Anti-Androgen Therapy Overcomes the Time Delay in Initiation of Salvage Radiation Therapy and Rescues the Oncological Outcomes in Men with Recurrent Prostate Cancer After Radical Prostatectomy: A Post Hoc Analysis of the RTOG-9601 Trial Data.

BACKGROUND: It is unknown whether the addition of anti-androgen therapy (AAT) to late salvage radiation therapy (sRT) can lead to oncological outcomes equivalent to that of early sRT in men with recurrent prostate cancer (CaP) after surgery. METHODS: Data on 670 men who participated in the Radiation Therapy Oncology Group (RTOG)-9601 trial and who experienced biochemical recurrence were extracted using the National Clinical Trials Network (NCTN) data archive platform. Patients were stratified into four treatment groups: early sRT (pre-sRT prostate-specific antigen [PSA] < 0.7 ng/mL) and late sRT (pre-sRT PSA ≥ 0.7 ng/mL) with/without concomitant AAT, based on cut-offs reported in the original trial. Time-varying Cox proportional hazards and Fine-Gray competing-risk regression analyses assessed the adjusted hazards of overall mortality, CaP-specific mortality, and metastasis among the four treatment groups. RESULTS: At 15-years (median follow-up of 14.7 years), for patients treated with early sRT, early sRT with AAT, late sRT, and late sRT with AAT, the overall mortality, CaP-specific mortality, and metastasis rates were 22.9, 22.8, 40.1, and 22.9% (log-rank p = 0.0039), 12.1, 3.9, 22.7, and 8.0% (Gray's p = 0.0004), and 18.8, 14.6, 35.9, and 19.5% (Gray's p = 0.0004), respectively. Time-varying multivariable adjusted analysis demonstrated increased hazards of overall mortality in patients receiving delayed sRT versus early sRT (hazards ratio [HR] 1.49, 95% confidence interval [CI] 1.02-2.17); however, no difference remained after the addition of concomitant AAT to late sRT (HR 0.85, 95% CI 0.55-1.32, referent early sRT). Likewise, the hazards of cancer-specific mortality and metastatic progression were worse for late sRT when compared with early sRT, but were no different after the addition of AAT to late sRT. CONCLUSIONS: Poorer outcomes associated with late sRT in men with recurrent CaP may be rescued by delivery of concomitant AAT.

Prevalence and factors associated with Trichomonas vaginalis infection among high-risk women in Los Angeles.

Remnant specimen from 1215 women screening for chlamydia/gonorrhea at 4 different venue types (sexually transmitted disease clinics, home-test kit users, juvenile and adult detention) in Los Angeles, California, were tested for Trichomonas vaginalis. Prevalence of T. vaginalis varied by screening population, and concurrent chlamydia or gonorrhea was independently associated with T. vaginalis.

Sexually transmitted infections and HIV prevalence among incarcerated men who have sex with men, 2000-2005.

OBJECTIVE: : Screening incarcerated populations, particularly men who have sex with men (MSM), for the identification, treatment, and prevention of sexually transmitted infections (STI) and HIV provides an effective way to access a hard-to-reach, high-risk population. GOAL: : To describe findings from a screening program designed to identify STIs and HIV among incarcerated MSM. STUDY DESIGN: : The Los Angeles County Sexually Transmitted Disease Program implemented a voluntary HIV and STI screening program in the segregated MSM unit of the Los Angeles County Men's Jail in March 2000. This analysis reports on data collected through December 2005. RESULTS: : Between March 2000 and December 2005, a total of 7004 inmates participated in the screening program. The overall positivity rate for chlamydia was 3.1% (127 of 4157) and 1.7% (69 of 4106) for gonorrhea. In addition, early syphilis was identified in 1.6% of inmates (95 of 6008) and the overall prevalence of HIV was 13.4% (625 of 4658). The level of repeat testing was relatively high with 15% (1048) of inmates repeatedly incarcerated and screened for STIs over the 5-year period. Although the seroprevalence of HIV was not significantly different between repeaters and nonrepeaters, 33 inmates were HIV seropositive after having tested negative at prior bookings, resulting in an HIV incidence of 1.9%. CONCLUSIONS: : Screening incarcerated MSM in Los Angeles revealed a high prevalence of STI and HIV infection. These inmates not only represent a high-risk group, but also a unique opportunity for the identification, treatment, and counseling of this hard-to-reach, high-risk population.

"Optimal" cytoreduction for advanced epithelial ovarian cancer: a commentary.

OBJECTIVE: To derive the most appropriate threshold to classify primary cytoreductive operations as "optimal" and address the clinical significance of this issue. METHODS: Criteria used to classify primary cytoreductive outcomes are reviewed. Survival outcomes are analyzed to address relative influences of the completeness of cytoreduction and "biological aggressiveness", as manifested by the extent of intra-abdominal metastases. RESULTS: Most cohorts analyzing relative influences of metastatic tumor burden and the dimension of residual disease on survival report completeness of cytoreduction to influence the prognosis more significantly than tumor burden, with necessity to perform various procedures having minimal or no influence. Equivalent survival is reported for completely cytoreduced patients with stage III disease whether substages IIIa/b (smaller tumor burden) are excluded or included. However, some stage IIIc series report more favorable median and 5-year survivals for small fractions of completely cytoreduced patients than series with a large visibly disease-free fraction. Increasing fractions of complete cytoreduction are reported in recent cohorts, without increase in morbidity. CONCLUSIONS: Complete primary cytoreduction improves the prognosis for survival significantly more than a small dimension of residual disease. Although prospective randomized trials addressing surgical issues have not been undertaken and numerous variables may reflect "biological aggressiveness" by influencing the prognosis, available data justify elimination of macroscopic disease to be the most appropriate objective of primary cytoreductive surgery. Stratification of survival by dimensions of residual disease in an investigational setting should include a visibly disease-free subgroup and if used, the term "optimal" should be applied to patients undergoing complete cytoreduction.

Splenectomy in the context of primary cytoreductive operations for advanced epithelial ovarian cancer.

OBJECTIVE: To determine if the need to perform splenectomy due to metastatic disease in the context of complete primary cytoreduction for ovarian cancer diminishes the prognosis for survival. METHODS: Between 1990 and 2004, 356 stage IIIC epithelial ovarian cancer patients underwent resection of all visible disease before systemic platinum-based combination chemotherapy. Forty-nine (13.8%) required a splenectomy due to metastatic disease. Survival was analyzed (log rank) on the basis of whether splenectomy was necessary. The frequency of performing other procedures, operative time, blood loss, transfusion rate, and hospitalization, was compared (Chi-square test; discrete and binomial data, t test; continuous data) on the basis of whether a splenectomy was required. RESULTS: Survival was not influenced (log rank) by the requirement of splenectomy (required; median 56.4 months, estimated 5-year survival of 48% vs. not required; median 76.8 months, estimated 5-year survival of 58% P = 0.4). The splenectomy subgroup more commonly required en-bloc resection of reproductive organs with rectosigmoid (89.8% vs. 55.7%, P < 0.001), diaphragm stripping (63.3% vs. 33.6%, <0.001)), full-thickness diaphragm resection (28.6% vs. 9.4%, P < 0.001), and resection of grossly positive retroperitoneal nodes (67.3% vs. 46.3%, P = 0.006). The splenectomy group had a longer operative time (238 min vs. 192 min, P = 0.004), estimated blood loss (1663 ml vs. 1167 ml, P = 0.001), transfusion rate (5.3 units prbc vs. 3.2 units prbc, P = 0.002), and hospitalization (16.1 vs. 12.2 days P = 0.001). CONCLUSIONS: The need for splenectomy to achieve complete cytoreduction is a reflection of advanced disease but is not a manifestation of tumor biology precluding long-term survival.

Relative influences of tumor volume before surgery and the cytoreductive outcome on survival for patients with advanced ovarian cancer: a prospective study.

OBJECTIVE: The purpose of this study was to determine the relative influences of the extent of disease present before surgery and completeness of cytoreduction on survival for patients with advanced ovarian cancer. METHODS: Patients (408) with stage IIIC epithelial ovarian cancer had cytoreductive surgery before systemic platinum-based combination chemotherapy. A ranking system (0-3) was devised to prospectively quantify the extent of disease involving: (1) right upper quadrant (diaphragm/hepatic, and adjacent peritoneal surfaces), (2) left upper quadrant (omentum/gastro-colic ligament, spleen, stomach, transverse colon, splenic flexure of colon), (3) pelvis (reproductive organs, recto-sigmoid, pelvic peritoneum), (4) retroperitoneum (pelvic/aortic nodes), and (5) central abdomen (small bowel, ascending/descending colon, mesentery, anterior abdominal wall, pericolic gutters). Survival was analyzed (log rank and Cox regression) on the basis of the rankings at these anatomic regions, the sum of intraabdominal rankings, and the cytoreductive outcome. RESULTS: Overall median and estimated 5-year survivals were 58.2 months and 49%. On univariate analysis, the central abdominal (P = 0.008) and left upper quadrant (P = 0.03) rankings, the sum of rankings (P = 0.01), and the cytoreductive outcome (P 1 cm residual, RR 2.98; P = 0.001). CONCLUSIONS: Cytoreduction to a visibly disease-free outcome has a more significant influence on survival than the extent of metastatic disease present before surgery. Operative efforts should not be abbreviated on the hypothesis that extensive disease at specific anatomic regions precludes long-term survival.

Reduction of blood loss during extensive pelvic procedures by aortic clamping--a preliminary report.

OBJECTIVE: The aim was to determine the effect of intraoperative aortic clamping during extensive pelvic procedures on blood loss, operative time, and morbidity. METHODS AND MATERIALS: Thirteen women with ovarian cancer, 1 with cervical cancer, and 1 with an extensive pelvic sarcoma had their aortas completely occluded with a vascular clamp before the pelvic phases of their operations. Heparin and protamine reversal were used. RESULTS: Patients requiring en bloc excision of the internal reproductive organs, pelvic peritoneum, and recto-sigmoid colon in the context of a cytoreductive operation had a median estimated total blood loss of 650 ml (range 200 to 3500), a median of 2 units (range 0 to 8) of blood transfused, and a median total operative time of 155 min (range 90 to 280). There were no complications due to the aortic clamping. CONCLUSION: Most procedures were completed with a less than anticipated blood loss and operative time. Clamping of the aorta may potentially diminish blood loss, operative time, and the incidence of transfusion-related morbidity associated with extensive pelvic operations. Intraoperative aortic clamping merits further investigation.

Prognostic factors following curative resection for pancreatic adenocarcinoma: a population-based, linked database analysis of 396 patients.

OBJECTIVE: To analyze prognostic factors influencing pancreatic cancer survival following curative resection, using prospectively collected, population-based data. SUMMARY BACKGROUND DATA: Several studies have analyzed the determinants of long-term survival in postresection pancreatic cancer patients, but the majority of these have been single-institutional chart reviews yielding inconsistent results. METHODS: This retrospective cohort study examined 396 Medicare-eligible patients over age 65 who were diagnosed with nonmetastatic pancreatic adenocarcinoma and who underwent surgical resection with curative intent while residing in one of the 11 Survival, Epidemiology, and End Results (SEER) registries between January 1991 and December 1996. Linked Medicare data provided information on treatment and comorbidity, while linked census tract data supplied sociodemographic characteristics. RESULTS: Median survival for the overall study population was 17.6 months, with 1- and 3-year survival rates of 60.1% and 34.3%, respectively. Survival appears to be gradually improving over time, concomitant with a rise in the proportion of patients undergoing surgery in teaching centers. Prognostic variables significantly diminishing survival on univariate analysis included African American race, treatment not in a teaching hospital, lack of adjuvant chemoradiation therapy, as well as histopathologic factors that included tumor size larger than 2 cm in diameter, moderate to poor histologic grade, and positive lymph node metastases. Higher socioeconomic status was associated both with an increased likelihood of receiving adjuvant therapy and improved overall survival. Multivariate analyses indicated the strongest predictors of survival were adjuvant combined chemoradiotherapy, small tumors (<2 cm in diameter), negative lymph nodes, well-differentiated histology, undergoing surgery in a teaching hospital, and high socioeconomic status. CONCLUSIONS: Although biologic characteristics remain important predictors of survival for patients with resected pancreatic cancer, the most powerful determinant is postoperative adjuvant chemoradiation therapy. An interesting finding that warrants further investigation is the effect of socioeconomic status on both the likelihood of receiving adjuvant treatment and subsequent survival, indicating a possible relationship between the quality of care delivered and outcomes.