Freezing of Gait Boot Camp: feasibility, safety and preliminary efficacy of a community-based group intervention.

Aim: In this pilot study, we evaluated the feasibility, safety and preliminary efficacy of a 6-week, community-based group intervention designed to reduce freezing of gait (FOG) for people with Parkinson's disease (PD).

Methods: Seven people with PD completed 'FOG Boot Camp' provided by the St. Louis Chapter of the American Parkinson Disease Association.

Practical management of adverse events associated with cabozantinib treatment in patients with renal-cell carcinoma.

Cabozantinib is an oral tyrosine-kinase inhibitor whose targets include VEGFR, MET, and AXL. Cabozantinib is approved for the treatment of patients with advanced clear-cell renal-cell carcinoma (RCC) who have received prior antiangiogenic therapy. In the pivotal Phase III trial of second-line RCC, cabozantinib was associated with a significant improvement in overall survival, progression-free survival, and antitumor response compared with everolimus.

Design and Rationale of the Metastatic Renal Cell Carcinoma (MaRCC) Registry: A Prospective Academic and Community-Based Study of Patients With Metastatic Renal Cell Cancer.

The Metastatic Renal Cell Cancer Registry, a large, nationally representative, prospective registry of patients with metastatic renal cell carcinoma (mRCC), aims to understand real-world treatment patterns and outcomes of patients with mRCC in routine clinical practice across the United States. This observational study is designed to enroll 500 patients with previously untreated mRCC from approximately 60 academic and community treatment sites; as of December 7, 2016, 500 patients have enrolled at 54 sites. Key endpoints include real-world data on reasons for treatment initiation and discontinuation; treatment regimens; disease progression; patient-reported outcomes; and healthcare resource utilization in this patient population.

Optimizing patient adherence to targeted therapies in renal cell carcinoma.

The current standard of care for treating metastatic renal cell carcinoma is sequential therapy with vascular endothelial growth factor-targeted agents (i.e., axitinib, bevacizumab, pazopanib, sorafenib, and sunitinib) and mammalian target of rapamycin inhibitors (i.

Current practices in the management of adverse events associated with targeted therapies for advanced renal cell carcinoma: a national survey of oncologists.

Background: Oncologists treating patients with targeted therapies encounter adverse events (AEs) that pose management challenges, lead to dosing inconsistencies, and impact patient quality of life. Oncologists' practices and attitudes in the management of targeted therapy-related AEs in patients with renal cell carcinoma (RCC) are poorly understood. We sought to identify unmet needs associated with AE management and understand oncologists' treatment optimization strategies.

A phase Ib study of combined VEGFR and mTOR inhibition with vatalanib and everolimus in patients with advanced renal cell carcinoma.

Background: Vatalanib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), whereas everolimus inhibits mammalian target of rapamycin (mTOR). Combination therapy with VEGFR and mTOR inhibitors has not been well tolerated to date but may have efficacy in renal cell carcinoma (RCC).

Patients And Methods: A phase Ib study of vatalanib and everolimus was performed in patients with advanced solid tumors to determine the maximum tolerated dose (MTD), safety, and tolerability of the combination.

Clinical pharmacology of an atrasentan and docetaxel regimen in men with hormone-refractory prostate cancer.

Purpose: This study was conducted to evaluate potential pharmacokinetic interactions between docetaxel and atrasentan as part of a phase I/II clinical trial.

Methods: Patients with prostate cancer were treated with intravenous docetaxel (60-75 mg/m(2)) every 3 weeks and oral atrasentan (10 mg) daily starting on day 3 of cycle 1 and then given continuously. The pharmacokinetics of both drugs were evaluated individually (cycle 1, day 1 for docetaxel; day 21 for atrasentan) and in combination (cycle 2, day 1 for both drugs).

A double-blind, randomized, neoadjuvant study of the tissue effects of POMx pills in men with prostate cancer before radical prostatectomy.

Pomegranates slow prostate cancer xenograft growth and prolong prostate-specific antigen (PSA) doubling times in single-arm human studies. Pomegranates' effects on human prostate tissue are understudied. We hypothesized that orally administered pomegranate extract (POMx; Pom Wonderful) would lower tissue 8-hydroxy-2'-deoxyguanosine (8-OHdG), an oxidative stress biomarker.

Sunitinib in metastatic renal cell carcinoma: recommendations for management of noncardiovascular toxicities.

The multitargeted tyrosine-kinase inhibitor sunitinib has emerged as one of the standards of care for good- and intermediate-risk metastatic renal cell carcinoma. Although generally associated with acceptable toxicity, sunitinib exhibits a novel and distinct toxicity profile that requires monitoring and management. Fatigue, diarrhea, anorexia, oral changes, hand-foot syndrome and other skin toxicity, thyroid dysfunction, myelotoxicity, and hypertension seem to be the most common and clinically relevant toxicities of sunitinib.

Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma.

Purpose: In April 2009, an expert group of 11 physicians and clinical nurses met to discuss the management of selected adverse events associated with the use of everolimus for the treatment of metastatic renal cell carcinoma (mRCC). Everolimus is an orally administered inhibitor of the mammalian target of rapamycin that recently received approval from the European Medicines Agency for the treatment of advanced RCC that has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy, and from the United States Food and Drug Administration for treatment of advanced RCC after failure of sorafenib or sunitinib. Before the approval of everolimus, no standard therapy existed for the treatment of mRCC after failure of VEGF-targeted therapy.

A pharmacodynamic study of rapamycin in men with intermediate- to high-risk localized prostate cancer.

Purpose: Given discrepancies between preclinical and clinical observations of mammalian target of rapamycin (mTOR) inhibition in prostate cancer, we sought to determine the pharmacodynamic effects of the mTOR/TORC1 inhibitor rapamycin in men with intermediate- to high-risk prostate cancer undergoing radical prostatectomy.

Experimental Design: Rapamycin was given at 3 or 6 mg orally for 14 days before radical prostatectomy in men with multifocal Gleason sum > or =7 prostate cancer; 10 untreated control subjects were included. The primary outcome was inhibition of phosphorylation of ribosomal S6 in posttreatment radical prostatectomy versus pretreatment biopsy tumor tissue, evaluated using a Simon two-stage design for pharmacodynamic efficacy.

Management of mTOR inhibitor side effects.

Although surgery remains the primary curative treatment for renal cell carcinoma (RCC), systemic therapy also is indicated in the advanced disease setting. This article reviews the role of mammalian target of rapamycin inhibitors in the treatment of metastatic RCC. A case study is presented to illustrate side-effect management issues commonly encountered by oncology nurses in clinical practice.

A phase I-II study of docetaxel and atrasentan in men with castration-resistant metastatic prostate cancer.

Purpose: The primary aims of this phase I-II study were to determine the maximum tolerated dose, dose-limiting toxicity, pharmacokinetics, and preliminary efficacy of the combination of docetaxel and the endothelin A receptor antagonist atrasentan as first-line treatment for men with metastatic castration-resistant prostate cancer.

Experimental Design: Patients were treated with docetaxel at doses ranging from 60 to 75 mg/m(2) every 21 days, with daily oral atrasentan 10 mg starting on day 3. Patients were treated until evidence of disease progression or unacceptable toxicity.

Improving outcomes with novel therapies for patients with newly diagnosed renal cell carcinoma.

With the approval of sunitinib and sorafenib, 2 new multitargeted tyrosine kinase inhibitors, for the treatment of advanced renal cell carcinoma (RCC), the natural history and prognosis of patients with this disease has significantly improved. These drugs were approved based upon clinical data demonstrating robust, unprecedented response rates in one case and dramatic prolongation of progression-free survival in the other. In both cases, these results were seen in study patients in whom standard therapy had failed and who, on average, carried substantial disease burden.