- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Orteronel fails to improve overall survival in metastatic prostate cancer: Study
USA: For patients with newly diagnosed metastatic hormone-sensitive prostate cancer, the addition of orteronel to androgen deprivation therapy (ADT) significantly improves progression-free survival but not overall survival (OS). The study has been published in the Journal of Clinical Oncology.
Prostate cancer is a major health issue, with approximately 1.3 million new cases diagnosed worldwide each year. Metastatic hormone-sensitive prostate cancer (mHSPC) is cancer that has spread past the prostate into the body but can be treated with hormone therapy. The revolution in the management of patients with metastatic hormone-sensitive prostate cancer (mHSPC) began recently with the addition of novel systemic therapies to androgen deprivation therapy (ADT). Orteronel (TAK-700) is an investigational, nonsteroidal 17,20-lyase inhibitor suppressing androgen synthesis.
Neeraj Agarwal, University of Utah Huntsman Cancer Institute, Utah, USA, and his team conducted an open-label randomized phase III trial to evaluate the clinical benefit of orteronel when added to androgen deprivation therapy (ADT) in patients with newly diagnosed metastatic hormone-sensitive prostate cancer.
Researchers enrolled 1,279 patients (median age was 68 years; 49% with extensive disease) with metastatic hormone-sensitive prostate cancer and randomly assigned them 1:1 to ADT with orteronel (300 mg orally twice daily; n=638 experimental arm) or ADT with bicalutamide (50 mg orally once daily; n=641 control arm). The primary endpoint was the comparison of overall survival (OS), targeting a 33% improvement in median survival. A stratified log-rank test with a one-sided P ≤ .022 would indicate statistical significance. Secondary endpoints were progression-free survival (PFS), prostate-specific antigen (PSA) level at 7 months (≤ 0.2 v 0.2 to ≤ 4 v > 4 ng/mL), and adverse event profile.
Key findings of the study,
• There was a significant improvement in PFS (median 47.6 v 23.0 months, HR- 0.58) and PSA response at 7 months, but not in OS (median 81.1 v 70.2 months, HR -0.86).
• More grade 3/4 adverse events occurred in the experimental versus the control arms (43% v 14%).
• Post protocol life-prolonging therapy was received by 77.4% of patients in the control arm and 61.3% of patients in the orteronel arm.
The authors conclude that the addition of orteronel to ADT resulted in a significant improvement in progression-free survival and prostate-specific antigen response but not in overall survival (OS), the primary endpoint. The median OS of patients in the control arm was higher than that in patients with metastatic hormone-sensitive prostate cancer who had similar disease severity and also received ADT plus bicalutamide.
Reference:
Neeraj Agarwal, Catherine M. Tangen, Maha H.A. Hussain, Shilpa Gupta, Melissa Plets et al.Journal of Clinical Oncology 0 0:0 Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216) DOI https://doi.org/10.1200/JCO.21.02517
BDS
Dr. Hiral patel (BDS) has completed BDS from Gujarat University, Baroda. She has worked in private dental steup for 8years and is currently a consulting general dentist in mumbai. She has recently completed her advanced PG diploma in clinical research and pharmacovigilance. She is passionate about writing and loves to read, analyses and write informative medical content for readers. She can be contacted at editorial@medicaldialogues.in.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751