TOKIO rationale and protocol: a phase II study to evaluate the activity and safety of third-line tyrosine kinase inhibitor after 2 tyrosine kinase inhibitors in patients with metastatic renal cell carcinoma.

Aims And Background: The introduction of agents targeting vascular endothelial growth factor has radically changed the approach to metastatic renal cell carcinoma (mRCC): sunitinib and pazopanib are now the standard first-line therapy in mRCC. At sunitinib failure, second-line axitinib or everolimus or sorafenib should be considered to improve the clinical outcome. No data are available for a third-line tyrosine kinase inhibitor (TKI) after 2 previous lines of therapy with TKIs.

Prognostic reclassification of patients with intermediate-risk metastatic germ cell tumors: Implications for clinical practice, trial design, and molecular interrogation.

Objectives: Approximately one-third of the metastatic germ cell tumors (GCT) in patients are classified as intermediate-risk metastatic GCT, and available guidelines recommend the same treatment of poor-risk cases. Yet the prognosis of these patients is heterogeneous, and consequently refining the intensity of treatment is warranted. We aimed to address the heterogeneity of this category by providing a proof of principle for reclassification attempt.

Clinical outcomes in a contemporary series of "young" patients with castration-resistant prostate cancer who were 60 years and younger.

Background: The prognosis of younger patients with prostate cancer is unclear, and the very few studies assessing those with metastatic castration-resistant prostate cancer (mCRPC) have mainly involved patients treated with older therapies. The aim of this observational study was to evaluate the clinical outcomes of a contemporary series of docetaxel-treated patients with mCRPC who were 60 years and younger.

Patients And Methods: We retrospectively identified 134 patients who were 60 years and younger who were treated with docetaxel in 25 Italian hospitals and recorded their predocetaxel history of prostate cancer, their characteristics at the start of chemotherapy, and their postdocetaxel treatment history and outcomes.

The changes of lipid metabolism in advanced renal cell carcinoma patients treated with everolimus: a new pharmacodynamic marker?

Background: Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of metastatic renal cell carcinoma (mRCC). We aimed to assess the association between the baseline values and treatmentrelated modifications of total serum cholesterol (C), triglycerides (T), body mass index (BMI), fasting blood glucose level (FBG) and blood pressure (BP) levels and the outcome of patients treated with everolimus for mRCC.

Methods: 177 patients were included in this retrospective analysis.

Sites of disease as predictors of outcome in metastatic renal cell carcinoma patients treated with first-line sunitinib or sorafenib.

Background: This study investigated whether the effectiveness of first-line tyrosine-kinase inhibitors was associated with sites of disease in patients with metastatic renal cell carcinoma (mRCC).

Methods: A retrospective cohort of consecutive mRCC patients receiving first-line sorafenib (SO) or sunitinib (SU) was analyzed.

Results: In total, 203 patients received SO and 99 SU.

Abuse and Intentional Misuse of Promethazine Reported to US Poison Centers: 2002 to 2012.

Objective: Promethazine abuse has been reported. The objective was to investigate promethazine abuse/misuse in the United States.

Methods: An 11-year retrospective review was conducted of promethazine abuse and intentional misuse cases without co-ingestants in persons 10 years and older reported to the National Poison Data System.

Clinical Outcomes of Metastatic Poor Prognosis Germ Cell Tumors: Current Perspective From a Referral Center.

Background: Survival estimates with first-line treatment for patients with metastatic poor prognosis germ cell tumors (GCT) are still suboptimal in the literature. We conducted a retrospective study to evaluate the outcome of patients referred to our tertiary cancer center.

Patients And Methods: A retrospective analysis was conducted on patients who received at least first-line chemotherapy at our center.

Rationale and protocol of SOAP: a phase II study to evaluate the efficacy of sorafenib as second-line treatment after pazopanib in patients with advanced renal cell carcinoma.

The introduction of agents targeting vascular endothelial grow factors has radically changed the approach to metastatic renal cell carcinoma; however, cure is not within definitive reach. In many cases, the tumor will progress several months after the start of first-line therapy and new lines of therapy are required. Pazopanib and sorafenib are two frequently used targeted agents, and no sound data are currently available for patients who relapsed after pazopanib.

Bone metastases in patients with metastatic renal cell carcinoma: are they always associated with poor prognosis?

Purpose: Aim of this study was to investigate for the presence of existing prognostic factors in patients with bone metastases (BMs) from RCC since bone represents an unfavorable site of metastasis for renal cell carcinoma (mRCC).

Materials And Methods: Data of patients with BMs from RCC were retrospectively collected. Age, sex, ECOG-Performance Status (PS), MSKCC group, tumor histology, presence of concomitant metastases to other sites, time from nephrectomy to bone metastases (TTBM, classified into three groups: <1 year, between 1 and 5 years and >5 years) and time from BMs to skeletal-related event (SRE) were included in the Cox analysis to investigate their prognostic relevance.

Response to targeted therapy in urachal adenocarcinoma.

We report the case of a young woman diagnosed with metastatic urachal carcinoma. A multimodal approach was used for the management of this patient. Due to disease progression despite surgery and two different chemotherapy regimens (neoadjuvant capecitabine + irinotecan + oxaliplatin and docetaxel + cisplatin after surgery), treatment with sunitinib was eventually started.

Prognostic significance of host immune status in patients with late relapsing renal cell carcinoma treated with targeted therapy.

We aimed to assess the prognostic role of pretreatment neutrophilia, lymphocytopenia, and neutrophil to lymphocyte ratio (NLR) in patients treated with vascular endothelial growth factor-tyrosine kinase inhibitors (VEGFR-TKIs) for late relapsing (>5 years) metastatic renal cell carcinoma (mRCC). Data were collected from 13 Italian centers involved in the treatment of metastatic RCC. Late relapse was defined as >5 years after initial radical nephrectomy.

Surgical resection does not improve survival in patients with renal metastases to the pancreas in the era of tyrosine kinase inhibitors.

Background: The aim of this study was to compare survival of resected and unresected patients in a large cohort of patients with metastases to the pancreas from renal cell carcinoma (PM-RCC).

Methods: Data from 16 Italian centers involved in the treatment of metastatic RCC were retrospectively collected. The Kaplan-Meier and log-rank test methods were used to evaluate overall survival (OS).

Clinical Outcomes of Castration-resistant Prostate Cancer Treatments Administered as Third or Fourth Line Following Failure of Docetaxel and Other Second-line Treatment: Results of an Italian Multicentre Study.

Background: The availability of new agents (NAs) active in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel treatment (abiraterone acetate, cabazitaxel, and enzalutamide) has led to the possibility of using them sequentially to obtain a cumulative survival benefit.

Objective: To provide clinical outcome data relating to a large cohort of mCRPC patients who received a third-line NA after the failure of docetaxel and another NA.

Design, Setting, And Participants: We retrospectively reviewed the clinical records of patients who had received at least two successive NAs after the failure of docetaxel.

Prognostic factors in patients receiving third line targeted therapy for metastatic renal cell carcinoma.

Purpose: Several prognostic models have been proposed for metastatic renal cell carcinoma but none has been validated in patients who receive third line targeted agents. We evaluated prognostic factors in patients with metastatic renal cell carcinoma who received a third line targeted agent.

Materials And Methods: We retrospectively reviewed data on 2,065 patients with clear cell metastatic renal cell carcinoma who were treated with targeted therapy at a total of 23 centers in Italy.

Inhibition of the VEGF/VEGFR pathway improves survival in advanced kidney cancer: a systematic review and meta-analysis.

Despite the improvement in progression-free survival and response rates, none of the five anti- VEGF/VEGFR agents used for treatment of metastatic renal cell carcinoma (mRCC) reported a significant increase in patients' survival. This analysis aims to investigate their effect on overall survival (OS), performing a meta-analysis of the available studies. MEDLINE/PubMed and the Cochrane Library were searched for randomised phase III trials that compared anti-VEGF/VEGFR agents with controls as upfront treatment for mRCC.

Time from nephrectomy as a prognostic factor in metastatic renal cell carcinoma patients receiving targeted therapies: overall results from a large cohort of patients.

Objective: To investigate whether time from nephrectomy (Nx) to the diagnosis of metastatic disease may be an independent prognostic factor in metastatic renal cell carcinoma (mRCC) patients treated with targeted therapies (TTs).

Subjects And Methods: All patients who underwent Nx and at least 1 TT were considered. The patients were divided into two groups based on time from Nx [>1 year (Nx >1) and <1 year (Nx <1)] and a third group for cytoreductive Nx (cNx).

Everolimus and temsirolimus are not the same second-line in metastatic renal cell carcinoma. A systematic review and meta-analysis of literature data.

Background: Two mTOR inhibitors, TEM and EVE, proved to be active in mRCC but have never been compared in a prospective trial. We aimed to compare their effectiveness in mRCC patients previously treated with a vascular endothelial growth factor receptor tyrosine kinase inhibitor, and performed a systematic review and meta-analysis of available evidence.

Materials And Methods: The MEDLINE/PubMed database was reviewed for studies that compared EVE with TEM from January 2006 to May 2014.

Highlights from the ASCO Genitourinary Symposium 2014: focus on renal and prostate cancer.

The genitourinary cancer symposium is one of the most important conferences focused on cancers of the prostate, penis, urethra, testes, bladder and kidney. This year the genitourinary symposium celebrated 10 years – its theme was 'integrating biology into patient-centric care'. The conference offered educational sessions and oral and poster abstract presentations; the general sessions throughout the meeting focused on prevention, screening, diagnosis, multidisciplinary treatment, translational research and current controversies in the field.

Safety profile and treatment response of everolimus in different solid tumors: an observational study.

Aim: Only few efforts have been taken to investigate the potential existence of disease-specific differences in the safety profile of everolimus. We analyze here the correlation between different patient and tumor characteristics on the safety profile of this molecule. Information on treatment response is also provided.

Targeted therapies in advanced renal cell carcinoma: the role of metastatic sites as a prognostic factor.

Aim: This retrospective study evaluates whether metastatic sites were associated with progression-free survival (PFS) and overall survival (OS) in patients with renal cell carcinoma treated with targeted therapies.

Patients & Methods: In total, 358 patients were analyzed.

Results & Conclusion: After a median follow-up of 56.

Sunitinib, pazopanib or sorafenib for the treatment of patients with late relapsing metastatic renal cell carcinoma.

Purpose: Late recurrence of renal cell carcinoma is not a rare event. In this retrospective study we investigate the clinicopathological features and the outcome of patients treated with sorafenib, sunitinib and pazopanib for late relapsing renal cell carcinoma.

Materials And Methods: Data were collected from 21 Italian centers involved in the treatment of metastatic renal cell carcinoma.

Safety and clinical outcomes of patients treated with abiraterone acetate after docetaxel: results of the Italian Named Patient Programme.

Objective: To assess the safety and efficacy of abiraterone acetate (AA) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated in a compassionate named patient programme (NPP).

Patients And Methods: We retrospectively reviewed the clinical records of patients with mCRPC treated with AA at the standard daily oral dose of 1000 mg plus prednisone 10 mg/day in 19 Italian hospitals.

Results: We assessed 265 patients with mCRPC treated with AA.

Sequential Tyrosine Kinase Inhibitors (TKIs) in metastatic renal cell carcinoma: results from a large cohort of patients.

Background: Only scanty data are available to evaluate the impact of sequential TKIs on overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC). This retrospective study investigated the efficacy of the sequence sorafenib-sunitinib (SO-SU) and vice versa (SU-SO) in a real-life scenario.

Patients And Methods: Median progression free-survival (PFS) and OS were evaluated.

Targeted treatments in advanced renal cell carcinoma: focus on axitinib.

Antiangiogenesis options have evolved rapidly in the last few years, with an increasing number of agents currently approved by the US Food and Drug Administration and European Medicines Agency. Angiogenesis inhibitors have been shown to be very effective for the treatment of metastatic renal cancer cell. Axitinib is a third-generation inhibitor of vascular endothelial growth factor receptor and is currently being developed for the treatment of various malignancies.