The efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5071-5071
Author(s):  
Andrew J. Armstrong ◽  
Taro Iguchi ◽  
Arun Azad ◽  
Arnauld Villers ◽  
Boris Alekseev ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Bone Metastases ◽  
Disease Spread ◽  
Post Hoc Analysis ◽  
Secondary Endpoints ◽  
Hormone Sensitive ◽  
Baseline Characteristics ◽  
Post Hoc ◽  
Docetaxel Chemotherapy ◽  
Clinical Trial Information

5071 Background: In ARCHES (NCT02677896), ENZA + ADT reduced the risk of radiographic progression and improved secondary clinical outcomes in patients with metastatic hormone-sensitive prostate cancer (mHSPC) with variable patterns of disease spread over placebo (PBO) + ADT. This post hoc analysis aimed to evaluate the efficacy of ENZA + ADT in patients with bone oligometastatic mHSPC compared to polymetastatic mHSPC in ARCHES. Methods: Patients with mHSPC (n = 1150) were randomized 1:1 to ENZA (160 mg/day) + ADT or PBO + ADT, stratified by disease volume and prior docetaxel chemotherapy. This post hoc analysis included patients with bone metastases only, categorized as oligometastatic (1–≤5 metastases) or as polymetastatic (≥6 metastases) based on central review at screening. Efficacy outcomes were compared across treatment arms. Results: Of the ARCHES population with bone metastases (n = 512), the largest subgroup included patients with ≤5 metastases (ENZA + ADT, n = 160; PBO + ADT, n = 136). Baseline characteristics were generally comparable between treatment arms and across subgroups. When compared to PBO + ADT, ENZA + ADT improved rPFS and secondary endpoints in patients with ≤5 metastases (Table). Similar results were observed across other oligometastatic subgroups (1–≤4) as well as in polymetastatic disease (≥6). The safety profile of ENZA + ADT versus PBO + ADT was similar across subgroups and consistent with previous findings. Conclusions: This post hoc analysis demonstrates that ENZA + ADT provides clinical benefit across bone oligometastatic as well as polymetastatic mHSPC, supporting the utility of ENZA irrespective of metastatic burden in the ARCHES study. Clinical trial information: NCT02677896. [Table: see text]

Outcome of second-line treatment (2L Tx) following nab-paclitaxel (nab-P) + gemcitabine (G) or G alone for metastatic pancreatic cancer (MPC).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 333-333 ◽  
Author(s):  
David Goldstein ◽  
E. Gabriela Chiorean ◽  
Josep Tabernero ◽  
Robert Hassan El-Maraghi ◽  
Wen Wee Ma ◽  
...  
Keyword(s):  
Phase Iii ◽  
Line Treatment ◽  
Post Hoc Analysis ◽  
Superior Efficacy ◽  
Kaplan Meier ◽  
Baseline Characteristics ◽  
Metastatic Sites ◽  
Post Hoc ◽  
The Impact ◽  
Clinical Trial Information

333 Background: The impact of 2L Tx in MPC is not well described. The phase III MPACT trial (N = 861) demonstrated superior efficacy for nab-P + G vs G alone for 1L Tx of MPC. This post hoc analysis examined 2L Tx use in pts in MPACT. Methods: OS was estimated by the Kaplan-Meier method, using the most updated information from MPACT. Data were summarized by type of 2L Tx. Results: 347 pts received 2L Tx. Baseline characteristics (at start of 1L) of those pts were balanced between arms and representative of the ITT population: median age, 61-62 years; 12% had > 3 metastatic sites, and ≈ 30% had Karnofsky PS 70-80 in each arm. 26% and 14% of pts in the nab-P + G and G arms, respectively, discontinued 1L Tx for adverse events. OS in the 347 pts was significantly longer for nab-P + G vs G (Table). The median time from the end of 1L Tx to death for pts receiving no 2L Tx was 2.5 and 1.6 mo in the nab-P + G and G arms, respectively (HR, 0.67; P < 0.001), less than half for those who received any 2L Tx (5.3 and 4.5 mo). 78% and 76% of pts received a 5FU/capecitabine (cape)–containing regimen as 2L Tx after nab-P + G and G and achieved 13.5 and 9.5 mo of median OS, respectively. Conclusions: 2L Tx after nab-P + G or G alone in MPC is feasible and may potentially improve pt outcomes. Clinical trial information: NCT00844649. [Table: see text]

Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 102-102
Author(s):  
Arun Azad ◽  
Arnauld Villers ◽  
Boris Alekseev ◽  
Russell Zelig Szmulewitz ◽  
Antonio Alcaraz ◽  
...  
Keyword(s):  
De Novo ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Initial Diagnosis ◽  
Phase Iii ◽  
Post Hoc Analysis ◽  
Secondary Endpoints ◽  
Psa Progression ◽  
Hormone Sensitive ◽  
Post Hoc

102 Background: In ARCHES (NCT02677896) ENZA + ADT reduced the risk of radiographic progression-free survival (rPFS) events, primary endpoint, and improved key secondary endpoints vs PBO + ADT in men with mHSPC (also known as metastatic castration-sensitive PC). Given the progressive nature of PC, this exploratory analysis evaluated efficacy of ENZA + ADT in patients (pts) who progressed to M1 HSPC following initial diagnosis (M0) vs pts who presented with de novo mHSPC at diagnosis (M1). Methods: mHSPC pts (n=1150) were randomized 1:1 to ENZA (160 mg/day) + ADT or PBO + ADT, stratified by disease volume and prior docetaxel use. In this post hoc analysis, pts previously centrally categorized as MX/unknown metastasis at initial diagnosis (n=213) were adjudicated as either M0 or M1 disease following review of their medical profiles; efficacy outcomes were compared according to M0 vs M1 disease at initial diagnosis. Results: In this analysis, 246 pts (ENZA n=117; PBO n=129) had M0 and 890 pts (ENZA n=448; PBO n=442) had M1 disease at initial diagnosis; metastatic status of 14 pts (ENZA n=9; PBO n=5) were unknown (data not shown). Baseline characteristics were generally comparable between treatment arms; however, a greater proportion of M1 pts had high disease volume (n=606; 68.1% vs n=116; 47.2% [M0]) and prior docetaxel (n=173, 19.4% vs n=29, 11.8% [M0]). ENZA + ADT improved rPFS vs PBO + ADT irrespective of M0 or M1 disease at diagnosis; similar improvements were observed for secondary endpoints including prostate-specific antigen (PSA) and objective responses, time to PSA progression, time to new antineoplastic therapy (Table). Safety profiles were generally similar between subgroups and the overall population; exceptions include higher fatigue in M0 ENZA and PBO treatment arms. Conclusions: This post hoc analysis demonstrates clinical benefit of ENZA + ADT vs PBO + ADT based on rPFS and secondary endpoints in men who progressed from M0 to M1 HSPC and those with de novo M1 HSPC. Clinical trial information: NCT02677896. [Table: see text]

scholarly journals PD34-07 ENZALUTAMIDE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER PATIENTS WHO RECEIVED PRIOR ANTIANDROGEN THERAPY: POST HOC ANALYSIS OF ARCHES

2021 ◽  
Vol 206 (Supplement 3) ◽  
Author(s):  
Neal D. Shore ◽  
Taro Iguchi ◽  
Arnauld Villers ◽  
Antonio Alcaraz ◽  
Francisco Gomez-Veiga ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Post Hoc Analysis ◽  
Hormone Sensitive ◽  
Post Hoc ◽  
Antiandrogen Therapy

Surgical treatment as option in treatment of metastatic hormone-sensitive prostate cancer after prior drug treatment

2022 ◽  
pp. 41-45
Author(s):  
Sh. G. Khakimova ◽  
G. G. Khakimova ◽  
G. A. Khakimov ◽  
J. B. Sadullaev
Keyword(s):  
Prostate Cancer ◽  
Surgical Treatment ◽  
Drug Treatment ◽  
Bone Metastases ◽  
Clinical Result ◽  
Metastatic Prostate Cancer ◽  
Clinical Case ◽  
Complex Treatment ◽  
Good Clinical Result ◽  
Hormone Sensitive

Currently, there is no consensus on the place of prostatectomy in the complex treatment of patients with metastatic prostate cancer. A description of a clinical case of complex treatment and observation of a patient with prostate cancer with an unfavorable baseline prognosis and the presence of bone metastases with a good clinical result is presented.

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

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 82-82
Author(s):  
Daniel E Lage ◽  
M Dror Michaelson ◽  
Richard J. Lee ◽  
Joseph A. Greer ◽  
Jennifer S. Temel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Adverse Events ◽  
Older Men ◽  
Similar Proportion ◽  
Androgen Ablation ◽  
Younger Men ◽  
Hormone Sensitive ◽  
The Impact ◽  
Docetaxel Chemotherapy

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 <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<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.

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