Sipuleucel-T immunotherapy in clinical practice: Patient characteristics, tolerability, and survival.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15211-e15211 ◽  
Author(s):  
Matthew O'Shaughnessy ◽  
Christopher Warlick ◽  
Matthew Ziegelmann ◽  
Badrinath Konety ◽  
Gautam Gopalji Jha
Keyword(s):  
Clinical Practice ◽  
Disease Burden ◽  
Patient Characteristics ◽  
High Dose ◽  
Castration Resistant Prostate Cancer ◽  
Moderate Disease ◽  
Significant Difference ◽  
Complete Treatment ◽  
Chemotherapy Patients ◽  
Practice Methods

e15211 Background: Sipuleucel-T has been shown to provide survival benefit to men with minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). In the 18 months following FDA approval of sipuleucel-T, we sought to characterize patients referred for consideration of sipuleucel-T, determine the tolerability of therapy, and evaluate survival outcomes in clinical practice. Methods: We reviewed the records of patients referred to our institution for consideration of sipuleucel-T. Clinical characteristics, disease characteristics, and previous treatments were identified. Tolerability and adverse events were characterized. Results: Patients with minimally symptomatic mCRPC were offered sipuleucel-T (n=90), whereas patients with ECOG>1, progressive disease, or lack of metastases were not (n=11). Post chemotherapy patients started sipuleucel-T if their CD4 count was >400 at least 3 weeks following chemotherapy. Treatments were well tolerated, with 96% completing an entire series. Three patients did not complete treatment due to disease progression. The biggest challenge with sipuleucel-T therapy was disease control immediately before, during and post therapy. Androgen receptor blockade with nilutamide or high dose bicalutamide was used to control the disease during this time. Mean patient age was 69.8±9.7 years and all had ECOG status of 0-1. 40% of patients had minimal metastases, while 36% and 19% had moderate or extensive metastases. Median survival time (MST) for men >65 years who received sipuleucel-T was 17.6 months, whereas MST for men ≤65 years was not reached. There was no significant difference in overall survival (OS) between these groups (p=0.27). When stratified by disease burden, we found that OS of patients with extensive disease was shorter than men with mild or moderate disease burden (p=0.002 and p=0.04), with MST of 6.0 months. MST was not reached for men with mild and moderate disease burden. Conclusions: Sipuleucel-T is well tolerated in clinical practice for well-selected patients with asymptomatic or minimally symptomatic mCRPC. Patients with extensive metastatic disease, even when minimally symptomatic, did not appear to benefit from sipuleucel-T.

scholarly journals The Relation between Stress of Clinical Practice and Burnout among Nursing Students: The Mediation Effect of Spiritual Well-being

2017 ◽  
Vol 23 (3) ◽  
pp. 300-308
Author(s):  
Do Young Lee ◽  
Jin Kyoung Park ◽  
Mi Young Choi
Keyword(s):  
Clinical Practice ◽  
Nursing Students ◽  
Negative Correlation ◽  
Well Being ◽  
Self Report ◽  
Mediation Effect ◽  
Mediating Effects ◽  
Significant Difference ◽  
Spiritual Well Being ◽  
Practice Methods

Purpose: The purpose of this study is to examine the factors that influence the clinical practice of nursing students and to identify the mediating effects of spiritual well-being in the relation between stress of clinical practice and burnout caused by clinical practice. Methods: Data were collected by self-report questionnaires targeting 420 nursing students in three nursing colleges located in Gyeonggi and Chungnam province. Results: Burnout of clinical practice according to general characteristics of the study subjects showed significant difference in religion (t=1.895, p=.049). Stress of clinical practice and burnout of clinical practice showed positive correlation (r=.42, p<.001), existential spiritual well-being showed negative correlation between stress of clinical practice (r=-.17, p<.001) and burnout of clinical practice (r=-.47, p<.001). In addition, religious spiritual well-being in spiritual well-being showed no mediating effects and existential spiritual well-being showed mediating effects between burnout in clinical practice stress. Conclusion: In order to alleviate the stress of clinical practice for burnout of clinical practice prevention of nursing students, solutions to improve the existential spiritual well-being will be required in the future.

Prognostic impact of immune-related adverse events with nivolumab in patients with advanced gastric cancer: A multicenter retrospective analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 347-347
Author(s):  
Yuno Ohya ◽  
Takayuki Ando ◽  
Akira Ueda ◽  
Kohei Ogawa ◽  
Iori Motoo ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Practice ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Retrospective Analysis ◽  
Prognostic Impact ◽  
Significant Difference ◽  
Metastatic Sites ◽  
Practice Methods ◽  
Ecog Ps

347 Background: Nivolumab was established as one of the standard treatments for previously treated advanced gastric cancer (AGC). The aim of this study is to evaluate the frequency of immune-related adverse events (irAEs) with Nivolumab and its impact on treatment efficacy in clinical practice. Methods: We performed multicenter retrospective analysis, which included 90 patients with advanced gastric cancer who received Nivolumab treatment between October 2017 and September 2019. The frequency of irAEs and its treatment outcome were evaluated, and survival was compared during Nivolumab treatment. Results: The characteristics of 90 patients in this analysis were as follows: median age (range), 68 (36-85); male/female, 56/34; ECOG PS 0-1/≥2, 62/28; number of metastatic sites 1/≥2, 36/56; treatment line 3/≥4, 63/27. Median treatment cycle of nivolumab treatment was 3 (range 1-26). The overall response in 68 patients with target lesions was 6.3% (4/68), and the median PFS and OS was 1.5 and 4.3 months, respectively. IrAEs were observed in 8 patients (8.8%), including grade 4 pneumonitis, grade 2 or 3 adrenal insufficiency, and grade 2 hypothyroidism, encephalitis, and immune thrombocytopenia. Median time to onset of irAEs was 1.3 (range 0.6-10.5) months. Six were treated with systemic corticosteroid therapy, and all irAEs were relieved. The median PFS and OS were 4.7 months (95%CI, 1.2-9.3) and 12.2 months (95% CI, 3.2-not reached) in patient with irAEs, and 1.4 months (95%CI, 1.1-1.9) and 4.1 months (95%CI, 2.6-6.6) in those without, respectively. There was significant difference in the PFS (p=0.005) and OS (p=0.03). Conclusions: Nivolumab was effective and well tolerated even in clinical practice. Development of irAEs may be associated with better outcome of Nivolumab in patients with AGC.

Clinical utility of CLIA-grade AR-V7 testing in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 183-183 ◽  
Author(s):  
Mark Christopher Markowski ◽  
John Silberstein ◽  
James R. Eshleman ◽  
Jun Luo ◽  
Emmanuel S. Antonarakis
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Targeted Therapies ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Line Therapy ◽  
Improved Outcomes ◽  
Practice Methods

183 Background: The AR-V7 splice variant may confer resistance to AR-targeted therapies but not taxane chemotherapies. Since August 2015, a clinical-grade assay to detect AR-V7 mRNA expression in circulating tumors cells (CTC) has been available through a CLIA-certified lab at Johns Hopkins. In the first 12 months after launch, 195 AR-V7 tests were ordered for clinical purposes. We contacted the ordering providers of the first 100 tests using a questionnaire-based survey to determine how (and if) the results of AR-V7 testing were used in clinical practice. Methods: We identified 100 consecutive mCRPC pts who underwent AR-V7 testing in our CLIA lab. Ordering providers received a questionnaire for each test ordered, asking how (and if) the results of the assay affected their clinical decision-making, and whether a PSA50 response was obtained on next-line therapy after AR-V7 testing was performed. Results: 80 of 100 questionnaires were completed by 26 providers from 17 sites across 14 states. AR-V7 assay results were reported either as CTC negative (21/80: 26%), CTC+ AR-V7 negative (26/80: 33%), or CTC+ AR-V7 positive (33/80: 41%). Prevalence of AR-V7 detection increased with prior exposure to AR targeted drugs (Abi/Enza-naive 29%, post-Abi or Enza 39%, post-Abi and Enza 62%). Overall, management was impacted by AR-V7 testing in 54% of cases (43/80), and even more so with AR-V7+ results (see Table). AR-V7+ pts were commonly switched from AR targeted therapies to a taxane (10/19: 53%) or were offered a clinical trial (8/19: 42%). Pts who had a change in management based on AR-V7 testing were more likely to achieve a PSA50 response on next-line therapy than those not changing treatment (18/36: 50% vs 10/30: 33%). Conclusions: Providers used AR-V7 testing to influence clinical practice more often than not. AR-V7+ pts were most often treated with taxane-based therapy or offered a clinical trial, which may have improved outcomes. Clinical qualification of AR-V7 is ongoing. [Table: see text]

Integration of radium-223 dichloride (Xofigo) into clinical practice for the treatment of castration-resistant prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 312-312
Author(s):  
Catherine Mary Doyle ◽  
Matthew Mills ◽  
Sultan Damgaci ◽  
Johnna Smith ◽  
Jingsong Zhang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Practice ◽  
Bone Metastases ◽  
Univariate Analysis ◽  
Treatment Completion ◽  
Categorical Variables ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223 ◽  
Complete Treatment

312 Background: Radium-223 dichloride (Xofigo) is an FDA-approved radionuclide used to treat symptomatic bone metastases in patients with castration-resistant prostate cancer (CRPC) with no known visceral metastases. Outside of clinical trial, the benefits of Radium-223 dichloride (Ra-223) in the treatment of CRPC have not yet been fully delineated in real life setting. Therefore, the purpose of this study was to evaluate the outcome of patients with CRPC who were treated with Ra-223, especially studying the variables associated with completion of 6 cycles of therapy. Methods: A total of 114 patients with CRPC and bone metastases referred for treatment with Ra-223 between March 2010 and February 2018 were identified for retrospective analysis. A chart review was conducted to analyze clinical characteristics, treatments, and outcomes including radiologic bone scans. Categorical variables were compared using Chi-square and independent student t test, and survival rates were generated using Kaplan-Meier analysis. Multivariate analysis (MVA) Cox proportional hazard ratios (HR) model was used in the assessment of OS and PFS. Results: Of the 114 patients referred for treatment, the overall median OS was 12.6 months. In MVA, improved OS was most strongly associated with completion of all six doses (p < 0.001). Median OS for the 56 patients who received full treatment was 24 months, while median OS for the 107 patients who did not complete treatment was 5.9 months. In univariate analysis, treatment completion was significantly associated with prior Sipuleucel-T (p = 0.002), concurrent Denosumab (p = 0.027), and baseline PSA < 30 ng/mL (p = 0.004). Conclusions: Completion of treatment with Ra-223 is a significant factor associated with improved OS. Therefore it is clinically important to delineate which patients are to the most appropriate candidates to complete treatment. Factors notable for treatment completion suggest patients might benefit from initiating Ra-223 treatment after receiving Sipuleucel-T and while their PSA remains low. Further consideration should be given to the sequence of Ra-223 in clinical practice, including use of concurrent Abiraterone and Enzalutamide.

Safety and efficacy of trifluridine/tipiracil (FTD/TPI) plus bevacizumab in clinical practice for patients with chemorefractory metastatic colorectal cancer: A retrospective comparative study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 112-112
Author(s):  
Yoshinori Kagawa ◽  
Yohei Nose ◽  
Taishi Hata ◽  
Kenji Kawai ◽  
Takuya Sakamoto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Practice ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Combination Regimen ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
Retrospective Comparative Study ◽  
Practice Methods

112 Background: Trifluridine/tipiracil (FTD/TPI) significantly improves overall survival (OS) in patients with chemorefractory metastatic colorectal cancer (mCRC). The phase I/II C-TASKFORCE study of FTD/TPI + bevacizumab (Bev) for patients with mCRC who are refractory to standard chemotherapy demonstrated promising efficacy results. FTD/TPI + Bev were linked to significant and clinically relevant improvements in progression-free survival (PFS) and OS compared with FTD/TPI monotherapy and a favorable safety profile in a Danish randomized trial. This retrospective study investigated the safety and efficacy of FTD/TPI alone or in combination with Bev for patients with refractory mCRC in clinical practice. Methods: We reviewed the outcomes of patients with chemorefractory mCRC who received FTD/TPI alone (monotherapy; 35 mg/m2, twice daily on days 1–5 and 8–12 in a 28-day cycle) or FTD/TPI + Bev (combination; 5 mg/kg, days 1 and 15) in our institution since 2014. We compared the safety and efficacy of the monotherapy and combination regimens. Adverse events were evaluated using Common Terminology Criteria for Adverse Eventsv4.0. Median PFS and OS were analyzed using the Kaplan–Meier method. Results: In total, 56 patients received chemotherapy containing FTD/TPI. Twenty-four patients were treated with monotherapy, and 32 patients received the combination regimen. The median PFS was 1.8 months in the monotherapy arm, versus 4.7 months in the combination arm (hazard ratio [HR] = 0.28; 95% confidence interval [CI] = 0.15–0.51; P < 0.0001). The median OS was 6.3 months for the monotherapy arm, versus 11.7 months for the combination arm (HR = 0.25; 95% CI = 0.13–0.48; P < 0.0001). There was no significant difference in the rates of adverse events between the groups excluding neutropenia. Neutropenia (Grade 3 or worse) developed in five patients (20.8%) in the monotherapy arm and 17 patients (53.1%) in the combination arm ( P = 0.030). There were no treatment-related deaths. Conclusions: In patients with chemorefractory mCRC, FTD/TPI + Bev significantly improved PFS and OS versus FTD/TPI monotherapy.

Diatrizoate (Gastrograffin®) Small Bowel Follow Through for Small Bowel Obstructions: Timing and Outcomes

2021 ◽  
pp. 000313482110508
Author(s):  
Andrew Licata ◽  
Ismail El Moudden ◽  
Nicholas Bandy ◽  
Molly Sternick ◽  
Rebecca Britt
Keyword(s):  
Small Bowel ◽  
Disease Burden ◽  
Patient Characteristics ◽  
Operative Intervention ◽  
Early Group ◽  
Readmission Rates ◽  
Total Cost ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
Do So

Introduction The advent of the Gastrograffin® small bowel follow through (G-SBFT) has resulted in a decreased rate of operative intervention of small bowel obstructions (SBO); however, there is no data to suggest when G-SBFT should be performed. Methods We retrospectively reviewed 548 patients, admitted to 1 of 9 hospitals with a diagnosis of SBO. Patients were divided into two categories with regards to timing of G-SBFT: before (early) or after (late) 48 hours from admission. Primary outcomes were length of stay (LOS) and total cost. Secondary outcomes were operative interventions and mortality. Results Of the reviewed patients, 71% had the G-SBFT ordered early. Comparing early versus late, there were no differences in patient characteristics with regards to age, sex, or BMI. There was a significant difference between LOS (4 vs 8 days, P < 0.05) and total cost ($17,056.19 vs $33,292.00, P < 0.05). There was no difference in mortality (1.3% vs 2.6%, P = 0.239) or 30-day readmission rates (15.6% vs 15.9%, P = 0.509). Patients in the early group underwent fewer operations (20.7% vs 31.9%, P = 0.05). Discussion Patients that had a G-SBFT ordered early had a decreased LOS, total cost, and operative intervention. This suggests there is a benefit to ordering G-SBFT earlier in the hospital stay to reduce the overall disease burden, and that it is safe to do so with regards to mortality and readmissions. We therefore recommend ordering a G-SBFT within 48 hours to reduce LOS, cost, and need for an operation

scholarly journals Late Central Airway Toxicity after High-Dose Radiotherapy: Clinical Outcomes and a Proposed Bronchoscopic Classification

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1313
Author(s):  
Juliët E. van Hoorn ◽  
Max Dahele ◽  
Johannes M. A. Daniels
Keyword(s):  
Classification System ◽  
Survival Rates ◽  
Patient Characteristics ◽  
High Dose ◽  
Vascular Changes ◽  
Significant Difference ◽  
Airway Symptoms ◽  
Suspected Recurrence ◽  
Central Airway

The study’s purpose was to identify the bronchoscopic patterns of central airway toxicity following high-dose radiotherapy or chemoradiotherapy, and to look at the consequences of these findings. Our institutional bronchoscopy database was accessed to identify main patterns of airway toxicity observed in a seven-year period. A total of 70 patients were identified with central airway toxicity, and the findings of bronchoscopy were used to derive a classification system. Patient characteristics, time from radiotherapy to toxicity, follow-up and survival were retrospectively analyzed. Results: The main bronchoscopic patterns of airway toxicity were vascular changes (telangiectasia, loss of vascularity, necrosis) and stenosis of the lumen (moderate, severe). Indications for bronchoscopy were airway symptoms (n = 28), assessment post-CRT/surgery (n = 12), (suspected) recurrence (n = 21) or assessment of radiological findings (n = 9). Stenosis was revealed by bronchoscopy at a median time of 10.0 months (IQR: 4–23.5) after radiotherapy and subsequent follow-up after identification was 23 months (IQR: 1.5–55). The corresponding findings for vascular changes were 29 months (IQR: 10.5–48.5), and follow-up after identification was nine months (IQR: 2.5–19.5). There was a statistically significant difference in survival rates between patients with necrosis and telangiectasia (p = 0.002) and loss of vascularity (p = 0.001). Eight out of 10 deceased patients with telangiectasia died of other causes and 4/8 patients with necrosis died of other causes. We identified two main patterns of central airway toxicity visualized with bronchoscopy after high-dose radiotherapy or chemoradiotherapy, and propose a bronchoscopic classification system based on these findings. Preliminary analysis suggests that the pattern and severity of radiation damage might be of prognostic value. Prospective data are required to confirm our findings.

Prior Therapy with Rituximab (R) in Patients (pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Does Not Affect Disease-Free (DFS) or Overall Survival (OS) Following High Dose Therapy (HDT) and Autologous Stem Cell Transplantation (ASCT).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3054-3054 ◽  
Author(s):  
Snehal G. Thakkar ◽  
John William Sweetenham ◽  
Lisa Rybicki ◽  
Ronald Sobecks ◽  
Steven Andresen ◽  
...  
Keyword(s):  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Patient Characteristics ◽  
High Dose ◽  
Prior Therapy ◽  
Large B Cell Lymphoma ◽  
Significant Difference ◽  
Previously Treated ◽  
Large B Cell

Abstract The addition of R to first line chemotherapy regimens for DLBCL has resulted in improvements in DFS and OS. HDT and ASCT have been shown to improve outcome for pts with relapsed DLBCL compared with conventional dose salvage regimens. The effectiveness of HDT and ASCT in pts with DLBCL who have received prior therapy including R is unknown. We reviewed 257 consecutive pts with DLBCL treated with ASCT from 1/94–12/02. Of these, 161 (63%) had received R as part of their initial therapy and 65 (25%) had not received prior R. A third group (N = 31, 12%) who had been treated with R as part of salvage therapy prior to ASCT were excluded from further analysis. Patient characteristics are shown in Table 1. All patients received a preparative regimen of Busulfan, Cyclophosphamide, and Etoposide. Greater than 75% of patients in both groups had evidence of disease at time of transplant. Univariable and multivariable analyses demonstrated no difference between the pts previously treated with R and those not treated with R. After median follow up of 76 months (13–142) no statistical difference in DFS or OS was observed between the two groups. Patients were then adjusted for age, gender, stage, prior chemotherapy/radiation, time from diagnosis to CR, IPI, and disease status and compared again. The matched propensity analysis also showed no significant difference in DFS (p=0.87) and OS (p=0.22) (Figures 1 and 2). Despite concerns that pts with DLBCL previously treated with regimens containing R may have more resistant disease at relapse, our results suggest that HDT and ASCT is equally effective for these pts compared with those who have not received prior R. A prospective analysis is needed to confirm these results. Table 1. Patient Characteristics Categories No Rituximab (n=65) Rituximab (n=161) Age-median (range) 48 (19–70) 53 (23–72) Gender (M/F) 42/23 93/68 Stage IV (n) 75% (49) 61% (98) Prior Chemo Regimens-median (range) 2 (1–4) 2 (1–6) Prior Radiation (n) 25% (16) 32% (51) IPI (Low/Low-Intermediate vs High-Intermediate/High) 66% vs 34% 55% vs 45% CD34 collection (x 10^6)-median (range) 8.3 (2.9–39.2) 4.4 (0–52.8) Time to Transplant (mos)-median (range) 14.7 (2.8–274.3) 14.5 (5.1–192.6) Diffuse Large B-cell Lymphoma - Matched Groups Diffuse Large B-cell Lymphoma - Matched Groups Diffuse Large B-cell Lymphoma - Matched Groups Diffuse Large B-cell Lymphoma - Matched Groups

Updated safety result of a large Italian early access program (EAP) with cabazitaxel plus prednisone (CbzP) in metastatic castration-resistant prostate cancer (mCRPC) patients who progressed during or after docetaxel (D) therapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15185-e15185
Author(s):  
Sergio Bracarda ◽  
Giuseppe Di Lorenzo ◽  
Donatello Gasparro ◽  
Paolo Marchetti ◽  
Francesco Boccardo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Daily Clinical Practice ◽  
Castration Resistant Prostate Cancer ◽  
Good Tolerability ◽  
Early Access ◽  
Castration Resistant ◽  
Heavily Pretreated ◽  
Practice Methods ◽  
Ecog Ps ◽  
Access Program

e15185 Background: A significant percentage of mCRPC pts, who have progressed on D therapy, have a long life expectancy and are candidates for additional treatments. In TROPIC trial pts who progressed during or after D had a statistically significant OS advantage and clinical benefit with CbzP in respect to mitoxantrone plus prednisone (MP). Benefits observed in the TROPIC study supported a global EAP, to allow pts with mCRPC to have an early access to CbzP and provide confirmatory data in daily clinical practice Methods: We report the safety results of the first 90 pts entered into EAP and treated with CbzP, out of 232 pts enrolled by 25 Italian centers between Jan and Aug 2011 Results: Pts characteristics were median age 70 years (≥ 75 years 22.2%); ECOG PS 0-1, 97.8%; median N. of previous D cycles 8 (median cumulative D 675mg/m2); 14.1% received 675 ÷ 900 mg and 40.0% ≥ 900 mg of D. Median time from last D dose to first CbzP dose was 5.29 months including any other chemotherapy treatment.At the time of this analysis 50% of pts had received 4 cycles of CbzP. 33 pts discontinued CbzP mainly due to PD (42.4%), AEs (related/not related, 27.3%), investigator’s (3.0 %) / pts decision (18.2%) and others (9.1%). AEs resulting in CbzP discontinuation (10.0%) are mainly fatigue, pyrexia and haematological disorders. A total of 57 pts were still on treatment. In the 33 discontinued pts, CbzP has been delayed in 24.2% while a dose reduction occurred in 21.2% of pts. AEs of any grade were observed in 81/90 pts. Most common G 3/4 AEs were leukopenia (25.6%), neutropenia (48.9%), anaemia (6.7%), diarrhoea (1.1%), asthenia (3.3%) and fatigue (5.6%). One death occurred during the study period in a heavily pretreated pt who received 33 cycles of D Conclusions: This preliminary safety analysis suggests the good tolerability of cabazitaxel, in terms of haematological as well as non-haematological AEs even in heavily pretreated pts according to the previous experience of Italian Centers in theTROPIC trial. This is remarkable because of the increased similarity of the patient’ populations treated in the EAP and daily clinical practice

Propensity score matched comparison of docetaxel and androgen receptor axis-targeted (ARAT) agents in castration-resistant prostate cancer patients with intraductal carcinoma of the prostate (IDC-P).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 80-80
Author(s):  
Akiyuki Yamamoto ◽  
Masashi Kato ◽  
Toyonori Tsuzuki ◽  
Momokazu Gotoh
Keyword(s):  
Prostate Cancer ◽  
Androgen Receptor ◽  
Propensity Score ◽  
Patient Characteristics ◽  
Intraductal Carcinoma ◽  
Castration Resistant Prostate Cancer ◽  
Carcinoma Of The Prostate ◽  
Castration Resistant ◽  
Significant Difference ◽  
Docetaxel Group

80 Background: Several studies have reported that intraductal carcinoma of the prostate (IDC-P) is a pathological adverse prognostic factor in patients with prostate cancer. However, the optimal treatment has not been established. The present study aimed to evaluate the efficacy of docetaxel and androgen receptor axis-targeted (ARAT) agents in patients with castration-resistant prostate cancer (CRPC) with IDC-P using a propensity score-matched analysis. Methods: We retrospectively identified 309 patients with CRPC from February 2007 to February 2016. They received initial androgen deprivation therapy (ADT) and after progression to CRPC, they received docetaxel or ARAT (abiraterone or enzalutamide) as the first-line life-prolonging therapy. The primary outcome of interest was OS from the time of CRPC diagnosis. We also investigated PFS from the time of docetaxel or ARAT initiation. Results: Propensity score-matching identified 85 patients in each group. There were no significant differences in patient characteristics between the groups. The median OS in the docetaxel group was 38.2 months versus 58.3 months in the ARAT group (HR 0.57; 95% CI 0.37–0.89; P =.01). Regarding patients with IDC-P, OS was significantly longer in the ARAT group than the docetaxel group (HR 0.48; 95% CI 0.26–0.86; P =.01), and there was no significant difference in each group, as in patients without IDC-P (HR 0.75; 95% CI 0.37–1.52; P =.43). The median PFS in the docetaxel group was 6.7 versus 7.8 months in the ARAT group (HR 0.65; 95% CI 0.45–0.94; P =.02). A multivariate analysis demonstrated that the presence of IDC-P, duration of primary ADT, visceral metastasis, and administration of ARAT as the first treatment for CRPC were independent prognostic factors for OS. Conclusions: Administration of ARAT as the first treatment for CRPC may prolong OS more than that of docetaxel, especially in patients with IDC-P.

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