Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial Rapid Communication

Purpose Enzalutamide, a potent oral androgen receptor inhibitor, improves survival in men with metastatic castration-resistant prostate cancer (CRPC) before and after chemotherapy. Bicalutamide, a nonsteroidal antiandrogen, is widely used to treat men with nonmetastatic or metastatic CRPC. The efficacy and safety of these drugs were compared in this randomized, double-blind, phase II study of men with CRPC. Patients and Methods A total of 396 men with nonmetastatic (n = 139) or metastatic (n = 257) CRPC were randomly assigned to enzalutamide 160 mg per day (n = 198) or bicalutamide 50 mg per day (n = 198). Androgen deprivation therapy was continued in both arms. The primary end point was progression-free survival (PFS). Results Enzalutamide reduced the risk of progression or death by 76% compared with bicalutamide (hazard ratio [HR], 0.24; 95% CI, 0.18 to 0.32; P
Source: Journal of Clinical Oncology - Category: Cancer & Oncology Authors: Tags: Systemic Therapy, Systemic Therapy, Rapid Communications Source Type: research

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Conclusions: 3D-HDR-BT achieves favorable clinical outcomes with mild late toxicity in patients with locally rNPC. Introduction Nasopharyngeal carcinoma (NPC), a tumor of epithelial origin, is a malignant disease of the head and neck common in southern China, especially in Guangdong province (1). As a result of advances in modern imaging and irradiation techniques, the 5-year overall survival (OS) of patients with newly diagnosed NPC without metastasis has reached 75% after external beam radiotherapy (EBRT) in Asia (2, 3). However, local recurrence, which occurs in 18–40% of patients, remains a major reason for...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
AbstractOral abiraterone acetate (Zytiga®) is a selective inhibitor of CYP17 and thereby inhibits androgen biosynthesis, with androgen signalling crucial in the progression from primary to metastatic prostate cancer (PC) and subsequently, in the development of metastatic castration-resistant PC (mCRPC). In large phase 3 trials and in the clinical practice setting, oral abiraterone acetate in combination with prednisone was an effective treatment and had an acceptable, manageable tolerability and safety profile in chemotherapy-naive and docetaxel-experienced men with mCRPC. In the pivotal global phase 3 trials, relative...
Source: Drugs - Category: Drugs & Pharmacology Source Type: research
SummaryBackground Docetaxel and prednisolone chemotherapy (DP) extends survival in metastatic castration resistant prostate cancer (mCRPC). However, emergent clinical resistance is almost inevitable. AKT pathway activation is highly prevalent in mCRPC contributing to disease progression and DP resistance. AZD5363 is a potent oral pan-AKT inhibitor with pre-clinical data indicating activity in mCRPC and synergy with docetaxel.Methods This phase I trial was to determine an AZD5363 recommended phase II dose (RP2D) for combination with DP. Eligibility criteria included chemotherapy naive mCRPC, PSA or radiographic disease prog...
Source: Investigational New Drugs - Category: Drugs & Pharmacology Source Type: research
Conclusions Enzalutamide provided clinically significant benefits in men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease. Patient summary Patients with metastatic castration-resistant prostate cancer—including those with or without visceral disease or widespread bone disease—benefitted from enzalutamide, an active well-tolerated therapy. Enzalutamide provided meaningful clinical benefit to men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without vi...
Source: European Urology - Category: Urology & Nephrology Source Type: research
Purpose Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit. Patients and Methods Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random as...
Source: Journal of Clinical Oncology - Category: Cancer & Oncology Authors: Tags: Systemic Therapy Urologic Oncology Source Type: research
Conclusions Radioligand therapy with 177Lu-PSMA I&T appears to be safe and active in heavily preatreated mCRPC patients. Further prospective, randomized and multicentric evaluation under a phase-III protocol is encouraged.
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: CMIIT Young Investigator Award Source Type: research
Background The usefulness of Gleason score (
Source: Annals of Oncology - Category: Cancer & Oncology Authors: Tags: urogenital tumors Source Type: research
ConclusionTreatment effects and safety in Japanese patients were generally consistent with the overall results from PREVAIL.
Source: International Journal of Urology - Category: Urology & Nephrology Authors: Tags: Original Article Source Type: research
Background Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial. Patients and methods PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall ...
Source: Annals of Oncology - Category: Cancer & Oncology Authors: Tags: urogenital tumors Source Type: research
Treatment options have significantly expanded in recent years for men with metastatic castration-resistant prostate cancer (mCRPC), with the routine use of immunotherapy (sipuleucel-T) and novel hormonal agents such as enzalutamide and abiraterone acetate prior to taxane-based chemotherapy or radium-223 radiotherapy. A number of immune checkpoints limit the immune response of the host to metastatic tumor progression in prostate cancer, one of which is an immunosuppressive and pro-angiogenic cell called the myeloid-derived suppressor cell (MDSC). Tasquinimod is a small molecular oral inhibitor of S100A9, a key cell surface ...
Source: Therapeutic Advances in Urology - Category: Urology & Nephrology Authors: Tags: Reviews Source Type: research
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