Comprehensive assessment of the morbidity of renal mass biopsy: A population-based assessment of biopsy-related complications.

INTRODUCTION: We sought to assess seven-day and 30-day complications following renal mass biopsy (RMB), including mortality, hospitalizations, emergency department (ED) visits, and operative and non-operative complications and compare these to rates in population-matched controls. METHODS: We performed a population-based, matched, retrospective cohort study of patients undergoing RMB following consultation with a urologist and axial imaging from 2003-2015 in Ontario, Canada. Data on seven-day and 30-day rates of mortality, as well as operative and non operative complications after RMB were reported. The seven-day and 30-day rates of mortality, operative and non-operative interventions, hospitalizations, and ED visits were compared to matched controls using multivariable logistic regression. RESULTS: Among 6840 patients who underwent RMB in the study period, 24 (0.4%) and 159 (2.3%) died within seven and 30 days of their biopsy, respectively. Seven- and 30-day operative intervention rates were 79 (1.2%) and 236 (3.4%), respectively. Seven- and 30-day non-operative intervention rates were 227 (3.3%) and 529 (7.7%), respectively. Thirty-day mortality (odds ratio [OR] 8.1, 95% confidence interval [CI] 5.1-13.0), hospitalizations (OR 12.6, 95% CI 10.6-15.2), and ED visits (OR 3.8, 95% CI 3.4-4.3) were more common among patients who underwent RMB than the matched controls (p<0.001 for each). CONCLUSIONS: Patients undergoing RMB may have a small but non-negligible increased risk of mortality, hospital readmission, and ED visits compared to matched controls. However, limitations in the granularity of the dataset limits the strength of these conclusions. Further studies are needed to confirm our results. These risks should be discussed with patients for shared decision-making and considered in the risk/benefit tradeoff for the management of small renal masses.

Assessment of Secondary Sarcomas Among Patients With Cancer of the Abdomen or Pelvis Who Received Combinations of Surgery, Radiation, and Chemotherapy vs Surgery Alone.

Importance: The association of radiation and chemotherapy with the development of secondary sarcoma is known, but the contemporary risk has not been well characterized for patients with cancers of the abdomen and pelvis. Objective: To compare the risk of secondary sarcoma among patients treated with combinations of surgery, radiation, or chemotherapy with patients treated with surgery alone and the general population. Design, Setting, and Participants: This population-based cohort study included 173 580 patients in Ontario, Canada, with nonmetastatic cancer of the prostate, bladder, colon, rectum or anus, cervix, uterus, or testis. Patients were enrolled from January 1, 2002, to January 31, 2017. Data analysis was conducted from March 1, 2019, to January 31, 2020. Exposures: Treatment combinations of radiation, chemotherapy, and surgery. Main Outcome and Measures: Diagnosis of sarcoma based on histologic codes from the Ontario Cancer Registry. Time to sarcoma was compared using a cause-specific proportional hazard model. Results: Of 173 580 patients, most were men (125 080 [72.1%]), and the largest group was aged between 60 and 69 years (58 346 [33.6%]). Most patients had genitourinary cancer (86 235 [51.4%]) or colorectal cancer (69 241 [39.9%]). Overall, 64 301 (37.1%) received surgery alone, 51 220 (29.5%) received radiation alone, 15 624 (9.0%) were treated with radiation and chemotherapy, 15 252 (8.8%) received radiation with surgery, and 11 822 (6.8%) received all 3 treatments. A total of 332 patients (0.2%) had sarcomas develop during a median (interquartile range) follow-up of 5.7 (2.2-8.9) years. The incidence of sarcoma was 0.3% among those who underwent radiation alone (138 of 51 220) and radiation with chemotherapy (40 of 15 624), 0.2% among those who received radiation and surgery (36 of 15 252) and all 3 modalities (25 of 11 822), and 0.1% among those who received surgery with chemotherapy (13 of 14 861) and surgery alone (80 of 64 801). Compared with a reference group of patients who had surgery alone, the greatest risk of sarcoma was found among patients who underwent a combination of radiation and chemotherapy (cause-specific relative hazard [csRH], 4.07; 95% CI, 2.75-6.01; P < .001), followed by patients who had radiation alone (csRH, 2.35; 95% CI, 1.77-3.12; P < .001), radiation with surgery (csRH, 2.33; 95% CI, 1.57-3.46; P < .001), and all 3 modalities (csRH, 2.27; 95% CI, 1.44-3.58; P < .001). In the general population, 7987 events occurred during 46 554 803 person-years (17.2 events per 100 000 person-years). The standardized incidence ratio for sarcoma among patients treated with radiation compared with the general population was 2.41 (95% CI, 1.57-3.69; 41.3 events per 100 000 person-years). The annual number of cases of sarcoma increased from 2009 (15 per 100 000 persons) to 2016 (32 per 100 000 persons), but the annual rate did not change during the study period. Conclusions and Relevance: In this cohort study, patients treated with radiation or chemotherapy for abdominopelvic cancers had an increased rate of sarcoma. Although the absolute rate is low, patients and physicians should be aware of this increased risk of developing sarcoma.

The cost of treatment and its related complications for men who receive surgery or radiation therapy for prostate cancer.

INTRODUCTION: We sought to examine the costs related to treatment and treatment-related complications for patients treated with surgery or radiation for localized prostate cancer. METHODS: We performed a population-based, retrospective cohort study of men who underwent open radical prostatectomy or radiation from 2004-2009 in Ontario, Canada. Costs, including initial treatment and inpatient hospitalization, emergency room visit, outpatient consultation, physician billings, and medication costs, were determined for five years following treatment using a validated costing algorithm. Multivariable negative binomial regression was used to assess the association between treatment modality and costs. RESULTS: A total of 28 849 men underwent treatment for localized prostate cancer from 2004- 2009. In the five years following treatment, men who underwent radiation (n=12 675) had 21% higher total treatment and treatment-related costs than men who underwent surgery ($16 716/person vs. $13 213/person). Based on multivariable analysis, while men who underwent XRT had a lower relative cost in their first year after treatment (relative rate [RR] 0.97; 95% confidence interval [CI] 0.94-1.0; p=0.025), after year 2, annual costs were significantly higher in the radiation group compared to the surgery group (total cost for year 5, RR 1.44; 95% CI 1.17-1.76; p<0.0001). Our results were similar when restricted to young, healthy men and to older men. CONCLUSIONS: Men who undergo radiation have significantly higher five-year total treatment-related costs compared to men who undergo open radical prostatectomy. While surgery was associated with slightly higher initial costs, radiotherapy had higher costs in subsequent years.

Evaluating the accuracy of multicomponent T2 parameters for luminal water imaging of the prostate with acceleration using inner-volume 3D GRASE.

PURPOSE: Prostate cancer can be detected using a multicomponent T2 mapping technique termed luminal water imaging. The purpose of this study is twofold: 1) To accelerate the luminal water imaging acquisition by using inner volume selection as part of a gradient and spin echo sequence, and 2) to evaluate the accuracy of luminal water fractions and multicomponent T2 relaxation times. METHODS: The accuracy of parameter estimates was assessed using Monte Carlo simulations, in phantom experiments and in the prostate (in 5 healthy subjects). Two fitting methods, nonnegative least squares and biexponential fitting with stimulated echo correction, were compared. RESULTS: Results demonstrate that inner volume selection in a gradient and spin echo sequence is effective for accelerating prostate luminal water imaging by at least threefold. Evaluation of the accuracy shows that the estimated luminal water fractions are relatively accurate, but the short- and long-T2 relaxation times should be interpreted with caution in noisy scenarios (SNR < 100) and when the corresponding fractions are small ( < 0.5). The mean luminal water fractions obtained at SNR above 100 are 0.27 ± 0.07 for the peripheral zone for both fitting methods, 0.16 ± 0.04 for the transition zone with nonnegative least squares, and 0.16 ± 0.03 for the transition zone with biexponential fitting including stimulated echo correction. CONCLUSION: The shortened scan duration allows the luminal water imaging sequence to be easily integrated into a standard multiparametric prostate MRI protocol.

A Population-Based Assessment of Urologic Procedures and Operations After Surgery or Pelvic Radiation for Cervical Cancer.

OBJECTIVE: The treatment of cervical cancer can result in genitourinary morbidity. We measured selected urologic procedures after the treatment of cervical cancer with either surgery or radiation. METHODS: We used administrative data from the province of Ontario Canada to identify adult women who had nonmetastatic cervical cancer and were treated with surgery or radiation between 1994 and 2014. Study outcomes were surgical or procedure codes representing ureteric repair or fistula repair. Stress incontinence surgery, minimally invasive urologic procedures, open bowel/bladder surgeries, and secondary malignancy were measured to compare between treatment modalities. Multivariable Cox proportional hazards models were used. RESULTS: Our final cohort consisted of 7311 women (median follow-up, 7.0 years [interquartile range, 2.9-13.3 years]), of which 3354 (44.9%) underwent radiation, and 3957 (54.1%) underwent surgery. After treatment of cervical cancer, ureteral repair was less common after surgery (3.4%) compared with radiation (10.3%) (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.19-0.32). Fistula repair was uncommon (0.9%) and occurred significantly more often in the surgery and radiation group compared with the radiation-alone group (HR, 4.02; 95% CI, 1.80-9.00). Overall, stress incontinence surgery was uncommon (2.2%) but was significantly more likely after surgery versus radiation (HR, 3.73; 95% CI, 2.13-6.53). Minimally invasive urologic procedures were less common after surgery compared with radiation (HR, 0.49; 95% CI, 0.44-0.54). Open bowel/bladder surgeries were similar among treatment modalities, and secondary malignancy was less common after treatment with surgery versus radiation (HR, 0.60; 95% CI, 0.39-0.92; P = 0.02). CONCLUSIONS: Women treated for cervical cancer undergo ureteral stricture interventions at 0.8% per year over the 20 years after their treatment; this risk is higher among women who receive radiation treatment. Fistula repair is rare after cervical cancer.

Radical cystectomy in patients with disseminated disease: An assessment of perioperative outcomes using the National Surgical Quality Improvement Program database.

INTRODUCTION: We sought to determine the effect of the presence of disseminated disease on perioperative outcomes following radical cystectomy for bladder cancer. METHODS: We identified 4108 eligible patients who underwent radical cystectomy for bladder cancer using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. We matched patients with disseminated cancer at the time of surgery to those without disseminated cancer using propensity scores. The primary outcome of interest was major complications (death, reoperation, cardiac or neurological event). Secondary outcomes included pulmonary, infectious thromboembolic, and bleeding complications, in addition to prolonged length of stay. Generalized estimating equations were used to examine the association between disseminated cancer and the development of complications. RESULTS: Following propensity score matching and adjusting for the type of urinary diversion, radical cystectomy in patients with disseminated disease was associated with a significant increase in major complications (8.6% vs. 4.0%; odds ratio [OR] 2.50; 95% confidence interval [CI] 1.02-6.11; p=0.045). The presence of disseminated disease was associated with an increase in pulmonary complications (5.8% vs. 1.2%; OR 5.17. 95% CI 1.00-26.66. p=0.049), but not infectious complications, venous thromboembolism, bleeding requiring transfusion, and prolonged length of stay (p values 0.07-0.79). CONCLUSIONS: Patients with disseminated cancer undergoing cystectomy are more likely to experience major and pulmonary complications. The strength of these conclusions is limited by sample size, selection bias inherent in observational data, and a lack of specific oncological detail in the database.

Adjuvant Versus Salvage Radiotherapy for Patients With Adverse Pathological Findings Following Radical Prostatectomy: A Decision Analysis.

Background: Patients undergoing surgery for prostate cancer who have adverse pathological findings experience high rates of recurrence. While there are data supporting adjuvant radiotherapy compared to a wait-and-watch strategy to reduce recurrence rates, there are no randomized controlled trials comparing adjuvant radiotherapy with the other standard of care, salvage radiotherapy (radiotherapy administered at the time of recurrence). Methods: We constructed a health state transition (Markov) model employing two-dimensional Monte Carlo simulation using a lifetime horizon to compare the quality-adjusted survival associated with postoperative strategies using adjuvant or salvage radiotherapy. Prior to analysis, we calibrated and validated our model using the results of previous randomized controlled trials. We considered clinically important oncological health states from immediately postoperative to prostate cancer-specific death, commonly described complications from prostate cancer treatment, and other causes of mortality. Transition probabilities and utilities for disease states were derived from a literature search of MEDLINE and expert consensus. Results: Salvage radiotherapy was associated with an increased quality-adjusted life expectancy (QALE) (58.3 months) as compared with adjuvant radiotherapy (53.7 months), a difference of 4.6 months (standard deviation 8.8). Salvage radiotherapy had higher QALE in 53% of hypothetical cohorts. There was a minimal difference in overall life expectancy (-0.1 months). Examining recurrence rates, our model showed validity when compared with available randomized controlled data. Conclusions: A salvage radiotherapy strategy appears to provide improved QALE for patients with adverse pathological findings following radical prostatectomy, compared with adjuvant radiotherapy. As these findings reflect, population averages, specific patient and tumor factors, and patient preferences remain central for individualized management.

Contemporary evidence for robot-assisted radical cystectomy for treating bladder cancer.

Robot-assisted radical cystectomy (RARC) is an evolving technique for the treatment of muscle-invasive bladder cancer (MIBC); however, its effectiveness compared with open radical cystectomy (ORC) - the established modality - is debated. Six specific areas of evidence are critically important for supporting the continuing use of RARC for MIBC, including technical aspects of surgery, perioperative outcomes, complications, oncological outcomes, functional outcomes, and financial costs. Considerable progress has been made regarding these aspects and data show that RARC replicates the technical benchmarks of ORC in terms of success of cystectomy, lymph node dissection, and urinary diversion, and could offer advantages over the more-established technique. Despite some clear benefits of RARC (such as reduced blood loss) other perioperative outcomes, including duration of inpatient stay and 30-90 day complication rates, seem to be similar to those of ORC. Current data on oncological and functional outcomes are promising, but robust data from prospective studies will help determine the indications for use of RARC for treating MIBC in the future.

Lymph node assessment and lymphadenectomy in prostate cancer.

The role of lymph node assessment for patients with clinically localized prostate cancer has significantly evolved over the last 20 years. The status of pelvic lymph nodes primarily served as a prognostic marker for prostate cancer. Improved methods in assessing the risk for cancer progression and metastasis have enhanced our ability to identify patients who require pelvic lymphadenectomy during radical prostatectomy. The status of pelvic lymph nodes is also being used to guide further treatments after surgery. Also, recent data has shown possible therapeutic benefit of lymphadenectomy in improving cancer specific survival.

Use of alternative and hormonal therapies in male infertility.

OBJECTIVES: To examine the patterns of use of alternative and hormonal therapies in men presenting for infertility evaluation. METHODS: We administered a questionnaire on the use of alternative and hormonal therapies to 500 consecutive men presenting for infertility evaluation at our male infertility clinic. The questionnaire asked about the use of specific therapies (eg, vitamins, herbal medicine, or hormones), the monthly cost of these therapies, and whether the principal healthcare provider had been made aware of the use of therapies. RESULTS: Of the 481 men who completed the questionnaire, 147 (31%) admitted to using one or more alternative therapies. Most of the men using alternative therapies (92 of 147, 63%) were taking one or more antioxidant vitamins or minerals (ie, vitamins C, E, selenium, zinc), and 18 men admitted to using herbal medicines. Of concern, 25 men reported using agents with clear hormonal activity (testosterone, clomiphene citrate), and 6 of these men had not informed their principal healthcare provider of this. CONCLUSIONS: Our data suggest that a significant percentage ( approximately 30%) of men presenting for infertility evaluation do use alternative therapies. It is important to inquire about the use of these therapies because some of these treatments may be toxic to the gonads.

Comprehensive assessment of candidate genes and serological markers for the detection of prostate cancer.

We examined whether selected polymorphisms in 11 candidate genes and serum levels of insulin-like growth factor I (IGF-I) help predict the presence of prostate cancer among patients prescreened with prostate-specific antigen (PSA) and digital rectal exam (DRE). We studied 1031 consecutive men who underwent one or more prostate biopsies because of an elevated PSA level (>4 ng/ml) or an abnormal DRE. Eleven candidate genes were examined, including the androgen receptor, SRD5A2, CYP17, CYP3A4, vitamin D receptor, PSA, GST-T1, GST-M1, GST-P1, IGF-I, and IGF binding protein 3. We also measured serum IGF-I levels before biopsy. Of the 1031 men, 483 had cancer on any biopsy (cases) and 548 men had no cancer (controls). Age, ethnicity, total PSA, and DRE result were strongly predictive of the presence of prostate cancer. The mean IGF-I level for cases (119.4 ng/ml) was lower than for controls (124.4 ng/ml, P = 0.05) and were not predictive for the presence of prostate cancer. We found no associations between the androgen receptor, SRD5A2, CYP17, CYP3A4, vitamin D receptor, GST-M1, GST-P1, and IGF binding protein 3 genotypes and prostate cancer risk. The adjusted odds ratios for having prostate cancer for patients with the GST-T1 and IGF-I variant alleles were 1.64 (95% confidence interval, 1.1-2.4; P = 0.01) and 1.70 (95% confidence interval, 1.1-2.7; P = 0.02), respectively. Nine of 11 candidate genes were not significantly predictive for prostate cancer in a clinical setting. The GST-T1 and IGF-I polymorphisms demonstrated modest associations with prostate cancer risk. IGF-I levels were not helpful in identifying patients with prostate cancer at the time of biopsy.