Chemohormonal Therapy Research Articles

Neoadjuvant Chemohormonal Therapy before Radical Prostatectomy for Japanese Patients with High-Risk Localized Prostate Cancer.

Background: Radical prostatectomy (RP) is the standard treatment in patients with high-risk prostate cancer (PCa). However, there is a high rate of recurrence, and new approaches are required to improve surgical efficacy. Here, we evaluated the feasibility and safety of neoadjuvant chemohormonal therapy (NCHT) before RP for Japanese patients with high-risk localized prostate cancer (PCa). Methods: From February 2009 to April 2016, 21 high-risk patients were enrolled in this prospective study. Patients were treated with docetaxel (70 mg/m2) every four weeks for three cycles and luteinizing hormone-releasing hormone agonist. Patients with grade 3–4 toxicities had 25% dose reductions for the following course. Results: Median follow-up was 88.6 months. The dose of docetaxel was reduced in 13 patients. The estimated five-year biochemical progression-free survival (bPFS) rate was 57.1%. National Comprehensive Cancer Network criteria (high-risk, but not very high-risk (nVHR) versus VHR) was associated with bPFS (p = 0.03). Five-year bPFS rates in the nVHR and VHR groups were 76.9% and 25.0%, respectively. There was a significant difference in bPFS between the nVHR and VHR groups (p = 0.023) by Kaplan–Meier analysis. Conclusions: Although our study included a small number of cases, at least in our exploration, NCHT was safe and feasible. However, more extensive treatment modalities are needed to improve outcomes, especially in VHR patients.

The prognostic nomogram including MRI for locally advanced prostate cancer treated by radical prostatectomy.

To establish the prognostic nomogram for locally advanced prostate cancer (LAPC) patients treated by radical prostatectomy (RP) based on clinical and multiparametric-MRI (mp-MRI) metrics. One hundred and twenty-one patients diagnosed with LAPC were included in this study. They were all examined by mp-MRI within one week before surgery and treated by RP (36 with RP alone, 48 with neoadjuvant hormonal therapy (NHT) and 37 with neoadjuvant chemohormonal therapy (NCHT)). The biochemical progression-free survival (bPFS) was analyzed by Kaplan-Meier method. Univariate and multivariate analysis were used to determine prognostic factors that were related with bPFS. The prognostic nomogram was established by factors that were significant in multivariate analyses. The median bPFS had significant difference in the subgroup of treatment (RP alone: 2 [0.00-5.04] vs. NHT: 9.3 [6.746-11.854] vs. NCHT: 11.17 [0.000-25.075] months [Log rank p < .001]), the subgroup of hyperintensity within prostate in DWI (negative: 15.97 [11.202-20.731] vs. positive: 5.2 [2.952-7.448] months [Log rank p < .001]) and the subgroup of pelvic lymph node metastasis (negative: 10.2 [8.404-11.996] vs. unilateral: 4.43 [0.000-11.086] vs. Bilateral: 1.83 [0.636~3.031] [Log rank p < .001]). The method of treatment (hazards ratio [HR], 0.566; 95% confidence interval [CI], 0.356-0.899; p = .016), hyperintensity within prostate in DWI (HR, 2.539; 95% CI, 1.349-4.779; p = .004) and the metastasis burden of pelvic lymph node (HR, 2.492; 95% CI, 1.645-3.777; p < .001) were identified as independent predictors with significance in multivariable Cox regression analysis. The nomogram was established based on these three factors. We established a nomogram based on three significant prognosis factors including the neoadjuvant therapeutic schedule, hyperintensity within prostate in DWI and the metastasis burden of pelvic lymph nodes, which were associated with the clinical outcomes in LAPC patients after surgery.

Baseline Testosterone Levels in Men with Clinically Localized High-Risk Prostate Cancer Treated with Radical Prostatectomy with or without Neoadjuvant Chemohormonal Therapy (Alliance).

Men with low serum testosterone at the time of prostate cancer diagnosis are frequently considered to have more aggressive disease. We examined treatment outcomes in men with clinically localized high-risk cancer to determine if baseline testosterone level identified men at higher risk for cancer progression after treatment. Alliance/CALGB 90203 randomized men with clinically localized high-risk prostate cancer to radical prostatectomy alone or neoadjuvant chemohormonal therapy and radical prostatectomy. Men with available baseline testosterone levels who had not received androgen deprivation prior to study enrollment were studied (656). Testosterone level was examined as a continuous variable, as quartiles, and separately in men with an absolute testosterone level above/below 150 ng/dl. Outcomes evaluated were overall survival and event-free survival with events defined by biochemical recurrence, secondary treatment, prostate cancer metastasis, and death. We were unable to demonstrate a difference between baseline serum testosterone level measured as a continuous variable, as quartiles, or as a dichotomous variable (above/below 150 ng/dl) with the outcomes measured. This finding was observed in both arms of the study. Baseline serum testosterone level did not predict outcomes in men with clinically localized high-risk prostate cancer treated with radical prostatectomy alone or neoadjuvant chemohormonal therapy and radical prostatectomy.

Cabazitaxel versus abiraterone or enzalutamide in metastatic castration-resistant prostate cancer: post hoc analysis of the CARD study excluding chemohormonal therapy for castrate-naive disease.

BackgroundIn the CARD study (NCT02485691), cabazitaxel significantly improved clinical outcomes versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen-signalling-targeted inhibitor. However, some patients received docetaxel or the prior alternative androgen-signalling-targeted inhibitor in the metastatic hormone-sensitive (mHSPC) setting. Therefore, the CARD results cannot be directly translated to a Japanese population.MethodsPatients (N = 255) received cabazitaxel (25 mg/m2 IV Q3W, prednisone, G-CSF) versus abiraterone (1000 mg PO, prednisone) or enzalutamide (160 mg PO) after prior docetaxel and progression ≤12 months on the alternative androgen-signalling-targeted inhibitor. Patients who received combination therapy for mHSPC were excluded (n = 33) as docetaxel is not approved in this setting in Japan.ResultsA total of 222 patients (median age 70 years) were included in this subanalysis. Median number of cycles was higher for cabazitaxel versus androgen-signalling-targeted inhibitors (7 versus 4). Clinical outcomes favoured cabazitaxel over abiraterone or enzalutamide including, radiographic progression-free survival (rPFS; median 8.2 versus 3.4 months; P < 0.0001), overall survival (OS; 13.9 versus 11.8 months; P = 0.0102), PFS (4.4 versus 2.7 months; P < 0.0001), confirmed prostate-specific antigen response (37.0 versus 14.4%; P = 0.0006) and objective tumour response (38.9 versus 11.4%; P = 0.0036). For cabazitaxel versus androgen-signalling-targeted inhibitor, grade ≥ 3 adverse events occurred in 55% versus 44% of patients, with adverse events leading to death on study in 2.7% versus 5.7%.ConclusionsCabazitaxel significantly improved outcomes including rPFS and OS versus abiraterone or enzalutamide and are reflective of the Japanese patient population. Cabazitaxel should be considered the preferred treatment option over abiraterone or enzalutamide in this setting.

Efficacy of Neoadjuvant Chemohormonal Therapy in Oligometastatic Hormone-Sensitive Prostate Cancer: A Prospective, Three-Arm, Comparative Propensity Score Match Analysis.

The study aimed to investigate the efficacy and safety outcomes in hormone-sensitive oligometastatic prostate cancer (OMPC) patients treated with docetaxel-based neoadjuvant chemohormonal therapy (NCHT) prior to radical prostatectomy (RP) compared with direct RP and standard androgen deprivation therapy (ADT) alone using propensity score match (PSM) analysis. A single-center, prospective, three-arm study was conducted with hormone-sensitive OMPC patients. Eligible patients (N=130) were divided into three groups-NCHT, RP, and standard treatment (ST)-and received their respective treatments. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were pathological response rate, radiographic progression-free survival (rPFS), and overall survival (OS). Further, propensity scores were calculated and group-wise comparisons were carried out: NCHT versus RP, ST versus RP, and ST versus NCHT. After PSM, in the NCHT group, two patients (11.76%) and four patients (23.52%) had complete and partial pathological responses, respectively. Univariate and multivariate Cox regression analysis showed that PFS and rPFS were significantly higher in the NCHT group. For NCHT versus RP, the PFS hazard ratio (HR)=0.11 (95% confidence interval [CI], 0.02-0.51; P=.004) and HR=0.016 (95% CI, 0.0015-0.17; P < .001); the rPFS HR=0.088 (95% CI, 0.011-0.71; P=.023) and HR=0.03 (95% CI, 0.0025-0.36; P=.006). Further, the median OS of the ST group was 44.6 months for ST versus RP, and it was 49.3 months for ST versus NCHT; it was not reached in either the NCHT or RP group. Furthermore, 17.65% and 47.06% patients had positive surgical margins in the NCHT and RP groups, respectively, and no therapy-related deaths were observed during the study period. PSM analysis revealed NCHT before RP in OMPC patients has potential therapeutic benefits with acceptable toxicities and lower incidence of postoperative positive surgical margins.

Preoperative predictors of biochemical recurrence in a phase II trial of neoadjuvant therapy in very high-risk prostate cancer.

74 Background: Understanding the lethal nature of high risk prostate cancer, there is a need for the development of multimodal therapies. Prior studies have confirmed a survival benefit with the addition of docetaxel to androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (HSPC). We conducted a Phase II trial enrolling men with very high risk localized, locally advanced or oligometastatic prostate cancer (PC) to examine resistance and response to neoadjuvant chemohormonal therapy. This analysis aims to identify the preoperative predictors of biochemical recurrence (BCR). Methods: UW17009 is an IRB-approved open-label, single-arm trial that recruited 26 men with newly diagnosed advanced PC. Patients received ADT and docetaxel for 3 months followed by prostatectomy. The primary endpoint was pathologic complete response rate. A secondary clinical objective was the rate of PSA recurrence 12 months after surgery. The pre-trial PSAs, age, cancer grade, stage, percent tumor involvement of the initial biopsy, metastatic disease on conventional and 18F-DCFPyL PSMA (DCFPyL) PET/CT and MRI imaging, completion of chemohormonal therapy and PSA nadirs following chemohormonal therapy were assessed in relationship to biochemical recurrence. One way ANOVA was used to evaluate differences among continuous values: age, PSA at diagnosis, percent tumor involvement, and PSA nadir after chemo ADT. Fisher’s exact tests were used to evaluate the differences among categorical variables: stage at diagnosis, positive bone scan, and positive PSMA PET. Results: 26 patients were enrolled and underwent neoadjuvant treatment, radical prostatectomy (RP) and lymph node dissection. The median age was 62 (IQR 58-66), mean PSA at diagnosis was 32.8 ng/dl and 88.4% had Gleason 9 cancer. At study initiation, 12/26 patients had metastatic disease detected by DCFPyL-based PSMA PET. Final pathology demonstrated 81%(21/26) had ≥ pT3 and 73%(19/26) patients had negative margins. Positive lymph nodes were found in 10/26(38.5%) patients on final pathology. At week 6 after surgery, 91%(24/26) had undetectable PSA. At a mean follow up of 12.1 months(5.2-21.4), the biochemical recurrence rate is 58%(15/26). Features associated with BCR include stage, % tumor involvement, and positive PSMA PET scan. All patients with positive margins and 9/10 patients with positive nodes at final pathology developed BCR at a mean follow up of 12 months. Conclusions: In this neoadjuvant cohort, stage T2c, elevated PSA, positive pre-operative PSMA PET/CT, and PSA nadir &gt; 1 following chemohormonal therapy predict biochemical recurrence. Clinically, and in the short term, neoadjuvant chemohormonal therapy prior to definitive surgery for very high risk localized and/or oligometastatic PC generates local tumor control with a high rate of negative surgical margins.

18F-DCFPyL PSMA PET imaging compared to conventional imaging in the detection of pelvic nodal metastases in patients with locally advanced or oligometastatic prostate cancer.

36 Background: Interest has arisen in the use of prostate specific membrane antigen (PSMA) PET/CT imaging to detect prostate cancer at metastatic sites using different tracers. Here, we examined the ability of 18F-DCFPyL (DCFPyL) PSMA-based PET imaging to detect nodal disease in comparison to conventional imaging in a cohort of men with locally advanced or oligometastatic prostate cancer (PC). Methods: UW17009 is an IRB-approved open-label, single-arm trial that enrolled 26 patients with newly diagnosed advanced PC. Patients received androgen deprivation therapy and docetaxel for 3 months followed by radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Exploratory interventions include PSMA PET/CT and MRI imaging as a method for determining treatment response and heterogeneity in primary PC and metastatic lesions performed before and after chemohormonal therapy. Prior to randomization, patients received DCFPyL PET/CT and PET/MR imaging as well as CTs and Bone Scans. A mean dose of 7.86 mCi DCFPyL was administered. Whole-body PET/CT images were acquired starting at approximately 60 minutes after radiotracer injection followed by dedicated pelvic PET/MR and whole-body PET/MR. PET imaging findings were compared to conventional dedicated CT imaging and were correlated to the results of final pathologic examination of each pelvic nodal dissection. Results: 26 patients underwent conventional and exploratory imaging with subsequent neoadjuvant treatment, RP and PLND. The mean diagnostic PSA was 32.1 ng/dl and 88.5% had Gleason 9 PCa. Using conventional imaging, pelvic nodal disease was identified in 6/26 patients. Pelvic lymph node uptake was identified in 12/26 patients using DCFPyL-based PSMA PET. Initial correlation of the pathologic specimens with pretreatment PSMA PET imaging revealed pelvic nodal metastatic PC in 10/12(83%) patients. On a per-lymph node packet basis (6 per patient), there were 156 evaluable regions, including 65 from patients with positive nodes. PSMA detected 14 packets that were positive for PC and 102 packets that were negative on imaging and final pathology. PC was missed in 5 packets. The mean tumor size in the missed nodes was 2.3 mm(range 1-4 mm). Calculated sensitivity was 73.7%(95% CI [48.8, 90.8]), 85.7 % specificity(95% CI[78.1, 91.4]), and 95.3 % negative predictive value(95% CI[90.5, 97.7]). Conclusions: In comparison to conventional imaging, in this cohort, DCFPyL PSMA-based PET imaging identified nodal positive disease at twice the rate and when evaluating on a per-packet basis, there was high negative predictive value. Ongoing analysis of post-chemohormonal therapy PET imaging may provide more information regarding tumor response in this cohort.

UnCHAARTED territory: The role of docetaxel rechallenge following chemohormonal therapy for metastatic castrate-sensitive prostate cancer.

117 Background: Since docetaxel has been advanced to the metastatic castrate-sensitive prostate cancer (mCSPC) setting, there is a lack of evidence guiding its re-introduction upon castrate-resistant (CR) progression. We sought to identify clinical characteristics and outcomes of patients subjected to docetaxel rechallenge (DR) following prior docetaxel exposure in the mCSPC realm. Methods: Patients rechallenged with docetaxel following treatment in the mCSPC setting were identified from three academic centres in Ontario, Canada. Retrospective chart reviews were performed to identify clinical, treatment and outcome variables. Results: Of the 45 patients with DR initiated between 06/2015 and 07/2020, the median age was 65, 60% had a Gleason score of ≥8, and 64% had an ECOG of ≤1. 56% had bone only metastasis, 4% lymph node only metastasis, 29% bone and lymph node metastasis, and 11% had visceral metastasis. In the mCSPC setting, 98% of patients received 6 cycles of docetaxel with 13% requiring dose delays. Of 43 informative patients, all had a PSA response to chemohormonal therapy. 91% achieved at least a 50% PSA response (PSA50), of which 40% had a 50-89% PSA reduction and 51% had a ≥90% PSA reduction. 29% of patients obtained a PSA nadir of &lt; 0.2 ng/mL. 16% had CR progression in &lt; 6 months, 56% in 6-12 months, and 28% in &gt; 12 months. DR was initiated after a median of 20.8 months (range 6.0-40.4) following the last dose of docetaxel for mCSPC, and was given as first line treatment for CR disease to 7%, second line to 51%, third line to 40%, and fourth line or beyond to 2% of patients. 69% of patients had received an androgen-receptor axis targeted therapy prior to DR, 18% radium 223, and 7% had received a trial drug. Notably, no patients had received cabazitaxel prior to DR. The median number of cycles of docetaxel received at rechallenge was 5 (range 1-11) with 18% of patients requiring treatment delays. 64% of patients stopped treatment due to progression, 16% due to side effects, 7% at the patient’s request, 7% due to completion of the planned number of cycles, and 6% due to death or other causes. Among 44 informative patients, 23% achieved at least a PSA50, with 18% having a 50-90% PSA reduction, and 5% having a ≥90% PSA reduction. The median time to progression (biochemical, radiographic, or death) was 2.3 months (95%CI 1.7-4.4) and the median overall survival was 11.0 months (95%CI 8.5-14.3). Conclusions: DR following exposure to docetaxel in the mCSPC setting resulted in a PSA50 in only around one quarter of patients. Both the median time to progression and overall survival were found to be short. With future investigations, we hope to identify clinical variables that will help predict which patients might benefit most from DR.

Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer.

82 Background: Most men who die of prostate cancer are older than 70 years, and the impact of therapy in this population is poorly defined. The ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC) to receive androgen deprivation therapy (ADT) with or without docetaxel. Methods: The results of CHAARTED showed an overall survival (OS) benefit for the addition of docetaxel to ADT in men with mHSPC. In a secondary analysis of this trial, we assessed patient characteristics and OS in patients ≥70 years (“older men”) versus &lt;70 years (“younger men”) with Cox proportional hazards models. Additionally, we compared adverse events, therapy completion rate, and subsequent treatment patterns between these two groups using Chi-squared tests. Results: Of the 790 patients enrolled, 177 (22.4%) were ≥70 years. A greater proportion of older men had an impaired performance status (Eastern Cooperative Oncology Group 1-2: 36.7% vs. 28.6%, p=0.038) and prior local therapy (31.7% vs. 25.9%, p&lt;0.001) compared to younger men. Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI: 0.53-0.95 for younger men). This treatment benefit was seen for subgroups of older men with high volume disease (HR 0.43, 95%CI 0.23-0.79) and de novo metastatic disease (HR 0.36, 95%CI 0.19-0.69). A similar proportion of older and younger men completed all six cycles of docetaxel (82.6% vs. 87.1%, p=0.28). Rates of grade 3-5 adverse events were similar between older and younger men (36.8% of older men vs. 26.8% of younger men, p=0.69). The rate of any Grade 4-5 adverse events did not differ significantly between older and younger men (14.9% vs. 11.9%, respectively, p=0.46). In the control arm, a smaller proportion of older men received subsequent cancer treatments (34.4% vs. 51.5%, p=0.017) or subsequent docetaxel (25.6% vs. 37.6%, p=0.035) compared to younger men. Conclusions: In summary, older men with mHSPC who were eligible to participate in a clinical trial had similar OS benefit and clinical outcomes compared to younger men when receiving docetaxel chemotherapy + ADT. Oncologists should consider docetaxel chemotherapy as a favorable treatment option for older men with mHSPC who are fit for chemotherapy. Clinical trial information: NCT00309985.

Predicted sensitivity to endocrine therapy for stage II-III hormone receptor-positive and HER2-negative (HR+/HER2−) breast cancer before chemo-endocrine therapy

We proposed that a test for sensitivity to the adjuvant endocrine therapy component of treatment for patients with stage II-III breast cancer (SET2,3) should measure transcription related to estrogen and progesterone receptors (SETER/PR index) adjusted for a baseline prognostic index (BPI) combining clinical tumor and nodal stage with molecular subtype by RNA4 (ESR1, PGR, ERBB2, and AURKA). Patients with clinically high-risk, hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) breast cancer received neoadjuvant taxane-anthracycline chemotherapy, surgery with measurement of residual cancer burden (RCB), and then adjuvant endocrine therapy. SET2,3 was measured from pre-treatment tumor biopsies, evaluated first in an MD Anderson Cancer Center (MDACC) cohort (n= 307, 11 years' follow-up, U133A microarrays), cut point was determined, and then independent, blinded evaluation was carried out in the I-SPY2 trial (n= 268, high-risk MammaPrint result, 3.8 years' follow-up, Agilent-44K microarrays, NCI Clinical Trials ID: NCT01042379). Primary outcome measure was distant relapse-free survival. Multivariate Cox regression models tested prognostic independence of SET2,3 relative to RCB and other molecular prognostic signatures, and whether other prognostic signatures could substitute for SETER/PR or RNA4 components of SET2,3. SET2,3 added independent prognostic information to RCB in the MDACC cohort: SET2,3 [hazard ratio (HR) 0.23, P= 0.004] and RCB (HR 1.77, P < 0.001); and the I-SPY2 trial: SET2,3 (HR 0.27, P= 0.031) and RCB (HR 1.68, P= 0.008). SET2,3 provided similar prognostic information irrespective of whether RCB-II or RCB-III after chemotherapy, and in both luminal subtypes. Conversely, RCB was most strongly prognostic in cancers with low SET2,3 status (MDACC P < 0.001, I-SPY2 P < 0.001). Other molecular signatures were not independently prognostic; they could effectively substitute for RNA4 subtype within the BPI component of SET2,3, but they could not effectively substitute for SETER/PR index. SET2,3 added independent prognostic information to chemotherapy response (RCB) and baseline prognostic score or subtype. Approximately 40% of patients with clinically high-risk HR+/HER2- disease had high SET2,3 and could be considered for clinical trials of neoadjuvant endocrine-based treatment.

Abstract PS6-34: Real life impact of TAILORx trial in a multi-center healthcare system: A comparison of management practice one year before and after the release of the trial

Abstract Introduction: Oncotype DX is a 21 gene assay which has been shown to be useful in predicting the risk of breast cancer recurrence. TAILORx trial compared survival with the use of hormonal therapy (HT) vs. chemo-hormonal therapy (CHT) in early-stage, Hormone receptor-positive, HER2-negative, axillary lymphnode-negative breast cancer who had an Oncotype DX recurrence score in the intermediate range (11-25), The study found HT to be non-inferior to CHT in that group, especially in women older than 50. Materials and methods: We studied 1084 patients with hormone receptor-positive, HER-2 negative early stage breast cancer at a multi-center setting in South Dakota and North Dakota who were diagnosed one year before and after the results of the TAILORx trial were presented. We aimed to identify any change in practice after the trial was published as compared to the year prior. Chi-square analysis was used to compare demographics of patients and management practices before and after the TAILORx trial publication. Results: We did not find any statistically significant change in Oncotype DX testing frequency across various age groups, tumor sizes, tumor grades or amongst patients who had lymphnode negative or one axillary lymph node positive disease (Table-1).We also did not find any statistically significant difference in management of early stage breast cancer patients (Table-2) that matched our inclusion criteria and had an intermediate risk Oncotype Dx score of 11-25(n=266). Conclusion: Our results indicate that management of early stage breast cancer at our center was not significantly impacted by the results of TAILORx. Rare use of CHT prior to TAILORx reporting suggests that practice prior to this trial was largely based on earlier trials suggesting minimal benefit for CHT in the intermediate risk group. Larger studies may be able to identify smaller changes in practice resulting from this study and should be pursued. Table-1: Frequency of Oncotype Dx testing one year before and after the TAILORx trial was released overall and in various sub-categories based on age of the patient, tumor size and tumor grade. Last row indicates the frequency comparison in patients who had one axillary lymph node positive status.Before TAILORx (N=512)After TAILORx (N=572)p-valuen (%)n (%)Overall204 (40)234 (41)0.7212Age&amp;lt; 5044 (46)31 (37)0.225450 - 69121 (46)146 (49)0.4519Equal or &amp;gt; 7039 (26)57 (30)0.3986Tumor Size&amp;lt; 1 cm41 (25)50 (28)0.53881 - 1.9 cm97 (51)122 (53)0.60552 - 2.9 cm40 (44)44 (42)0.77283+ cm24 (39)18 (32)0.4161Tumor Grade156 (39)63 (42)0.62002113 (48)135 (47)0.8542334 (26)35 (27)0.9768LN Positive31 (33)36 (32)0.9403 Table-2: Comparison of treatment received by patients in the intermediate risk group (score:11-25) based on Oncotype Dx test before and after the release of TAILORx trial , Chi sq p-value=0.5635, HT (Hormonal Therapy), CT (Chemotherapy).Before TAILORxAfter TAILORxHT + CTn=15n=135.91%5.12%HT Alonen=108n=11842.52%46.46% Citation Format: Mahum Shahid, Moataz Ellithi, Mohamed Abdallah, Arsalan Arshad, Mansi Oberoi, Mckenna L Eisenbeisz, Christopher M VanHove, Ty A Moody, Isaak N Ailts, Andrew J Foley, Morgan Nelson, Jonathan Bleeker. Real life impact of TAILORx trial in a multi-center healthcare system: A comparison of management practice one year before and after the release of the trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-34.

Abstract GS3-00: First results from a phase III randomized clinical trial of standard adjuvant endocrine therapy (ET) +/- chemotherapy (CT) in patients (pts) with 1-3 positive nodes, hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) &amp;lt; 25: SWOG S1007 (RxPonder)

Abstract Funding: Supported by National Cancer Institute grants U10CA180888, U10CA180819, U10CA180820, U10CA180821, U10CA180868, U10CA180863; and in part by Susan G. Komen for the Cure® Research Program, The Hope Foundation for Cancer Research, Breast Cancer Research Foundation, and Genomic Health, Inc. Acknowledgement: The authors wish to thank Dr. Ana M. Gonzalez-Angulo, MD, for her invaluable contributions to the design and implementation of this study. Background: The clinical utility of the RS to determine CT benefit is well established in pts with HR+, HER2-, axillary lymph node (LN)-negative BC. Retrospective analyses from SWOG S8814 support the potential prognostic and predictive role of RS for CT benefit in postmenopausal pts with LN+ BC. SWOG S1007 is a prospective, randomized trial of endocrine therapy (ET) vs. chemoendocrine therapy (CET) in women with 1-3 +LN and a RS &amp;lt; 25 (NCT01272037). Methods: Eligibility criteria included women &amp;gt; 18 years of age with HR+, HER2- BC and 1-3 +LN and no contraindications to taxane and/or anthracycline based CT. Women with a RS &amp;lt; 25 were randomized to receive ET or CET in 1:1 randomization using 3 stratification factors: (1) RS (0-13 vs.14-25); (2) menopausal status; and (3) axillary nodal dissection vs. sentinel node biopsy. The primary objective was to determine the effect of CT on invasive disease-free survival (IDFS) and whether the effect depended on the RS. The primary analysis was to test for a significant interaction of the treatment arm and continuous RS using a Cox regression model for IDFS, adjusting for treatment, RS, and menopausal status. A total of 832 IDFS events were expected for the final analysis. Secondary objectives included overall survival (OS). The protocol specified that interaction between treatment and the stratification variables was to be tested and, if significant, separate analyses performed by stratum. Annual interim analyses were planned starting at 24% of events. At the third interim analysis with 410 IDFS events, the Data and Safety Monitoring Committee recommended reporting results, with a decision by the NCI’s Cancer Therapy Evaluation Program, the study sponsor. Results: Of the 9,383 women screened from 2/28/11-9/29/17, 5,083 pts (54.2%) were randomized. With a median follow-up of 5.1 years, 447 IDFS events have been observed. For the primary analysis, the interaction test for CT benefit and continuous RS was not statistically significant, p=0.30. In a model with CT, RS, and menopausal status (no interaction term), higher continuous RS was associated with worse IDFS [HR 1.06, 2-sided p&amp;lt;0.001, 95% Confidence Interval (CI) 1.04-1.07], and CT was associated with an improvement in IDFS (HR 0.81, p=0.026, 95% CI 0.67-0.98). In a pre-specified analysis, a significant interaction was identified between CT and menopausal status (p=0.004), necessitating separate analyses by menopausal status. In postmenopausal pts (N=3350, 67%), adjusting for continuous RS, the HR for CET vs. ET was not significant (HR=0.97, p=0.82, 95% CI 0.78-1.22; 5-year IDFS 91.6% vs. 91.9%) indicating no benefit from CT. In premenopausal pts (N=1665, 33%), the HR (0.54) was statistically significant (p=0.0004, 95% CI 0.38-0.76; 5-year IDFS 94.2% vs. 89.0%), indicating CT benefit. In premenopausal pts, ovarian suppression was performed in 15.9% vs. 3.7% (ET vs. CET), and 47.9% vs. 26.4% reported menstruation after 6 months of treatment. Although the number of events is limited, the HR for treatment adjusted by RS for OS in premenopausal pts was 0.47 (p=0.032, 95% CI 0.24-0.94). At this time, there is no differential effect with CT in regard to other stratification factors. Conclusions: There is a significant differential treatment effect of CT benefit based on RS for premenopausal vs. postmenopausal women requiring separate analyses. While only 54% of the protocol specified events are recorded and pts will be followed for 15 years, the current data show that adjuvant therapy can be de-escalated to ET alone in postmenopausal pts with a RS &amp;lt; 25 and 1-3 +LN. However, there is a strong IDFS benefit for CET in premenopausal pts, with an early indication of an OS improvement. Citation Format: Kevin Kalinsky, William E Barlow, Funda Meric-Bernstam, Julie R Gralow, Kathy S Albain, Daniel Hayes, Nancy Lin, Edith A Perez, Lori J Goldstein, Stephen Chia, Subkhbinder Dhesy-Thind, Priya Rastogi, Emilio Alba, Suzette Delaloge, Miguel Martín, Miguel Gil Gil, Claudia Arce-Salinas, Etienne Brain, In Hae Park, Jean-Yves Pierga, Ana Hernandez Lluch, Manuel Ramos Vasquez, Manuel Ruiz Borrego, Kyung Hae Jung, Jean-Marc Ferrero, Anne Schott, Steve Shak, Priyanka Sharma, Danika L Lew, Jieling Miao, Debu Tripathy, Gabriel Hortobagyi, Lajos Pusztai. First results from a phase III randomized clinical trial of standard adjuvant endocrine therapy (ET) +/- chemotherapy (CT) in patients (pts) with 1-3 positive nodes, hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) &amp;lt; 25: SWOG S1007 (RxPonder) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr GS3-00.

Abstract PS4-27: A prospective multicenter study evaluating the impact of the 21-Gene Breast Recurrence Score® upon physician treatment decision and cost in lymph node-positive breast cancer patients in Quebec

Abstract Background: Locoregional lymph node involvement has historically been used as the most important deciding factor for the administration of chemotherapy in the adjuvant setting of breast cancer patients. The 21-gene Breast Recurrence Score® assay (the assay) is emerging as an important tool to assist with chemotherapy decisions amongst hormone receptor (HR)-positive, node-positive breast cancer (BC) patients. Previous studies have suggested that node-positive patients with low Recurrence Score (RS) results do not benefit from chemotherapy. We wanted to better understand the impact of the assay upon physician treatment decisions and treatment cost in this patient cohort. Methods: We conducted a multicenter prospective observational trial for ER/PR-positive HER2-negative BC patients that have undergone surgical treatment for T1-T3 disease and 1-3 positive lymph nodes. Physicians were required to complete a questionnaire indicating treatment choice prior to and post availability of Recurrence Score results. Patients were enrolled in the study from the time of consent to 6 months after the start of adjuvant therapy. The primary endpoint was change in the physician’s recommendation for chemotherapy prior to and post assay results. Secondary endpoints include the change in recommendation for additional growth factor (GF) supportive therapy, change in physician’s expressed level of confidence, and changes in estimated cost of recommended treatments prior to and post assay results. Results: 70 patients were enrolled between March 2018 and September 2019 at five hospital centers, as part of the McPeak Sirois Group of Quebec. The median age of the cohort was 61 years (range, 38 to 82 years). 18.5% (n=13) of the cohort consisted of patients &amp;lt; 50 years, and 81.4% (n=57) were &amp;gt; or = to 50 years. 64.3% (n=45) of the patients had one positive lymph node and 35.7% (n=25) of the patients had 2 or 3 positive lymph nodes. 25.7% (n=18) of the patients had a RS &amp;lt; 11 and 68.6% (n=48) had a RS result between 11-25. For the entire cohort, we found that the proportion of patients for whom chemo-hormonal therapy was recommended was reduced by an absolute 67.1% by knowledge of the RS result (OR (odds of having chemo-hormonal therapy post-RS recommendation versus pre-RS recommendation) = 0.03 [95% CI: 0.01-0.08]; P&amp;lt;0.0001). The RS results led to an absolute reduction in physician recommendation in chemo-hormonal therapy by 38.5% for patients &amp;lt; 50 years, and by 73.7% of patients (OR=0.02 [95% CI: 0.01-0.06]; P &amp;lt;0.0001) for patients &amp;gt; or = to 50 years. Changes in treatment recommendation were identified for patients with one positive node, 73.3% (OR=0.02 [95% CI: 0.01-0.07]; P&amp;lt;0.0001); and for patients with two or three positive nodes, 56.0% (OR=0.06 [95% CI: 0.02-0.23]; P&amp;lt;0.0001). Recommendations for GF supportive therapy due to RS results decreased by 42.6% (OR=0.16 [95% CI: 0.07-0.34]; P &amp;lt;0.0001). Moreover, RS results led to an increase in confidence in physician treatment decisions for 68.6% of patients (OR=18.3 [95% CI: 7.90-42.28]; P &amp;lt;0.0001). We found that the cost of chemotherapy, in addition to anti-emetics and GF supportive therapy, decreased by 69.9% per patient (pre-RS mean, $3,968 CAN; versus post-RS mean, $1,196 CAN) (P &amp;lt;0.0001). Conclusions: Overall, we found that the 21-gene Breast Recurrence Score® assay changed physician treatment decisions in about two-thirds of all patients with hormone receptor-positive, node-positive BC, regardless of the number of positive nodes (up to 3). The assay increased physician confidence and was associated with an important decrease in treatment cost. Taken together, the assay is a cost-effective approach that can decrease the use of chemotherapy amongst HR-positive, node-positive BC patients in Quebec. Citation Format: Saima Hassan, Rami Younan, Erica Patocskai, Louise Provencher, Brigitte Poirier, Lucas Sideris, Pierre Dubé, Jean-Francois Boileau, Catalin Mihalcioiu, André Robidoux. A prospective multicenter study evaluating the impact of the 21-Gene Breast Recurrence Score® upon physician treatment decision and cost in lymph node-positive breast cancer patients in Quebec [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS4-27.

Abstract PS6-18: Are we missing something? Ki-67 evaluation is important in African American women with an oncotype DX score&amp;lt; 26: A multi-institutional study

Abstract INTRODUCTION: The literature suggests that there is no difference in the Oncotype DX® (ODX) recurrence score between African American (AA) women and Caucasian (CA) women; however, an analysis of clinical outcomes in participants enrolled in the TAILORx trial found that AA women had worse clinical outcomes than CA women, despite similar ODX recurrence scores. The TAILORx trial suggested that chemoendocrine therapy may not be necessary in women with hormone-positive, HER2-negative, node-negative invasive breast carcinomas with an ODX recurrence score &amp;lt; 26. We examine Ki-67 (a marker of tumor proliferation) in relation to an ODX recurrence score of 26 in AA and CA women from two seperate institutions. METHODS: A total of 851 consecutive cases of AA (n = 78) and CA women (n = 773) with ER+ invasive breast cancer and available ODX recurrence scores from the University of Rochester and the University of Louisville were included in this study. For all results, a p-value of &amp;lt; 0.05 was considered significant. RESULTS: Consistent with the previous literatuere, there was no significant difference between the average ODX recurrence score of AA and CA women (p = 0.44, Table 1), and we found no significant difference in average ER, PR, Nottingham score, or tumor size between AA and CA patients; however, the Ki-67 was significantly higher in AA patients with an ODX recurrence score &amp;lt; 26 compared to CA patients with and ODX recurrence score &amp;lt; 26 (p = 0.002, Table 2). This significant difference in Ki-67 was not evident with an ODX recurrence score ≥ 26 (p = 0.98, Table 2). CONCLUSIONS: Our preliminary results suggest that compared to CA women, AA patients are more likely to have a higher Ki-67 if the ODX recurrence score is &amp;lt; 26. AA breast cancer patients with an ODX &amp;lt; 26 are at increased risk for recurrence compared to CA women with an ODX &amp;lt; 26. Ki-67 evaluation is not routinely done as part of the breast cancer workup in many institutions. Ki-67 evaluation may be helpful to help guide treatments decisions in AA patients with and ODX &amp;lt; 26. Additional investigation is warranted. Table 1: Oncotype DX and histopathologic variables for African American and Caucasian womenODXRS* (mean)ER** (mean)PR** (mean)NS***(mean)Ki-67 (mean)****Tumor size (mean)ODXRS &amp;lt; 26 (n) ODXRS ≥ 26 (n)ALL17.6255.3168.96.016.42.2713138AA18.3250.7175.96.321.42.26315CA17.5255.8168.26.015.92.2650123*Oncotype DX recurrence score** modified H-score*** Nottingham score****n = KI-67 available for 777 total patients (650 with ODXRS &amp;lt; 26 and 127 with ODXRS ≥ 26); KI-67 available for 71 AA patients (51 with ODXRS &amp;lt; 26 and 14 with ODXRS ≥ 26); KI-67 available for 706 CA patients (593 with ODXRS &amp;lt; 26 and 113 with ODXRS ≥ 26) Table 2: Oncotype DX &amp;lt; 26 and ≥ 26 and associated histopathologic variables for African American and Caucasian womenODXRS* (mean)ER** (mean)PR** (mean)NS*** (mean)Ki-67 (mean)****Tumor size (mean)ODXRS &amp;lt; 2614.5260.5189.15.813.72.2AA15.4262.8200.76.019.22.3CA14.4260.3188.05.813.12.2ODX ≥ 2633.8228.464.47.330.52.1AA30.3199.871.97.730.41.6CA34.2231.963.57.330.52.2*Oncotype DX recurrence score** modified H-score*** Nottingham score****n = KI-67 available for 777 total patients (650 with ODXRS &amp;lt; 26 and 127 with ODXRS ≥ 26); KI-67 available for 71 AA patients (51 with ODXRS &amp;lt; 26 and 14 with ODXRS ≥ 26); KI-67 available for 706 CA patients (593 with ODXRS &amp;lt; 26 and 113 with ODXRS ≥ 26) Citation Format: Bradley M Turner, Mary Ann Gimenez-Sanders, Huina Zhang, Ioana Moisini, Xi Wang, Linda Schiffhauer, Hani Katerji, Kristin Skinner, Jessica Gooch, Michelle Shayne, Marilyn Ling, Carla Falkson, David Hicks. Are we missing something? Ki-67 evaluation is important in African American women with an oncotype DX score&amp;lt; 26: A multi-institutional study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-18.

Abstract PS6-24: Are we missing something? Increased recurrence rates in patients with an oncotype DX score &amp;lt; 26 and a modified magee score &amp;gt; 18: A multi-institutional study

Abstract INTRODUCTION: Oncotype DX® (ODX) is a multigene assay estimating risk of distant recurrence and chemotherapy benefit in estrogen receptor (ER) positive breast cancer patients. Cost ($4,620.00) impedes its adoption in poorer countries, and the cost is unnecessary in certain patients. TAILORx results suggest that adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-positive, HER2-negative, node-negative invasive breast carcinomas with an ODX recurrence score &amp;lt; 26. Bhargava et al. and Turner et al. have suggested that a Magee scoreTM or a modified Magee score, respectively, of &amp;lt; 18 will identify patients who are highly likely to have an ODX recurrence score of &amp;lt; 26, and we previously presented data at SABCS 2019 (Abstract P3-07-06) that there is no significant difference in recurrence rate between patients with a modified Magee score of ≤ 18 and patients with an ODX recurrence score &amp;lt; 26 (in preparation for publication). We now present additional recurrence data on patients with a modified Magee score of &amp;gt; 18. METHODS: A total of 301 consecutive patients with ER+ invasive breast cancer from the University of Rochester and the University of Louisville were included in this study, with a mean of 6.6 years of follow-up. All patients had at least 5 years of follow-up (range 5-11 years) except for seven patients , who had a breast cancer recurrence prior to five years. Information on ER, PR, HER-2, Ki-67, Nottingham score , and tumor size were extracted from the pathology report in order to calculate the modified Magee score. Information, on hormone therapy, chemotherapy, radiation therapy, recurrence status, and mortality were extracted from the medical record. For all results, a p-value of &amp;lt; 0.05 was considered significant. RESULTS: 117/301 (39%) patients had a modified Magee score of &amp;gt; 18. The recuurence rate for patients with a modified Magee score &amp;gt; 18 was 11.1%. There was no significant difference in recurrence rate between patients with both a modified Magee score &amp;gt; 18 and ODX recurrence score &amp;lt; 26 compared to patients with both a modified Magee score &amp;gt;18 and ODX recurrence score ≥ 26 (p = 0.547, Table 1). CONCLUSIONS: Patients with a modified Magee score &amp;gt; 18 may be at increased risk for breast cancer recurrence, even if the ODX recurrence score is &amp;lt; 26. Additional studies are necessary to further evaluate these findings. Table 1: Modified Magee score &amp;gt; 18, Oncotype DX recurrence score (ODXRS), and outcomeRecurrenceNo recurrenceModified Magee score &amp;gt; 18 and ODXRS &amp;lt; 26870Modified Magee score &amp;gt; 18 and ODXRS ≥ 26633 Citation Format: Bradley M Turner, Mary Ann Gimenez-Sanders, Ioana Moisini, Huina Zhang, Xi Wang, Linda Schiffhauer, Hani Katerji, Kristin Skinner, Jessica Gooch, Michelle Shayne, Marilyn Ling, Carla Falkson, David Hicks. Are we missing something? Increased recurrence rates in patients with an oncotype DX score &amp;lt; 26 and a modified magee score &amp;gt; 18: A multi-institutional study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-24.

Abstract PS4-47: Multi-country clinical validation of can assist breast in Europe indicates robustness of the test

Abstract Background: CanAssist Breast (CAB) is a prognostic test for early stage hormone receptor positive breast cancer patients, that predicts risk of distant recurrence in five years post-diagnosis. Its support vector machine-based algorithm utilizes immunohistochemistry profiles of five biomarkers involved in tumor biology (CD44, ABCC4, ABCC11, N-Cadherin and pan-Cadherin) and three clinical parameters (tumor size, grade, and node status) to categorize patients into low- or high-risk of distant recurrence. CAB was developed on Indian patients, and has been validated in Indian and US patients. The current study presents first ever multi-country, blinded, retrospective validation of CAB. Methods: A total of 669 patients’ breast tumors from Austria (n=327), Spain (n=292) and Italy (n=50) diagnosed 5-10 years ago along with known clinical parameters were included. CAB was performed on the formalin fixed tumor samples using Roche’s automated immunohistochemistry platform at OncoStem’s CAP accredited reference laboratory in India. CAB risk predictions were matched with the clinical outcomes by the respective hospitals. Distant Metastasis Free Survival (DMFS), negative predictive value (NPV) and Hazard Ratio (HR) were computed from Kaplan-Meier survival curves using MedCalc software. Results: The median age of the cohort was 60 years (range: 28-92 years), with only 28% of patients aged &amp;lt; 50 years. The cohort had equal proportions of stage I and stage II patients and 19% of patients with poorly differentiated tumors (G3). Amongst stage II patients 57% had three nodes positive (N1) disease. Total cohort had of 72% N0 patients and 28% N1 patients. The DMFS of this cohort was 95% in low-risk versus 82% in high-risk category (p &amp;lt; 0.0001). The recurrence rate was 5% in low-risk category as against 18% in high-risk category. The risk stratification of patients treated with endocrine therapy alone (68%) was similar to chemo-endocrine therapy (32%) treated patients, both had 95% DMFS in low-risk category. Subtle differences in the NPV was observed across different European patient cohorts: Spain-96%, Italy-100%, Austria-93%. The performance of CAB in European cohort was comparable to the mixed validation cohort of ~1100 patients from India and US, with identical DMFS of 95% in the low-risk category. In a sub-cohort of T1N0 patients (50%), the DMFS in low-risk group was still higher at 97%. In the multivariate Cox proportional hazards model, CanAssist Breast risk score had the highest and significant hazard ratio of 2.9 (p=0.0013, CI: 1.5-5.5) over clinical parameters (node, grade, tumor size), age and type of therapy (endocrine vs. chemo-endocrine). Conclusion: The current study demonstrates the robustness of risk prediction by CAB in an European cohort of diverse nationalities and ethnicities. Similar accuracy of CAB in the Indian and European cohort emphasizes that CAB based risk predictions are driven by tumor biology and are independent of conventional prognostic factors. Citation Format: Somashekhar SP, Aparna Gunda, Chandra Prakash V Serkad, Aditya K Sengupta, Patricia Gomez, Cristina Saura, Vicente Peg, Jose Jimenez, Susanne Sprung, Heidelinde Fiegl, Christine Brunner, Daniel Egle, Manjiri M Bakre. Multi-country clinical validation of can assist breast in Europe indicates robustness of the test [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS4-47.

Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial

IntroductionSurvival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in...

Primary metastatic prostate cancer between prognosis or adequate/proper medical therapy

PurposeTo define the efficacy of standard androgen deprivation therapy (ADT) in the treatment of metastatic prostate cancer (PCa).Materials and methodsFifty patients with mean age of 70.48 ± 9.95 years old (range 52–87) who had metastatic PCa and received ADT between 2014 and 2019 were retrospectively evaluated. Median values of pre-therapeutic PSA and Gleason scores were 50 ng/ml (range 8–1201) and 8 (range 6–9), respectively. All patients received luteinizing hormone-releasing hormone (LHRH) analogue and anti-androgen. The patients were evaluated in terms of age, pre-therapeutic PSA serum levels, Gleason scores, presence of metastasis, number and percentage of cores involved, nadir PSA, time to nadir PSA, duration of ADT, and PSA at last follow-up. Multivariate analysis was used to define the factors which have impact on ADT response. The mean follow-up period was 13.87 ± 7.78 months, (range 2–32).ResultsAll patients showed reduction in serum PSA level after initiation of ADT, and the median value of nadir PSA was 1.12 ng/ml (range 0.02–50). The mean value of time to nadir PSA was 3.85 ± 1.57 months (range 2–7). The median value of PSA at last follow-up was 2 ng/ml (range 0.02–50.21). Multi-variant analysis showed that nadir PSA have a significant correlation with pre-therapeutic PSA, PSA at last follow-up, age, and Gleason scores (p < .05).ConclusionStandard ADT is a feasible option in the treatment of metastatic PCa. Gleason scores, age, pre-therapeutic PSA, and PSA at last follow-up have significant impact on outcomes of ADT. Further studies of high number of patients with long-term follow-up including other chemo-hormonal therapy and androgen receptor blockers should be carried out to confirm and improve efficacy of ADT.

A Shoulder Mass Revealing a Metastatic Prostate Cancer

Introduction: A shoulder mass revealing metastatic prostate cancer is very rare. We report a case of metastatic prostate cancer diagnosed on a shoulder mass and treated with analgesic radiotherapy and chemotherapy and androgen deprivation therapy (ADT). Observations: A 66 years old patient was referred for a painful right shoulder mass whose biopsy and pathological examination found a Gleason 8 (4 + 4) moderately differentiated adenocarcinoma. The PSA level was 508.52 ng/ml. The patient was treated with analgesic radiotherapy on the right shoulder and chemo-hormonal therapy. At 2 years follow-up, the disease was well controlled. Conclusion: A shoulder mass revealing metastatic prostate cancer is not common. Local treatment of the symptomatic metastasis while continuing chemotherapy and ADT improves the quality of life.

Choice of treatment options for metastatic hormone-sensitive prostate cancer

The arsenal of available treatments and treatments for metastatic hormone-sensitive prostate cancer (mHRPC) has increased significantly over the past 5 years. Although androgen-preferential therapy (ADT) remains the mainstay of treatment, the addition of docetaxel, abiraterone, enzalutamide, apalutamide, or local external beam radiation therapy improves the outcome of patients with mHRPC and becomes the standard of care. Choosing a therapy to improve treatment outcomes for patients with mHRPC is becoming increasingly challenging as there are different options for this stage of the disease. This article provides an overview of clinical trials that included ADT in combination with chemotherapy, new hormonal therapy, and radiation therapy. We will also consider recent advances in the choice of treatment for men diagnosed with mHPCR and the impact of previous therapy on the subsequent biology of the disease. Options include chemohormone therapy, androgen receptor (AR) targeted therapy in addition to ADT or, less commonly, ADT alone. The choice of treatment should be based on a consideration of the clinical characteristics and characteristics of the disease, as well as taking into account the patient’s preferences, territorial constraints and financial resources.