An economic analysis comparing health care resource use and cost of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin versus gemcitabine and cisplatin as neoadjuvant therapy for muscle invasive bladder cancer.

PURPOSE: To compare healthcare resource utilization (HRU) and costs associated with dose-dense methotrexate, vinblastine, doxorubicin, cisplatin (ddMVAC) and gemcitabine, cisplatin (GC) as neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC). METHODS: Patient treated at Dana-Farber Cancer Institute from 2010 to 2019 were identified. HRU data on chemotherapy administered, supportive medications, patient monitoring, clinic, infusion, emergency department (ED) visits and hospitalization were collected retrospectively. Unit costs for HRU components were obtained from the Centers for Medicare and Medicaid Website and HRU was compared between groups using quantile regression analysis. RESULTS: 137 patients were included; 51 received ddMVAC and 86 GC. Baseline characteristics were similar, except lower mean age (P < 0.001) and higher proportion of ECOG-PS = 0 (P < 0.001) for ddMVAC. ddMVAC required more granulocyte-colony stimulating factor support (P < 0.001), central line placement (P = 0.017), cardiac imaging (P < 0.001), and infusion visits (P < 0.001), whereas GC required more clinic visits. ED visits were higher for ddMVAC (P = 0.048), while chemotherapy cycle delays and hospitalization days were higher for GC (P = 0.008). After adjusting for ECOG-PS and age, the cost per patient was approximately 41% lower (95%CI: 28% to 52%; P < 0.001) for GC vs. ddMVAC, which translated to a median adjusted cost savings of $7,410 (95%CI: $5,474-$9,347) per patient. CONCLUSIONS: Although excess HRU did not clearly favor one regimen, adjusting for PS and age indicated lower costs with GC vs. ddMVAC. Given the similar cumulative cisplatin delivery with both regimens, the associated values and costs supports the preferential selection of GC in the neoadjuvant setting of MIBC.

Predictors of positive retroperitoneal lymph nodes in patients with high risk testicular cancer.

PURPOSE: Percent of embryonal carcinoma and lymphovascular invasion in the primary tumor are risk factors for occult retroperitoneal metastatic disease. High risk patients with clinical stage I and IIA nonseminomatous germ cell tumor who underwent primary retroperitoneal lymph node dissection were identified to discern any other risk factors for metastatic disease. MATERIALS AND METHODS: Patients who had undergone retroperitoneal lymph node dissection at our institution from 1993 to 2009 were identified and clinical charts were reviewed. A total of 90 patients with orchiectomy specimens containing more than 30% embryonal carcinoma who underwent primary retroperitoneal lymph node dissection were identified and perioperative data were obtained. RESULTS: Of 353 patients 90 (25%) had greater than 30% embryonal carcinoma and underwent primary retroperitoneal lymph node dissection. Of these patients 45 (50%) had lymphovascular invasion. Median followup was 1.1 years. Positive lymph nodes identified at retroperitoneal lymph node dissection were noted in 30 (46%) and 15 (60%) patients with clinical stage I vs clinical stage II disease. On multivariate analysis embryonal carcinoma (OR 1.02, 95% CI 1.00-1.04) and lymphovascular invasion (OR 3.52, 95% CI 1.43-8.67) were associated with positive lymph nodes at retroperitoneal lymph node dissection. The positive predictive value for 100% embryonal carcinoma was 65.5%, although the negative predictive value for 30% embryonal carcinoma was 85.7%. CONCLUSIONS: Embryonal carcinoma and lymphovascular invasion were significantly and independently associated with the risk of occult retroperitoneal metastatic disease. These results should be considered when counseling patients about appropriate treatment options.

Management of low-stage nonseminomatous germ cell tumors of the testis.

Testicular cancer has become one of the most curable of all solid neoplasms. High cure rates associated with modern treatment regimens for low-stage testis cancer have resulted in a shift in focus toward reducing morbidity of potentially toxic treatment regimens.

Combination of symptom score, flow rate and prostate volume for predicting bladder outflow obstruction in men with lower urinary tract symptoms.

PURPOSE: The severity of lower urinary tract symptoms associated with benign prostatic enlargement correlates poorly with bladder outlet obstruction. Since urodynamic studies are presumed to be relatively complex, invasive and not cost-effective, they are not routinely performed by physicians treating men with lower urinary tract symptoms. As a result, a large number of patients are treated for bladder outlet obstruction when in fact obstruction may not be present. Since other noninvasive methods have not been effective for predicting bladder outlet obstruction, we investigated whether a combination of prostate volume, uroflowmetry and the American Urological Association (AUA) symptom index would be reliable for predicting this condition. MATERIALS AND METHODS: We prospectively evaluated 204 men with a mean age plus or minus standard deviation of 66.7 +/- 7.5 years who presented with lower urinary tract symptoms. Each patient completed an AUA symptom index questionnaire and underwent uroflowmetry, post-void residual urine volume measurement, pressure flow study and transrectal ultrasound of the prostate to estimate prostatic volume. We constructed receiver operating characteristics curves using various threshold values for maximum urine flow and prostate volume. Threshold values for maximum urine flow and prostate volume were used alone and combined with the AUA symptom index for predicting bladder outlet obstruction. We selected a cutoff value for maximum urine flow of 10 or less ml. per second and prostate volume of 40 gm. or greater, and used these values with an AUA symptom index of greater than 20 to predict bladder outlet obstruction in the group overall. RESULTS: Differences in the mean symptom index score in men with and without bladder outlet obstruction were not statistically significant. There was no obstruction in 19%, 28.9% and 35% of those with severe, moderate and mild symptoms, respectively. The selected cutoff values of maximum urine flow, prostate volume and symptom score combined correctly predicted obstruction in all 39 patients. Therefore, our combination of cutoff values proved to be highly accurate for predicting bladder outlet obstruction. Sensitivity, specificity, and positive and negative predictive values were 26%, 100%, 100% and 32%, respectively. CONCLUSIONS: Our study showed that combining the AUA symptom index, maximum urine flow and prostate volume reliably predicted bladder outlet obstruction in a small subset of patients only. Although bladder outlet obstruction was correctly predicted by our threshold values of AUA symptom index, maximum urine flow and prostate volume in only 39 men (26%) with obstruction, these patients represent a substantial group in any large urological practice treating male lower urinary tract symptoms.

The National Cancer Data Base report on patterns of care for testicular carcinoma, 1985-1996.

BACKGROUND: Previous Commission on Cancer data from the National Cancer Data Base (NCDB) have examined time trends in stage of disease, treatment patterns, and survival for selected cancers. In the current study data relating to patients diagnosed with testicular carcinoma in 1985, 1986, 1990, 1991, 1995, and 1996 are described. METHODS: The data reported in this review were collected from hospital cancer registries from across the U.S. Case information is submitted to the NCDB following guidelines established by the North American Association of Central Registries. Data items include patient demographics, tumor characteristics, initial course of therapy, and follow-up status. Eight calls for data have yielded a total of 6.9 million cases for the years 1985-1996, including 2280 testicular carcinoma cases in 1985-1986, 5677 cases in 1990-1991, and 7452 cases in 1995-1996. These data represent approximately 22.6%, 47.3%, and 51.4%, respectively, of the estimated cases of testicular carcinoma diagnosed in the U.S. in each of these 3 respective time periods. Cases diagnosed and reported to the NCDB between 1985-1991 and that had been staged according to the 4th edition of the American Joint Committee on Cancer (AJCC) manual for the staging of cancer (1567) were used in the analysis of survival outcomes. RESULTS: Four principle findings are reported. First, young men (age < 25 years) are diagnosed with advanced stage nonseminomatous germ cell tumors more frequently than are older men (age >/= 30 years). Second, although surgery and concomitant radiation are the standard therapy for early stage seminomas, surgery alone increasingly is being used. In the treatment of patients with advanced stage seminomas the use of surgery and radiation has declined slightly whereas surgery with concomitant chemotherapy appears to be employed with greater frequency. Third, surgery alone is the treatment of choice for patients with early stage nonseminomatous germ cell tumors and has been employed with increasing frequency over the three time periods studied. The use of surgery and concomitant chemotherapy has remained relatively stable over time in the treatment of patients with advanced stage nonseminomas. And fourth, survival rates decrease with increasing AJCC stage of disease. CONCLUSIONS: The NCDB data regarding testicular carcinoma highlight a number of important trends in the presentation and management of testicular tumors. These trends not only evaluate new protocols of treatment but also can be used to direct new strategies toward achieving earlier patient presentation.

Detrusor contraction duration as a urodynamic parameter of bladder outlet obstruction for evaluating men with lower urinary tract symptoms.

PURPOSE: Recent studies suggest that detrusor contraction duration increases with bladder outlet obstruction and correlates with the American Urological Association (AUA) symptom index. Since the detrusor contraction duration may also depend on detrusor contractility and bladder volume, its use alone in characterizing bladder outlet obstruction is debatable. Therefore, we studied the relationship between detrusor contraction duration and bladder outlet obstruction, bladder capacity, detrusor contractility and symptoms to determine whether detrusor contraction duration is a useful parameter for characterizing bladder outlet obstruction in men with lower urinary tract symptoms. MATERIALS AND METHODS: Pressure-flow studies were performed in men with lower urinary tract symptoms. Bladder outlet obstruction was defined as passive urethral resistance relation greater than grade II and contractility was determined from Schäfer's nomogram. Detrusor contraction duration was defined as the contraction time elapsed between the first rise in detrusor pressure from baseline to the time at which detrusor pressure returned to baseline at the end of voiding. AUA symptom index was attained from each patient and categorized as mild (0 to 7), moderate (8 to 19) and severe (20 to 35). RESULTS: Detrusor contraction duration was determined from 58 consecutive pressure-flow studies. This parameter was not significantly different among 23 patients with mild (116.7+/-34.0 seconds), 15 with moderate (102.7+/-61.9 seconds) and 9 with severe (89.2+/-44.4 seconds) AUA symptom index scores. AUA symptom index, as well as irritative and obstructive scores did not significantly correlate with detrusor contraction duration. Detrusor pressure at maximal flow was weakly correlated with detrusor contraction duration (r=0.322, p=0.014). However, detrusor contraction duration in 27 obstructed patients (111.6+/-53.7 seconds) was not significantly different from that of 31 nonobstructed patients (91.5+/-41.5 seconds) and it did not increase with the severity of bladder outlet obstruction. Detrusor contraction duration in 40 patients with good contractility (94.3+/-49.2 seconds) was significantly lower than in 18 patients with poor contractility (115.5+/-43.3 seconds). Detrusor contraction duration was significantly lower in nonobstructed patients with good contractility (72.0+/-21.7 seconds) compared with either nonobstructed patients with poor contractility (118.4+/-47.7 seconds) or obstructed patients with good contractility (112.5+/-58.0 seconds). There was no difference in detrusor contraction duration between nonobstructed patients with poor contractility and obstructed patients with good contractility. Multiple regression analysis showed that detrusor contraction duration can be best predicted by a combination of detrusor pressure at maximal flow, bladder capacity and contractility (r=0.576). CONCLUSIONS: Our study showed that detrusor contraction duration cannot distinguish patients with from those without bladder outlet obstruction, and it does not correlate with the severity of symptoms. Since our results also showed that detrusor contraction duration depends on several factors related to detrusor and outlet function, it cannot be used as a reliable parameter to diagnose bladder outlet obstruction.

Transitional cell carcinoma of the fossa navicularis.

We report a case of transitional cell carcinoma of the fossa navicularis in an elderly white male. The patient presented in urinary retention, with a large exophytic mass at the external urethral meatus. Both the pathogenesis and natural history of this highly unusual tumor are unclear. Treatment depends on grade and stage of disease. Transurethral resection and fulguration have been successfully used to treat superficial lesions. Segmental resection and partial penectomy, with or without inguinal lymph node dissection, form the mainstay of treatment for invasive disease. The role of chemotherapy for advanced disease is unknown.

Transurethral needle ablation of the prostate: a urodynamic based study with 2-year followup.

PURPOSE: We evaluated the efficacy of transurethral needle ablation of the prostate for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH). This study was urodynamic based with 2-year followup to determine whether transurethral needle ablation of the prostate could reduce bladder outlet obstruction and, if so, whether the effect was durable. MATERIALS AND METHODS: A total of 47 patients with symptomatic BPH underwent transurethral needle ablation of the prostate under local anesthesia and intravenous sedation. All patients were evaluated subjectively using the American Urological Association symptom index and the quality of life score. Patients were evaluated objectively with uroflowmetry, post-void residual volume and pressure-flow studies. All patients underwent subjective and objective evaluation before treatment. Followup was conducted at 1, 3, 6, 12 and 24 months after treatment. Short and long-term complications were assessed. RESULTS: At 6-month followup there was 71% improvement in mean cases (22.4 to 6.6, 42 patients symptom index, p < 0.05), and 66% improvement in mean quality of life score (4.6 to 1.56, 42 patients, p < 0.05). Maximum flow rate, post-void residual volume and detrusor pressure at maximum flow rate also showed statistically significant improvements throughout the study. At 12-month followup there was a 55% increase in maximum flow rate (6.6 to 10.23 ml. per second, 29 patients, p < 0.05). A 37% reduction in mean detrusor pressure at maximum flow rate (92.4 cm. to 58 cm. water, 31 patients, p < 0.05) was recorded at 24-month followup, thus indicating that transurethral needle ablation of the prostate can lower bladder pressure-significantly. Post-void residual volume decreased from a pretreatment mean of 76.1 ml. to a mean of 36.9 ml. (31 patients, p < 0.05) at 24 months. Short-term complications (3 months) included transient posttreatment urinary retention in 8 patients (17%), duration 1 to 9 days, mild to moderate transient frequency dysuria all patients which resolved in more than 90% by 5 weeks and epididymitis in 1. A patient questionnaire was used to evaluate changes in sexual function and there were no reports of disturbances in erectile function or retrograde ejaculation. There were no long-term complications. However, 6 patients (12.7%) had persistent bothersome symptoms during the followup period and underwent transurethral prostate resection. Further analysis of this subset of patients with respect to pretreatment evaluation and transurethral needle ablation procedure did not reveal significant differences between them and patients with successful outcomes. CONCLUSIONS: Transurethral prostate resection is a safe and effective technique for treating lower urinary tract symptoms related to benign prostatic hyperplasia. The technique can be performed in the office as an outpatient, or as a same day surgical procedure, using topical anesthesia with intravenous sedation, if necessary. In the majority of patients subjective and objective improvements were sustained for the duration of this study, which included 2-year followup with pressure-flow studies.

Current role of retroperitoneal lymph node dissection in testicular cancer.

Carcinoma of the testis is the most common malignancy in males 15 to 35 years of age. Testicular cancer has become one of the most curable solid neoplasms and as such, serves a paradigm for the multimodality treatment of malignancies. The cure rate for patients with clinical stage I disease is nearly 100%, and patients with advanced disease now achieve complete remission rates of over 90%. The markedly improved outlook for patients with this cancer over the past 15 years has led to a reassessment of management options, especially in patients with clinical stage I disease. The realization that platinum-based chemotherapy could cure most patients with an advanced nonseminomatous germ cell tumor (NSGCT), especially those with minimal disease, led to the introduction of various strategies to decrease the morbidity associated with surgical management. These strategies include surveillance protocols, chemotherapy for clinical stage II disease, and observation protocols for a subset of patients with advanced disease who have had a partial response to chemotherapy. Retroperitoneal lymph node dissection (RPLND) has an important place in the management of both low- and high-stage testicular cancer. It offers the patient two basic benefits: accurate staging and the possibility of a surgical care, even in the presence of metastatic disease.

Advanced prostate cancer with normal serum prostate-specific antigen values.

Prostate-specific antigen is a specific and sensitive marker of prostate cancer, and most patients with advanced prostate cancer have elevated serum prostate-specific antigen values. Over a period of 45 months, 976 cases of advanced prostate cancer (stages C and D) were investigated to determine the serum prostate-specific antigen level at presentation. Eight cases of advanced prostate cancer are documented in which the serum prostate-specific antigen values were within normal limits. Six of the eight cases showed the features of invasive moderately differentiated acinar carcinoma; one case of small-cell carcinoma and one of cribriform carcinoma were noted. Direct immunohistochemical assessment of tumor tissue was performed, and the correlation between monoclonal and polyclonal antibody staining was assessed. In seven of the eight cases, monoclonal antibodies showed no convincing staining, while all but one (small cell) were positive for polyclonal stains.