Talazoparib,a Poly(ADP-ribose) Polymerase Inhibitor,for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses

BackgroundThe phase II TALAPRO-1 study ({"type":"clinical-trial","attrs":{"text":"NCT03148795","term_id":"NCT03148795"}}NCT03148795) demonstrated durable antitumor activity in men with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). Here, we detail the safety profile of talazoparib.Patients and MethodsMen received talazoparib 1 mg/day (moderate renal impairment 0.75 mg/day) orally until radiographic progression, unacceptable toxicity, investigator decision, consent withdrawal, or death. Adverse events (AEs) were evaluated: incidence, severity, timing, duration, potential overlap of selected AEs, dose modifications/discontinuations due to AEs, and new clinically significant changes in laboratory values and vital signs.ResultsIn the safety population (N = 127; median age 69.0 years), 95.3% (121/127) experienced all-cause treatment-emergent adverse events (TEAEs). Most common were anemia (48.8% [62/127]), nausea (33.1% [42/127]), decreased appetite (28.3% [36/127]), and asthenia (23.6% [30/127]). Nonhematologic TEAEs were generally grades 1 and 2. No grade 5 TEAEs or deaths were treatment-related. Hematologic TEAEs typically occurred during the first 4-5 months of treatment. The median duration of grade 3-4 anemia, neutropenia, and thrombocytopenia was limited to 7-12 days. No grade 4 events of anemia or neutropenia occurred. Neither BRCA status nor alteration origin significantly impacted the safety profile. The median (range) treatment duration was 6.1 (0.4-24.9) months; treatment duration did not impact the incidence of anemia. Only 3 of the 15 (11.8% [15/127]) permanent treatment discontinuations were due to hematologic TEAEs (thrombocytopenia 1.6% [2/127]; leukopenia 0.8% [1/127]).ConclusionCommon TEAEs associated with talazoparib could be managed through dose modifications/supportive care. Demonstrated efficacy and a manageable safety profile support continued evaluation of talazoparib in mCRPC.ClinicalTrials.gov identifier{"type":"clinical-trial","attrs":{"text":"NCT03148795","term_id":"NCT03148795"}}NCT03148795     

Management practices of tuberculosis in children among pediatric practitioners in Mangalore,South India

Introduction

In spite of having BCG vaccination and tuberculosis control program for the last 50 years, prevalence of tuberculosis continues to be high in India. Inadequate diagnostic methods, suboptimal treatment and monitoring, and the lack of vigilant reporting system are some of the contributing factors for the failure of TB control.

Prevalence of peripheral neuropathy among type 2 diabetes mellitus patients in a rural health centre in South India

International Journal of Diabetes in Developing Countries - There is a huge burden of diabetes-related complications, both microvascular and macrovascular, in India. With the rising prevalence of...     

How the Term ‘Self-Management’ is Used in HIV Research in Low- and Middle-Income Countries: A Scoping Review

AIDS and Behavior - This scoping review assessed how the term ‘self-management’ (SM) is used in peer-reviewed literature describing HIV populations in low- and middle-income countries...     

A salivary sensor for the management of xerostomia in edentulous patients

This article describes a method for managing xerostomia in edentulous patients with a newly developed salivary sensor. A micropressure sensor unit with a capsule to hold artificial salivary substitute was built into the dental prosthesis. This sensor prosthesis can help patients overcome mouth dryness, improves patient comfort, and aids in retention of the prosthesis.     

Management of cancer in the older adult

Cancer incidence and mortality rise exponentially in the elderly. With the aging of the population there is an urgent need to address this issue with evidence-based guidelines. Delayed diagnosis and incomplete workup and treatment are well documented in this population. Incorporation of a geriatric evaluation in oncology practice should be routinely implemented to prevent adverse outcomes. Treatment decisions in the elderly should not be based solely on survival gains but should also take quality of life into consideration. Cancer treatment is safe and effective in the elderly population. Social issues and other comorbidities should be addressed to improve compliance and outcome. Many unanswered questions regarding the optimal management of elderly cancer patients can be addressed only with the new clinical trials. Eliminating age bias among health care providers by providing education will help achieve optimal care for the elderly with cancer.