scholarly journals Real-World Treatment Patterns and Overall Survival of Patients with Metastatic Castration-Resistant Prostate Cancer in the US Prior to PARP Inhibitors

2021 ◽  
Author(s):  
Neal D. Shore ◽  
François Laliberté ◽  
Raluca Ionescu-Ittu ◽  
Lingfeng Yang ◽  
Malena Mahendran ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Real World ◽  
Parp Inhibitors ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
The Us

scholarly journals Treatment characteristics for nonmetastatic castration-resistant prostate cancer in the United States, Europe and Japan

2019 ◽  
Vol 15 (35) ◽  
pp. 4069-4081 ◽  
Author(s):  
Ruchitbhai Shah ◽  
Marc Botteman ◽  
Reginald Waldeck
Keyword(s):  
Prostate Cancer ◽  
Eastern Cooperative Oncology Group ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Androgen Synthesis ◽  
Castration Resistant ◽  
The Us ◽  
Androgen Synthesis Inhibitors

Aim: We conducted this study to describe nonmetastatic castration-resistant prostate cancer (nmCRPC) patient characteristics and treatment patterns in the US, Europe and Japan. Materials & methods: Descriptive analyses were conducted using the 2015–2017 Ipsos Global Oncology Monitor Database. Results: A total of 2065 (442 in the US, 509 in Europe and 1114 in Japan) patients (median age: 74–80 years; stage III at diagnosis : 38.5%; Eastern Cooperative Oncology Group [ECOG] score ≤1: 79.4%; treated by urologist : 88.4%) were included in the analytic cohort. Luteinizing hormone-releasing hormone agonists and antiandrogens were the most commonly used first regimen treatments. With subsequent nmCRPC regimens their use decreased, while the use of chemotherapy, corticosteroids, androgen synthesis inhibitors and second-generation androgen receptor inhibitors increased. Conclusion: These data represent real-world treatment patterns in nmCRPC.

scholarly journals Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy: Treatment Patterns From the PROXIMA Prospective Registry

2018 ◽  
pp. 1-12 ◽  
Author(s):  
Hideyuki Akaza ◽  
Giuseppe Procopio ◽  
Choosak Pripatnanont ◽  
Gaetano Facchini ◽  
Sergio Fava ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Treatment Patterns ◽  
Treatment Modalities ◽  
Treatment Sequence ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant ◽  
Previously Treated

Purpose There is a major clinical need to devise an optimal treatment sequence for the multiple therapy options available for patients with metastatic castration-resistant prostate cancer (mCRPC). In the absence of prospective clinical trials, sequencing information can be derived from large, real-world registry studies. Patients and Methods PROXIMA (Treatment Patterns in Patients With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy) is a large, global, prospective registry study evaluating real-world treatment patterns of patients with mCRPC who experience disease progression during or after docetaxel therapy. Patients were enrolled worldwide between 2011 and 2014. Treatments were determined by the treating physicians and recorded in categories of chemotherapy, hormonal therapy, targeted therapy, immunotherapy, and palliative therapy. Treatment sequencing patterns, response to treatment, and types of progression were recorded and analyzed. Progression-free survival and overall survival with different treatment modalities were analyzed using Kaplan–Meier method. Results Treatment patterns were evaluated in 903 patients. Therapy selection was influenced by region. Hormonal therapy (57.5%) and taxane chemotherapy (26.4%) were the most frequently administered first subsequent treatments after docetaxel. Tumor responses to first subsequent treatment were observed in 22.6% of evaluable patients. Overall survival and progression-free survival did not differ significantly across different treatment modalities. Conclusion Identifying an optimal treatment sequence is vital for improving the care of patients with mCRPC. The PROXIMA registry provided a representative sample of global data on real-world treatment patterns for patients with mCRPC previously treated with docetaxel. These data can be used to devise optimal therapy sequences and inform treatment decisions.

scholarly journals PD10-06 REAL-WORLD TREATMENT PATTERNS IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER

2020 ◽  
Vol 203 ◽  
pp. e247-e248
Author(s):  
Hari T. Vigneswaran* ◽  
Anna Warnqvist ◽  
Therese M. L Andersson ◽  
Amy Leval ◽  
Frida Schain ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

The effect of treatment sequence on overall survival for men with metastatic castration-resistant prostate cancer: A multicenter retrospective study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 238-238
Author(s):  
Shingo Hatakeyama ◽  
Kazutaka Okita ◽  
Hayato Yamamoto ◽  
Takahiro Yoneyama ◽  
Yasuhiro Hashimoto ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Real World ◽  
Cox Regression ◽  
Sequential Therapy ◽  
Treatment Sequence ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Castration Resistant ◽  
Significant Difference

238 Background: We aimed to evaluate the treatment sequence for patients with metastatic castration-resistant prostate cancer (mCRPC) in real-world practice and compare overall survival in each sequential therapy. Methods: We retrospectively evaluated 146 patients with mCRPC who were initially treated with androgen deprivation therapy as metastatic hormone-naïve prostate cancer in 14 hospitals between January 2010 and March 2019. The agents for the sequential therapy included new androgen receptor-targeted agents (ART: abiraterone acetate or enzalutamide), docetaxel, and/or cabazitaxel. We evaluated the treatment sequence for mCRPC and the effect of sequence patterns on overall survival. Results: The median age was 71 years. A total of 35 patients received ART-ART, 33 received ART-docetaxel, 68 received docetaxel-ART, and 10 received docetaxel-cabazitaxel sequences. The most prescribed treatment sequence was docetaxel-ART (47%), followed by ART-ART (24%). Overall survival calculated from the initial diagnosis reached 83, 57, 79, 37 months in the ART-ART, ART-docetaxel, docetaxel-ART, and docetaxel-cabazitaxel, respectively. Multivariate Cox regression analyses showed no significant difference in overall survival between the first-line ART (n = 68) and first-line docetaxel (n = 78) therapies (hazard ratio: HR 0.84, P = 0.530), between the ART-ART (n = 35) and docetaxel-mixed (n = 111) sequences (HR 0.82, P = 0.650), and between the first-line abiraterone (n = 32) and first-line enzalutamide (n = 36) sequences (HR 1.58, P = 0.384). Conclusions: The most prescribed treatment sequence was docetaxel followed by ART. No significant difference was observed in overall survival among the treatment sequences in real-world practice.

DAROL: DARolutamide ObservationaL study patients in nonmetastatic castration-resistant prostate cancer (nmCRPC) patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS5593-TPS5593
Author(s):  
Evan Y. Yu ◽  
Christopher Michael Pieczonka ◽  
Alberto Briganti ◽  
Declan G. Murphy ◽  
Thierry Lebret ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Real World ◽  
Specific Antigen ◽  
Clinical Effectiveness ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Event Time ◽  
Castration Resistant ◽  
The Us

TPS5593 Background: Patients (pts) with prostate cancer treated with prolonged androgen deprivation therapy (ADT) will eventually develop castration-resistant disease. Treatment of pts with nmCRPC with darolutamide (DARO) delays the development of metastases, which are associated with cancer-related morbidity. DARO is a structurally unique oral androgen receptor inhibitor approved by the FDA for the treatment of nmCRPC, based on prolonged metastasis-free survival (MFS) compared with placebo (median 40.4 months vs.18.4 months, respectively) in the ARAMIS phase III clinical trial. DARO showed a similar incidence of adverse events (AEs) compared to ADT alone and has a low potential for drug-drug interactions. However, phase III clinical trials cannot fully reflect all the facets of real-world pts. Therefore, non-interventional studies in the real-world setting, such as DAROL, are able to provide additional insight into the patterns of use and real-world safety profile of recently approved drugs. Methods: (NCT04122976) will enrol participants in the US, Brazil, Japan, and the EU. Eligible pts include men with histologically confirmed nmCRPC aged ≥18 yrs, life expectancy ≥3 months, and initiated on DARO treatment as per investigators’ decision within 3 days prior to enrollment. DAROL opened for enrollment in December 2019 in the US with a projected enrollment of 1000 pts. The primary endpoint of DAROL is safety. Treatment-emergent AEs will be collected during the study. Secondary endpoints to measure clinical effectiveness are MFS, time to symptomatic skeletal event, time to prostate-specific antigen progression, survival rate, and duration of DARO therapy. Other endpoints include pt demographics and characteristics, and prior and subsequent therapy. The estimated primary completion date is December 30, 2024. Clinical trial information: NCT04122976 .

scholarly journals Differential Activity of PARP Inhibitors in BRCA1- Versus BRCA2-Altered Metastatic Castration-Resistant Prostate Cancer

2021 ◽  
pp. 1200-1220
Author(s):  
Fadi Taza ◽  
Albert E. Holler ◽  
Wei Fu ◽  
Hao Wang ◽  
Nabil Adra ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Parp Inhibitor ◽  
Specific Antigen ◽  
Germline Mutations ◽  
Parp Inhibitors ◽  
Parp Inhibition ◽  
Missense Mutations ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

PURPOSE Two poly (ADP-ribose) polymerase (PARP) inhibitors (olaparib and rucaparib) are US Food and Drug Administration–approved for patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/ 2 mutations, but the relative efficacy of PARP inhibition in BRCA1- versus BRCA2-altered mCRPC is understudied. METHODS We conducted a multicenter retrospective analysis involving 12 sites. We collected genomic and clinical data from 123 patients with BRCA1/ 2-altered mCRPC who were treated with PARP inhibitors. The primary efficacy end point was the prostate-specific antigen (PSA) response (≥ 50% PSA decline) rate. Secondary end points were PSA progression-free survival (PSA-PFS), clinical or radiographic PFS, and overall survival. We compared clinical outcomes, and other genomic characteristics, among BRCA1- versus BRCA2-altered mCRPC. RESULTS A total of 123 patients (13 BRCA1 and 110 BRCA2) were included. PARP inhibitors used were olaparib (n = 116), rucaparib (n = 3), talazoparib (n = 2), and veliparib (n = 2). At diagnosis, 72% of patients had Gleason 8-10 disease. BRCA1 patients were more likely to have metastatic disease at presentation (69% v 37%; P = .04). Age, baseline PSA, metastatic distribution, and types of previous systemic therapies were similar between groups. There were equal proportions of germline mutations (51% v 46%; P = .78) in both groups. BRCA1 patients had more monoallelic (56% v 41%; P = .49) and concurrent TP53 (55% v 36%; P = .32) mutations. PSA50 responses in BRCA1- versus BRCA2-altered patients were 23% versus 63%, respectively ( P = .01). BRCA2 patients achieved longer PSA-PFS (HR, 1.94; 95% CI, 0.92 to 4.09; P = .08), PFS (HR, 2.08; 95% CI, 0.99 to 4.40; P = .05), and overall survival (HR, 3.01; 95% CI, 1.32 to 6.83; P = .008). Biallelic (compared with monoallelic) mutations, truncating (compared with missense) mutations, and absence of a concurrent TP53 mutation were associated with PARP inhibitor sensitivity. CONCLUSION PARP inhibitor efficacy is diminished in BRCA1- versus BRCA2-altered mCRPC. This is not due to an imbalance in germline mutations but might be related to more monoallelic mutations and/or concurrent TP53 alterations in the BRCA1 group.

scholarly journals 661P Real-world treatment (Tx) patterns of metastatic castration-resistant prostate cancer (mCRPC) patients (pts) in the US

2020 ◽  
Vol 31 ◽  
pp. S534-S535
Author(s):  
N. Shore ◽  
F. Laliberté ◽  
R. Ionescu-Ittu ◽  
A. Gayle ◽  
S. Amin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
The Us
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