TORONTO, May 8 — A rapid molecular test for breast cancer micrometastases in the sentinel lymph node can reduce the need for additional lymph node surgery, an international team of researchers said.

• Explain to interested patients that during breast cancer surgery doctors typically remove the nearest lymph node and test it for signs the cancer has spread.
• If such signs are present, a second procedure removes all of the lymph nodes.
• Note that this study showed that a rapid test can identify signs of spread during the original surgery, reducing the need for another procedure.

The test — marketed by Veridex LLC of North Raritan, NJ — takes about 35 minutes to produce results and can be done while the primary tumor is being removed, according to Denis Larsimont, M.D., Ph.D., of the Jules Bordet Institute in Brussels, and colleagues.

Typically, surgeons remove the sentinel node and test it for micrometastases after the tumor resection is over, Dr. Larsimont said at the first IMPAKT Breast Cancer Conference.

Then, if the node contains tumor cells, a woman must undergo a second operation for a complete axillary lymph node dissection, he said.

In contrast, if the molecular test is positive, surgeons can perform the axillary node dissection immediately after tumor removal — eliminating the need for additional surgery.

The key finding of the study, Dr. Larsimont said, is that if the test is negative, it’s highly unlikely that the cancer has spread to the other nodes.

For the study, the test was used during breast cancer surgery on 1,138 women in four U.S. sites and one each in Belgium and the U.K. The researchers compared results of the molecular test with what was seen using traditional permanent section histology.

Analysis showed that traditional histology had a negative predictive value of 90%, compared with 96% for the new test, Dr. Larsimont reported.

When the two methods were combined, the negative predictive value was 99%.

Of the 1,138 patients, only 18 — or 1.6% — had a negative result on the molecular test but a positive result on the histology, Dr. Larsimont said.

“The assay dramatically reduces the need for second surgery,” he said, and the high negative predictive value should “assure the pathologist, surgeon, and patient that occult metastases are unlikely.”

Identifying micrometastases “takes a lot of time and money,” said conference co-chair Martine Piccart, M.D., Ph.D., also of Institut Jules Bordet but not part of the study.

“The new technique allows you to make the diagnosis of micrometastases while the surgery is underway, meaning the patient does not have to suffer the disruption of undergoing another operation,” Dr. Piccart said in a statement.

“Remarkably, when the new test gives a negative result — meaning it finds no spread of cancer to the sentinel node — it really predicts very well the status of the other lymph nodes,” she said.

The researchers did not report study support or potential conflicts.

Primary source: IMPAKT Breast Cancer Conference

Source reference:
Larsimont D, et al “Prediction of axillary status from sentinel lymph node testing with an intra-operative RT-PCR test - multi-center analysis of 1138 patients” IMPAKT 2009; Abstract 400.

SAN FRANCISCO, May 8 — Childhood hypertension, determined by ambulatory blood pressure monitoring, more than doubles the risk of left ventricular hypertrophy.

Risk rose progressively as hypertension increased — to a 2.58-fold risk for those having blood pressure above the 95th percentile, found Alisa A. Acosta, M.D., M.P.H., of the University of Texas Health Science Center at Houston, and colleagues.

• Explain to interested patients that blood pressure in children is based on percentiles reflecting the range of normal values for those of the same age and height.
• Note that this study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

However, a single casual blood pressure measurement in the office did not predict left ventricular hypertrophy, they reported here at the American Society of Hypertension meeting.

These findings add to growing evidence that childhood blood pressure not only tracks into adulthood but has immediate consequences as well. (See Kid’s BP Can Predict Adult Readings)

Hypertrophy is evidence that end-organ damage has already occurred in childhood, commented William B. White, M.D., of the University of Connecticut in Farmington, who moderated a press conference at which the findings were presented.

“In young adults and middle age adults, left ventricular hypertrophy is an independent risk factor for heart failure,” he said. “So if it continues and nothing is done about it, it does cause harm.”

Dr. Acosta added that it also acts as a surrogate marker for increased risk of stroke, heart attack, and other cardiovascular events in adulthood, although these events are rare in healthy children.

Although lifestyle measures and antihypertensive medication may halt this progression, opportunities for early intervention are often missed, she said. (See Childhood Hypertension Usually Goes Undiagnosed)

The American Heart Association recommends yearly blood pressure measurement for children older than 3, but blood pressure norms can be time consuming to determine for individual children, and measurement still, at times, goes overlooked in pediatric care, Dr. Acosta said.

Given recent publication of AHA ambulatory blood pressure classifications for children, Dr. Acosta’s group studied blood pressure in 241 children ages 6 to 17 and naive to blood pressure management.

About a third had left ventricular hypertrophy measured on echocardiography (greater than 38.6 gm/m^2.7 under pediatric criteria).

As blood pressure category rose from normal to severe ambulatory hypertension, the average left ventricular mass rose from 34.3 to 38.6 g/m^2.7 (P=0.018 for trend).

Prevalence of hypertrophy also rose with hypertension category (P<0.001).

After adjustment for age, gender, race or ethnicity, and body mass index, the risk compared with normal blood pressure tended to be:

• Lower for those with so-called white coat hypertension, defined as high blood pressure within 25% above the 95th percentile on in-office monitoring only (odds ratio 0.37, 95% confidence interval 0.12 to 1.17)
• Lower for masked hypertension, defined as high blood pressure on ambulatory but not in-office monitoring (OR 0.73, 95% CI 0.23 to 2.29)
• Elevated for prehypertension, defined by an in-clinic systolic pressure more than 25% to 50% above the 95th percentile blood pressure (OR 1.14, 95% CI 0.45 to 2.85)
• Elevated for ambulatory hypertension, defined by a systolic load 25% to 50% above the 95th percentile on both in-clinic and ambulatory monitoring (OR 1.33, 95% CI 0.36 to 4.94)

After adjustment, risk compared with normal blood pressure was significantly elevated for severe ambulatory hypertension, additionally defined by systolic load more than 50% above the 95th percentile on both measures (OR 2.58, 95% CI 1.05 to 6.33).

Because the ambulatory measurements predicted a child’s risk for left ventricular hypertrophy better than casual measurement in the clinic alone, the researchers recommended the AHA staging criteria as more accurate.

“Improved identification of patients at risk for target organ damage will allow for early treatment and delay the onset of overt cardiovascular events,” Dr. Acosta’s group concluded.

The researchers reported no conflicts of interest. Dr. White reported conflicts of interest with SunTech Medical, Takeda, NicOx, Teva, Boehringer Ingelheim, and Novartis Pharmaceuticals.

Primary source: American Society of Hypertension

Source reference:
Acosta AA, et al “Association of left ventricular hypertrophy (LVH) and hypertension (HTN) by ambulatory blood pressure (ABP) stages” ASH

Related Article(s):

• Kid’s BP Can Predict Adult Readings
• Childhood Hypertension Usually Goes Undiagnosed

Breast cancer patients, individuals at risk for osteoporosis and those undergoing certain types of bone cancer therapies often take drugs containing bisphosphonates. These drugs have been found to place people at risk for developing osteonecrosis of the jaws (a rotting of the jaw bones). Dentists, as well as oncologists, are now using X-rays to detect “ghost sockets” in patients that take these drugs and when these sockets are found, it signals that the jawbone is not healing the right way. Early detection of these ghost sockets can help the patient avoid permanent damage to their jawbone, according to an article in the March/April 2009 issue of General Dentistry, the Academy of General Dentistry’s (AGD) clinical, peer-reviewed journal.

A ghost socket occurs when the jawbone is not healing and repairing itself the right way. “The good news is that even though these ghost sockets may occur, by using radiographic techniques we can see that the soft tissue above these sockets can still heal,” according to Kishore Shetty, DDS, MS, MRCS, lead author of the report. Dr. Shetty states these findings are important news to learn about because early prevention and detection can halt permanent damage from happening to a patient’s jawbone.

In 2006, about 191 million prescriptions of oral bisphosphonates worldwide were written. The National Osteoporosis Foundation estimates that nearly 44 million people in the United States are at risk for developing osteoporosis. Currently, approximately 10 million Americans suffer from the disease.

Bisphosphonates are a family of drugs used to prevent and treat osteoporosis, multiple myeloma, Paget’s disease (bone cancers), and bone metastasis from other cancers. These drugs can bond to bone surfaces and prevent osteoclasts (cells that break down bone) from doing their job. Other cells are still working trying to form bone, but it may turn out to be less healthy bone leading to the ghost-like appearance on X-rays.

“Healthy bones can easily regenerate,” says Dr. Shetty. “But, because jawbones have rapid cell turnover, they can fail to heal properly in patients taking any of the bisphosphonate drugs. It’s very important for patients to know about complications from dental surgery or extractions. Since these drugs linger in the bone indefinitely, they may upset the cell balance in how the jaws regenerate and remove unhealthy bone.”

According to AGD spokesperson Carolyn Taggart-Burns, DDS, FAGD, patients who are taking bisphosphonates should inform their dentist to prevent complications from dental surgical procedures.

“Widespread use of bisphosphonates to prevent or treat early osteoporosis in relatively young women and the likelihood of long-term use is a cause for concern,” says Dr. Taggart-Burns.

Drs. Shetty and Taggart-Burns agree that, “how bisphosphonates interfere with healing after dental surgery is still unclear and further research will be needed. It is imperative that the public understands there is no present treatment or cure for this problem.”

Source:
Stefanie Schroeder

Academy of General Dentistry

The FDA (Food and Drug Administration, USA) approved Avastin (bevacizumab) for patients with GBM (glioblastoma multiforme) whose cancer carries on progressing after standard therapy. GBM is a rapidly progressing cancer - it invades brain tissue and can may have a significant effect on a patient´s mental abilities and physical activities. Approximately 6,700 people each year in the USA are affected by GBM.

Unfortunately, the cancer nearly always comes back, even when treated with surgery, radiation and/or chemotherapy.

Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said “This type of cancer is very resistant to therapy and thus challenging to treat. Avastin provides a therapy for patients with progressive GBM who have not responded to other medications.”

Avastin is a monoclonal antibody that is produced in the laboratory. It mimics the antibodies our immune system produces to combat harmful substances. Avastin reduces the action of vascular endothelial growth factor that helps in the development of new blood vessels which can nourish a tumor and help it grow. The new blood vessels may also become a pathway for the cancer cells to spread around the body.

Avastin was first approved in 2004 by the FDA for the treatment of metastatic cancer of the colon or rectum. It has subsequently been approved to treat non-squamous, non-small cell lung cancer and metastatic breast cancer.

Two clinical trials showed that approximately one quarter of all patients with GBM responded to Avastin with an average duration of response of about 4 months.

Avastin´s most serious side effects include, gastrointestinal perforation, wound healing complications, hemorrhage, and blood clots - some of these side effects can be fatal. Other side effects include severe hypertension (high blood pressure), nervous system and vision disturbances, lower white blood cell counts, infection, myocardial infarction, stroke, and kidney problems. Common side effects include nosebleeds, hypertension, runny nose, headache, excess urine protein, alteration of taste, rectal bleeding, excessive tearing, dry skin, and skin peeling.

Genentech Inc. of San Francisco manufactures Avastin.

Source: FDA

Written by Christian Nordqvist

View drug information on Avastin.

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