Prolonged PSA stabilization and overall survival following sipuleucel-T monotherapy in metastatic castration-resistant prostate cancer patients.

Background: Sipuleucel-T is an autologous cellular immunotherapy that is FDA approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). The IMPACT registry trial demonstrated a 4.1 month survival benefit, but not a consistent PSA response or improvement in progression-free survival.

Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial.

Background: Non-clear cell renal cell carcinomas are histologically and genetically diverse kidney cancers with variable prognoses, and their optimum initial treatment is unknown. We aimed to compare the mTOR inhibitor everolimus and the VEGF receptor inhibitor sunitinib in patients with non-clear cell renal cell carcinoma.

Methods: We enrolled patients with metastatic papillary, chromophobe, or unclassified non-clear cell renal cell carcinoma with no history of previous systemic treatment.

Chemotherapy dosing in overweight and obese patients with cancer.

Retrospective and prospective preclinical and clinical data have demonstrated an association between chemotherapy dose intensity and both clinical efficacy and toxicity. The optimum tolerable and effective dose and schedule of chemotherapeutic agents is based on data from dose-finding studies and early clinical trials. There is considerable evidence that reductions in the recommended dose intensity often occurs in actual clinical practice, particularly among overweight and obese patients with cancer.

Thrombosis and cancer: emerging data for the practicing oncologist.

The American Society of Clinical Oncology (ASCO) recently updated clinical practice guidelines on the treatment and prevention of venous thromboembolism (VTE) in patients with cancer. Although several new studies have been reported, many questions remain about the close relationship between VTE and malignant disease. The risk of VTE among patients with cancer continues to increase and is clearly linked to patient-, disease- and treatment-specific factors.

Comparative effectiveness research in oncology.

Although randomized controlled trials represent the gold standard for comparative effective research (CER), a number of additional methods are available when randomized controlled trials are lacking or inconclusive because of the limitations of such trials. In addition to more relevant, efficient, and generalizable trials, there is a need for additional approaches utilizing rigorous methodology while fully recognizing their inherent limitations. CER is an important construct for defining and summarizing evidence on effectiveness and safety and comparing the value of competing strategies so that patients, providers, and policymakers can be offered appropriate recommendations for optimal patient care.

Pharmacoeconomics of the myeloid growth factors: a critical and systematic review.

Background: The pharmacoeconomics of the myeloid growth factors (MGFs) is an important topic that has received substantial attention in recent years. The use of the MGFs as primary prophylaxis to prevent febrile neutropenia (FN) has grown considerably over the past decade and professional guidelines regarding their use have broadened the settings in which these agents are indicated. Recent data also suggest a potential role for them in reducing infection-related and all-cause mortality.

Biosimilars: are they ready for primetime in the United States?

The introduction of alternative versions of biologic products, also known as biosimilars, into the United States market has been gaining increasing visibility as patents for many agents are nearing expiration. Unlike generics, which are regulated under the Hatch-Waxman legislation passed in 1984, the approval process for biosimilars in the United States has not been defined. In 2004, the European Union established a regulatory pathway for these agents, and the FDA is now following suit.

Therapy for non-clear cell histologies in renal cancer.

The advent of targeted systemic therapies has significantly improved treatment options for patients with metastatic renal cell carcinoma (RCC). Multiple agents that inhibit angiogenesis cell growth and proliferation via the VEGF and mTOR (TORC1) pathways have been USFDA-approved for locally advanced or metastatic renal cell carcinoma in recent years although the majority of clinical trials have focused only on clear cell RCC. While clear cell RCC is the most common histologic subtype nearly 25% of RCC cases are histologic variants representing a diverse group of diseases with different prognoses underlying biology and molecular targets and therapies.