Cancer Control Outcomes Research Articles

Centralization of radical cystectomy for bladder cancer in a universal healthcare system: Early results from a Canadian academic center.

516 Background: Radical cystectomy for bladder cancer is a complex surgical oncology procedure. Centralization of this procedure to high volume, fellowship-trained surgeons may improve clinical outcomes. Our objective was to compare outcomes of radical cystectomy before and after centralization of care. Methods: A retrospective analysis of data from the University of Alberta Radical Cystectomy Database was performed. Eligible subjects were those with histologically proven urothelial carcinoma of the bladder (cTanyN1-3M0) undergoing curative intent surgery. Patients were classified into pre-centralization era (1994-2007; N = 523) and post-centralization era (2013-present; N = 134) cohorts for analyses. Pre-centralization era patients were treated by 1 of 11 urologic surgeons at 2 academic teaching hospitals. Post-centralization era patients were treated by 1 of 2 fellowship-trained urologic oncologists at 1 academic teaching hospital. Outcomes were overall survival, 90-day mortality rate, positive surgical margin (R1) resection rate, total number of lymph nodes evaluated, and 90-day blood product transfusion rate. The Kaplan-Meier method and multivariable regression analyses were used to analyze survival outcomes. Statistical tests were two-sided (p≤0.05). Results: The median follow-up duration in the pre- and post-centralization era was 33 months and 16 months, respectively. The predicted 2-year overall survival rate was 62% in the pre-centralization era and 84% in the post-centralization era (Log rank P = 0.0007; multivariable HR 0.40, 95% CI 0.24 to 0.68, P < 0.0001). Treatment in the post-centralization era was associated with lower 90-day mortality (6.3% versus 1.5%, multivariable OR 0.23, 95% CI 0.06 to 0.99, P = 0.049), R1 resection (13.0% versus 1.5%; multivariable OR 0.07, 95% CI 0.01 to 0.51, P = 0.009), and 90-day blood product transfusion (59% versus 6%, P < 0.0001) as well as higher total number of lymph nodes evaluated (7 versus 30 lymph nodes, P < 0.0001). Conclusions: Surgical treatment in the post-centralization era was associated with superior survival, cancer control, and perioperative outcomes.

A decision-support tool to assist muscle-invasive bladder cancer patients choosing between radical cystectomy and chemoradiotherapy.

505 Background: Patients with high-risk muscle-invasive bladder cancer (MIBC) who are borderline medically operable for radical cystectomy (RC) face a difficult decision between RC which has higher short-term treatment-related morbidity/mortality & chemoradiotherapy (CRT) which is better tolerated in the short-term but may have worse long-term cancer control outcomes. There are no existing decision support tools to assist patients & providers in understanding these trade-offs. Herein, we developed a visualization tool to inform patients & providers how the relative risks & benefits of RC & CRT vary over time with respect to overall survival (OS). Methods: We identified cT2-3 N0 M0 urothelial bladder cancer patients ≥65 y/o treated with RC +/- chemo (n = 5981) or definitive-dose CRT after TURBT (n = 793) in the National Cancer Database, 2003-2011. The database was split into a development & validation cohort. Multivariate Cox regression with time-varying hazard ratio was performed to assess pre-treatment factors associated with OS. The inverse probability of treatment weighting method using the propensity score was employed to reduce selection bias. External validation was performed. Visualization tool showing adjusted survival curves based on pre-op patient features was generated with input from patients & a multidisciplinary expert panel. Tool calculates median OS & the “break-even point,” where the short-term OS disadvantage of RC equals the long-term advantage of RC (i.e. the point where the restricted mean survival for RC & CRT are equal). Results: On MVA, significant predictors of OS were age, Charlson Deyo comorbidity index, & cT stage (p < 0.001 for all). Using these results, we iteratively developed a web application that utilizes clinical inputs to generate patient-specific survival curves that display estimated OS differences over time. Median OS, the break-even point, & percent alive at the break-even point are provided. Conclusions: This is the first decision-support tool developed to assist high-risk borderline operable MIBC patients & their providers in understanding the short-term & long-term trade-offs between RC & CRT. Additional testing is underway.

Long-term outcomes of magnetic resonance image-guided partial prostate brachytherapy for favorable-risk prostate cancer.

138 Background: To report long-term outcomes of magnetic resonance image-guided partial prostate brachytherapy of the peripheral zone. Methods: We conducted an institutional-board approved retrospective review of all men who underwent 0.5 Tesla GE Signa SP MRI-guided partial prostate brachytherapy to the peripheral zone. We estimated actuarial rates of biochemical progression (nadir +2 definition), as well as cumulative incidences of biopsy proven local recurrence, distant metastasis, and prostate cancer specific mortality. Fine and Gray’s competing risk regression was utilized in order to evaluate clinical factors associated with times to metastasis and prostate cancer specific mortality. Results: Between 1997 and 2008, 354 men underwent MRI-guided partial prostate brachytherapy. The numbers of patients with low and intermediate risk disease were 295 (83%) and 59 (17%), respectively. Sixty-seven (19%) patients received supplemental external beam radiotherapy. The median follow-up was 8.6 years. For National Cancer Center Network (NCCN) low risk-disease, 8-year estimates of biochemical progression, local recurrence, metastasis, and prostate cancer specific mortality were 23.5% (17.4-29.1), 6.4% (3.6-10.2), 2.0% (0.6-4.8), and 0%. Corresponding estimates for intermediate risk disease were 51.2% (31.3-65.4), 21.2% (10.2-34.9), 6.6% (1.7-16.3), and 5.4% (0.9-16.2). Twenty of 45 biopsy proven local recurrences occurred outside of the implanted peripheral zone. Of the 22 patients who developed distant metastases, 14 events occurred more than 10 years from therapy. On multivariate analyses, biopsy proven local recurrence was the only factor to demonstrate a significant association with metastasis (hazard ratio 2.50; p = 0.05) and a trend with prostate cancer specific mortality (5.02; p = 0.09). Conclusions: MRI-guided partial prostate brachytherapy to the peripheral zone in men with favorable risk prostate cancer is suboptimal with respect to long term cancer control outcomes. Additional studies using contemporary MRI techniques including 3 Tesla based multi-parametric imaging and fusion biopsy may lead to improved outcomes.

Outcomes and toxicities in patients with intermediate-risk prostate cancer treated with brachytherapy alone or brachytherapy and supplemental external beam radiation therapy.

To evaluate the cancer control outcomes and long-term treatment-related morbidity of brachytherapy as well as combination brachytherapy and external beam radiation therapy (EBRT) in patients with intermediate-risk prostate cancer. A retrospective review was conducted in a prospectively collected database of patients with intermediate-risk prostate cancer who were treated either with brachytherapy or brachytherapy and EBRT, with or without androgen deprivation therapy (ADT), in the period 1990-2014. Urinary and erectile dysfunction symptoms were measured using the International Prostate Symptom Score (IPSS), the Mount Sinai erectile function scale and the Sexual Health Inventory for Men (SHIM). Cancer control endpoints included biochemical failure and development of distant metastases. All statistical analyses were carried out using the Statistical Package for Social Science (SPSS). Survival curves were calculated using Kaplan-Meier actuarial methods and compared using log-rank tests. Cox regression multivariate analyses were used to test the effect of multiple variables on treatment outcomes. A total of 902 patients were identified, with a median follow-up of 91 months. Of these, 390 received brachytherapy and 512 received combination therapy with EBRT. In patients with one intermediate-risk factor, the addition of EBRT did not significantly affect freedom from biochemical failure or distant metastases. Among patients with two or three intermediate-risk factors, added EBRT did not improve freedom from biochemical failure. Significant differences in late toxicity between patients treated with brachytherapy vs combination brachytherapy and EBRT were identified including urge incontinence (P < 0.001), haematuria (P < 0.001), dysuria (P < 0.001), and change in quality-of-life IPSS (P = 0.002). These symptoms were reported by patients at any point during treatment follow-up. Analysis of patients who were potent before treatment using actuarial methods showed that patients receiving combination therapy more frequently experienced loss of potency, as measured by the Mount Sinai erectile function scale (P = 0.040). Brachytherapy monotherapy results in equal biochemical and distant control in both patients with one and more than one intermediate-risk features. While no significant benefit was shown, we believe that the addition of EBRT may prevent recurrence in patients with multiple intermediate-risk features and should be considered.

Adjuvant Therapies in Nonmetastatic Renal-Cell Carcinoma: A Review of the Literature

To conduct a review of literature on adjuvant therapy in nonmetastatic renal-cell carcinoma (nmRCC) treated with nephrectomy and to describe the efficacy of adjuvant agents on cancer control outcomes. A review of the literature was performed in January 2018 to identify all studies evaluating adjuvant therapy in patients with nmRCC treated with nephrectomy using PubMed, Embase, Medline, and Cochrane Library databases. The following keywords were used: adjuvant therapy, renal-cell carcinoma, nonmetastatic, targeted molecular therapy, kidney cancer. The ClinicalTrials.gov website was queried to identify ongoing trials. Traditional adjuvant therapy agents consisted of interferon α, interleukin 2, autologous tumor cell vaccines, and monoclonal antibodies. None provided survival benefit. Three contemporary studies (S-TRAC, ASSURE, and PROTECT) using targeted therapy compared sunitinib to placebo (S-TRAC), sunitinib or sorafenib to placebo (ASSURE), and pazopanib to placebo (PROTECT), with controversial results. In contrast to ASSURE and PROTECT, S-TRAC demonstrated improved disease-free survival. Several trials that use checkpoint immunotherapy agents or vascular endothelial growth factor receptor tyrosine kinase inhibitors are ongoing. Many traditional therapies have shown no success as adjuvant therapy for nmRCC after nephrectomy. Targeted adjuvant therapy for nmRCC after nephrectomy showed controversial results, and its routine use is not currently endorsed.

Focal cryotherapy: step by step technique description

ABSTRACTIntroduction and objective:Focal cryotherapy emerged as an efficient option to treat favorable and localized prostate cancer (PCa). The purpose of this video is to describe the procedure step by step.Materials and methods:We present the case of a 68 year-old man with localized PCa in the anterior aspect of the prostate.Results:The procedure is performed under general anesthesia, with the patient in lithotomy position. Briefly, the equipment utilized includes the cryotherapy console coupled with an ultrasound system, argon and helium gas bottles, cryoprobes, temperature probes and an urethral warming catheter. The procedure starts with a real-time trans-rectal prostate ultrasound, which is used to outline the prostate, the urethra and the rectal wall. The cryoprobes are pretested and placed in to the prostate through the perineum, following a grid template, along with the temperature sensors under ultrasound guidance. A cystoscopy confirms the right positioning of the needles and the urethral warming catheter is installed. Thereafter, the freeze sequence with argon gas is started, achieving extremely low temperatures (-40°C) to induce tumor cell lysis. Sequentially, the thawing cycle is performed using helium gas. This process is repeated one time. Results among several series showed a biochemical disease-free survival between 71-93% at 9-70 month- follow-up, incontinence rates between 0-3.6% and erectile dysfunction between 0-42% (1–5).Conclusions:Focal cryotherapy is a feasible procedure to treat anterior PCa that may offer minimal morbidity, allowing good cancer control and better functional outcomes when compared to whole-gland treatment.

Evaluation of Single Fraction High-Gradient Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-Risk Stage 0 and I Breast Cancer—Early Results of a Single Institution Prospective Clinical Trial

To test the hypothesis that a single fraction of external beam radiotherapy to breast tissue one centimeter around a partial mastectomy cavity will result in acceptable ipsilateral breast tumor recurrence rates, tolerance, and cosmesis in select women with low-risk early stage breast cancer. Postmenopausal women undergoing breast conserving surgery for breast cancers less than or equal to 2 cm in size were enrolled in a single institution prospective clinical trial. Patients had to be at least 50 years old and have estrogen receptor positive cancers without her2/neu gene amplification. Radiotherapy was administered with MR-guided teletherapy except in cases were MR was contraindicated in the outpatient setting within 8 weeks of surgery. Surgical margins were required to be negative by at least 2 mm. A dose of 20 Gy was prescribed to a planning target volume (PTV) defined as the surgical cavity truncated as least 5 mm from the skin surface while simultaneously prescribing a dose of 7 Gy to the surface of a PTV defined as a 1 cm expansion of the surgical cavity in breast tissue truncated 5 mm from the skin surface. The resulting high-gradient treatment was administered in a single fraction as the sole radiotherapy treatment. To date 19 of a planned total fifty women have been treated. The mean age was 64 years. Three patients had pTisN0, 10 pT1bN0, and 6 pT1cN0 disease. MR-guided teletherapy via Cobalt-60 was used in all but one patient who had a pacemaker. With a mean and median follow up time of 10.3 and 10 months from diagnosis there have been no breast cancer recurrences and no intercurrent deaths. No patient has been lost to follow up. All toxicities have been grade 1 with six patients having skin hyperpigmentation in the treatment region and three having transient breast pain. Cosmesis has remained excellent in all patients. Early results of our trial demonstrate that a single fraction of high-gradient radiotherapy is well tolerated. Continued enrollment and follow up is needed to determine cancer control outcomes.

Outcomes After Cryoablation Versus Partial Nephrectomy for Sporadic Renal Tumors in a Solitary Kidney: A Propensity Score Analysis

BackgroundWhile partial nephrectomy (PN) is considered the standard approach for a tumor in a solitary kidney, percutaneous cryoablation (PCA) is emerging as an alternative nephron-sparing option. ObjectiveTo compare outcomes between PCA and PN for tumors in a solitary kidney. Design, setting, and participantsPatients who underwent PCA or PN between 2005 and 2015 for a single primary renal tumor in a solitary kidney were identified using Mayo Clinic Registries. Exclusion criteria were inherited tumor syndromes and salvage procedures. InterventionPCA and PN. Outcome measurements and statistical analysisTo achieve balance in baseline characteristics, we used inverse probability of treatment weighting (IPTW) based on propensity to receive treatment. The risk of having a post-treatment complication and percent drop in estimated glomerular filtration rate (eGFR), as well as the risks of local/ipsilateral recurrence, distant metastasis, and cancer-specific mortality, were compared between groups using logistic, linear, and Fine-and-Gray competing risk regression models. Results and limitationsThe cohort included 118 patients (PCA: 54; PN: 64) with a median follow-up of 47 mo (interquartile range 18, 74). In unadjusted analyses, PCA was associated with a lower risk of complications (15% vs 31%; odds ratio [OR]=0.38; 95% confidence interval [CI] 0.15, 0.96; p=0.04). However, upon accounting for baseline differences with IPTW adjustment, there was no longer a significant difference in the risk of complications (28% vs 29%; OR=0.95; 95% CI 0.53, 1.69; p=0.9). There were no significant differences between PCA and PN in percentage drop in eGFR at discharge (mean: 11% vs 16%; β=–5%; 95% CI –13, 3; p=0.2) or at 3 mo (12% vs 9%; β=3%; 95% CI –3, 10; p=0.3). Likewise, no significant differences were noted in local recurrence (HR=0.87; 95% CI 0.38, 1.98; p=0.7), distant metastases (HR=0.60; 95% CI 0.30, 1.20; p=0.2), or cancer-specific mortality (HR=1.13; 95% CI 0.32, 3.98; p=0.8). Limitations include the sample size, given the relative rarity of renal masses in solitary kidneys. ConclusionsOur study found no significant difference in complications, renal function outcomes, and oncologic outcomes between PN and PCA for patients with a tumor in a solitary kidney. Validation in a larger multi-institutional analysis may be warranted. Patient summaryPartial nephrectomy (surgery) and percutaneous cryoablation are both options for treating a kidney tumor while preserving the normal portion of the kidney. In patients with a tumor in their only kidney, we found no difference in the risk of complications, kidney function outcomes, or cancer control outcomes between these two approaches.

Efficacy of Local Treatment in Prostate Cancer Patients with Clinically Pelvic Lymph Node-positive Disease at Initial Diagnosis

BackgroundThere is limited evidence supporting the use of local treatment (LT) for prostate cancer (PCa) patients with clinically pelvic lymph node-positive (cN1) disease. ObjectiveTo examine the efficacy of any form of LT±androgen deprivation therapy (ADT) in treating these individuals. Design, setting, and participantsUsing the National Cancer Database (2003–2011), we retrospectively identified 2967 individuals who received LT±ADT versus ADT alone for cN1 PCa. Only radical prostatectomy (RP) and radiation therapy (RT) were considered as definitive LT. InterventionLT±ADT versus ADT alone. Outcome measurements and statistical analysisInstrumental variable analyses (IVA) were performed using a two-stage residual inclusion approach to compare overall mortality (OM)-free survival between patients who received LT±ADT versus ADT alone. The same methodology was used to further compare OM-free survival between patients who received RP±ADT versus RT±ADT. Results and limitationsOverall, 1987 (67%) and 980 (33%) patients received LT±ADT and ADT alone, respectively. In the LT±ADT group, 751 (37.8%) and 1236 (62.2%) patients received RP±ADT and RT±ADT, respectively. In IVA, LT±ADT was associated with a significant OM-free survival benefit (hazard ratio=0.31, 95% confidence interval [CI]=0.13–0.74, p=0.007), when compared with ADT alone. At 5 yr, OM-free survival was 78.8% (95% CI: 74.1–83.9%) versus 49.2% (95% CI: 33.9–71.4%) in the LT±ADT versus ADT alone groups. When comparing RP±ADT versus RT±ADT, IVA showed no significant difference in OM-free survival between the two treatment modalities (hazard ratio=0.54, 95% CI=0.19–1.52, p=0.2). Despite the use of an IVA, our study may be limited by residual unmeasured confounding. ConclusionsOur findings show that PCa patients with clinically pelvic lymph node-positive disease may benefit from any form of LT±ADT over ADT alone. While not necessarily curative by itself, the use of RP or RT could be the first step in a multi-modality approach aiming at providing the best cancer control outcomes for these individuals. Patients summaryWe examined the role of local treatment for clinically pelvic lymph node-positive prostate cancer. We found that the delivery of radical prostatectomy or radiation therapy may be associated with an overall mortality-free survival benefit compared with androgen deprivation therapy alone.

Marital status and gender affect stage, tumor grade, treatment type and cancer specific mortality in T1-2 N0 M0 renal cell carcinoma.

To examine the effect of marital status and gender on stage at diagnosis, tumor grade, treatment type and cancer specific mortality (CSM) in patients with localized renal cell carcinoma (RCC). Within Surveillance, Epidemiology, and End Results registry (2001-2013), we identified 57,700 patients with T1-2 N0 M0 RCC. Logistic regression and competing-risks regression models tested the effect of marital status and gender on stage, tumor grade, treatment type and cancer specific mortality (CSM). Of all patients, 8.8, 10.6 and 14.8% were, respectively, widowed, separated/divorced and never married. The three categories accounted for 3.9, 9.0 and 14.9% of males (35,641) and for 16.7, 13.1 and 14.7% of females (22,059). Widowed (OR 1.13, p=0.04), separated/divorced (OR 1.16, p=0.02) and never married status (OR 1.38, p<0.001) predisposed to higher rate of no surgical treatment. Widowed (HR 1.32, p<0.001) and separated/divorced (HR 1.32, p<0.001) status predisposed to higher CSM. Male gender predisposed to higher T-stage (OR 1.12, p<0.001), higher tumor grade (OR 1.35, p<0.001), no surgical treatment (OR 1.23, p<0.001) and higher CSM (1.13, p=0.01). Interaction tests between gender and marital status failed to reach independent predictor status in all analyses. Male patients are at higher risk of less favorable baseline characteristics. Additionally, male, widowed and separated/divorced patients exhibit worse cancer control outcomes after treatment for T1-2 N0 M0 RCC. These observations indicate the need of more focused attention to those patients prior to, as well as after treatment for localized RCC.

Two-year clinical outcomes of de-intensified chemoradiotherapy for low-risk HPV-associated oropharyngeal squamous cell carcinoma.

6044 Background: We here-in report 2 year cancer control outcomes from a prospective phase II clinical trial evaluating de-intensified chemoradiotherapy (CRT) for patients with favorable risk, HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). Methods: The major inclusion criteria were: T0-T3, N0-N2c, M0, HPV or p16 positive, and minimal smoking history. Treatment was limited to 60 Gy intensity modulated radiotherapy with concurrent weekly intravenous cisplatin (30 mg/m2). Patients neither received induction chemotherapy nor definitive surgery. The primary study endpoint was pathologic complete response rate (pCR) based on required biopsy of the primary site and dissection of pretreatment positive lymph node regions, regardless of radiographic response. Secondary endpoint measures included 2 year local control (LC), regional control (RC), cause specific survival (CSS), distant metastasis free survival (DMFS), and overall survival (OS), and patient reported symptoms (PRO-CTCAE) and quality of life (EORTC QLQ-C30 &amp; H&amp;N35). Results: Forty-four patients enrolled and the median f/u was 36 months (range 5-53 months, 93% with &gt; / = 1 year, 88% &gt; / = 2 years). We have previously reported the pCR to be ~ 86%. Two year LC, RC, CSS, DMFS, and OS are the following: 100%, 100%, 100%, 100%, and 95%. All 6 patients who had pathological partial responses are alive with no evidence of disease with a median f/u of 34 months (range 9-48 months). Two patients have died (stroke and glioblastoma). Mean pre and 2-year post EORTC QOL scores were: Global 80/82 (lower worse), Swallowing 11/10 (higher worse), Dry Mouth 16/54, and Sticky Saliva 6/33. 39% of patients required a feeding tube (none permanent) for a median of 15 weeks (5 - 22 weeks). Mean pre and 2 year post PRO-CTCAE (1 to 4 scale, higher worse) scores were: Swallowing 0.4/0.8 and Dry mouth 0.4/1.8. There were no &gt; / = Grade 3 late adverse events. Conclusions: The 2-year clinical outcomes with decreased intensity of therapy with 60 Gy of IMRT and weekly low-dose cisplatin are excellent in favorable risk OPSCC with evidence of better preservation of quality of life as compared to standard therapies. Clinical trial information: NCT01530997 .

Contemporary Incidence and Cancer Control Outcomes of Primary Neuroendocrine Prostate Cancer: A SEER Database Analysis.

Neuroendocrine carcinoma of the prostate (NEPC) is a rare entity. We aimed at providing contemporary data on incidence and survival figures of de-novo NEPC. Within the Surveillance, Epidemiology, and End Results (SEER) database, we identified 309 individuals with de-novo NEPC diagnosed between 2004 and 2013. We evaluated age-adjusted incidence rates over the study. Kaplan-Meier analyses assessed overall survival (OS) after stratification according to histologic subtype, metastatic status, and treatment. Cox regression analyses tested the predictors of overall mortality, after adjusting for confounders. A total of 309 cases of NEPC were identified from 510,913 cases of prostate cancer. Metastatic disease was identified in 198 (64.1%) cases. The most common histologic subtype (n= 186; 60.2%) was small-cell carcinoma (SCC). The age-adjusted incidence of NEPC significantly increased over the study span. However, this increase only affected SCC (from 0.13/1,000,000 person-years in 2004 to 0.30/1,000,000 person-years in 2013; P= .001). Median survival for NEPC was 10 months. After stratification by metastatic status, no difference was observed according to SCC versus non-SCC. Treatment with radical prostatectomy improved OS only among individuals with non-metastatic disease, whereas radiation therapy did not affect OS rates. In multivariable Cox regression analyses predicting overall mortality, metastatic stage (hazard ratio, 1.52; 95% confidence interval, 1.12-2.06; P< .01) and radical prostatectomy (hazard ratio, 0.38; 95% confidence interval, 0.20-0.74; P< .01) achieved independent predictor status. De-novo NEPC is extremely rare and will be encountered in clinical practice by few urologists. Most cases are metastatic at diagnosis. Prognosis is poor regardless of histologic type, especially in metastatic stage.

Functional Outcomes Following Nerve Sparing Prostatectomy Augmented with Seminal Vesicle Sparing Compared to Standard Nerve Sparing Prostatectomy: Results from a Randomized Controlled Trial

Seminal vesicle sparing may reduce the risk of neurovascular bundle injury and improve functional outcomes after prostatectomy. While several observational studies have shown better functional outcomes following seminal vesicle sparing approaches, evidence from randomized trials is lacking. We performed a randomized controlled trial comparing functional and cancer control outcomes between nerve sparing prostatectomy augmented with seminal vesicle sparing and standard nerve sparing prostatectomy. A total of 140 men with early stage prostate cancer were enrolled in a randomized phase II trial comparing nerve sparing prostatectomy augmented with seminal vesicle sparing to standard nerve sparing prostatectomy. Patient reported sexual and urinary functional scores were assessed prior to surgery, and 6 and 12 months postoperatively. Surgical margin status and prostate specific antigen recurrence were evaluated as secondary outcomes. There were no differences in sexual or urinary function scores after surgery between the study groups. The median urinary incontinence domain score was 92 in the nerve sparing group and 87.5 in the nerve plus seminal vesicle sparing group at 12 months (p = 0.77). Median sexual function domain scores were 73.7 in the nerve sparing group and 77.1 in the nerve sparing plus seminal vesicle sparing group at 12 months (p = 0.29). Margin status and 12-month biochemical recurrence were similar in the groups. Recovery of continence and sexual function was similar between the groups in this randomized controlled trial. Seminal vesicle sparing did not negatively affect margin status or 12-month biochemical (prostate specific antigen) recurrence. These results suggest limited usefulness of seminal vesicle sparing prostatectomy.

MP53-18 EFFICACY OF LOCAL TREATMENT IN PROSTATE CANCER PATIENTS WITH CLINICALLY PELVIC LYMPH NODE-POSITIVE DISEASE AT INITIAL DIAGNOSIS

Abstract Background There is limited evidence supporting the use of local treatment (LT) for prostate cancer (PCa) patients with clinically pelvic lymph node-positive (cN1) disease. Objective To examine the efficacy of any form of LT±androgen deprivation therapy (ADT) in treating these individuals. Design, setting, and participants Using the National Cancer Database (2003–2011), we retrospectively identified 2967 individuals who received LT±ADT versus ADT alone for cN1 PCa. Only radical prostatectomy (RP) and radiation therapy (RT) were considered as definitive LT. Intervention LT±ADT versus ADT alone. Outcome measurements and statistical analysis Instrumental variable analyses (IVA) were performed using a two-stage residual inclusion approach to compare overall mortality (OM)-free survival between patients who received LT±ADT versus ADT alone. The same methodology was used to further compare OM-free survival between patients who received RP±ADT versus RT±ADT. Results and limitations Overall, 1987 (67%) and 980 (33%) patients received LT±ADT and ADT alone, respectively. In the LT±ADT group, 751 (37.8%) and 1236 (62.2%) patients received RP±ADT and RT±ADT, respectively. In IVA, LT±ADT was associated with a significant OM-free survival benefit (hazard ratio=0.31, 95% confidence interval [CI]=0.13–0.74, p =0.007), when compared with ADT alone. At 5 yr, OM-free survival was 78.8% (95% CI: 74.1–83.9%) versus 49.2% (95% CI: 33.9–71.4%) in the LT±ADT versus ADT alone groups. When comparing RP±ADT versus RT±ADT, IVA showed no significant difference in OM-free survival between the two treatment modalities (hazard ratio=0.54, 95% CI=0.19–1.52, p =0.2). Despite the use of an IVA, our study may be limited by residual unmeasured confounding. Conclusions Our findings show that PCa patients with clinically pelvic lymph node-positive disease may benefit from any form of LT±ADT over ADT alone. While not necessarily curative by itself, the use of RP or RT could be the first step in a multi-modality approach aiming at providing the best cancer control outcomes for these individuals. Patients summary We examined the role of local treatment for clinically pelvic lymph node-positive prostate cancer. We found that the delivery of radical prostatectomy or radiation therapy may be associated with an overall mortality-free survival benefit compared with androgen deprivation therapy alone.

619 - Incidence rates and cancer control outcomes of contemporary primary neuroendocrine prostate cancer: Analysis of SEER database

619 - Incidence rates and cancer control outcomes of contemporary primary neuroendocrine prostate cancer: Analysis of SEER database

Long-term cancer control outcomes of robot-assisted radical prostatectomy for prostate cancer treatment: a meta-analysis.

Robot-assisted radical prostatectomy (RARP) provides significant advantages in short-term oncological outcomes for prostate cancer patients. However, data regarding the long-term cancer control outcomes of RARP are limited and inconsistent. This study aimed to evaluate these long-term outcomes. Medline, Scopus, and other databases were searched for studies published from January 2010 to July 2016. Case series and prospective cohort studies on the long-term cancer control outcomes of patients who underwent RARP were subjected to meta-analyses by using the R statistical software. The rates of 5- and 10-year biochemical recurrence-free survival (BCRFS) and cancer-specific survival (CSS) were extracted from the included studies to assess these outcomes. Twenty studies involving RARP with more than 5years of follow-up were included. The pooled proportions of the 5-year BCRFS and CSS from 20 and 4 studies on RARP were 80% [95% confidence interval (CI) 0.77-0.82] and 97% (95% CI 0.96-0.98), respectively. The 10-year BCRFS rate from 5 studies was 79% (95% CI 0.72-0.86). Compared with the rate observed in open radical prostatectomy (ORP), the pooled 5-year BCRFS rate in the RARP group from 5 studies was significantly increased (P<0.001, odds ratio 1.10, 95% CI 1.03-1.16). Their survival hazard ratios did not significantly differ (log rank P>0.05). The effect size of the 5-year BCRFS was greater in the samples from the USA than in the samples from other regions (Z=-10.424, P<0.001). Publication date and clinical baselines, including preoperative PSA, Gleason scores, pathological stage, margin positive rate, lymph-node positive rate, and adjuvant therapy, also influenced the effect size of BCRFS (P<0.001). The meta-analysis of long-term cancer control outcomes demonstrated that RARP yielded satisfactory long-term BRFS and CSS, although the former was influenced by clinical baselines and unbalanced operative technological advantages in different study regions and years. The long-term BCRFS rates of RARP were higher than those of ORP, but the advantages of these survivals from these procedures were similar.

Abstract P1-11-05: Influence of race and age on mastectomy rates in women with stage I, hormone-sensitive breast cancers: A SEER-based study

Abstract Background: Breast conserving therapy (lumpectomy [L] and breast radiotherapy [RT]) results in equivalent cancer control outcomes in comparison to mastectomy (M) for early stage breast cancer (BC) based on randomized controlled trials (RCT). Since 2004, RCT support that L alone without RT yields equivalent survival and acceptable local regional outcomes in women ≥70 years old with stage I (T1N0) hormone-sensitive (HS) BC on endocrine therapy. Based on this, we hypothesized that M rates should decrease substantially in this low risk elderly population and sought to examine the influence of race on M rates in this group and how these trends compare to younger aged Stage I HS patients. Methods: We used the Surveillance Epidemiology and End Results (SEER) registry data to conduct this study. We included women with T1N0 HS BC classified as either ER-positive or PR-positive from 2000-2012 divided into 2 age groups [elderly (≥70 years old) and non-elderly (20-69 years old)] and 3 race groups [white, black, and Asian-Pacific-Islander/American Indian/Alaskan Native (API)]. We compared M rates in women diagnosed before 2004 compared to those diagnosed from 2005-2012. Statistical analyses were performed using differences in proportions (p&amp;lt;0.05 considered statistically significant). Results: 261,079 women met the study criteria (N=87,009 elderly; N=174,070 non-elderly). In elderly Stage I HS BC, a 5.2% reduction in the M rate is seen: 32.6% before 2004 to 27.4% after 2004 (p&amp;lt;0.0001). M rates remained higher (with less reduction) in elderly Black (30.8 %) and API (33.6 %) vs. White (26.8%) [p&amp;lt;0.0001 for White vs. Black and for White vs. API]. In non-elderly Stage I HS BC, after 2004 M rates increased from 29.2% to 31.8% (p&amp;lt;0.0001). Non-elderly white women had the largest absolute increase in M rates (31.2% vs. 28.5%, p&amp;lt;0.0001) followed by API women (35.1% vs. 37.1%, p=0.0222). M rates did not change after 2004 in non-elderly black women (31.7% vs. 31.7%, p=0.9953). Conclusions: In patients with favorable stage I HS BC, M rates have decreased only modestly in elderly women since 2004 when L alone w/o RT was established as appropriate treatment. In comparison, M has increased since 2004 in non-elderly women. These trends are driven mostly by white women in both the elderly and non-elderly. Further research is needed to identify why M, which is associated with higher cost and morbidity than L alone, has not changed substantially in elderly very favorable BC, particularly for non-whites. Citation Format: Bazan JG, Bittoni MA, Fisher JL, White JR. Influence of race and age on mastectomy rates in women with stage I, hormone-sensitive breast cancers: A SEER-based study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P1-11-05.

The Prognostic Factors of Biochemical Recurrence-Free Survival Following Radical Prostatectomy

Objective:To evaluate outcomes, biochemical recurrence-free survival (BCRFS) and to identify parameters influencing BCRFS of radical prostatectomy (RP) and bilateral pelvic lymph node dissection in a single-institution.Methods:A retrospective review of prostate cancer (PC) patients received RP was identified from the medical records. Data was collected from 2007 to 2016. 178 patients received RP were enrolled in a study. These patients were evaluated on efficacy of RP by using prostate-specific antigen (PSA) to analyze BCRFS and compared with Gleason score, pathologic staging, margin status and lymph node status with BCRFS.Results:The median follow up was 32.5 months (n = 178). Sixty-nine patients had extracapsular extension on pathologic results whereas 93 patients were classified as a high risk group. The median time for biochemical recurrence (BCR) was 22.3 months. The 3-year BCRFS in patients with a Gleason score 6, 3+4, 4+3, 8 and 9-10 were 85.8%, 84.6%, 78.7%, 53.3% and 35.8% . Multivariate analysis showed that extracapsular extension was independently associated with BCRFS.Conclusions:New group grading system indicates impact on BCRFS on univariate analysis but show negative impact on a multivariate Cox regression, only pathologic staging was independently associated with the cancer control outcome.

Factors Associated With the Use of Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer in Alberta, Canada: A Population-based Study.

BackgroundCancer care in Alberta, Canada is publicly funded and provides patients with access to health care facilities and providers. The distribution of patients and health services across Alberta presents challenges to the delivery of cancer care, especially radiation therapy. In this study, we examined the association between patient and health system factors, the use of radiation therapy and survival outcomes in patients with stage III non-small cell lung cancer (NSCLC).Patients and methodsThe provincial cancer registry was used to identify all patients who presented with clinical stage III NSCLC, diagnosed from 2005 to 2007, in Alberta. Patient characteristics, diagnostic method, treatment modality and treatment outcomes were collected from provincial health information systems for analyses. Factors influencing overall survival (OS) were analyzed using Cox proportional hazards models.ResultsNine hundred twenty-nine patients were identified. Sixty-two percent of patients received radiation therapy (RT) as part of their initial cancer treatment and had a median OS of 1.04 vs. 0.34 years with a hazard ratio (HR) of 0.54. On multivariable analysis, patients who were less likely to receive any therapy were older, had higher comorbidity scores and were registered in community cancer centers without radiation therapy infrastructure. Patients registered in tertiary cancer centers had a higher likelihood of accessing multimodality treatment than patients in community centers, with a statistical significance of P<0.001 after correcting for age, gender, histology, substage, and comorbidity.InterpretationImproving access to radiotherapy treatment for patients presenting to non-radiation therapy centers at diagnosis has the potential to decrease variations in cancer care and improve cancer control outcomes in clinical stage III NSCLC.

A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors

ABSTRACTConsumption of navy beans (NB) and rice bran (RB) have been shown to inhibit colon carcinogenesis. Given the overall poor diet quality in colorectal cancer (CRC) survivors and low reported intake of whole grains and legumes, practical strategies to increase consumption merit attention. This study determined feasibility of increasing NB or RB intake in CRC survivors to increase dietary fiber and examined serum inflammatory biomarkers and telomere lengths. Twenty-nine subjects completed a randomized controlled trial with foods that included cooked NB powder (35 g/day), heat-stabilized RB (30 g/day), or no additional ingredient. Fasting blood, food logs, and gastrointestinal health questionnaires were collected. The amount of NB or RB consumed equated to 4–9% of subjects' daily caloric intake and no major gastrointestinal issues were reported with increased consumption. Dietary fiber amounts increased in NB and RB groups at Weeks 2 and 4 compared to baseline and to control (P ≤ 0.01). Telomere length correlated with age and HDL cholesterol at baseline, and with improved serum amyloid A (SAA) levels at Week 4 (P ≤ 0.05). This study concludes feasibility of increased dietary NB and RB consumption to levels associated with CRC chemoprevention and warrants longer-term investigations with both foods in high-risk populations that include cancer prevention and control outcomes.