scholarly journals Useful predictors of progression‐free survival for Japanese patients with LATITUDE‐high‐risk metastatic castration‐sensitive prostate cancer who received upfront abiraterone acetate

2021 ◽  
Author(s):  
Kiyoshi Takahara ◽  
Taku Naiki ◽  
Toshiki Ito ◽  
Keita Nakane ◽  
Takuya Koie ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Progression Free Survival ◽  
Japanese Patients ◽  
Abiraterone Acetate ◽  
Free Survival

scholarly journals Abiraterone versus bicalutamide in combination with gonadotropin releasing hormone antagonist therapy for high risk metastatic hormone sensitive prostate cancer.

2021 ◽  
Author(s):  
Takashi Ueda ◽  
Takumi Shiraishi ◽  
Saya Ueda ◽  
Motoharu Ohashi ◽  
Toru Matsugasumi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Progression Free Survival ◽  
Gonadotropin Releasing Hormone ◽  
Free Survival ◽  
Releasing Hormone ◽  
Group A ◽  
Psa Progression ◽  
Hormone Sensitive ◽  
Group B

Abstract ObjectivesTo compare the efficacy of abiraterone with that of bicalutamide in combination with gonadotropin-releasing hormone antagonist treatment for high risk metastatic hormone-sensitive prostate cancer patients.MethodsOne hundred and forty-nine patients with high risk metastatic hormone-sensitive prostate cancer at our hospital and affiliated hospitals between December 2013 and July 2020 were retrospectively identified. Fifty patients were administered abiraterone (1000mg/day) plus prednisolone (5mg/day) with gonadotropin-releasing hormone antagonist (degarelix) (group A) and 99 patients were administered bicalutamide (80mg/day) with gonadotropin-releasing hormone antagonist (group B). ResultsPSA- progression-free survival of group A was significantly longer than that of group B. Abiraterone therapy and Gleason score were significant independent factors for PSA-progression-free survival. By propensity score matching, total 56 matched patients were obtained. PSA-PFS (p<0.001) and OS (p=0.0071) of high risk mHNPC patients were significantly longer in abiraterone group of matched patients. Abiraterone therapy and Gleason score were still shown to be significant independent factors for PSA-PFS in matched patients.ConclusionsPSA-progression-free survival and overall survival in patients who were treated with abiraterone in combination with gonadotropin releasing hormone antagonist were significantly better than those of bicalutamide.

Efficacy and safety of abiraterone acetate (AA) and low-dose prednisone (P) in Japanese patients with newly diagnosed, metastatic, hormone-naïve prostate cancer (mHNPC): Subgroup analysis of LATITUDE trial.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 286-286
Author(s):  
Satoshi Fukasawa ◽  
Hiroyoshi Suzuki ◽  
Fuminori Sato ◽  
Katsuyoshi Hashine ◽  
Hisashi Hasumi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Group Versus ◽  
Progression Free Survival ◽  
Japanese Patients ◽  
Bone Lesions ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind

286 Background: Patients with high-risk mHNPC have a poor prognosis. In Japan, mHNPC accounts for approximately 10% of newly diagnosed prostate cancers. AAP was approved for the treatment of castration-resistant prostate cancer in Japan in July 2014. We now report the clinical benefit of AAP with ADT in Japanese patients with newly diagnosed, high-risk mHNPC. Methods: Interim analysis of the multinational, randomized, double-blind, placebo-controlled, phase 3 study, LATITUDE, was previously reported at ASCO2017. We evaluated the superiority of AA 1g + P 5 mg + ADT (AAP group) to ADT+PBOs of AA and P (P group) in mHNPC with ≥ 2 of 3 risk factors (Gleason ≥ 8, ≥ 3 bone lesions, measurable visceral metastases) for the subgroup of Japanese patients. Results: Of 1199 total patients in LATITUDE trial, 70 patients were Japanese (AAP group, n = 35; P group, n = 35). The hazard ratio (HR) for overall survival in the AAP group versus the P group was 0.635 (95% confidence interval [CI], 0.152 to 2.659) and HR for radiographic progression-free survival was 0.219 (95%CI, 0.086 to 0.560). The incidence of adverse events (AE) was 97% (34/35) in both groups. AEs that occurred in the AAP group at a frequency ≥10% compared with the P group included hypertension, hypokalemia, rib fracture, hematuria and hyperbilirubinemia. The incidence of Grade 3 and 4 AEs was 66% in the AAP group and 20% in the P group. As a whole, efficacy and safety of Japanese patients in LATITUDE were shown to be consistent with those of overall population. Conclusions: AAP has shown a favorable risk/benefit balance and may serve as a new treatment option to improve the prognosis of Japanese mHNPC patients with high-risk prognostic factors. Clinical trial information: NCT01715285.

Time to second progression (PFS2) in patients (pts) from TITAN with metastatic castration-sensitive prostate cancer (mCSPC) by first subsequent therapy (hormonal vs. taxane).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 82-82 ◽  
Author(s):  
Neeraj Agarwal ◽  
Simon Chowdhury ◽  
Anders Bjartell ◽  
Byung Ha Chung ◽  
Andrea Juliana Pereira de Santana Gomes ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Disease Progression ◽  
Progression Free Survival ◽  
High Volume ◽  
Abiraterone Acetate ◽  
Double Blind Study ◽  
Double Blind ◽  
Free Survival ◽  
Disease Characteristics ◽  
Post Hoc

82 Background: TITAN, a phase 3, randomized, double-blind study of apalutamide (APA) vs placebo (PBO) added to androgen deprivation therapy (ADT), demonstrated significant improvement in radiographic progression-free survival and overall survival in a broad pt population with mCSPC who received APA (Chi KN et al. NEJM 2019). This post hoc analysis evaluates whether type of 1st life-prolonging subsequent therapy (hormonal vs taxane) has an effect on PFS2 benefit shown with APA + ADT. Methods: PFS2 (the time from randomization to disease progression on 1st subsequent therapy for prostate cancer or death, whichever occurs first) was evaluated for pts from TITAN based on 1st subsequent life-prolonging therapy (hormonal vs taxane) after study treatment. Analysis censored all other 1st subsequent systemic therapies after start of treatment. Results: 277 pts (APA, 87; PBO, 190) received subsequent systemic therapy for prostate cancer; 86 pts (APA, 24; PBO, 62) received hormonal therapy (abiraterone acetate + prednisone or enzalutamide) and 99 (APA, 30; PBO, 69) received taxane (docetaxel or cabazitaxel) as 1st subsequent therapy. Baseline demographic and disease characteristics were generally similar between groups. The taxane group had a higher proportion of pts with high volume and pts with > 10 bone metastases, and a lower proportion with prior docetaxel exposure when compared with the hormonal group. Median treatment duration with APA and PBO was 11.9 and 11.1 mos in the hormonal group and 11.0 and 11.3 mos in the taxane group. Regardless of subsequent therapy, PFS2 was significantly longer for APA vs PBO (HR 0.66 [95% CI 0.50-0.87], p = 0.0026). Pts in both groups who received APA had a significant reduction in risk of 2nd progression compared with PBO (hormonal: HR 0.68 [0.48-0.97], p = 0.0326; taxane: HR 0.67 [0.48-0.94], p = 0.0189; medians not reached). Safety analyses were not conducted; all pts had discontinued therapy, most due to disease progression. Conclusions: The addition of APA to ADT for treatment of mCSPC results in risk reduction of 2nd progression regardless of choice of hormonal or taxane as the 1st life-prolonging subsequent therapy. Clinical trial information: NCT02489318.

Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991

2016 ◽  
Vol 34 (15) ◽  
pp. 1748-1756 ◽  
Author(s):  
Michel Bolla ◽  
Philippe Maingon ◽  
Christian Carrie ◽  
Salvador Villa ◽  
Petros Kitsios ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Lymph Nodes ◽  
Clinical Evidence ◽  
Progression Free Survival ◽  
Metastatic Spread ◽  
Localized Prostate Cancer ◽  
Free Survival ◽  
Pelvic Lymph Nodes ◽  
Androgen Suppression

Purpose Up to 30% of patients who undergo radiation for intermediate- or high-risk localized prostate cancer relapse biochemically within 5 years. We assessed if biochemical disease-free survival (DFS) is improved by adding 6 months of androgen suppression (AS; two injections of every-3-months depot of luteinizing hormone–releasing hormone agonist) to primary radiotherapy (RT) for intermediate- or high-risk localized prostate cancer. Patients and Methods A total of 819 patients staged: (1) cT1b-c, with prostate-specific antigen (PSA) ≥ 10 ng/mL or Gleason ≥ 7, or (2) cT2a (International Union Against Cancer TNM 1997), with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread, with PSA ≤ 50 ng/mL, were centrally randomized 1:1 to either RT or RT plus AS started on day 1 of RT. Centers opted for one dose (70, 74, or 78 Gy). Biochemical DFS, the primary end point, was defined from entry until PSA relapse (Phoenix criteria) and clinical relapse by imaging or death of any cause. The trial had 80% power to detect hazard ratio (HR), 0.714 by intent-to-treat analysis stratified by dose of RT at the two-sided α = 5%. Results The median patient age was 70 years. Among patients, 74.8% were intermediate risk and 24.8% were high risk. In the RT arm, 407 of 409 patients received RT; in the RT plus AS arm, 403 patients received RT plus AS and three patients received RT only. At 7.2 years median follow-up, RT plus AS significantly improved biochemical DFS (HR, 0.52; 95% CI, 0.41 to 0.66; P < .001, with 319 events), as well as clinical progression-free survival (205 events, HR, 0.63; 95% CI, 0.48 to 0.84; P = .001). In exploratory analysis, no statistically significant interaction between treatment effect and dose of RT could be evidenced (heterogeneity P = .79 and P = .66, for biochemical DFS and progression-free survival, respectively). Overall survival data are not mature yet. Conclusion Six months of concomitant and adjuvant AS improves biochemical and clinical DFS of intermediate- and high-risk cT1b-c to cT2a (with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread) prostatic carcinoma, treated by radiation.

scholarly journals Androgen Receptor Targeted Therapy + Radiotherapy in Metastatic Castration Resistant Prostate Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Maria Massaro ◽  
Giuseppe Facondo ◽  
Gianluca Vullo ◽  
Anna Maria Aschelter ◽  
Alessandro Rossi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Receptor ◽  
Targeted Therapy ◽  
Progression Free Survival ◽  
Conformal Radiotherapy ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant

ObjectivesTo investigate whether radiotherapy as metastasis-directed therapy (MDT) on oligo-progressive sites in metastatic castration-resistant prostate cancer (mCRPC) patients during treatment with androgen receptor-targeted therapy (ARTT) may lead to control resistant lesions, prolonging ARTT. We analysed progression free survival, overall survival and prognostic parameters that can identify patients that best suit to this approach.Patients and MethodsRetrospective analysis of a total of 67 lesions in 42 mCRPC patients treated with ablative or palliative RT to oligoprogressive lesions during ARTT. Twenty-eight patients (67%) underwent ARTT with Abiraterone acetate and 14 patients (33%) underwent ARTT with Enzalutamide. Median time between the start of ADT and ARTT beginning was 50.14 months (range 3.37-219 months). We treated 58 lesions (87%) with 3D conformal radiotherapy (3DCRT) and nine lesions (13%) with stereotactic body radiotherapy (SBRT). The Kaplan Meier method was used to assess the median overall survival (OS) and the progression-free survival (PFS).ResultsMedian follow-up was 28 months (range 3-82 months). Median OS was 32.5 months (95% CI 25.77-39.16), 1 and 2-year OS were 71.6% and 64.1%, respectively. Median PFS was 19,8 months (95% CI 11.34–28.31), 1 and 2-year PFS were 67.2% and 47.4%, respectively. Median OS for patients that underwent radiotherapy before 6 months from the start of ARTT was 23.4 months (95% CI 2.04-44.89) and 45.5 months (95% CI 31.19-59.8) for patients that underwent radiotherapy after 6 months (p = 0.009).ConclusionLocal ablative radiation therapy directed to progressive metastasis is a non-invasive, well tolerated treatment with efficacy on prolonging clinical benefit of systemic therapies with ARTT. Patients who underwent RT &gt;6 months from the start of ARTT presented a statistically better OS and PFS compared with patients who underwent radiotherapy &lt;6 months from the start of ARTT.

scholarly journals Radical prostatectomy vs radiotherapy in high-risk prostate cancer patients: two centre experience

2015 ◽  
Vol 13 (4) ◽  
pp. 234-243
Author(s):  
Albertas Ulys ◽  
Agne Ulyte ◽  
Pavel Dziameshka ◽  
Oleg Sukonko ◽  
Sergei Krasny ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Gleason Score ◽  
Independent Predictor ◽  
Progression Free Survival ◽  
Free Survival ◽  
T Stage ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

Background/objectiveThere are no randomized trials on the comparative effectiveness of radical prostatectomy (RP) and radiotherapy (RT) for high-risk prostate cancer. Our aim was to compare treatment outcomes of high-risk prostate cancer after RP and RT, including overall survival (OS), biochemical-progression-free survival (bPFS) and disease-progression-free survival (dPFS), using two cancer treatments centers’ patient data.MethodsData on high-risk prostate cancer patients between 2005 and 2009 were retrospectively reviewed in two cancer centers: National Cancer Institute, Vilnius, Lithuania and N.N. Alexandrov National Cancer Centre of Belarus, Minsk, Belarus; 210 patients were included in the study group treated with RP (n = 174) or RT (n = 36). The mean follow-up time was 5.6 and 6.6 years, respectively.ResultsLower T stage was an independent predictor of better OS (p = 0.01) and bPFS (p = 0.03). Only the highest Gleason score ≥8 was significantly predictive of a worse OS (p = 0.05), bPFS (p = 0.02) and dPFS (p = 0.001). A high PSA level was predictive of a worse bPFS (p = 0.007 for PSA ≥20) and dPFS (p = 0.008 for ≥20). The treatment modality in this study was insignificant after T stage, Gleason score and PSA level adjustment for OS, bPFS survival and dPFS survival (p = 0.17, p = 0.39, p = 0.20).ConclusionsThe T stage, Gleason score and pretreatment PSA level are significant factors for OS, bPFS survival, and dPFS survival of highrisk prostate cancer patients. Treatment option (RP or RT) was not an independent predictor of survival in this study.

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