489 The impact of education on novel concepts in adjuvant melanoma: a closer look at high risk stage II disease

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A525-A525
Author(s):  
Kinjal Parikh ◽  
Charlotte Warren ◽  
Emily Van Laar ◽  
Jason Luke
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Adjuvant Treatment ◽  
Stage Ii ◽  
Educational Activity ◽  
List Type ◽  
Optimal Care ◽  
Multi Media ◽  
The Impact ◽  
Post Assessment

BackgroundAdjuvant therapy for patients with melanoma is currently recommended for patients with stage III disease with either immune checkpint inhibitors or combination dabrafenib/trametinib based on BRAF-status. Adjuvant treatment demonstrates improvement in recurence-free survival and overall survival. However, risk models suggesting that patients with stage IIB/IIC disease may have a higher risk of recurrence than patients with stage IIIA disease have prompted exploration into the use of adjuvant therapy in this patient subgroup as well. With several ongoing trials due to report, oncologists need education to stay up-to-date on the available data and contextualize this potential treatment option to implement therapy at the earliest point of clinical benefit to patients while also collaborating with surgical teams for optimal care planning.MethodsAn online continuing education (CME) activity consisted of a multi-media 30-minute video panel of a medical oncologist and surgical oncologist discussing the rationale, available clinical trial data, and future directions of adjuvant therapy for the treatment of patients with stage II melanoma. Educational effect was assessed using a repeated paired pre-assessment/post-assessment study design and compared the pre- and post-assessment responses. A chi-square test was used to identify differences between pre- and post-assessment responses. Effect size was calculated using Cramer’s V test by determining the strength of the association between the activity and the outcomes (V = 0.16–0.26 is considerable and V > 0.26 is extensive). P values were calculated and those < 0.05 were considered statistically significant. Data from 65 oncologists and 138 surgeons are represented here through 8/12/2020.ResultsParticipation in education resulted noticeable educational effects for both oncologists (p < 0.01, V=0.143) and surgeons (p = 0.001, V=0.114): Statistically significant improvements in knowledge and competence were also seen regarding: -Knowledge regarding the rationale for adjuvant therapy in stage II diseaseo Oncologists: 46% pre; 69% post, p < 0.01o Surgeons: 24% pre; 36% post, p < 0.05 -Competence utilizing patient and tumor characteristics to identify potential candidates for adjuvant therapy in stage II diseaseo Oncologists: 52% pre; 77% post, p < 0.01o Surgeons: 29% pre; 43% post, p < 0.05-Increase in confidence was also observed for coordinating with the multidisciplinary team to augment surgical care with potential systemic adjuvant treatment for eligible patientso 22% improvement for oncologists o 19% improvement for surgeonsConclusionsThis online, interactive, multi-media, expert-led, CME-certified educational activity resulted in significant gains in oncologist and surgeon knowledge and competence with improvements in confidence regarding the role of adjuvant therapy in the management of high risk stage II melanoma and recommending clinical trials for eligible patients. These results demonstrate the effectiveness of education, especially in online and on-demand formats and those requiring cross-discipline collaboration, and also highlights an ongoing need to further educate on this topic.AcknowledgementsThis educational initiative was supported through independent educational grants from Bristol Myers Squibb.ReferenceLuke J, Yoon C. Adjuvant Melanoma Treatment: Can We Improve Outcomes for More Patients: https://www.medscape.org/viewarticle/932047.

scholarly journals 488 The impact of education on novel concepts in metastatic melanoma: triplet therapy

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A524-A524
Author(s):  
Kinjal Parikh ◽  
Sara Fagerlie ◽  
Patrick Kugel ◽  
Richard Caracio ◽  
Ryan Sullivan
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Panel Discussion ◽  
Clinical Trial Data ◽  
Advanced Melanoma ◽  
Trial Data ◽  
Educational Activity ◽  
List Type ◽  
The Impact ◽  
Post Assessment

BackgroundAdvanced melanoma treatment selection is guided by BRAF-mutation status and patient and disease-specific factors. Historically, oncologists decided between targeted therapy or immune checkpoint inhibitors (ICI). However, given the differences in onset of activity, response durability, and adverse events combination BRAF/MEK inhibitors and ICI (triplet therapy) are being evaluated to optimize outcomes. With several trials due to report, oncologists need education to stay up-to-date on the available data and contextualize this potential treatment option.MethodsAn online continuing education (CME) activity consisting of a multi-media 30-minute video panel discussion explored the rationale, available clinical trial data, and future directions of triplet therapy for the treatment of advanced BRAF-mutated melanoma. Educational effect was assessed using a repeated pairs pre-assessment/post-assessment study design and compared the pre- and post-assessment responses. A chi-square test was used to identify differences between pre- and post-assessment responses. Effect size was calculated using Cramer’s V test by determining the strength of the association between the activity and the outcomes (V = 0.16–0.26 is considerable and V > 0.26 is extensive). P values were calculated and those < 0.05 were considered statistically significant. Data from oncologist participants were collected between 12/23/2019 through 2/26/20.ResultsParticipation in education resulted in statistically significant improvements and noticeable educational effect for oncologists (n=49; p < 0.05, V =0.136). • 39% of pre-assessment questions were correctly answered increasing to 52% post-assessment • 15% of oncologists had a measurable improvement in confidence regarding the rationale for use of triplet therapy in advanced melanoma• Significant improvement in knowledge regarding clinical trial data in triplet therapy was observed (35% vs. 55%; p < 0.05, V = 0.205)ConclusionsThis online, interactive, expert-led, CME-certified educational activity resulted in significant gains in oncologist knowledge and confidence regarding triplet therapy in the management of melanoma. These results demonstrate the effectiveness of on-demand education but also highlight an ongoing need for education on this topic as further data becomes available.AcknowledgementsThis educational initiative was supported through educational grants from Novartis Pharmaceuticals Corporation and GenentechReferenceSullivan RJ, Salama AKS. Managing Melanoma: Emerging Concepts of Triplet Therapy. https://www.medscape.org/viewarticle/923003

Time Trends in Systemic Adjuvant Treatment for Node-Negative Breast Cancer

1999 ◽  
Vol 17 (5) ◽  
pp. 1458-1458 ◽  
Author(s):  
Nicole Hébert-Croteau ◽  
Jacques Brisson ◽  
Jean Latreille ◽  
Gilles Gariépy ◽  
Caty Blanchette ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Adjuvant Treatment ◽  
Minimal Risk ◽  
Node Negative ◽  
Risk Of Recurrence ◽  
Consensus Recommendations ◽  
Node Negative Breast Cancer ◽  
Systemic Adjuvant Therapy

PURPOSE: We conducted a population-based study in Quebec, Canada, to assess longitudinal changes in systemic adjuvant therapy for node-negative breast cancer. MATERIALS AND METHODS: A stratified random sample was selected among women with newly diagnosed node-negative breast cancer in 1988, 1991, and 1993. Information on the patient, her tumor, source of care, and treatment was abstracted from medical charts. Patients were classified as being at minimal, moderate, or high risk of recurrence on the basis of criteria proposed at the 4th International Conference on Adjuvant Therapy of Primary Breast Cancer (St. Gallen, Switzerland, 1992), and systemic adjuvant treatment received was dichotomized as being consistent or not consistent with consensus recommendations. RESULTS: Overall, 1,578 cases of invasive breast carcinoma were reviewed. The proportion of patients who were given hormonal or cytotoxic treatment increased from 51.7% to 73.1% from 1988 to 1993. Virtually all women at minimal risk were treated in 1991 and 1993 according to the consensus statement. The proportions of women so treated were 75.0% and 65.4% in the moderate- and high-risk categories, respectively, in 1991. In 1993, these proportions were 71.4% and 67.0%, respectively. Omission of chemotherapy, especially in high-risk women with estrogen receptor–negative tumors who were 50 to 69 years of age, was the most frequent inconsistency with guidelines. CONCLUSION: Systemic adjuvant therapy for node-negative breast cancer has gained acceptance. Better understanding of the decision-making process, of the perception of the risks and benefits involved, and of the impact of alternative strategies for the dissemination of consensus recommendations are needed to promote the use of chemotherapy in specific categories of women who are at high risk of recurrence.

Retrospective assessment of adherence to ASCO Surveillance Guidelines following treatment for stage II and III colorectal cancer (CRC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17517-e17517
Author(s):  
J. M. Davies ◽  
S. Lupichuk ◽  
E. Batuyong ◽  
R. J. Hilsden ◽  
J. Easaw
Keyword(s):  
Ct Scan ◽  
Adjuvant Treatment ◽  
Laboratory Data ◽  
Primary Care Providers ◽  
Stage Ii ◽  
Stage Iii ◽  
Care Providers ◽  
Cancer Centre ◽  
The Impact

e17517 Background: The 2005 ASCO guidelines for surveillance following adjuvant therapy for CRC outlined recommended surveillance tests and their frequencies including history and physical examination, CEA testing, CT scan and colonoscopy. The purpose of this study was to assess the impact of these guidelines post treatment of stage II and III CRC in the Calgary Health Region (CHR) before and after implementation of a computer generated, personalized discharge letter (DL). Methods: Cohort 1 patients completed adjuvant chemotherapy or radiotherapy for stage II and III CRC between September 1, 2006, and November 30, 2007, prior to implementation of the DL. Cohort 1 was retrospectively identified from the Alberta Cancer Registry. Registry data was collated with laboratory data and diagnostic imaging data is forthcoming. Adherence to the guidelines at 1-year follow-up in cohort 1 was measured. Prospective data collection on patients who completed adjuvant treatment after implementation of the DL (cohort 2) is ongoing. Comparison of adherence rates to surveillance testing between the two cohorts will be reported upon study completion. Results: For cohort 1, 209 of 238 patients referred to the cancer centre were from the CHR and hence included in the analysis. The average age was 65 and 53% were male. Most patients (136/209) had stage III CRC. 1/209 had a local recurrence only. 27/209 progressed to metastatic disease during the 1-year follow-up period, of which 23 of these patients were initially diagnosed with stage III CRC. CEA adherence (≥4 tests taken within 1-year follow-up period) was 38.3% (95% CI 31.7–44.9). CT scan adherence and use of “inappropriate” surveillance testing for cohort 1 will be available at the meeting. Conclusions: This study assesses compliance with the 2005 ASCO CRC surveillance guidelines at 1-year follow-up post adjuvant treatment at a tertiary cancer centre. Analysis of cohort 1 reveals that adherence to CEA testing is suboptimal. The next phase of this study will assess the impact of a DL, sent to patients and primary care providers outlining recommended surveillance tests and dates, on adherence rates. No significant financial relationships to disclose.

Validation of a genomic classifier (ColoPrint) for predicting outcome in the T3-MSS subgroup of stage II colon cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3510-3510 ◽  
Author(s):  
Ramon Salazar ◽  
Josep Tabernero ◽  
Victor Moreno ◽  
Ulrich Nitsche ◽  
Thomas Bachleitner-Hofmann ◽  
...  
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
Lower Risk ◽  
Low Risk ◽  
Stage Ii ◽  
Disease Relapse ◽  
Risk Of Disease

3510 Background: Adjuvant therapy for stage II patients is recommended for patients with high risk features, especially with T4 tumors. Adjuvant therapy is not indicated for patients with MSI-H status who are considered of being at low risk of disease relapse. However, this leaves the majority of patients with an undetermined risk. ColoPrint is an 18-gene expression classifier that identifies early-stage colon cancer patients at higher risk of disease relapse. Methods: ColoPrint was developed using whole genome expression data and was validated in public datasets (n=322) and independent patient cohorts from 5 European hospitals. Tissue specimen, clinical parameters, MSI-status and follow-up data (median follow-up 70 months) for patients were available and the ColoPrint index was determined using validated diagnostic arrays. Uni-and multivariate analysis was performed on the pooled stage II patient set (n=320) and the subset of patients who were T3/ MSS (n=227). Results: In the analysis of all stage II patients, ColoPrint classified two-third of stage II patients as being at lower risk. The 3-year Relapse-Free-Survial (RFS) RFS was 91% for Low Risk and 74% for patients at higher risk with a HR of 2.9 (p=0.001). Clinicopathological parameters from the ASCO recommendations (T4, perforation, <12 LN assessed, and/ or high grade) or NCCN guidelines (ASCO factors plus angio-lymphatic invasion) did not predict a differential outcome for high risk patients (p< 0.20). In the subgroup of patients with T3 and MSS phenotype, ColoPrint classified 61% of patients at lower risk with a 3-year RFS of 91% (86-96%) and 39% of patients at higher risk with a 3-year RFS of 73% (63-83%) (p=0.002). No clinical parameter was significantly prognostic in this subgroup. Conclusions: ColoPrint combined with established clinicopathological factors and MSI, significantly improves prognostic accuracy, thereby facilitating the identification of patients at higher risk who might be considered for additional treatment.

The effect of gaps in chemotherapy on survival in patients with high-risk stage II and stage III colon cancer.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 180-180
Author(s):  
Yvonne Sada ◽  
Zhigang Duan ◽  
Hashem El-Serag ◽  
Jessica Davila
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Stage Ii ◽  
Stage Iii ◽  
Clinical Factors ◽  
Stage Iii Colon Cancer ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Multivariable Regression ◽  
The Impact

180 Background: Current guidelines recommend six months of chemotherapy (CT) for stage III colon cancer and consideration for high-risk stage II colon cancer. No previous studies have examined the impact of CT gaps on survival. This retrospective study examines determinants of CT gaps and the effect of gaps on survival. Methods: Using national Surveillance, Epidemiology, and End Results registry-Medicare linked data, high-risk stage II and stage III colon cancer patients diagnosed between 2000-2007 who received surgery and CT were identified. CT duration and gaps were calculated. CT gap was defined as 30 to 90 days between two CT claims. Data on demographics, clinical factors (comorbidity, tumor grade), and treatment factors (time to CT initiation, toxicity, hospitalization) were collected. Multivariable regression was used to examine factors associated with gaps. Cox proportional hazards analysis examined the effect of gaps on risk of mortality. Results: 7,371 patients were identified. Median age was 75 (IQR: 71-79); 47% were male. Among all patients, 1,803 (24%) had a gap. 2,674 patients (36%) received 5 to 7 months of CT, of which 469 (18%) had a gap. Multivariable regression analysis showed that patients who were black (OR 1.3, 95% CI: 1.1-1.7), stage III (1.2, 1.0-1.3), had toxicity (1.3, 1.1-1.4), or had 3 to 4 months of CT (vs. 5-7 months, 2.6, 2.3-3.0) were more likely to have a gap, while patients with a more recent diagnosis in 2007(vs. 2000, 0.6, 0.5-0.8) were less likely to have a gap. 3-year cancer-specific survival was the same in all patients with CT gaps compared with no gaps (80%, 95% CI: 78%-82% vs. 81%, 95% CI: 80%-82%). Cox proportional hazard models showed that patients with gaps did not have increased risk of mortality (HR 0.99, 0.89-1.1) adjusting for patient and clinical factors. Among those who received 5 to 7 months of CT, 3-year survival was 8% lower in patients with gaps compared to those with no gaps (80%, 95% CI: 75%-83% vs. 88%, 95% CI: 87%-90%). Conclusions: Nearly 25% of high-risk stage II and III patients who received CT had a gap. CT gaps were associated with worse survival in patients who received 5 to 7 months of CT. Interventions to improve CT toxicity management and reduce gaps are needed to maximize the benefit of CT.

Cohort study evaluating the impact of a discharge letter (DL) compared with usual care on adherence to surveillance following treatment for stage II/III colorectal cancer (CRC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 620-620 ◽  
Author(s):  
Janine Marie Davies ◽  
Eugene Batuyong ◽  
Sasha M. Lupichuk ◽  
Robert Hilsden ◽  
Misha Eliasziw ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adjuvant Therapy ◽  
Clinical Laboratory ◽  
Ct Imaging ◽  
Care Physician ◽  
Stage Ii ◽  
Disease Stage ◽  
Cancer Centre ◽  
The Impact

620 Background: The 2005 ASCO guidelines recommend surveillance testing and frequencies following surgical +/− adjuvant therapy for stage II/III CRC. In Canada, many patients are discharged from their oncologist to their primary care physician (PCP) for ongoing surveillance. However, adherence to surveillance recommendations is low. This cohort study evaluated adherence to surveillance 1 year after treatment of stage II/III CRC prior to and following implementation of a DL. Methods: Cohort 1 (C1) patients were retrospectively identified from the Alberta Cancer Registry following adjuvant therapy (as applicable) at a tertiary cancer centre (07/2006 - 09/2007). Cohort 2 (C2) patients were prospectively identified from the Registry and clinic records following adjuvant therapy (as applicable), as those discharged from the centre (10/2007 - 4/2009); DL was sent to the patient and PCP recommending surveillance tests and dates. Clinical, laboratory, diagnostic imaging, and endoscopy data was collated. Adherence at 1 year follow-up was compared between cohorts using Kaplan-Meier time-to-event analyses. Results: C1 (n=218) was larger than C2 (n=114) despite the longer accrual time for C2. There were no differences between cohorts by age, sex, primary site of disease, stage, or adjuvant oxaliplatin use. During year 1 of follow-up, 11.8% and 11.4% recurred (local or metastatic) and 6.5% and 2.7% died (p=0.1) in C1 and C2 respectively. Comparing C1 with C2, 14.8% vs. 23.0% of patients had one CEA test within 3 months, 45.2% vs. 72.2% within 6 months, and 71.7% vs. 85.1% within 1 year (p<0.001). Only 44.0% (C1) and 68.6% (C2) had 2 CEA tests within 1 year. Only 3.9% (C1) vs. 6.6% (C2) of patients had 4 CEA tests within the year following treatment as recommended. The rate of CT imaging was 32.3% (C1) and 56.1% (C2); endoscopy was 36.7% (C1) and 42.1% (C2). Conclusions: Implementation of a DL improved compliance with surveillance at 1 year of follow-up following discharge from a tertiary cancer centre, although optimal adherence remains low. However, adherence to CT imaging nearly doubled. Evaluation of compliance at 3 years of follow-up is ongoing.

Effect of Oncotype DX colon cancer test results on treatment recommendations in patients with stage II colon cancer: Preliminary results.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 398-398
Author(s):  
Thomas H. Cartwright ◽  
Calvin Chao ◽  
Margarita Lopatin ◽  
Tanya GK Bentley ◽  
Michael Samuel Broder ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Adjuvant Treatment ◽  
Recurrence Score ◽  
Treatment Recommendations ◽  
Oncotype Dx ◽  
Stage Ii ◽  
Medical Oncologists ◽  
Stage Ii Colon Cancer ◽  
The Impact

398 Background: The Oncotype DX Colon Cancer Recurrence Score (RS) has been clinically validated as an independent predictor of individual recurrence risk in stage II colon cancer patients following surgery. As a result, physicians have been ordering the Oncotype DX assay for stage II colon cancer patients since January 2010, yet no data exist on the assay’s impact on adjuvant treatment planning in practice. We performed a survey to characterize the impact of the assay on adjuvant treatment recommendations in stage II colon cancer. Methods: U.S. medical oncologists (N=277) who ordered Oncotype DX for ≥3 patients with stage II colon cancer were contacted and asked to complete a web-based survey regarding the single most recent stage II colon cancer patient for whom the assay was ordered. The survey was developed through cognitive interviews with four medical oncologists, and the protocol was institutional review board approved. Results: As a planned preliminary analysis, we analyzed surveys from 92 eligible physicians. Physicians were more often in community (85%) than academic or other practices, and had a median of 14.5 years (range, 2-40) of practice experience. The median patient age was 62 years (range, 34–81). 84% of patients had T3 disease. Patients had ≤8, 9-11 and ≥12 nodes examined 2%, 14% and 84% of the time and 36% had comorbidities. Of the 60 patients tested for MMR/MSI, 9 (15%) were MMR-D or MSI-high and 37 (62%) were MMR-P or MSI-low; 14 (23%) unknown. Median RS was 20 (range, 1-77). Before obtaining the RS, chemotherapy was planned in 38 (41%) patients, observation in 35 (38%), and there was no recommendation in 19 (21%). For the 73 patients with pre-assay recommendations, recommended treatment changed after obtaining the RS for 23 patients (32%), including changes from chemotherapy to observation and vice-versa. Conclusions: These preliminary findings indicate that for stage II colon cancer patients, treatment recommendations were changed by RS results approximately one-third of the time. Final results will be reported to include accrual through December 2011.

Uptake of adjuvant chemotherapy for colon cancer in older and younger patients in the Irish population.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 478-478
Author(s):  
Seamus Coyle ◽  
Zia Rehman ◽  
Chalen Lee ◽  
Sandra Deady ◽  
Harry Comber ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Practice ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Older Patients ◽  
The Elderly ◽  
Stage Ii ◽  
Stage Iii ◽  
Younger Patients ◽  
The Impact

478 Background: Colon cancer is predominantly a disease of the elderly, with recent evidence supporting the use of adjuvant chemotherapy in the older population. However, it remains unclear to what degree such patients are receiving adjuvant therapy in clinical practice. We examined uptake of adjuvantchemotherapy and it’s impact on survival in older patients with stage II and stage III colon cancer in a national cohort. Methods: Using the National cancer Registry of Ireland, we identified 3,486 patients with stage II and III colon cancer who were treated with curative resection from 2004-2009. Clinopathological features and chemotherapy use were compared between those ≥70 years and those < 70 years. Results: A total of 2,026 patients with stage II disease were identified, 56% male and 60% ≥ 70 years. T3 tumors accounted for 81%, T4 19% and 89% were grade 2/3. Adjuvant chemotherapy was utilized in 10% and 40% of ≥ 70 and <70 years, respectively (p<0.0001). A benefit for chemotherapy over observation alone was seen in both the older [HR 0.36; 95% CI 0.36 – 0.68; p <0.0001] and younger patient groups [HR 0.43; 95% CI 0.2701 - 0.6881; p<0.0004]. Of 1,460 patients with stage III disease, 51% were ≥ 70 years, 54% male. 34% of older and 83% of younger patients received adjuvant therapy (p<0.0001). A similar magnitude of benefit from chemotherapy compared to observation was seen in patients ≥ 70 years [HR 0.30; 95% CI 0.29 - 0.45 ; p <0.0001] and <70 years [HR 0.22 95%CI 0.1 – 0.2; p<0.0001] with stage III disease. Conclusions: Adoption of adjuvant chemotherapy appears to be associated with significant survival benefit in older patients (age ≥ 70 years), however, is still underutilized in clinical practice. The impact of sociodemographic and clinicopathological features as potential drivers of treatment decisions in a cohort of this population will be reported.

scholarly journals Validation of a genomic risk classifier to predict metastasis and prostate cancer-specific mortality in men with positive lymph nodes.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 125-125
Author(s):  
Bruce J. Trock ◽  
R. Jeffrey Karnes ◽  
Frank Claessens ◽  
John W. Davis ◽  
Zaid Haddad ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Lymph Nodes ◽  
Adjuvant Treatment ◽  
Odds Ratio ◽  
Clinical Model ◽  
Specific Mortality ◽  
Cancer Specific Mortality ◽  
Positive Lymph Nodes

125 Background: Men with lymph node involvement (LNI) at prostatectomy (RP) are at high risk of dying from prostate cancer. However, survival following RP is highly variable, with some men apparently cured. Nomograms developed for men with LNI have been based on series where all or the vast majority of men received adjuvant treatment. Because administration of adjuvant treatment is not universal, even for LNI, we evaluated whether the Decipher genomic classifier (GC) can improve upon clinical models to predict metastasis within 5 years (MET5) and prostate cancer specific mortality within 10 years (PCSM10) in a cohort of LNI patients, the majority of whom did not receive adjuvant treatment. Methods: 141 patients from 4 institutions (Johns Hopkins, Mayo Clinic, Leuven, MD Anderson) had LNI at RP, had adequate tissue and clinical data for analysis of MET5, and 86 were analyzed for PCSM10. 43% of men received adjuvant therapy. RP tumor tissue was analyzed by Affymetrix Human Exon 1.0 ST GeneChip; the GC was calculated based on 22 genes in the previously trained and validated algorithm. Logistic regression evaluated whether the GC, dichotomized as high risk (GC score > 0.6) vs low-intermediate risk (≤0.6), improved prediction of MET5 and PCSM10 beyond that achieved with established clinical prognostic factors. Results: 62 men (43%) developed MET5, and 35 (41%) developed PCSM10. For both MET5 and PCSM10 CAPRA-S, number of positive lymph nodes, and age were significant; adjuvant therapy was not significant. GC was a significant independent strong prognostic factor when added to the clinical model for prediction of MET5, odds ratio = 4.04 (95% CI: 1.48, 11.02), p = 0.006, and prediction of PCSM10, odds ratio = 6.71 (95% CI: 2.01, 22.38), p = 0.002. Addition of GC to the clinical model improved the AUC from 0.77 to 0.79 for MET5, and from 0.65 to 0.74 for PCSM10. Conclusions: The Decipher GC significantly improves upon clinical variables to predict metastasis and prostate cancer specific mortality in men at high risk due to LNI. This is the first study to show a genomic classifier predicts outcomes in men with LNI; validation is needed to determine if Decipher can improve treatment decisions in men with LNI.

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