In Other News? ? OncoFacts

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?Is aspirin as good as FOLFOX4 in the adjuvant therapy of colon cancer?

A recent article in the British Journal of Cancer (BJC 106:1564) reports that taking two aspirin daily after being diagnosed with colon cancer can reduce the risk of dying from colon cancer by 30%. At ASCO 2009, the MOSAIC investigators reported that the 6 year overall survival for stage III colon cancer patients who received adjuvant FOLFOX4 arm was 72.9%. The survival in the comparator LV5FU2 arm was 68.7%.

The current study reported in the BJC states that the ?Aim of the present observational population-based study was to assess the therapeutic effect on overall survival of aspirin/NSAIDs as adjuvant treatment used after the diagnosis of colorectal cancer patients?. The results of the study demonstrate that ?In total, 1176 (26%) patients were non-users, 2086 (47%) were pre-diagnosis and post-diagnosis users and 1219 (27%) were only post-diagnosis users (total n=4481). Compared with non-users, a survival gain was observed for aspirin users; the adjusted rate ratio (RR) was 0.77 (95% confidence interval (CI) 0.63?0.95; P=0.015). Stratified for colon and rectal cancer, the survival gain was only present in colon cancer (adjusted RR 0.65 (95%CI 0.50?0.84; P=0.001)). For frequent users survival gain was larger (adjusted RR 0.61 (95%CI 0.46?0.81; P=0.001).In rectal cancer, aspirin use was not associated with survival (adjusted RR 1.10 (95%CI 0.79?1.54; P=0.6). The NSAIDs use was associated with decreased survival (adjusted RR 1.93 (95%CI 1.70?2.20; P<0.001).?

This, of course, was an observational, retrospective study and not a prospective comparison of FOLFOX4 versus aspirin as adjuvant therapy, but it may be food for thought.

Who do you trust?

Recent political PAC advertisements have suggested that the Affordable Care Act will cost senior citizens millions of dollars in added expenses for their prescription medications. However, the Centers for Medicare & Medicaid Services (CMS) recently released data that since the enactment of the ACA law, seniors and people with disabilities on Medicare have saved a total of $3.4 billion dollars on prescription drugs. In the first 3 months of 2012 alone, more than 220,000 people are said to have saved an average of $837 on the prescription drugs they purchased after they hit the drug donut hole.

ASH urges federal agencies to support research in seven specific areas

The American Society of Hematology has released a list of seven promising areas of scientific investigation in Hematology that ASH believes warrant strong federal support.

These include:

1. Stem Cells and Regenerative Medicine to improve current technologies to cure blood disorders.
2. Myelodysplastic Syndromes and Acute Myeloid Leukemia to find and effective and personalized treatment for the elderly.
3. Hematopoietic Stem Cell Transplantation to increase success rates by improving management of Graft versus host disease.
4. Sickle Cell Disease to reduce barriers to care, burden of pain, end organ injury and premature death.
5. Deep Vein Thrombosis and Venous Thromboembolism to understand the risk factors and develop targeted therapies.
6. Childhood Leukemia to improve cure rates by performing coordinated research on novel targeted therapies.
7. Translating Laboratory Advances into the Clinic to use novel genomic technologies to improve treatment of hematologic diseases.

Onyx Pharmaceuticals releases early results of Phase III trial in GIST

Onyx Pharmaceuticals Inc recently released information regarding their phase III GRID study in gastrointestinal stromal tumors that had progressed despite prior treatment with at least imatinib and sunitinib. 199 patients were randomized in a 2:1 fashion to regorafenib plus best supportive care versus placebo plus BSC. The study was completed in July 2011 and is said to have met its primary endpoint of Progression Free Survival.

You may recall that the results of the CORRECT trial in relapsed/refractory advanced colorectal cancer were presented by Axel Grothey at the ASCO GI Cancer Symposium earlier this year. In that phase 3 study regorafenib demonstrated not only an increase in PFS but also in overall survival compared to placebo in CRC patients who were heavily pretreated.

Galeterone (TOK-001) shows efficacy in Castrate Resistant Prostate Cancer

Over the past few years a number of exciting new agents for advanced prostate cancer have presented new therapeutic options for CRPC. These include abiraterone acetate, MDV3100, Cabazitaxel and Radium-223.

At the 2012 AACR meeting, Dr. Mary Ellen Taplin from the Dana Farber Cancer Institute reported the results of the phase I ARMOR-1 study of galeterone or TOK-001 in CRPC. Galeterone is a unique small molecule, oral semi-synthetic steroid analog that attacks prostate cancer through three mechanisms. It blocks CYP17 lyase similar to abiraterone acetate. It acts as an androgen receptor inhibitor similar to MDV3100 and it degrades the androgen receptor, the levels of which are characteristically elevated in CRPC.

Patients enrolled in this phase 1 study had progressed through prior androgen ablation therapy, but were chemotherapy na?ve. Galeterone was very well tolerated with primarily grade 1 and 2 adverse events. Transient elevation of liver enzymes occurred in 25-36% of patients. A Maximum Tolerated Dose (MTD) was not reached in this phase 1 study. PSA reductions of >30% were achieved in 49% of the patients. Objective reductions in tumor size were noted in a number of patients. A phase 2 study will begin later in 2012.

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