Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial
Motzer, Robert J; Nosov, Dmitry; Eisen, Timothy; Bondarenko, Igor; Lesovoy, Vladimir; Lipatov, Oleg; Tomczak, Piotr; Lyulko, Oleksiy; Alyasova, Anna; Harza, Mihai; Kogan, Mikhail; Alekseev, Boris Y; Sternberg, Cora N; Szczylik, Cezary; Cella, David; Ivanescu, Cristina; Krivoshik, Andrew; Strahs, Andrew; Esteves, Brooke; Berkenblit, Anna; Hutson, Thomas E
PURPOSE: Tivozanib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR1), -2, and -3. This phase III trial compared tivozanib with sorafenib as initial targeted therapy in patients with metastatic renal cell carcinoma (RCC). PATIENTS AND METHODS: Patients with metastatic RCC, with a clear cell component, prior nephrectomy, measurable disease, and 0 or 1 prior therapies for metastatic RCC were randomly assigned to tivozanib or sorafenib. Prior VEGF-targeted therapy and mammalian target of rapamycin inhibitor were not permitted. The primary end point was progression-free survival (PFS) by independent review. RESULTS: A total of 517 patients were randomly assigned to tivozanib (n = 260) or sorafenib (n = 257). PFS was longer with tivozanib than with sorafenib in the overall population (median, 11.9 v 9.1 months; hazard ratio [HR], 0.797; 95% CI, 0.639 to 0.993; P = .042). One hundred fifty-six patients (61%) who progressed on sorafenib crossed over to receive tivozanib. The final overall survival (OS) analysis showed a trend toward longer survival on the sorafenib arm than on the tivozanib arm (median, 29.3 v 28.8 months; HR, 1.245; 95% CI, 0.954 to 1.624; P = .105). Adverse events (AEs) more common with tivozanib than with sorafenib were hypertension (44% v 34%) and dysphonia (21% v 5%). AEs more common with sorafenib than with tivozanib were hand-foot skin reaction (54% v 14%) and diarrhea (33% v 23%). CONCLUSION: Tivozanib demonstrated improved PFS, but not OS, and a differentiated safety profile, compared with sorafenib, as initial targeted therapy for metastatic RCC.
PMCID:5569677
PMID: 24019545
ISSN: 0732-183x
CID: 549032
Mind-body medicine therapies for a range of depression severity: a systematic review
D'Silva, Sahana; Poscablo, Cristina; Habousha, Racheline; Kogan, Mikhail; Kligler, Benjamin
OBJECTIVE: Of the 34 million adult Americans (17%) using mind-body medicine therapies, 8 million (24%) have anxiety/depression. The evidence for using mind-body therapies to address varying depressive symptoms in populations with and without other chronic comorbidities is reviewed. METHODS: Systematic literature searches of PubMed (Medline), Embase, CINAHL, and the seven databases encompassed by Current Contents, Web of Science, and Web of Knowledge were conducted. Studies designed as prospective control-comparison, adult population, English, at least 2 weeks long, sample size >30, and with primary or secondary outcome as depression measured on an established scale were included. Methodologic quality was evaluated using the modified scale for assessing scientific quality of investigations (SASQI) for Complementary and Alternative Medicine (CAM). RESULTS: Ninety papers of about 2900 met both inclusion and exclusion criteria; 60% of them scored a SASQI >9 and were deemed of sufficient quality to be included in the review; 74% of these selected quality papers demonstrated positive effects on the improvement of depressive symptoms. All mind-body modalities included in the study had at least one positive study. For cancer patients, several studies noted the positive effects of yoga and combination therapies on depression severity. For both diagnosed depression and fibromyalgia, several studies noted the positive effects of mindfulness on depression severity. CONCLUSION: The use of evidence-based mind-body therapies can alleviate depression severity. They could be used with established psychiatric treatments of therapy and medications. The likely long-term increased cost-effectiveness of integrating these therapies deserves further investigation.
PMID: 22902090
ISSN: 0033-3182
CID: 549042
Mirror box therapy: seeing is believing
Lamont, Kelly; Chin, May; Kogan, Mikhail
Working with patients with different chronic pain syndromes can be challenging. Pharmacological therapies are often associated with variety of side effects. Mind-body modalities are thought to play a role; however, the lack of clear consensus and large body of clinical experience makes it hard to provide good evidence-based recommendation to most of our chronic pain patients. In recent years the Phantom Limb Pain (PLP) and to some degree Complex Regional Pain Syndrome (CRPS) may prove to be an exception. In this review we summarize the current evidence supporting use of Mirror Box Therapy and its successor, Immersive Virtual Reality.
PMID: 22051561
ISSN: 1550-8307
CID: 549052