TWO BIG CANCER TRIALS FAIL

Trial # 1:
Avastin, Roche’s bestselling cancer drug failed to meet primary endpoints in a key Phase III prostate cancer trial. Roche’s daughter company Genentech announced the trial results showed that Avastin does not extend survival in patients with late stage prostate cancer. Just last month, the industry was also disappointed with Avastin’s poor performance in  a trial on inoperable or advanced stomach cancer. Avastin is approved for the treatment of colorectal, breast, lung and kidney cancer and a type of brain tumor.

Trial # 2:
Pfizer’s Sutent failed to meet endpoints in two Phase III trials on late-stage breast cancer. Sutent (sunitinib) is indicated for metastatic renal cell carcinoma and gastrointestinal stromal tumor. The company will continue testing Sutent on other solid tumors.

THE LATEST UPDATES ON CANCER SCREENING

1 in 4 states cut back on routine mammograms
The new US breast cancer screening guidelines have started to make an effect. Some states have already started cutting back on routine mammograms for women under 50 and uninsured. Proponents of the guidelines might be pleased but some groups are concerned about this trend.

According to Dr. James Thrall, chair of the American College of Radiology’s Board of Chancellors:

“Lawmakers at all levels need to act now to ensure that these recommendations do no further damage, and that women have full and ready access to mammography.”

Panel Calls for Reducing Colorectal Cancer Deaths by Striking Down Barriers to Screening
A National Institutes of Health panel met in February to discuss how to increase the use of colorectal screening. A 2008 survey showed that the screening rate among 50-year old adults is 55%, which experts consider to be too low.

According to Dr. Donald Steinwachs, panel chair, and professor and director of the Health Services Research and Development Center at the Johns Hopkins University

“We recognize that some may find colorectal cancer screening tests to be unpleasant and time-consuming. However, we also know that recommended screening strategies reduce colorectal cancer deaths. We need to find ways to encourage more people to get these important tests.”

Harry Smith colonoscopy to air on ‘Early Show’
The co-anchor of “The Early Show” Harry Smith had a colonoscopy scheduled on Wednesday, March 10 and the procedure was shown live in observance of the National Colorectal Cancer Awareness month.

Cancer society stops urging docs to offer PSA test
The American Cancer Society (ACS) has not supported routine PSA screening for prostate cancer since the 1990s and its stand remains the same. However, it is urging doctors to discuss the pros and cons of the procedure openly with their patients. ACS recommends the following to primary care physicians:

• Discuss the pros and cons of testing with patients, offering written information or videos that discuss the likelihood of false test results and the side effects of treatment.
• Stop routinely giving the rectal exam because it has not clearly shown a benefit, though it can remain an option.
• Use past PSA readings to determine how often follow-up tests are needed and to guide conversations about treatment.

When we talk about things environmental, we think of air and water. And when we talk about environmental carcinogens, we think of man-made toxic chemicals in the things that we eat and drink and the air we breathe. This way of thinking is basically right. But there is more to environmental carcinogens than what many people are aware of. Let us take a look.

Carcinogens in body care products

You don’t have to eat carcinogens to get exposed to them.

What you might not know: Carcinogens may also be present in the soap and shampoo, in your household cleaning liquids. The Environmental Working Group (EWG) has prepared a safety guide to body care products called Skin Deep Cosmetic Safety Database.

What you might not know: Lots of these chemicals are found in significant amounts in natural waters that could potentially contaminate our drinking water. Phthalates, triclosan and bisphenol A (BPA) are just 3 examples of chemicals identified.

Carcinogens in the air

Ok, so everybody knows that smoking can kill you. Smoking is associated mainly with lung cancer but also increase in risk for other cancers including breast, prostate, and neck cancers.

What you might not know: You don’t have to be a smoker to get lung cancer. Passive or secondhand smokers can get lung cancer, too. Exposure to asbestos, an industrial chemical can also cause lung cancer.

What you might not know: And finally, carcinogens need not be dirty, stinky, or man-made. Radon is an odorless, colorless naturally-occurring gas that causes most of the lung cancer cases among non-smokers.

Carcinogens in your food

Organic food is becoming popular. The American Cancer Society advocates the use of organic food to avoid taking in pesticides, preservatives, and other food additives. The EWG regularly tests fresh produce for pesticides and releases their so-called Dirty Dozen and Clean 15 lists.

What you might not know: Carcinogens may not be in the food itself. It might be in the food packaging (e.g. bisphenol A). It might be in your teflon cookware. It might be in your granite countertops (e.g. radon and uranium.

Carcinogens and electromagnetic field

Still a hotly debated topic is whether the use of mobile phones causes cancer or not. But phone manufacturers are developing phones that emit less and less radiation. The EWG has just released its 2010 Cell Phone Radiation Report.

What you might not know: The cancer threat is not only coming from your handset, but also from phone masts and antennas.

The story of BPA aka bisphenol A takes an unexpected yet welcome turn last Janaury when no less than the US FDA admitted that BPA may be bad you and for your family.

Yes, this is the same FDA that in October 2008 issued the following statement:

“Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.”

In “Update on Bisphenol A (BPA) for Use in Food: January 2010”, the US FDA expressed some “concerns” about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. Working together with the National Toxicology Program, FDA’s National Center for Toxicological Research, the regulatory body is conducting studies to further clarify questions about the health risks of BPA. In the meantime, the FDA is

• taking reasonable steps to reduce human exposure to BPA in the food supply. These steps include: a) supporting the industry’s actions to stop producing BPA-containing baby bottles and infant feeding cups for the U.S. market; b) facilitating the development of alternatives to BPA for the linings of infant formula cans; and c) supporting efforts to replace BPA or minimize BPA levels in other food can linings.
• supporting a shift to a more robust regulatory framework for oversight of BPA.
• seeking further public comment and external input on the science surrounding BPA.
• not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure

The European Food Safety Authority which was also at first skeptical about the BPA threat also issued an update on this issue. In particular, EFSA gives some conservative estimates of BPA exposure through diet in the table below.

Table 1. Conservative estimates of total dietary exposure to bisphenol A at different ages

*  Based on the upper value of 50 microgrammes BPA/litre of infant formula

#  Based on the typical value of 10 microgrammes BPA/litre of infant formula

About BPA

Bisphenol A is an industrial chemical widely used in the manufacture of plastics. It is present in many hard plastic bottles and in food packaging, particularly metal-based food containers and beverage cans. BPA has been shown to leach out of food containers into the food and drinks we consume. BPA is thought to be potentially carcinogenic, endocrine-disruptive, and has been associated with a wide range of diseases.

BPA Resources

Additional resources on BPA:

Food ingredients and packaging: BPA

Bisphenol A (BPA) Information for Parents from the US Department of Health and Human Services.

Full Update on Bisphenol A for Use in Food Contact Applications: January 2010

Tips to avoid BPA exposure by the Environmental Working Group

March is Colorectal Cancer Awareness Month in the US and several events have been scheduled to observe this health observance.

Put on Your Running Shoes for S.C.O.P.E.

The University of Texas MD Anderson Cancer Center is urging your participation in SCOPE – short for Sprint for Colorectal Oncology Prevention and Education. SCOPE started in 2006 and participation continues to grow at an annual rate of 25%. The aim of SCOPE is build awareness, promote education, celebrate survivorship and raise funds for colorectal cancer research. The next SCOPE is scheduled on March 27 at M. D. Anderson and has adult as well as children categories.

According to Cathy Eng, SCOPE co-founder and a race participant:

“S.C.O.P.E. was created because of the prevalence of colorectal cancer, and it’s potential to be preventedThe point of the race is to reach those without symptoms and those who have a family history of the disease to convey the importance of screening. Another goal of S.C.O.P.E. is to recognize and celebrate colorectal cancer patients and survivors. It’s very special to see my patients, often with their families, coming across that finish line.”

The National Super Colon^TM Tour

The Super Colon is on tour again. It is basically is a large inflatable model of a human colon, measuring 8 feet high and 20 feet long. The replica is a walk-through exhibition where people can get a closer look at:

• healthy colon tissue
• tissue with non-malignant colorectal disease like Crohns and colitis
• colorectal polyps
• various stages of colorectal cancer

The National Super Colon Tour is a travelling exhibition sponsored by Amgen. It has already started last March 3 in San Diego California but more events are scheduled later in the year.

Here are the events planned during the first half of the 2010:

• Amgen Campus, Thousand Oaks, CA – March 17, 2010
• Spring Training with the Arizona Diamondbacks, Tucson, AZ – March 19, 2010
• Dempsey Cancer Center, Auburn, ME – April 15, 2010
• Atlanta, GA – May 2010
• Monahan Center, Cornell, New York, NY – June 7, 2010

Colon Webchat  at Cleveland Clinic

Monday, March 22, 2010 – 12 Noon Caring for Your Colon: Healthy Lifestyle, Cancer Prevention and Treatment Options with Cleveland Clinic gastroenterologist Dr. Carol Burke, colorectal surgeon Dr. Jon Vogel and oncologist Dr. Robert Pelley.

Free colorectal cancer screening

March 20 is National Colorectal Cancer Awareness and Screening Day in the US and the American Gastroenterological Association (AGA) Institute is organizing free colonoscopies on March 19 and 20. The free screening is offered by AGA member gastroenterologists in the following states:

• Colorado
• Connecticut
• Maryland
• Massachusetts
• Minnesota
• New York
• Ohio
• Rhode Island
• South Carolina
• Washington

Check out the institute’s brochure on CRC Prevention and Treatment.

The Colon Health Centers of America also offers free colorectal cancer screen this month.

Even in this day and age, palliative care and euthanasia are still highly sensitive topics, much more so when it comes to terminally ill children. A study by researchers at the Dana Farber Cancer Institute interviewed parents who experienced loss of a child to cancer and brought into the open some revealing aspects about these issues. The study revealed that some parents would prefer to spare their children from pain even it means hastening death.

According to senior author Dr. Joanne Wolfe who is head of the Division of Pediatric Palliative Care at Dana-Farber and Director of Palliative Care at Children’s Hospital Boston:

“The problem is that conversations about these family worries may not always happen. Parents may not have the opportunity to express these feelings and considerations, and as clinicians, we may not be adequately enabling sufficient opportunity for them to talk about their concerns.”

The researchers interviewed parents of pediatric patients at the Dana-Farber, Children’s Hospital Boston, or Children’s Hospitals and Clinics of St. Paul and Minneapolis, Minn. who died of cancer. The parents were interviewed about their feeling and behaviors before, during, and even up to more than a year after the death of their child. 13% (1 out of thought of euthanasia and considered asking their child’s health care provider of hastening death. However, only 9% had openly discussed the issue with the health professionals. Five parents eventually requested hastening their child’s death to prevent unnecessary pain and but in only three cases was the request granted, carried out by morphine injection.

Parents were also asked to react to hypothetical vignettes and in case of a child being in uncontrollable pain or irreversible coma, 50% of the respondent parents were in favor of hastening death.

In recent years, the field of palliative care has made progress in helping the terminally ill in the final days of their lives. The emotional and psychological impact on the love ones, however, has also to be considered, especially in parents of young children. The researchers admit that there are gaps in providing palliative care to patients and support to the family, partly because this is an aspect of health care that is necessary given priority when it comes to research funding.

Dr. Wolfe continues:

“We’ve come a long way, because we have a good palliative and supportive care program for children with cancer. [However], I can never promise that their child will be pain free. We still have quite a way to go in figuring out the best way to ease suffering at the end of life.”

March is National Colorectal Cancer Awareness Month in the US

Information on Life after Cancer Now Available on NIHSeniorHealth.gov
Life after Cancer is the newest addition to the NIHSenior Health resource center of the National Institutes of Health (NIH). NIHSeniorHealth is a health and wellness site focusing on the needs of older adults. It was developed by the National Institute on Aging (NIA) and the National Library of Medicine (NLM), both part of the NIH. Life after Cancer addresses the needs of the elderly cancer survivors which make up almost 60% of all cancer survivors. Topics include follow-up care, physical and emotional changes, age-related complications, and relationships with family and friends

Researchers chart genomic map spanning over two dozen cancers
This is the largest study of its kind – mapping the genomes of 26 different cancers. The groundbreaking study started in 2004 by a group of international scientists led by researchers at Dana-Farber and the Broad Institute. The cancers studied some of the most common, e.g. lung, prostate, breast, ovarian, colon, esophageal, liver, brain, and blood cancers. Over 2,500 cancer specimens were collected and analyzed using chip technology. The analysis focused on a particular type of genetic abnormalities called somatic copy-number alterations or SCNAs present in many tumor types. According to senior author Matthew Meyerson:

“Our findings show that many genome alterations are universal across different cancers. Although this has been known for some types of changes, the degree to which so many alterations are shared was pretty surprising to us.”

Costly Tests May Not Help Detect Bladder Cancer Recurrence, M. D. Anderson Study Finds
Are these some of those costly but unreliable cancer screening tests? Cystoscopy is currently in gold standard in screening for recurrence of early-stage bladder cancer. Researchers at The University of Texas M. D. Anderson Cancer Center report that this is a cost-effective technique in detecting bladder tumors. However, some doctors tend to do additional tests such as testing for ancillary urinary markers. These tests, however, said the researchers, will simply increase costs without real benefits to the diagnosis. In fact, these tests could actually increase the rate of false positives that would cause distress and unnecessary procedures. According to senior research Dr. Ashish Kamat:

“The tests frequently added to cystoscopy have many more false positives than commonly believed, and they can lead to unnecessary work-ups. Our findings also may help reduce the cost of caring for bladder cancer patients, which currently in is the range of $4 billion annually.”

Online Health Chats at the Cleveland Clinic

• March 22: Caring for Your Colon: Healthy Lifestyle, Cancer Prevention and Treatment Options with Dr. Carole Burke and Dr. Robert Pelley
• March 30: Breast Cancer Genetics: Lessons for Both Men and Women with Dr. Charis Eng

The story of Stinne Holm Bergholdt is living proof as to what medical advancement can do to improve people’s lives in more ways than one. Six years ago, the 27-year old Danish woman was fighting for her life when she was diagnosed with bone cancer. Although, the fighting chance for cancer victims are better than ever nowadays due to better treatment options, survival sometimes come with a high price – loss of the potential to reproduce as chemo- or radiation therapy can cause irreparable damage to the human reproductive system.

The day before Bergholdt started chemotherapy, her doctors removed 13 strips of ovarian tissue from her right ovary and cryopreserved them. She then underwent 8 months of cancer treatment which proved effective. After a year of recovery, the doctors reimplanted seven strips of the frozen ovary tissue, which was equivalent to 20% of an entire ovary. The reimplanatation was successful and the reimplanted ovary could produce eggs that were then used for in vitro fertilization (IVF). The IVF resulted in a baby girl named Aviaja, now aged 3 years old. About a year later after Aviaja’s birth, Bergholdt and her husband decided to have a second child and went back to the fertility clinic. However, tests showed that another IVF cycle is not necessary because Bergholdt was already pregnant – the natural way! She is now the proud mom of a second daughter name Lucca, now aged 1 year old.

“It’s hard to believe it’s really true.It’s like a dream that I never would have thought possible a few years ago.”,  said the two-time mother of Odense, Denmark.

Bergholdt’s case is proof that preserving cancer patients’ fertility is possible. Even her doctors were happily surprised. According to Dr. Claus Yding Andersen, one of Bergholdt’s doctors at University Hospital of Copenhagen:

“We were really surprised that she had done it herself. We did not expect the ovary transplant to still be working after four years.”

In fact, Bergholdt’s ovary is working so well that she has now to practice control to avoid becoming pregnant again. So far, only 8 children have been born through ovary transplants, mostly in cancer patients and Bergholdt is the first woman to successful reproduce twice after the procedure, one through natural conception. She and her daughters made medical history, as published in the journal Human Reproduction.

Yet, the technique may have some far-reaching consequences, e.g. stopping the clock for women who want to delay having children by freezing their ovarian tissue. However, such a procedure would face ethical issues because of its invasiveness.

According to Allan Pacey, a fertility expert at the University of Sheffield:

“To suggest that a healthy woman would have two operations (to remove and reimplant the ovary) for the sake of social convenience, to have children later, is ludicrous. It’s far easier to just freeze your eggs.”

Photo credit: stock.xchng

What does the small pox virus has to do with prostate cancer? Well, scientists are using relatives of the deadly virus to develop a vaccine that holds lots of promise for patients with advanced prostate cancer. The vaccine Prostvac-VF is still in the testing stage and is a ground-breaking project of BN ImmunoTherapeutics, a division of Danish biotech firm Bavarian Nordic.

In the clinical trial development program of Prostvac-VF, the vaccine the vaccine was tested in 125 male patients with advanced prostate cancer that was resistant to most cancer drugs. The study conducted with the help of researchers at the Dana-Farber Cancer Institute and Harvard Medical School in Boston.

The results of the trial was very promising, with patients treated with the vaccine having extended survival of 8 months or more compared to those who did not receive the vaccine. According to researcher Dr. Philip Kantoff:

“The average survival for these men is two years…At three years, 30 percent of the men who got the vaccine were still alive.”

Prostvac is one of therapeutic vaccines currently in the development stage Therapeutic vaccines are used to treat diseases that have been diagnosed and are therefore different from prophylactic vaccines which prevent diseases.

Prostvac was developed from genetically-engineered cowpox virus and fowlpox viruses which are related to the small pox virus. The viruses were weakened and genetically engineered to carry irregular versions of the prostate specific antigen (PSA), which are produced only by prostate cells. In addition, the vaccine also induces the production of “three costimulatory molecules that spur the immune system to a more vigorous attack on tumor cells.”

The results of the study have been published in the Journal of Clinical Oncology. The authors concluded that immunotherapy with Prostvac-VF was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median overall survival rate in patients with metastatic castration-resistant prostate cancer. However, larger studies needed to confirm these findings.

Dr. Kantoff continues:

“Although this study is relatively small, it offers encouraging evidence of a clinically meaningful benefit from this vaccine approach.”

A trial that intends to include about 600 patients is in the planning.

There is a large economic potential for an effective prostate vaccine. Prostate cancer is a leading cause of mortality among American men, ranking second only to lung cancer as cancer killer. 2009 statistics from the American Cancer Society give 192,000 diagnosed cases 27,000 deaths. Financial analysts foresee a billion-dollar market for such a vaccine.

First of all, this is not meant to scare you. This is simply to make you aware. Through the use of radiation, imaging techniques have greatly helped diagnostic medicine in saving lives. Through radiotherapy, cancer patients have gotten a new lease in life. But let’s face it. Despite its benefits, radiation especially ionizing radiation has its share of risks. Radiation can affect the cells, tissues and organs to cause cell damage and death that may be irreversible.

In a previous post, I have cited recent studies which lament lack of regulations of the use of imaging techniques, especially computer tomography (CT) scans.

This lack of proper regulations has led to several tragic accidents, that is, radiation overdoses. I describe these cases below.

Radiation overdose through CT scan

In October 2009, the New York Times reported two cases in California.

Case 1: This involved the well-known Cedars-Sinai Medical Center in Los Angeles. The hospital reported that it is possible that as many as 206 patients (median age 70 years) who underwent a CT brain perfusion scans were exposed to radiation up to 8 times more than the normal dose. The patients were suspected to have had a stroke and this type of diagnostic procedure can determine the presence of blood flow problems in the brain. Upon discovering the mistake, the hospital immediately alerted the health authorities. The US FDA then in turn alerted other clinics using this type of CT procedure.

Case 2: This case is so tragic because it involved a 2 ½-year-old boy evaluated at Mad River Community Hospital in Arcata. The child was subjected to over an hour of CT scan, a procedure which should normally take a few minutes. The hospital did not report the incident to the health authorities. The most difficult part of such cases is the fact that the damage, which may range from cataract to cancer, will only come out in years or even decades. And this kid still has whole life before him.

According to USCF researchers who evaluated CT scan safety:

“…Our results highlight the need for greater standardization because this is a medical safety issue.”7

Radiotherapy overdose

Radiation is used as therapy for many conditions, including cancer. Unfortunately, overdoses in radiotherapy also happen. Last month, the New York Times published a report about cases of radiation therapy that proved more fatal than the diseases they are supposed to cure.

Case 1: One case was 43-year old Sparks who was treated for tongue cancer. Unfortunately, due to computer error, the linear accelerator blasted high-energy radiation to his brain and neck for 3 consecutive days.

Case 2: In another case, a 32-year old breast cancer patient was subjected to radiation 3 times the prescribe dose – for 27 days. The accelerator used had a missing filter which the operators never noticed. The radiation overdose burned a hole into her chest. The report continued to explain that while the latest in radiation technology helps to diagnose tumors more swiftly and precisely, it has also become so complex that there is a lot of room for error that includes “software flaws, faulty programming, poor safety procedures or inadequate staffing and training.” Furthermore, there is no regulatory agency overseeing the use of medical radiation and there are no guidelines about reporting accidents and medical errors involving radiation. A search of records showed that some hospitals never report radiation-related errors. Some errors go on for months, up to a year being discovered, thus affecting a large number of patients.

Health experts are calling for more regulations about radiation use in medicine whether as a diagnostic or as a therapeutic tool.

To be fair, some hospitals are trying to do the right thing by informing patients of the risks, and reporting errors.

In the case of Cedars Sinai, they reported the cases and admitted that their flawed procedures might be responsible for the overdoses. However, its chief executive, Thomas M. Priselac, said the manufacturer could help to prevent future errors by improving its internal settings and by installing more safeguards.

The Henry Ford Health System issued a statement to inform their patients of potential risks. Furthermore, the recommend patients to ask questions before a CT scan that would include:

• 1. Why do I need this exam?
• 2. How will having this exam improve my health care?
• 3. Are there alternatives that do not use radiation which are equally as good?
• 4. Is my child receiving a “kid-size” radiation dose? (for pediatric exams)

FDA Cancer Drug Approval Rate Highlighted in JNCI
A review in the Journal of the National Cancer Institute gives positive feedback on US FDA’s rate of cancer drug approval. Between July 2005 and end of 2007, the regulatory body Office of Oncology Drug Products approved more than 50 new indications in oncology as well as hematology drugs and biologics. In addition, the review reports:

• New treatments were approved for six of the seven most deadly forms of cancer in the United States (lung, colon, breast, ovarian, cervical and pancreatic)
• 35 of the approvals were existing products seeking new treatment indications
• New molecular entities represented 18, or 34 percent, of the 53 approvals
• Approvals included treatments for pediatric patients, supportive care indications aimed at improving the side effects of cancer therapies, and treatment options for rare diseases
• Three new treatments were approved for advanced kidney cancer
• Nine drugs received accelerated approval, a regulatory mechanism allowing the FDA to approve a drug with subsequent studies performed after approval to demonstrate an effect on survival or other clinically meaningful endpoints
• Twenty five percent of the indications approved were based on improvement in overall survival or improvement in both progression-free survival and overall survival

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
One of the latest approved cancer drug is Rituxan (rituximab), indicated for the treatment of chronic lymphocytic leukemia (CLL). CLL is a slowly progressing cancer of the blood and bone marrow primarily affecting people older than 50. It arises from a group of white blood cells known as B-cells—part of the body’s immune system. About 16,000 people in the US are diagnosed with CLL each year, resulting in 4,400 deaths. Rituxan is indicated for patients for chemotherapy-naive as well as chemotherapy-experienced patients not responding to ongoing therapy. Rituxan is administered in combination with two other chemotherapy drugs, fludarabine and cyclophosphamide.

According to Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research

“Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA’s commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases.”

Merck: Studies boost Gardasil for new uses
The HPV vaccine Gardasil is effective against other conditions, according to its manufacturer Merck. Gardasil was initially approved for prevention of cervical cancer in females from age 9 to 26. Last year, it was approved for the prevention of genital warts in males aged 9 to 26. New studies indicate that the vaccine is also effective in preventing cervical cancer and genital warts in older women (up to 45 years) and anal cancer in men. Merck is applying for approval for these new indications.

Wishing you all a relaxing weekend!