Oncotype DX Colon Cancer Test Changes Treatment in Close to One-Third of Patients

A survey of oncologists suggests that the Oncotype DX colon cancer test changes treatment recommendations for 29 percent of patients with Stage II colon cancer. These results will be presented at the 2012 Gastrointestinal Cancers Symposium.

This test is usually used for patients with lymph node negative breast cancer.

Gene expression profiling explores the patterns of genes that are active in tumor cells. Studies suggest that gene expression may provide important information about prognosis or likely response to treatment in several types of cancer. For example, among selected women with early-stage breast cancer, the Oncotype DX breast cancer test has been shown to predict the likelihood of cancer recurrence and the likelihood of benefit from chemotherapy. As a result, the test has been added to medical guidelines for early-stage breast cancer.

A similar test became available for patients with Stage II colon cancer in 2010. Stage II colon cancer refers to cancer that extends through the wall of the colon but has not invaded lymph nodes or spread to distant parts of the body. Many patients with this stage of disease have good outcomes with surgery alone, and routine adjuvant (post-surgery) chemotherapy is not currently recommended for Stage II colon cancer. Chemotherapy may, however, be considered for Stage II patients with a higher risk of cancer recurrence.

Thanks cancerconnect.com

This will be a great tool for patients with stage II colon cancer and will make the decision to administer adjuvant chemotherapy or not easier.

Tony Talebi, MD

FDA approves axitinib for Kidney Cancer (renal cell carcinoma)

he FDA today approved axitinib tablets for use in patients with previously treated advanced renal cell carcinoma.

The FDA approved Axitinib (Inlyta, Pfizer) based on a single international, randomized, open-label trial involving patients with advanced renal cell carcinoma after failure of one prior systemic regimen.

Researchers evaluated 723 patients who were randomly assigned to receive axitinib 5 mg orally twice daily (n=361) or sorafenib 400 mg orally twice daily (n=362). Patients continued in their treatment until disease progression, the point of unacceptable toxicity or consent withdrawal. Enrollment criteria included an ECOG performance status of 0 or 1 and at least one prior systemic therapy that consisted one of the following treatments: sunitinib, temsirolimus, bevacizumab or cytokine(s).

Patients in the axitinib group demonstrated significantly extended PFS (HR=0.67; 95% CI, 0.54-0.81,P<.0001), with a median PFS of 6.7 months (95% CI, 6.3-8.6) compared with 4.7 months (95% CI, 4.6-5.6) for patients in the sorafenib group. That represented a 43% improvement in median PFS compared with sorafenib.

The most common adverse reactions (≥20% of patients) in the axitinib-treated group were diarrhea, diminished appetite, hypertension, fatigue, constipation, palmar-plantar erythrodysesthesia syndrome, nausea, dysphonia, weight loss, vomiting and asthenia. Other severe adverse reactions reported were hypertensive crisis, hemorrhage, gastrointestinal perforation and fistula formation, arterial and venous thrombotic events, and reversible posterior leukoencephalopathy syndrome.

Thanks hemonctoday.com

This gives us even more weapons to utilize in our growing armamentarium against metastatic renal cell cancer.

Tony Talebi, MD

Study: Obesity increases risk of esophageal and gastric adenocarcinoma

Obesity may be linked to an increased risk of esophageal and gastric adenocarcinoma, according to a large prospective cohort study.

BMI was associated with a higher risk of esophageal and gastric cardia adenocarcinoma. Abdominal obesity — measured by waist size and waist-to-hip ratio — was associated with increased risk of esophageal cancer.

The study cohort included 218,854 subjects from the NIH–AARP Diet and Health Study, conducted in 1995 and 1996.

Investigators found that waist circumference alone was related to an increased risk of gastric cardia adenocarcinoma. They also found that in patients with normal BMI (18.5 <Kg/m?), a positive association persisted between waist-to-hip ratio and esophageal adenocarcinoma.

Obesity is the single most important problem facing first world as well as developing nations as decreased human activity coupled with increased calorie intake is causing an epidemic wave of children and adults.

Not only does obesity lead to diabetes, cardiovascular complications, and strokes but also many cancers such as breast cancer, prostate cancer, colon cancer and gastric as well as esophageal cancer.

In my opinion, children need to exercise much more and eat a healthier diet.   Restaurants need to be required by law to disclose the calorie content of every single meal on the menu, and insurance companies should pay for personal trainers and cooks for those who need to change their lifestyle drastically for at least a period of 6 months.

Tony Talebi, MD

IP cisplatin, early start of chemotherapy associated with improved efficacy of iceMFP chemotherapy

2012 Gastrointestinal Cancers Symposium

SAN FRANCISCO — Phase 3 results from the AMC 0101 study showed patients treated with iceMFP chemotherapy for serosa-positive advanced gastric cancer had superior outcomes when assigned to intraperitoneal cisplatin and/or early start of chemotherapy.

Patients were assigned to Mf (20 mg/m² of mitomycin-C and daily oral 460-600 mg/m² doxifluridine) or iceMFP (mitomycin-C and doxifluridine plus cisplatin). Patients received 100 mg intraperitoneal cisplatin for two hours during surgery, and 15 mg/m² IV mitomycin-C one day after surgery. Doxifluridine was administered 4 weeks after surgery for a total of 12 months, along with six shots of monthly 60 mg/m²cisplatin.

As of April 2011, a median follow-up of 6.6 years, patients assigned to iceMFP demonstrated superior 5-year recurrence-free survival (HR=0.73; 95% C.I. 0.57-0.93) and 5-year OS (HR=0.77; 95% C.I. 0.60-0.98) compared with patients assigned to Mf chemotherapy.

That represented a 9% improvement in OS compared with 3-year results, said Yoon-Koo Kang, MD, PhD,with the Asan Medical Center in Seoul, South Korea.

I have always wondered if intraperitoneal chemotherapy could improve survival in gastric cancer since the cancer cells are often in the peritoneal cavity.

We will have to see our own trials in the USA.

Tony Talebi, MD

FDA approves glucarpidase injection for treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function

On January 17, 2012, the U. S. Food and Drug Administration approved glucarpidase  injection (Voraxaze®, BTG International Inc.) for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function.* 

The approval was based on the pharmacodynamic endpoint of a rapid and sustained clinically important reduction (RSCIR) in plasma methotrexate concentration, defined as an attainment of plasma methotrexate concentration less than or equal to 1 μmol/L within 15 minutes following glucarpidase administration and sustained for up to 8 days.

Efficacy was established in 22 patients with delayed methotrexate clearance (more than 2 standard deviations above the average indicated on standard nomograms) secondary to renal dysfunction.  The efficacy assessment was limited to patients having pre- and post-treatment plasma samples collected and handled according to a validated procedure to yield reliable methotrexate measurements by HPLC.

All patients received glucarpidase, 50 Units/kg, as an intravenous injection over 5 minutes. Patients with pre-glucarpidase methotrexate concentrations >100 μmol/ L were to receive a second dose of glucarpidase 48 hours after the initial dose.  All patients received vigorous intravenous hydration, urinary alkalinization, and leucovorin rescue. 


Thanks ASCO.org


Tony Talebi, MD

What You Should Know about Denosumab (Prolia) for Increasing Bone Mass during Breast and Prostate Cancer Therapies

In September 2011, the monoclonal antibody RANKL inhibitor denosumab (Prolia) was approved for use in increasing bone mass in patients at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer or aromatase inhibitor therapy for breast cancer.¹ Under the trade name Xgeva, denosumab has an indication for prevention of skeletal-related events in patients with bone metastases from solid tumors at a different dose (120 mg subcutaneously every 4 weeks) than in the current indications. Denosumab (as Prolia) also has a nononcologic indication for treatment of postmenopausal women with osteoporosis at high risk for fracture.


Visit ASCOPOST.ORG

Tony Talebi, MD

FDA approves Bristol's Yervoy (ipilimumab) for melanoma

This is also a ground breaking event in the history of melanoma treatment for our patients.

The FDA has approved Yervoy (ipilimumab), a closely-watched new drug for advanced melanoma. 

The drug approval is a rare win in the field of melanoma, which has experienced more than its fair share of new drug failures. Melanoma that has spread to other organs is notoriously difficult to treat, leaving patients with few options. Researchers observed higher one- and two-year survival rates for patients on Yervoy, and although ipilimumab is linked to some severe side effects--including colon inflammation, diarrhea and skin rashes and even death--the dearth of options for advanced-stage melanoma patients prompted the agency to approve the drug.

Tony Talebi, MD

Bevacizumab delayed progression of epithelial ovarian cancer

The use of bevacizumab during and after carboplatin and paclitaxel chemotherapy prolonged progression free survival (meaning delay in progression) in patients with epithelial ovarian cancer by approximately 4 months, according to trial data published in the Dec. 29 issue of The New England Journal of Medicine (the gold standard Journal for physicians).

In a double blind, placebo-controlled, phase 3 trial (the most accurate trials that doctors pay attention to), 1,873 patients were enrolled from 336 sites in the United States, Canada, South Korea and Japan. Researchers randomly assigned eligible patients — eligibility determined as previously untreated or incompletely resectable stage III or any stage IV ovarian cancer.

At the conclusion of the study, patients who received bevacizumab with chemotherapy throughout demonstrated a longer median of progression free survival (14.1 months) compared with patients in the control group (10.3 months) and the bevacizumab/placebo group (11.2 months).

This is certainly an option which may be entertained in patients with metastatic ovarian cancer.

Tony Talebi, MD

This could be the biggest deal in colon cancer

Hi,

This is tremendous news for metastatic colon cancer patients.   The trial was actually stopped early since the data was in such favor for patients who were being treated with this new drug called Regorafenib.

Tony Talebi, MD

Phase III Trial of Regorafenib in Metastatic Colorectal Cancer Meets Primary Endpoint of Improving Overall Survival

Trial stopped based on positive data from a pre-planned interim analysis

Berlin, October 26, 2011 – Bayer HealthCare today announced positive results from its Phase III trial evaluating its investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies: The trial met its primary endpoint of statistically significantly improving overall survival. This is the result of a pre-planned interim analysis conducted by an independent Data Monitoring Committee (DMC) of the CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Per the recommendation of the DMC, the study has been unblinded and patients in the placebo arm will be offered treatment with regorafenib. In this trial, the safety and tolerability of regorafenib were generally as expected and did not show any new or unexpected toxicities. Data from the study are expected to be presented at a forthcoming scientific meeting. 

“These data are significant because they demonstrate that regorafenib increases overall survival in patients with heavily pretreated mCRC, an area of high unmet medical need,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. “We are extremely encouraged by the result of this analysis and we are hopeful about the potential of regorafenib to fill this unmet treatment need.”

Bayer will continue discussions with health authorities worldwide, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) regarding next steps in filing for approval of regorafenib in the treatment of mCRC.

Bayer recently entered into an agreement with Onyx Pharmaceuticals, Inc. under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.

About the CORRECT Study 
The CORRECT trial is an international, multicenter, randomized, double-blind, placebo-controlled study that enrolled 760 patients with mCRC whose disease has progressed after approved standard therapies. The study was conducted in North America, Europe, China, Japan and Australia.

Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint of this trial was overall survival. Secondary endpoints included progression-free survival, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups were also compared.

About Colorectal Cancer
Colorectal cancer (CRC) is a disease in which malignant (cancer) cells form in the tissues of the colon or rectum. The majority of cancers occurring in the colon and rectum are adenocarcinomas, which account for more than 90 percent of all large bowel tumors. 

CRC is the fourth most common cancer worldwide, with over one million cases occurring every year. The mortality rate from CRC is approximately half of its global incidence. The five-year survival estimate for CRC on average is 55 percent, but varies very much dependent on the stage of the disease (from 74 percent for patients with Stage I disease to only 6 percent for Stage IV patients). 

About Regorafenib 
Regorafenib is an investigational oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). Regorafenib inhibits angiogenic kinases like receptors for VEGF which play central roles in angiogenesis. It also inhibits various oncogenic kinases including RAF, RET as well as stromal kinases such as KIT and PDGFR, thereby helping to stop the proliferation of cancer cells. Regorafenib has shown antitumor activity in preclinical studies by inhibiting tumor growth in multiple xenograft models via antiangiogenic and antiproliferative mechanisms. Based on these results, regorafenib is currently being investigated in clinical trials for its potential to treat patients with various tumor types. 

Regorafenib is an investigational agent and is not approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.

Regorafenib was granted orphan drug designation by the FDA for the treatment of patients with gastrointestinal stromal tumors (GIST). Orphan drug designation aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. 

Regorafenib was granted Fast Track designation by the U.S. FDA for the treatment of patients with metastatic and/or unresectable GIST whose disease has progressed despite at least imatinib and sunitinib as prior treatments, as well as for the treatment of patients with mCRC who have progressed after approved standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need.

About Oncology at Bayer
Bayer is committed to advancing the science of cancer, and translating this science into therapies that can help people with cancer live longer. With several potential first- and best-in-class compounds in clinical development, Bayer’s oncology portfolio demonstrates the Company’s commitment to improving the lives of people living with cancer. 

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

Find more information at www.bayerpharma.com.

We will await approval of this medicine in the USA

Tony Talebi, MD

hemonc101.com

www.HemOnc101.com at ASH

The HemOnc101 team wanted to thank everyone who stopped by our booth at ASH.
We enjoyed meeting people from all over the world.