Overall survival beyond first-line docetaxel in patients with metastatic castrate-resistant prostate cancer treated with abiraterone acetate or enzalutamide.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e570-e570
Author(s):  
Mi Hwa Heo ◽  
Se Hoon Park ◽  
Hee Kyung Kim ◽  
Jinhyun Cho ◽  
Youjin Kim ◽  
...  

e570 Background: In post-docetaxel setting of metastatic castrate-resistant prostate cancer (mCRPC), survival benefit with abiraterone acetate or enzalutamide is well established. This retrospective study was performed with the data obtained our cancer chemotherapy registry to evaluate real-world mCRPC patient outcomes. Methods: All consecutive patients treated with either abiraterone acetate or enzalutamide in post-docetaxel setting between 2013 and 2014 were included. The decision for administering second-line agents was, in most cases, at the discretion of the treating oncologists. The primary endpoint of this study was overall survival (OS), and the secondary endpoints included safety, prostate-specific antigen (PSA) response ( ≥ 50% decline) and progression-free survival (PFS). Univariate and multivariate analyses for OS were performed on the recognized baseline parameters and therapy. Results: A total of 54 eligible mCRPC patients received either abiraterone acetate (n = 25) or enzalutamide (n = 29). At the time of commencing second-line therapy, the patients’ median age was 70 years (range, 45-86) and 30 patients (56%) had a symptomatic disease. Visceral disease was present in 12 patients, and 12 had bone-only metastasis. Both were well-tolerated without significant toxicities. PSA response was observed in 36% and 52% for abiraterone acetate and enzalutamide, respectively. The estimated median PFS and OS were 5 and 15 months, respectively. Multivariate analysis revealed that the presence of clinical symptoms was the only independent prognostic factor for OS. Conclusions: Within the limitation of small sample size, the results are consistent with existing literature suggesting that both abiraterone acetate and enzalutamide appear to be effective as second-line therapy for docetaxel-pretreated mCRPC.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e16104-e16104
Author(s):  
Martin Richardet ◽  
Matias Nicolas Cortes ◽  
Matias Molina ◽  
Patricia Hernandez ◽  
Romina Brombin ◽  
...  

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 77-77
Author(s):  
Eric Zhuang ◽  
Edward M. Uchio ◽  
Michael B. Lilly ◽  
John P. Fruehauf

77 Background: Lycopene, the carotenoid responsible for the red colors seen in tomatoes, grapefruit, and other foods, has demonstrated synergism with docetaxel in prostate cancer cell culture and tumor xenograft models. This phase II study investigated the clinical activity and safety profile of docetaxel plus lycopene in advanced castrate resistant prostate cancer. Methods: Eligible patients had histologically confirmed adenocarcinoma of the prostate, two rising pre-study prostate specific antigen (PSA) values ≥ 1 ng/ml, and no prior treatment with any chemotherapy, biological therapy, or investigational drug. All patients initially received docetaxel 75mg/m2 every 21 days in combination with lycopene 30 mg orally once daily. The primary endpoint was PSA response rate, defined as the proportion of subjects achieving a ≥ 50% reduction in PSA at any point after starting therapy. Secondary endpoints included median time to PSA progression, duration of response (DOR), and overall survival (OS). Results: Fourteen patients were screened, and thirteen patients were initiated on protocol therapy. Median age was 77 years (range 55-90). Twelve patients (92%) had bone metastases. Four patients (30%) had bone and visceral metastases. The PSA response rate was 76.9% [95% confidence interval (CI), 46.2-94.9], comprising of ten PSA responses. Two patients had a best response of stable disease, yielding a disease control rate of 92% [95% CI, 57.2-98.2]. Median time to PSA progression was 8 months [95% CI, 3.5-8.7]. Median duration of response was 7.3 months [95% CI, 4.8-13.2]. On 5-year follow-up, median overall survival was 35.1 months [95% CI, 25.7-57.7]. The most frequently reported ( > 15%) non-hematologic adverse events included diarrhea, nausea, vomiting, peripheral neuropathy, weight loss, fatigue, onycholysis, and alopecia. One patient (7%) experienced febrile neutropenia. No patients experienced grade 3 or above anemia. Conclusions: The combination of docetaxel with lycopene led to improved PSA response rate and tolerability in patients with advanced castrate resistant prostate cancer. Docetaxel plus lycopene merits further research in this patient population. Clinical trial information: NCT01882985.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 356-356
Author(s):  
Adam McLain Kase ◽  
Cheryl Cook ◽  
Winston Tan

356 Background: Approval of multiple therapeutic agents for castrate resistant prostate cancer (CPRPC) has improved survival and also quality of life. However, how to optimize sequencing is still an ongoing challenge for most clinicians. Methods: A retrospective chart review of patients treated with FDA approved regimens for castrate resistant prostate cancer from 2002 to 2017 at Mayo Clinical Florida was completed. Data on progression free survival of the various treatment sequences including abiraterone, docetaxel, and enzalutamide were reviewed. Results: One hundred patients were included in the study. Those on clinical trial were excluded. All patients were on LHRH agonist /antagonist and were continued while on the subsequent treatments. The first line therapy progression free survival (PFS) was 245 days with abiraterone acetate (AA), 307 days with enzalutamide (E) and docetaxel 285 days, respectively. The second line therapy PFS was 201 days with AA and 166 days with E. When AA was given after E PFS was 97 days and when E was given after AA the PFS was 68 days. E given after docetaxel resulted in a PFS of 390 days for one patient. Conclusions: In this chart review, enzalutamide had the longest PFS when used as the first line therapy and the PFS was improved when used as a second line after docetaxel. This retrospective review suggests therapy sequencing may be optimized to increase progressive free survival in patients with metastatic castrate resistant prostate cancer.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15183-e15183
Author(s):  
James W. Gilmore ◽  
Sally Haislip ◽  
Stephen Szabo ◽  
Sean D Sullivan ◽  
Scott David Ramsey ◽  
...  

e15183 Background: Clinical studies showed that chemotherapy (CT) yields survival benefits for Metastatic Castrate resistant prostate cancer (CRPC) patients. This study investigated the relationship between patients with 2nd CT and OS using a real-world data. Methods: TheGeorgia Cancer Specialist Database containing chemotherapy, medical and pharmacy information, and lab results for patients with various types of cancer (2005-2011) was used. Patients (PTs) over 18 years of age with initial stage IV CRPC were followed from the first administration of CT (index date, ID) to the earlier of death or loss to follow-up (FU). PTs with one type of CT protocol (PL) were defined as first line CT PTs (1st), those with two types were identified as second line PTs (2nd), and those with three or more types were (3rd) line PTs. Kaplan-Meier survival curve was compared across the three groups using log-rank test. The impact of line of therapy on OS was further examined using multivariate Cox model with adjustment of PTs’ baseline age, race, Charlson Comorbidity Index (CCI), bisphosphonate use, and ECOG performance scores. Sensitivity analyses (SA) was conducted using different definition to define CT lines. Results: The study included148 PTs, with 86 (58.1%) as 1st, 38 (25.7%) as 2nd, and 24 (16.2%) as 3rd, 29 (19.6%) median age 73 with a range from 18 to over 82, 52.7% as race White, 33.8% African American, and 13.5% other or unknown race, average weight was 179 LB (range 100-279), average baseline PSA was 694 ng/ml (range: 0.05-21,743), 14 (9.5%) patients ECOG score of 3 or 4, 131 (88.5%) with one or more CCI comorbid conditions. Median survival was 17 months for overall, and 12, 19, and 23 months for 1st, 2nd, and 3rd line PTs, respectively (P=0.0355). Multivariate COX model found a higher likelihood of survival for 2nd line PTs (HR=0.361, P=0.006), but not for 3rd line PTs (HR=1.25, P=0.648). SA showed same results. Conclusions: This study suggested that second line of CT was associated with prolonged OS in metastatic CRPC. 3rd line CT survival benefit was not observed. Limitations include potential channeling bias and small sample size.


2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 5033-5033
Author(s):  
Sundhar Ramalingam ◽  
Michael Sandon Humeniuk ◽  
Rachel Hu ◽  
Julia Rasmussen ◽  
Patrick Healy ◽  
...  

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