phase I trial including patients with transformed DLBCL after ≥1 prior therapy. Patients received up to 4 cycles of R-GemOx-+Atezo. Patients in CR could then proceed to Ratezo maintenance until progression. A safety lead-in with dose-limiting toxicity (DLT) evaluation was enrolled to confirm the recommended phase 2 dose (RP2D), followed by 2 expansion cohorts: one for transformed follicular lymphoma (FL) and another for non-FL transformed DLBCL, including RT. Twenty-seven patients were enrolled. One of the 6 safety lead-in patients had a DLT attributed to atezolizumab, a grade 4 Stevens-Johnson syndrome (SJS). The most common grade ≥3 events were neutropenia (18.5%), lymphopenia (18.5%), and thrombocytopenia (14.8%). The overall and complete response rates (ORR and CRR) were 59% and 33%, respectively. The ORR and CRR in transformed FL were 79% and 43%, and 38% and 23% in transformed non-FL, respectively. The median PFS and OS of the total population were 4.2 and 7.7 months, respectively. R-GemOx+Atezo was well tolerated and demonstrated promising preliminary efficacy in patients with R/R transformed DLBCL.

A phase I study of Mirvetuximab Soravtansine and gemcitabine in patients with FRα-positive recurrent ovarian, primary peritoneal, fallopian tube, or endometrial cancer, or triple negative breast cancer.

OBJECTIVE: Platinum-resistant epithelial ovarian cancer (EOC), recurrent endometrial cancer (EC), and triple negative breast cancer (TNBC) are difficult to treat after failing standard therapies. This phase I study evaluated mirvetuximab soravtansine (MIRV) and gemcitabine in patients with recurrent FRα-positive EOC, EC, or TNBC to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) (primary endpoint). METHODS: FRα-positive patients with platinum-resistant EOC, EC, or TNBC with ≤4 prior chemotherapy regimens (2 for EC) were enrolled. FRα expression requirement varied among eligible tumors and changed during the study. RESULTS: Twenty patients were enrolled; 17 were evaluable for DLT. Half the patients received ≥3 prior chemotherapy lines. Most EOC and EC patients (78%) were medium (50-74%) or high(75-100%) FRα expressors. TNBC patients were low (25-49%) FRα expressors. The MTD/RP2D was MIRV 6 mg/kg AIBW D1 and gemcitabine 800 mg/m2 IV, D1 and D8, every 21 days (Dose Level [DL] 3), where 5/7 patients demonstrated a partial response (PR) as their best response, including 2 confirmed ovarian responses whose time-to-progression and duration of response were 7.9/5.4 and 8.0/5.7 months respectively. Most common treatment-related adverse events at MTD were anemia and neutropenia (3/7 each, 43%), diarrhea, hypophosphatemia, thrombocytopenia, and leukopenia (2/7 each, 29%). DLTs were thrombocytopenia (DL1), oral mucositis (DL4) and diarrhea (DL4). Nine of 20 patients (45%; 95% CI: 21.1-68.9%) achieved PR as their best response, with 3/20 patients or 15% (95%CI, 0-32.1%) confirmed PR. CONCLUSION: MIRV and gemcitabine demonstrate promising activity in platinum resistant EOC at RP2D, but frequent hematologic toxicities.

Impact of Sodium Thiosulfate on Prevention of Nephrotoxicities in HIPEC: An Ancillary Evaluation of Cisplatin-Induced Toxicities in Ovarian Cancer.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin confers a survival benefit in epithelial ovarian cancer (EOC) but is associated with renal toxicity. Sodium thiosulfate (ST) is used for nephroprotection for HIPEC with cisplatin, but standard HIPEC practices vary. METHODS: A prospective, nonrandomized, clinical trial evaluated safety outcomes of HIPEC with cisplatin 75 mg/m2 during cytoreductive surgery (CRS) in patients with EOC (n = 34) and endometrial cancer (n = 6). Twenty-one patients received no ST (nST), and 19 received ST. Adverse events (AEs) were reported according to CTCAE v.5.0. Serum creatinine (Cr) was collected preoperatively and postoperatively (Days 5-8). Progression-free survival (PFS) was followed. Normal peritoneum was biopsied before and after HIPEC for whole transcriptomic sequencing to identify RNAseq signatures correlating with AEs. RESULTS: Forty patients had HIPEC at the time of interval or secondary CRS. Renal toxicities in the nST group were 33% any grade AE and 9% grade 3 AEs. The ST group demonstrated no renal AEs. Median postoperative Cr in the nST group was 1.1 mg/dL and 0.5 mg/dL in the ST group (p = 0.0001). Median change in Cr from preoperative to postoperative levels were + 53% (nST) compared with - 9.6% (ST) (p = 0.003). PFS did not differ between the ST and nST groups in primary or recurrent EOC patients. Renal AEs were associated with downregulation of metabolic pathways and upregulation of immune pathways. CONCLUSIONS: ST significantly reduces acute renal toxicity associated with HIPEC with cisplatin in ovarian cancer patients. As nephrotoxicity is high in HIPEC with cisplatin, nephroprotective agents should be considered.

Multi-institutional review of non-hypospadiac penile urethral stricture management and outcomes.

OBJECTIVES: Penile urethral stricture disease not associated with hypospadias is rare, and there is a wide range of commonly used surgical repair techniques for this disease. We sought to compile a multi-institutional database of patients who had surgical correction of strictures in the penile urethra not limited to the meatus, and who had no history of hypospadias, for analysis using the Trauma and Urologic Reconstructive Network of Surgeons length, urethral segment and etiology classification system. METHODS: A retrospective database from 13 institutions was compiled of patients who had undergone surgical correction of Trauma and Urologic Reconstructive Network of Surgeons length, urethral segment and etiology urethral stricture segments S2b/S2c and excluding E5, with a minimum follow-up time of 4 months. Failure was defined as cystoscopically confirmed recurrence of a stricture measuring less than 16-Fr. RESULTS: We analyzed 222 patients with a median age of 57 years and a follow-up of 49 months. The overall surgical success rate was 80.2%. On multivariate analysis, the two variables identified that were predictive of surgical success were stricture length ≤2 cm as well as use of a buccal mucosa graft as compared to use of a fasciocutaneous flap, which had success rates of 83% and 52%, respectively (P = 0.0004). No statistically significant differences were found based on incisional approach or surgical technique, nor were outcomes different based on etiology or preoperative patient demographics. CONCLUSIONS: Surgical repair of penile urethral strictures of non-hypospadiac origin have a favorable overall success rate, at 80.2%. Regardless of incisional approach or surgical technique, all operations appear to have similar outcomes other than repairs using fasciocutaneous flap, which were statistically less successful than those using buccal mucosa graft.

Virtue male sling outcomes and application to a contemporary nomogram.

INTRODUCTION To report outcomes of our Virtue male sling series and evaluate predictors of surgical success and failure. We also retrofit the Male Stress Incontinence Grading Scale (MSIGS) refined nomogram, including the standing cough test (SCT), to assess its application to our cohort. MATERIALS AND METHODS: A retrospective review was completed at a single institution over a 4 year period of all Virtue male slings implanted for stress urinary incontinence (SUI). Patient demographics including pad usage per day (PPD) and MSIGS were obtained on all patients after their bladders were filled cystoscopically. Failure was defined as > 1 PPD and/or conversion to another anti-incontinence procedure. Incidence, management and outcomes of complications were also evaluated. RESULTS: Forty-six men who underwent Virtue male sling at a median follow up of 15.6 months were analyzed with an objective success rate of 78% and a subjective success rate of 85%. Preoperative predictors of surgical success were ability to stop stream on physical exam, lack of total incontinence and no history of posterior urethral stricture. MSIGS alone was not predictive of sling success or failure. Penile numbness occurred in 11% of patients and reoperation with incision of the sutured together transobturator arms improved sensation in all patients. CONCLUSION: Virtue male sling has high objective and subjective success rates with a manageable side effect profile. Evidence of residual sphincteric function appears to be more predictive of sling success rather than MSIGS.

Spirituality in cancer patients on phase 1 clinical trials.

OBJECTIVES: Patients with cancer who are at a transition to Phase I investigational treatments have been identified as an underserved population with regard to palliative care. This disease transition is often accompanied by spiritual and existential concerns. The study objective was to conduct a secondary analysis of data from a larger study testing a palliative care intervention. This paper reports the findings of this secondary focus on the spiritual needs of this population. METHODS: Patients (n = 479) were accrued to this study prior to initiating a Phase I clinical trial with data collected at baseline, and 4, 12, and 24 week follow-up. RESULTS: Qualitative data revealed that the transition to Phase 1 trial participation is a time of balancing hope for extended life with the reality of advancing disease. Quantitative results demonstrated increased spirituality over time in both religious- and non-religious-affiliated patients. CONCLUSIONS: Patients entering Phase I trials have important spiritual needs as they face treatment decisions, advancing disease, and often mortality. Spiritual care should be provided to seriously ill patients as a component of quality care.

Pilot study of a telehealth perioperative physical activity intervention for older adults with cancer and their caregivers.

BACKGROUND: Older adults undergoing cancer surgery are at greater risk for poor postoperative outcomes. Caregivers also endure significant burden. Participation in perioperative physical activity may improve physical functioning and enhance overall well-being for both patients and caregivers. In this study, we assessed the feasibility of a personalized telehealth intervention to enhance physical activity for older (≥ 65 years) gastrointestinal (GI) and lung cancer surgery patients/caregivers. METHODS: Participants completed four telehealth sessions with physical therapy/occupational therapy (PT/OT) before surgery and up to 2 weeks post-discharge. Outcomes included preop geriatric assessment, functional measures, and validated measures for symptoms and psychological distress. Pre/post-intervention trends/trajectories for outcomes were explored. RESULTS: Thirty-four patient/caregiver dyads (16, GI; 18, lung) were included. Accrual rate was 76% over 8 months; retention rate was 88% over 2 months. Median for postop of a 6-min walk test, timed up and go, and short physical performance battery test scores improved from baseline to postop. Participant satisfaction scores were high. CONCLUSION: Our conceptually based, personalized, multimodal, telehealth perioperative physical activity intervention for older patient/caregiver dyads is feasible and acceptable. It offers an opportunity to improve postoperative outcomes by promoting functional recovery through telehealth, behavior change, and self-monitoring approaches. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03267524.

Prospective randomised non-inferiority trial of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy.

OBJECTIVE: To determine if eliminating the prophylactic placement of a pelvic drain (PD) after robot-assisted radical prostatectomy (RARP) affects the incidence of early (90-day) postoperative adverse events. PATIENTS AND METHODS: In this parallel-group, blinded, non-inferiority trial, we randomised patients planning to undergo RARP to one of two arms: no drain placement (ND) or PD placement. Patients with demonstrable intraoperative leakage upon bladder irrigation were excluded. Randomisation sequence was determined a priori using a computer algorithm, and included a stratified design with respect to low vs intermediate/high D'Amico risk classifications. Surgeons remained blinded to the randomisation arm until final eligibility was verified at the end of the RARP. The primary endpoint was overall incidence of 90-day complications which, based on our standard treatment using PD retrospectively, was estimated at 13%. The non-inferiority margin was set at 10%, and the planned sample size was 312. An interim analysis was planned and conducted when one-third of the planned accrual and follow-up was completed, to rule out futility if the delta margin was in excess of 0.1389. RESULTS: From 2012 to 2016, 189 patients were accrued to the study, with 92 patients allocated to the ND group and 97 to the PD group. Due to lower than expected accrual rates, accrual to the study was halted by regulatory entities, and we did not reach the intended accrual goal. The ND and PD groups were comparable for median PSA level (6.2 vs 5.8 ng/mL, P = 0.5), clinical stage (P = 0.8), D'Amico risk classification (P = 0.4), median lymph nodes dissected (17 vs 18, P = 0.2), and proportion of patients receiving an extended pelvic lymph node dissection (70.7% vs 79.4%, P = 0.3). Incidence of 90-day overall and major (Clavien-Dindo grade >III) complications in the ND group (17.4% and 5.4%, respectively) was not inferior to the PD group (26.8% and 5.2%, respectively; P < 0.001 and P = 0.007 for difference of proportions <10%, respectively). Symptomatic lymphocoele rates (2.2% in the ND group, 4.1% in the PD group) were comparable between the two arms (P = 0.7). CONCLUSIONS: Incidence of adverse events in the ND group was not inferior to the group who received a PD. In properly selected patients, PD placement after RARP can be safely withheld without significant additional morbidity.

Biochemical recurrence after robot-assisted extended pelvic lymphadenectomy for prostate cancer.

INTRODUCTION: Extended lymph node dissection (ELND) compared to limited lymph node dissection (LLND) at time of prostatectomy improves staging and lymph node (LN) yield. The effect on biochemical recurrence (BCR) and survival is less well understood. We sought to evaluate the benefit of robotic ELND and LLND with respect to BCR. MATERIALS AND METHODS: Between 2008-2012, 584 consecutive men with intermediate or high risk clinically localized adenocarcinoma of the prostate underwent robotic assisted radical prostatectomy (RARP) with concomitant LLND (n = 326) or ELND (n = 258). Survival estimates were made using the Kaplan-Meier method. Log-rank statistic was used for comparison of curves. BCR predictors were determined with multivariable Cox regression analysis. Chi-square and Wilcoxon rank-sum tests were used to compare discrete and continuous variables, respectively, across the two groups. RESULTS: Median follow up for ELND and LLND patients was 46 and 54 months, respectively. ELND yielded more LNs (20 versus 6, p < 0.0001) and had higher node positivity (15.1% versus 3.4%, p < 0.0001). BCR free survival (BCRFS) at 3 and 5 years for ELND and LLND was 85% and 75% (p = 0.01), and 76% and 67% (p = 0.10), respectively. In subgroup analysis, ELND was associated with higher 5 year BCRFS in node-negative patients (84% versus 68%, p = 0.0005) and in intermediate risk patients (93% versus 80%, p = 0.0002). In multivariable analysis, ELND was a significant predictor of BCRFS in node-negative (HR = 0.50, p = 0.003) and intermediate risk patients (HR = 0.54, p = 0.03). CONCLUSIONS: ELND improves LN yield and detection of positive nodes. BCR analysis suggests a reduced risk of PSA failure for robotic ELND in intermediate risk and node-negative patients.

Ureteroenteric anastomotic revision as initial management of stricture after urinary diversion.

OBJECTIVE: To report our experience with ureteroenteric anastomotic revision as initial treatment of stricture after urinary diversion. METHODS: An institutional review board-approved retrospective study was carried out. A total of 41 patients who underwent primary ureteroenteric anastamotic revision were identified between 2007 and 2015. Data analyzed included patient characteristics, type of diversion, estimated blood loss, operative time, change in renal function, length of stay, postoperative complications and time with nephrostomy/stent. Success of revision was defined as an improvement in hydronephrosis on radiographic imaging and/or reflux during pouchogram. Predictors of length of stay and complications were analyzed using analysis of covariance. RESULTS: A total of 50 renal units were revised with a success rate of 100%. The median length of stay was 6 days (2-16 days). There were a total of 15 complications (one major, 14 minor) in 14 patients (33% 30-day complication rate). The most common were wound infection (n = 4) and arrhythmia (n = 4). Robotic revision (n = 5) had a median length of stay of 3 days (2-4) with no complications. CONCLUSIONS: Primary ureteroenteric anastomotic revisions have an excellent success rate at an experienced center and might obviate the need for multiple interventions. Open revision is associated with mostly minor complications. Robotic revision might reduce the morbidity of open revision in select cases.

Phase Ib Trial of mFOLFOX6 and Everolimus (NSC-733504) in Patients with Metastatic Gastroesophageal Adenocarcinoma.

OBJECTIVES: Based upon preclinical data showing synergy with mTOR inhibition and platinum chemotherapy, this study explores the safety and tolerability of combining everolimus with mFOLFOX6 for patients with metastatic gastroesophageal adenocarcinoma. METHODS: Eligible patients with metastatic gastroesophageal adenocarcinoma received standard-dose mFOLFOX6 chemotherapy in combination with escalating doses of everolimus. RESULTS: Six patients were accrued to the first dose level of 2.5 mg everolimus daily with mFOLFOX6. Overall, the toxicity profile was manageable with expected grade 3 toxicities of mucositis and neutropenia. The dose-limiting toxicity (DLT) included a week delay in therapy greater than 7 days as a result of the first 2 courses of mFOLFOX6. Two patients experienced DLTs at the first dose level due to delays in their treatment caused by prolonged grade 2 neutropenia and fever with fatigue. They were allowed to continue with a dose reduction of their chemotherapy. The median overall survival and progression-free survival were 20.3 and 14.5 months, respectively. CONCLUSIONS: The combination of mFOLFOX6 and everolimus is an active regimen with 83% of the patients experiencing a partial response. p53 mutations were found in the 5 samples analyzed.

Pilot study of an interdisciplinary supportive care planning intervention in pancreatic cancer.

PURPOSE: A diagnosis of pancreatic cancer is often associated with higher symptom burden, lower functional status, and worse quality of life (QOL). To date, few interventions have focused on the unique QOL needs of patients with pancreatic cancer. The purpose of this pilot study is to determine the feasibility of an interdisciplinary supportive care planning intervention in patients with pancreatic cancer during disease-focused treatments. METHODS: Patients enrolled in this prospective, pre- and post-intervention pilot study received a supportive care intervention that included the following three components: comprehensive QOL assessment, case presentation at interdisciplinary care meetings, and two nurse-administered educational sessions on QOL concerns. Patients completed outcome measures that included the FACT-Hep, FACIT-Sp-12, and self-report of finances and out-of-pocket costs since diagnosis. Measures were completed at baseline prior to receiving the intervention, and follow-up occurred at 1 and 2 months post-intervention. RESULTS: A total of 10 patients were enrolled during a 4-month period who provided informed consent, received the intervention, and completed the study (58 % accrual). Examination of pre- and post-intervention QOL outcomes revealed changes across the three evaluation time points that were not statistically significant. Patients were highly satisfied with the intervention, with 80 % reporting that the intervention was "excellent." Discussions during the interdisciplinary care meetings and educational sessions were largely focused on physical and psychosocial needs. CONCLUSIONS: An interdisciplinary supportive care planning intervention was potentially feasible and acceptable for pancreatic cancer patients in an ambulatory care setting.

A phase II study of vorinostat and rituximab for treatment of newly diagnosed and relapsed/refractory indolent non-Hodgkin lymphoma.

This study examines the activity and tolerability of a regimen combining vorinostat and rituximab in patients with indolent B-cell non-Hodgkin lymphoma. A total of 28 patients with newly diagnosed or relapsed/refractory follicular, marginal zone, or mantle cell lymphoma, with 4 or less prior therapies were eligible for this open-label phase II study. Oral vorinostat 200 mg was administered twice daily on days 1-14 along with 375 mg/m(2) of intravenous rituximab on day 1 of a 21-day cycle, continuing until disease progression or unacceptable toxicity. Primary end point was objective response rate, with secondary end points of progression-free survival, time to progression, duration of response, safety, and tolerability. Median follow up was 25.6 months and median number of vorinostat cycles was 11.5. Overall response rate was 46% for all patients, 67% for previously untreated, and 41% for relapsed/refractory patients. Median progression-free survival was 29.2 months for all patients, 18.8 months for previously treated patients, and not reached for untreated patients. The regimen was well tolerated over long treatment periods with the most common grade 3/4 adverse events being asymptomatic thrombosis, neutropenia, thrombocytopenia, lymphopenia, and fatigue. The vorinostat/rituximab combination exhibits activity in indolent B-cell non-Hodgkin lymphoma with an acceptable safety profile and durable responses. Re-treatment was effective in 2 of 3 relapsing responders. This phase II clinical trial was registered at clinicaltrials.gov identifier: 00720876.

Oncologic outcomes in men with metastasis to the prostatic anterior fat pad lymph nodes: a multi-institution international study.

BACKGROUND: The presence of lymph nodes (LN) within the prostatic anterior fat pad (PAFP) has been reported in several recent reports. These PAFP LNs rarely harbor metastatic disease, and the characteristics of patients with PAFP LN metastasis are not well-described in the literature. Our previous study suggested that metastatic disease to the PAFP LN was associated with less severe oncologic outcomes than those that involve the pelvic lymph node (PLN). Therefore, the objective of this study is to assess the oncologic outcome of prostate cancer (PCa) patients with PAFP LN metastasis in a larger patient population. METHODS: Data were analyzed on 8800 patients from eleven international centers in three countries. Eighty-eight patients were found to have metastatic disease to the PAFP LNs (PAFP+) and 206 men had isolated metastasis to the pelvic LNs (PLN+). Clinicopathologic features were compared using ANOVA and Chi square tests. The Kaplan-Meier method was used to calculate the time to biochemical recurrence (BCR). RESULTS: Of the eighty-eight patients with PAFP LN metastasis, sixty-three (71.6%) were up-staged based on the pathologic analysis of PAFP and eight (9.1%) had a low-risk disease. Patients with LNs present in the PAFP had a higher incidence of biopsy Gleason score (GS) 8-10, pathologic N1 disease, and positive surgical margin in prostatectomy specimens than those with no LNs detected in the PAFP. Men who were PAFP+ with or without PLN involvement had more aggressive pathologic features than those with PLN disease only. However, there was no significant difference in BCR-free survival regardless of adjuvant therapy. In 300 patients who underwent PAFP LN mapping, 65 LNs were detected. It was also found that 44 out of 65 (67.7%) nodes were located in the middle portion of the PAFP. CONCLUSIONS: There was no significant difference in the rate of BCR between the PAFP LN+ and PLN+ groups. The PAFP likely represents a landing zone that is different from the PLNs for PCa metastasis. Therefore, the removal and pathologic analysis of PAFP should be adopted as a standard procedure in all patients undergoing radical prostatectomy.

Early and late complications of robot-assisted radical cystectomy: a standardized analysis by urinary diversion type.

PURPOSE: Minimally invasive surgical treatment for bladder cancer has gained popularity but standardized data on complications are lacking. Urinary diversion type contributes to complications and to our knowledge diversion types after minimally invasive cystectomy have not yet been compared. We evaluated perioperative complications stratified by urinary diversion type in patients treated with robot-assisted radical cystectomy. MATERIALS AND METHODS: We analyzed the records of 209 consecutive patients who underwent robot-assisted radical cystectomy at our institution from 2003 to 2012 with respect to perioperative complications, including severity, time period (early and late) and diversion type. All complications were reviewed by academic urologists. Urinary diversion was also done. As outcome measurements and statistical analysis, univariate and multivariate logistic regression models were used to determine predictors of various complications. RESULTS: The American Society of Anesthesiologists(®) (ASA) score was 3 or greater in 80% of patients and continent diversion was performed in 68%. Median followup was 35 months. Within 90 days 77.5% of patients experienced any complication and 32% experienced a major complication. The 90-day mortality rate was 5.3%. Most complications were gastrointestinal, infectious and hematological. On multivariate analysis patients with ileal conduit diversion had a decreased likelihood of complications compared to patients with Indiana pouch and orthotopic bladder substitute diversion despite the selection of a more comorbid population for conduit diversion. Continent diversion was associated with a higher likelihood of urinary tract infection. Our results are comparable to those of previously reported open and minimally invasive cystectomy series. CONCLUSIONS: Open or minimally invasive cystectomy is a complex, morbid procedure. Urinary diversion is a significant contributor to complications, as is patient comorbidity. Although patients with an ileal conduit had more comorbidities, they experienced fewer complications than those with an orthotopic bladder substitute or Indiana pouch diversion.

Complications and outcomes of salvage robot-assisted radical prostatectomy: a single-institution experience.

OBJECTIVE: To determine the peri-operative outcomes of men undergoing salvage robot-assisted prostatectomy (RARP) and to examine the complications, functional consequences and need for additional treatments after salvage RARP. PATIENTS AND METHODS: At total of 51 consecutive patients underwent salvage RARP after previous failed local therapy. Biochemical recurrence (BCR) was defined as two postoperative PSA measurements ≥0.2 ng/mL. Complications at any time postoperatively were recorded prospectively using a modified Clavien system. The Kaplan-Meier method was used for survival estimation, and regression models were used to identify the predictors of BCR or progression-free survival (PFS) and complications. RESULTS: The median age at salvage RARP was 68 years and a median of 68 months had elapsed from the time of primary treatment. The median follow-up was 36 months. The median operation duration was 179 min with a median estimated blood loss of 175 mL. In all, 50% of patients had pathological stage 3 disease and positive surgical margins were found in 31% of patients. The estimated 3-year BCR-free or PFS was 57%. The overall complication rate was 47%, with a 35% major complication rate (Grade III-V). Potency was maintained in 23% of preoperatively potent patients and 45% of all patients regained urinary control. No clinical variables were predictive of major complications, but all patients with postoperative bladder neck contracture were incontinent. A higher PSA level and extracapsular extension were significantly associated with BCR or progression (P < 0.01). CONCLUSIONS: Salvage RARP provides oncological control with potential avoidance of systemic non-curative therapy. Complication, incontinence and erectile dysfunction rates are significant but frequently correctable. This reinforces the need for proper patient counselling and selection.

Increased Rate of Mesh Erosion in Breast Cancer Survivors Taking Antiestrogen Therapy.

IMPORTANCE: There are no current data investigating the relationship between mesh-exposure complications after midurethral sling surgery and antiestrogen therapy. OBJECTIVES: We sought to determine if there are increased mesh-exposure complications between a breast cancer population versus a noncancer population particularly in conjunction with hormone suppression (HS) therapy. STUDY DESIGN: A retrospective chart review was performed on patients with a history of breast cancer undergoing tension-free vaginal tape (TVT) surgery at our institution between 2013 and 2021. A group of patients who underwent TVT surgery without a history of cancer served as our control. Univariate and multivariate logistic regression analyses were performed to identify predictors of mesh exposure complications. RESULTS: One hundred twenty-one patients with breast cancer had TVT surgery. Two hundred ninety-seven patients without cancer had TVT surgery during the same period. Baseline characteristics across all groups were similar. Twenty-nine patients (6.9%) experienced mesh exposure. This occurred at a higher rate in our cancer (15.7%) versus the noncancer population (3.4%). Women with breast cancer taking HS therapy had a higher rate of mesh exposure complications compared with those not taking HS therapy (25.0% versus 6.6%; P = 0.005). The highest rate of mesh exposure complications occurred in the cohort taking estrogen receptor modulators, selective estrogen receptor modulator (10/36 [27.8%]) versus aromatase inhibitors (5/24 [20.8%]) versus no HS therapy (4/61 [6.6%]; P = 0.014). On multivariate analysis, HS therapy use (odds ratio, 1.57; P = 0.007) and diabetes mellitus (odds ratio, 4.53; P = 0.018) were associated with increased TVT-related complications. CONCLUSION: Women with breast cancer had a higher rate of mesh exposure complications from TVT surgery compared with women without cancer, particularly those taking antiestrogenic therapy.

Indiana Pouch Continent Cutaneous Urinary Diversion After Robotic-assisted Radical Cystectomy: A 16-Year Experience.

BACKGROUND: Population-based practice patterns in the United States reveal continent diversions are only performed in 8%-10.4% of patients.1-4 Ideally, for patients undergoing radical cystectomy the choice of urinary diversion should be influenced by clinical factors and patient preference, with discussions surrounding quality of life. Unfortunately, receipt of continent diversion has been shown to be influenced by a plethora of other factors such as surgeon preference/training, geography, socioeconomic status, gender, and hospital volume.1-3 Thus, by providing detailed instruction and long-term follow-up, we hope to mitigate some of these disparities by changing the perceptions regarding feasibility and complications of continent diversions. OBJECTIVE: To provide step-by-step instruction and to report long-term clinical outcomes in bladder cancer patients receiving an Indiana pouch continent cutaneous urinary diversion (CCUD) after robot-assisted radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS: After Institutional Review Board approval, a prospectively maintained bladder cancer database was queried for patients with T1-T4, N0-N1, M0 bladder cancer undergoing radical cystectomy with CCUD at a tertiary referral center from 2004 to 2020. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Complications at 30- and 90-day were recorded according to the Clavien-Dindo classification. Continence rates were recorded by chart review. RESULTS AND LIMITATIONS: A total of 97 patients were included with a median follow-up of 93months. Clinically, 91.8% had ≤T2 disease and 29.9% received neoadjuvant chemotherapy. The median length of surgery was 8.0 hours, length of hospital stay was 8.3days, and urinary continence rate was 99.0%. The overall complication rate was 73.2% and 76.5% at 30- and 90-day, respectively. The major complication rate (Clavien III-V) was 17.5% at 30-day and 22.7% at 90-day. The most common major complications were abdominal infection and uretero-colonic stricture. The readmission rate was 21.4% and median overall survival was 108months. CONCLUSION: CCUD provides exceptional functional outcomes with acceptable complication rates compared to other diversion types. CCUD is a reliable reconstructive option and with this step-by-step video as a reference, we hope it will be offered to more patients.