Impact of decipher test on adjuvant and salvage treatments received following radical prostatectomy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 112-112 ◽  
Author(s):  
John L. Gore ◽  
Marguerite Du Plessis ◽  
Darlene Dai ◽  
Kasra Yousefi ◽  
Darby Thompson ◽  
...  
Keyword(s):  
High Risk ◽  
Radical Prostatectomy ◽  
Decisional Conflict ◽  
P Value ◽  
Salvage Radiation Therapy ◽  
Recommended Treatment ◽  
Patient Reported ◽  
The Us ◽  
Psa Progression ◽  
The Impact

112 Background: Prostate cancer (PC) patients and providers have tremendous uncertainty as they decide on intervention with adjuvant or salvage radiation therapy (ART, SRT) after radical prostatectomy (RP). We prospectively evaluated the impact of Decipher test, a genomic classifier which predicts metastasis post-RP, on providers’ decision-making for ART and SRT. Methods: 150 men considering ART and 115 men considering SRT from 19 sites across the US were enrolled. Participating providers submitted a management recommendation prior to processing the Decipher test and again after receiving test results. We then followed patients for 12 months to assess actual treatment received and patient reported decisional conflict scale (DCS) and a validated survey on PC-related anxiety. Results: Pre-Decipher, observation was recommended for 89% of adjuvant men and 58% of salvage men. Post-Decipher, 17% of treatment recommendations changed in the adjuvant arm and 30% of recommendations changed in the salvage arm. Among adjuvant men, 78% maintained their recommended management 12 months after Decipher; 76% of salvage men maintained their recommended treatment after Decipher. Among 21 adjuvant men who intensified their treatment (observation to ART or ART to ART plus androgen deprivation therapy), 5 (24%) experienced biochemical recurrence with detectable PSA. In adjuvant men, PC-specific anxiety decreased differently among Decipher risk categories (p-value = 0.045), most notably among Decipher high risk men (9.07 [7.87, 10.26] pre-Decipher, 5.61 [5.35,5.88] 12 months post-Decipher). In salvage men, PC-specific anxiety decreased differently among those whose treatment were concordant (10.28 [8.1,12.47] pre-Decipher, 7.18 [6.82,7.54] 12 months post-Decipher) and those whose treatment were intensified (p-value = 0.01), and decreased differently among low-risk and high-risk Decipher patients (p = 0.04). Conclusions: Use of the Decipher test changed treatment decisions that was consistent with the eventual treatment received in three-fourths of adjuvant and salvage men after RP. Several men that pursued ART experienced PSA progression. PC-specific anxiety decreased in both adjuvant and salvage men. Clinical trial information: NCT02080689.

Prospective randomized trial of genomic classifier impact on treatment decisions in patients at high risk of recurrence following radical prostatectomy (G-MINOR).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS154-TPS154 ◽  
Author(s):  
Todd Matthew Morgan ◽  
David Christopher Miller ◽  
Rodney Dunn ◽  
Linsell Susan ◽  
Linda Okoth ◽  
...  
Keyword(s):  
High Risk ◽  
Radical Prostatectomy ◽  
Treatment Decisions ◽  
Risk Of Recurrence ◽  
Clinical Center ◽  
Patient Reported ◽  
Impact On Treatment ◽  
The Impact

TPS154 Background: Approximately 30% of patients will have ≥pT3 disease and/or positive surgical margins at radical prostatectomy (RP), indicating a high risk of local recurrence. While current guidelines recommend consideration of adjuvant radiotherapy (aRT) in this setting, < 10% undergo aRT. The Decipher assay is a novel, tissue-based genomic classifier (GC) developed and validated in the post-RP setting as a predictor of metastasis. Current retrospective evidence suggests that patients with a high GC score may benefit from aRT, while observation may be safe for those with a lower GC score. However, there are no randomized prospective data evaluating the clinical utility of biomarkers in men with adverse features after RP. Here we see to determine the impact of GC test results on adjuvant treatment decisions for high-risk post-RP patients vs. clinical factors alone. Methods: Genomics in Michigan ImpactiNg Observation or Radiation (G-MINOR) is a 4-year (12-month enrollment, 3-year follow-up) prospective, cluster-crossover, unblinded, study of 350 subjects from twelve Urology practices in the Michigan Urological Surgery Improvement Collaborative (MUSIC). MUSIC is a physician-led quality improvement consortium nearly all academic and community urology practices within the state of Michigan. Each clinical center participating in this trial will be randomly assigned to either a Genomic Classifier (GC)-based strategy or control arm for a period of 3 months. Patients in both arms will receive a predicted risk of recurrence based on a validated clinical nomogram, the CAPRA-S score, enabling a head-to-head comparison of the Decipher assay with a freely-available validated prognostic tool. Random assignments will be generated centrally by a study statistician and provided to centers immediately before commencing enrollment in each 3-month period. Each center will have two GC and two UC enrollment periods, maintaining study-wide balance and blinding of assignments in subsequent periods. Patients will be followed for receipt of adjuvant therapy as well as oncologic (recurrence, metastasis, and death) and patient-reported quality of life. Clinical trial information: NCT02783950.

Effect of decipher test on adjuvant treatment decision-making among men with high-risk pathology at radical prostatectomy: Results from a multicenter prospective PRO-IMPACT study.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 24-24
Author(s):  
John L. Gore ◽  
Marguerite du Plessis ◽  
Maria Santiago-Jimenez ◽  
Kasra Yousefi ◽  
Darby Thompson ◽  
...  
Keyword(s):  
Decision Making ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Treatment Decision ◽  
Decisional Conflict ◽  
Low Risk ◽  
Decision Quality ◽  
Treatment Decision Making ◽  
Before And After ◽  
The Impact

24 Background: The decision to provide adjuvant therapy to men with high risk pathology after radical prostatectomy (RP) is confounded by tremendous uncertainty. We prospectively evaluated the impact of the Decipher test, which predicts metastases after RP, on men and providers decision quality. Methods: 150 adjuvant pts were enrolled by 43 urologists from 19 practices. Pts with pathologic T3 stage or positive surgical margins (SM+) after RP were included. Participating physicians provided a treatment (Tx) recommendation before and after exposure to Decipher test results. Pts completed validated surveys on health-related quality of life, decisional conflict, and PCa-related anxiety. Results: Median patient age at RP was 64 years; 67% and 50% had pT3 and SM+ pathology, respectively. Decipher classified 46%, 22% and 32% of men as low-, intermediate- and high-risk, respectively. Pre-Decipher, observation was recommended for 89%. Post-Decipher, 18% (95% CI 12-25%) of Tx recommendations changed. Men’s Decisional Conflict Scale (DCS) scores decreased (indicating higher decision quality) after exposure to Decipher results (median DCS pre-Decipher 25 [IQR 8-44], median DCS post-Decipher 19 [IQR 2-30], p<0.001), with greatest decreases in the subdomains of decision uncertainty and decision support. Low-risk Decipher results experienced a trend toward decreased PCa-specific anxiety (p=0.13) and a significant reduction in fear of PCa recurrence (p=0.02). Physicians’ median DCS scores decreased from 32 [IQR 28-36] to 28 [IQR 12-42] (p<0.001). Decipher results were associated with the decision to pursue ART in an MVA analysis (OR 1.48; 95% CI 1.19-1.85, p<0.001). Conclusions: Observation is the predominantly prescribed management strategy for men with high risk features at RP. Knowledge of Decipher results was associated with Tx decision-making: men at low risk for metastasis had higher rates of observation recommendations and men at high risk had higher rates of ART recommendations. Decision quality was improved and PCa-specific anxiety was decreased for men exposed to Decipher results. Clinical trial information: NCT02080689.

Effect of Using Silver Nylon Dressings on Postoperative Pain after Cesarean Delivery

2021 ◽  
Author(s):  
Sheila Connery ◽  
Jean Paul Tanner ◽  
Linda Odibo ◽  
Olivia Raitano ◽  
Dusan Nikolic-Dorschel ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Cesarean Delivery ◽  
Secondary Analysis ◽  
Single Site ◽  
Secondary Outcome ◽  
P Value ◽  
Scar Assessment ◽  
Patient Reported ◽  
The Impact ◽  
Nonopioid Analgesic

Objective Silver dressings have been associated with a decrease in postoperative pain in selected populations, but it is unknown if the benefit can be observed after cesarean deliveries. We sought to evaluate the impact of silver nylon dressings in reducing postoperative pain after cesarean delivery. Study Design A secondary analysis of data from a blinded randomized clinical trial of women undergoing cesarean delivery scheduled and unscheduled at a single site was conducted. Women were recruited for participation from a single site and randomized to a silver nylon dressing or an identical-appearing gauze wound dressing. Wounds were evaluated in the outpatient clinic at 1 and 6 weeks after delivery and patient responded to the modified patient scar assessment scale. The primary outcome of this analysis was inpatient opioid and nonopioid analgesic dispensed. The secondary outcome was patient-reported pain at the 1- and 6-week postpartum visits. Data were analyzed using chi-square test, Student's t-test, Fisher's exact test, Wilcoxon–Mann–Whitney's test, and logistic regression where appropriate. A p-value of < 0.05 was considered significant. Results Among the 649 participants, women allocated to the silver nylon dressing group, when compared with the gauze group, were similar in the amount of dispensed opioid and nonopioid analgesic medications (morphine equivalent milligrams of opioids dispensed [82.5 vs. 90 mg, p = 0.74], intravenous nonsteroidal anti-inflammatory drugs (NSAIDs) [120 vs. 120 mg, p = 0.55], and oral NSAIDs [4,800 vs. 5,600 mg in the gauze group, p = 0.65]). After adjusting for confounding variables, postoperative wound infection (adjusted odds ratio [aOR]: 11.70; 95% confidence interval [CI]: 4.51–30.31) at 1-week postoperative and again at 6-week postoperative (aOR: 5.59; 95% CI: 1.03–30.31) but not gauze dressing was associated with patient-reported postoperative pain. Conclusion Among women undergoing cesarean delivery, silver nylon dressing was not associated with a reduction in postoperative pain. Key Points

scholarly journals Adjuvant vs. salvage radiation therapy in men with high-risk features after radical prostatectomy: Survey of North American genitourinary expert radiation oncologists

2018 ◽  
Vol 13 (5) ◽  
Author(s):  
Shearwood McClelland 3rd ◽  
Kiri A. Sandler ◽  
Catherine Degnin ◽  
Yiyi Chen ◽  
Timur Mitin
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Radical Prostatectomy ◽  
North American ◽  
Randomized Clinical Trials ◽  
Current View ◽  
Adjuvant Radiation ◽  
Exact Test ◽  
Salvage Radiation Therapy ◽  
Radiation Oncologists

Introduction: The management of patients with high-risk features after radical prostatectomy (RP) is controversial. Level 1 evidence demonstrates that adjuvant radiation therapy (RT) improves survival compared to no treatment; however, it may overtreat up to 30% of patients, as randomized clinical trials (RCTs) using salvage RT on observation arms failed to reveal a survival advantage of adjuvant RT. We, therefore, sought to determine the current view of adjuvant vs. salvage RT among North American genitourinary (GU) radiation oncology experts. Methods: A survey was distributed to 88 practicing North American GU physicians serving on decision-making committees of cooperative group research organizations. Questions pertained to opinions regarding adjuvant vs. salvage RT for this patient population. Treatment recommendations were correlated with practice patterns using Fisher’s exact test. Results: Forty-two of 88 radiation oncologists completed the survey; 23 (54.8%) recommended adjuvant RT and 19 (45.2%) recommended salvage RT. Recommendation of active surveillance for Gleason 3+4 disease was a significant predictor of salvage RT recommendation (p=0.034), and monthly patient volume approached significance for recommendation of adjuvant over salvage RT; those seeing <15 patients/month trended towards recommending adjuvant over salvage RT (p=0.062). No other demographic factors approached significance. Conclusions: There is dramatic polarization among North American GU experts regarding optimal management of patients with highrisk features after RP. Ongoing RCTs will determine whether adjuvant RT improves survival over salvage RT. Until then, the almost 50/50 division seen from this analysis should encourage practicing clinicians to discuss the ambiguity with their patients.

Treatment Intensification of Traditional BFM Therapy with 3 Chemotherapy Blocks and Double Delayed Intensification (Protocol II) Improves Outcome in Infants with High Risk (HR) Acute Lymphoblastic Leukemia (ALL): Results of Two Consecutive AIEOP Studies.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 871-871 ◽  
Author(s):  
Carmelo Rizzari ◽  
Maria Grazia Valsecchi ◽  
Paola De Lorenzo ◽  
Maurizio Aricò ◽  
Giuseppe Basso ◽  
...  
Keyword(s):  
High Risk ◽  
Lymphoblastic Leukemia ◽  
Treatment Strategies ◽  
High Dose Chemotherapy ◽  
P Value ◽  
High Dose ◽  
Treatment Intensification ◽  
Treatment Protocols ◽  
Hematopoietic Stem ◽  
The Impact

Abstract Introduction: Cure rates of ALL in children aged less than one year (i.e. infants) at diagnosis are in the range of 35–40%. Encouraging results have been recently reported in infants by using intensified treatment, including high dose chemotherapy, with or without allogeneic hematopoietic stem cell transplantation (HSCT) in first complete remission (CR). Aim: To evaluate the impact of the two treatment strategies adopted in the AIEOP ALL 91 and 95 studies on the outcome of ALL in infants. Patients and Methods: Fifty-two infants with ALL were enrolled between 1991 and 1999 in two consecutive studies, named AIEOP ALL 91 and ALL 95. Infants with an identified t(4;11) translocation had to be included in the high risk (HR) groups whilst those without this genetic abnormality could be treated in the intermediate (IR) or HR groups according to presenting features and treatment response. Patients belonging to the IR groups received a traditional BFM back-bone based treatment (protocols I, M and II), while those classified in the HR groups underwent an tensified treatment including induction (BFM protocol IA only, in study AIEOP ALL 91, and IA+IB in study ALL 95), consolidation with either 9 blocks of non-cross-resistant drugs (ALL 91) or 3 blocks followed by the 8-drug reinduction regimen - BFM protocol II - repeated twice (ALL 95). All patients were given a continuation phase (reinforced in HR patients of study ALL 95 by vincristine/prednisone pulses). Overall treatment duration was 2 years in both studies. Results: Infants in studies ALL 91 (n=21) and ALL 95 (n=31) had similar biological and clinical characteristics. The overall event-free survival (EFS) at 5 years was 45.0% (SE 7.0%). The EFS, after censoring for HSCT in 1st CR, was 38.1% (SE 11.4%) in ALL 91 and 51.6% (SE 9.9%) in ALL 95 (p-value=0.29). Patients treated in the IR arm of the two studies had a similar outcome. Better results were obtained in patients treated in the HR arm of ALL 95 study, where 9/17 chemotherapy-only patients and 3/4 HSCT patients are alive in CCR as compared to 1/7 and 0/2, respectively, in patients treated in the ALL 91 study. Discussion: These data show that full traditional BFM therapy intensified by 3 post-induction chemotherapy blocks and double protocol II (adopted in study ALL 95), is associated with a better outcome in infants with HR ALL.

The Clinical Usefulness of Novel Prognostic Factors in CLL: A Study of 477 Patients with Low-Risk (Non-11q, Non-17p) FISH and Known IGVH Mutation Status.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3079-3079 ◽  
Author(s):  
Constantine S. Tam ◽  
Michael J. Keating ◽  
Apostolia M. Tsimberidou ◽  
Susan O’Brien ◽  
Alessandra Tsimberidou ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
High Risk ◽  
Hazard Ratio ◽  
Low Risk ◽  
P Value ◽  
Mutation Status ◽  
Trisomy 12 ◽  
The Impact ◽  
Standard Risk ◽  
Active Disease

Abstract In order to develop integrated models utilizing commonly available prognostic factors, we studied the clinical signficance of IGVH mutation, CD38 and ZAP-70 in 477 CLL patients (pts) with low-risk (non-11q, non-17p) FISH findings. All pts were untreated at the time of FISH assessment, and were collected prospectively in the MD Anderson CLL database. Two hundred & fifteen pts (45%) had mono- (n=160) or bi-alleleic (n=55) deletion of 13q {DEL13Q}, 162 pts (34%) had a negative FISH panel {NEG}, and 100 pts (21%) had trisomy 12 as sole FISH abnormality (n=78) or in association with deletion 13q (n=22) {T12}. Compared to other FISH groups, DEL13Q pts had lower B2m (median 2.2 v 2.6mg/L, p=0.01) and were less likely to be IGVH unmutated (33% v 48%, p=0.001). In contrast, T12 pts were more likely to present with advanced stage disease (Rai≥2 36% v 23%, p=0.01), be CD38 positive (44% v 13%, p<0.001), and have karyotypic abnormalities (48% v 7%, p<0.001). One hundred and twenty-three pts had active disease requiring immediate therapy and 354 pts had stable disease, of whom 291 were evaluable for disease progression. At a median follow-up of 20 months, 73 pts had developed active disease with NCI-WG indication(s) for treatment. Actuarial 2 year time to treatment (TTT) was 26%, with no significant difference between 13q, NEG and T12 pts (p=0.27). TTT was associated with elevated B2m (≥1.5ULN), IGVH mutation status and ZAP-70 in DEL13Q and NEG pts, but not in T12 patients (Table). For DEL13Q/NEG pts, a simple model using IGVH mutation and B2m separated high risk pts (unmutated or high B2m, 2yr TTT 43%) from standard risk pts (mutated and low B2m, 2yr TTT 11%, p<0.0001). For T12 pts, a model based on CD38 positivity and karyotypic abnormalities separated high risk pts (2 factors, 2yr TTT 75%) from standard risk pts (0 or 1 factor, 2yr TTT 15%, p=0.008). These results show that the impact of prognostic factors on TTT is dependent on the underlying FISH karyotype, and underscores the need for future studies in CLL prognostic factors to take into account the complete risk profile of the pt. NEGATIVE FISH DELETION 13Q TRISOMY 12 p-value hazard ratio p-value hazard ratio p-value hazard ratio IGVH Mutation <0.001 8.0 0.003 2.9 0.97 0.98 B2m ≥1.5ULN <0.001 4.5 0.07 2.2 0.54 0.68 CD38 Positivity 0.05 2.5 0.05 2.4 0.06 7.4 Abn Cytogenetics <0.001 11.0 0.27 2.2 0.09 2.8 ZAP-70 0.02 2.9 0.007 3.1 0.70 1.3 Figure Figure Figure Figure

Extended radical prostatectomy following neoadjuvant chemohormononal therapy (low dose estrmustine + LHRH agonist/antagonist) contributes to good cancer control for patients with high risk localized prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 185-185
Author(s):  
Hideki Enokida ◽  
Hirofumi Yoshino ◽  
Masayuki Nakagawa
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Cancer Control ◽  
Muscle Layer ◽  
Pathological Stage ◽  
Psa Progression ◽  
Risk Categories

185 Background: Patients with high-risk prostate cancer (PCa) according to D’Amico risk categories are prone to a pathological diagnosis of positive margins or lymph node invasion and biochemical recurrence, despite having undergone radical prostatectomy (RP). Therefore, it is controversial whether RP should be done for high risk PC patients. Methods: 87 high-risk PCa patients prospectively underwent ‘extended’ RP following neoadjuvant chemohormonal therapy (NAC); primarily 6 months of estramustine phosphate 280 mg bid, along with a LH-RH agonist/antagonist. Our surgical technique was developed to reduce the rates of positive surgical margins. The goal is to approach the muscle layer of the rectum by dissecting the mesorectal fascia and continuing the dissection through the mesorectum until the muscle layer of the rectum is exposed. The procedure was safely performed as a result of good recognition of the structure between the perineal body and the rectal surface. We also performed extended lymphadenectomy if the patients meet two or more of D’Amico risk categories Results: More than 1 year had elapsed after surgery in 69 of the 87 patients with the median follow-up period of 36.2 months. Among those 69 patients, 18 (26.1%) experienced PSA failure. Kaplan-Meier analyses revealed that significant poorer PSA progression-free survival were observed in patients with higher positive biopsy core ratio, lymph node metastasis, and higher pathological stage (pT3a/b). Multivariate Cox-regression analysis revealed that higher pathological stage (pT3a/b) was the only independent valuable for predicting PSA progression failure. These 18 cases received salvage androgen deprivation therapy followed-by external beam radiotherapy and showed no progression after the salvage therapies (median follow-up period, 34.6 months after PSA progression). Conclusions: NAC concordant with extended RP is feasible and contributes to negative surgical margins that might provide good cancer control for patients with high-risk PCa.

Redefining the role of adjuvant versus salvage radiation therapy for prostate cancer after radical prostatectomy for T3 disease and/or positive margins.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 367-367
Author(s):  
Barry W. Goy ◽  
In-Lu Amy Liu
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Hormonal Therapy ◽  
Salvage Therapy ◽  
Low Risk ◽  
Adjuvant Radiation ◽  
Positive Margins ◽  
Salvage Radiation Therapy

367 Background: SWOG 8794 recommends adjuvant radiation therapy (ART) after radical prostatectomy (RP) for T3 and/or positive margins. Our purpose was to assess 12-year outcomes on 862 RP patients who had either T3 and/or positive margins who underwent surveillance, salvage radiation therapy (SRT), or hormonal therapy (HT), while categorizing these patients into very low risk (VLR), low risk (LR), high risk (HR), and ultra high risk (UHR) groups. Methods: From 2004 - 2007, 862 RP patients had adverse factors of extracapsular penetration (T3a), seminal vesicle invasion (T3b), positive margins, and/or detectable post-operative PSA. Management included surveillance (54.8%), SRT (36.8%), and HT (8.5%) as first salvage therapy, and 21.5% eventually received hormonal therapy. Twenty patients underwent ART, and were excluded from this analysis. We assessed prognostic factors using multivariable analysis, and 12-year estimates of freedom from biochemical failure (FFBF), freedom from salvage therapy (FFST), distant metastases-free survival (DMFS), prostate cancer-specific survival (PCSS), and overall survival (OS). VLR were those with Gleason Score (GS) of 6. LR were GS 3+4 with only T3a or positive margins, but an undetectable postoperative PSA <0.1. HR were T3b with GS 7-10, any GS 7-10 with T3a/b and positive margins, but an undetectable PSA. UHR were those with a detectable PSA with a GS 7-10. Results: Median follow-up was 12.1 years. Median age was 61.6 years. Median time to first salvage treatment for VLR, LR, HR, and UHR were 10.8, 11.1, 5.3, and 0.6 years, p<0.001. 12-year estimates of FFBF for VLR, LR, HR, and UHR were 60.2%, 52.9%, 28.4%, and 0%, p<0.0001. For FFST, 70.9%, 68.6%, 40.5%, and 0%, p<0.0001. For DMFS, 99.1%, 97.8%, 88.6%, and 63.6%, p<0.0001. For PCSS, 99.4%, 99.5%, 93.5%, and 78.9%, p<0.0001. For OS, 91.8%, 91.8%, 81.0%, and 69.9%, p<0.0001. Conclusions: Outcomes of T3 and/or positive margins using surveillance or SRT as initial management yields excellent outcomes for VLR and LR groups, in which ART should be avoided. For HR, ART can be considered reasonable, since FFBF is only 28.4%. For VHR, these patients may benefit from combined hormonal therapy and ART.

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