Friday, December 31, 2010

Best Wishes in the New Year

I wish you all a healthy and blessed 2011.


Monday, December 20, 2010

Healthy Eating: Fiber in Whole Wheat

I have been taught to avoid breads—they mean fat, right? But whole grains also mean high fiber, which translates to a healthy heart. Whole grains actually soak up cholesterol, especially LDL, or bad, cholesterol. It’s a strong image. For most of my life, I have imagined bread soaking up only the bad things on my plate—gravy, for example. So, when I try to eat healthy, I avoid it. Instead, I should have been imagining what bread was doing inside my body—soaking up bad cholesterol. And I should have been eating it.

Based on my age, I am supposed to have five ounces of grains a day, at least half of which should be whole grains, according to the food pyramid. What’s in an ounce? One slice of bread, a cup of ready-to-eat cereal, a half cup of cooked cereal, or a half cup of cooked rice.

So, in a day, I should have, something like:

A cup of ready-to-eat cereal (1 oz)

Two slices of bread (2 oz)

A cup of cooked rice (2 oz)

Of course, you have to eat your whole grains in a healthy way. Pass up the high-fat butter and margarine as a topping and go instead for heart-healthy olive oil. But keep that low as well. (A tablespoon has 119 calories, all from fat. While that is good fat—monounsaturated—it still can add up.)

I have discovered Sara Lee’s whole wheat bread with 45 calories a slice and five grams of dietary fiber, or 18 percent of your daily value. It’s good, healthy, and filling. Nice work, Sara.

Even knowing this, I recently ate a quick lunch-on-the-go with my family after a funeral. To keep my calories down, I skipped the bread and ate the cold cuts. Good grief. Seriously? Was my nutritional brain born yesterday? Apparently. I ate the unhealthy part of the meal—the cold cuts—and passed up the cholesterol sponges—whole wheat bread. Next time, if I screw my head on, I will do it the opposite.

Friday, December 17, 2010

Lumpectomy Better for Early-Stage Hormone-Negative

From the San Antonio Breast Cancer Symposium via WebMD

Women with early-stage hormone-negative breast cancer who undergo a lumpectomy—often called breast-conserving therapy—fare slightly better than those who undergo a mastectomy, according to research presented today. And women from both groups do well, with the great majority alive after four years.

Specifically, those under 50 with lumpectomies were 13 percent to 29 percent less likely to die from their cancer than women with mastectomies. Women over 50 with hormone-negative who underwent a lumpectomy were 17 percent less likely to die than those with a mastectomy. The variation in percentages relates to variations in tumor sizes.

Data on 114,277 women from the California Cancer Registry were evaluated; 62,770 of these had a lumpectomy followed by radiation and 51,507 had a mastectomy. Ninety-three percent of the lumpectomy group and 87 percent of the mastectomy group were alive four years after diagnosis.

Read Charlene Laino’s report on the study in WebMD.

Avastin and TNBC: Let's Refocus the Research

Recent research has shown that Avastin can be effective against triple-negative when paired with standard chemo; when used with the chemo drug Xeloda; and when paired with taxanes. It has shown special promise for metastatic triple-negative. As a targeted therapy, it offers a way of treating cancer that goes beyond typical chemo. Still, the drug's effects are usually limited to triple-negative, extending patients lives by several months. And the numbers are small, because the percentage of women with triple-negative in any study of overall breast cancer tends to be fewer than 20 percent, usually between 15 percent and 18 percent.

Yesterday the FDA said the evidence of the drug's effectiveness in treating breast cancer was weak and it began the process of pulling its approval for use of Avastin in breast cancer. The cost, they say—some $8,000 a treatment—outweighs the benefits. It is still allowed for other forms of cancer, such as brain, colon, kidney, and lung.

Once again, the experts lump all breast cancers together. The drug was not effective for hormone-positive, so its use is pulled for all breast cancer. I hope this does not stop research on Avastin and other biologic agents, which may ultimately be the future of triple-negative treatment.

The side-effects of Avastin can be significant, including high blood pressure and internal bleeding. And its benefits are usually limited to an average of a few months. Plus, there is some indication that keeping women on the drug too long can actually cause a recurrence. So much remains to be learned about the drug.

Yet, there are plenty of stories of women who have done extremely well on Avastin. Josh Turnage of Mississippi wrote eloquently about how the drug saved his mother. And Stacey Singer, writing in Palm Beach Post Health offers another excellent patient story plus a good perspective on why some doctors and patient advocates think the FDA made the wrong move.

More research is needed specifically on Avastin and triple-negative. This requires a change in focus, but that focus might ultimately yield enough evidence to demonstrate the drug's effectiveness--or lack thereof--for this important and specific subgroup.

Rather than triple-negative being an add-on, it should be the focus of research on Avastin.

Thursday, December 16, 2010

FDA Removes Approval of Avastin As Breast Cancer Drug


For Immediate Release: Dec. 16, 2010
Media Inquiries: Erica Jefferson, 301-796-4988,
Consumer Inquiries: 888-INFO-FDA

FDA begins process to remove breast cancer indication from Avastin label
Drug not shown to be safe and effective in breast cancer patients

The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

Removing the breast cancer indication from the Avastin label will be a process. This is the first step. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

The agency has informed Genentech, Avastin’s manufacturer, of its proposal to withdraw marketing approval of the drug for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, and FDA will begin proceedings to remove the breast cancer indication.

Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA’s accelerated approval program, based on the results of a clinical trial known as “E2100,” which evaluated the drug in patients who had not received chemotherapy for their metastatic HER2-negative breast cancer. Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.

After the accelerated approval of Avastin for breast cancer, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on “progression-free survival” without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in “progression-free survival” reflects a small, temporary effect in slowing tumor growth.

Avastin has also been associated with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

On the basis of all available data relating to the use of Avastin to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use.

FDA is open to working with Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug’s benefits exceed the risks.

For more information:

FDA: Bevacizumab (marketed as Avastin) Information

NCI: Breast Cancer

Wednesday, December 15, 2010

A Young Man's Testimonial for Avastin

Later this week, on December 17, the FDA will reconsider its approval of the cancer drug Avastin (bevacizumab )because of concerns that it has not been effective against most breast cancers. It has, however, had success as treatment for triple-negative. Josh Turnage, a sophomore at Mississippi State University, says the drug saved his mother, and he has lobbied for its continuance. His essay about his mother's experience has appeared in media all around the country. The SF Gate version is here. He also created a video to help make his case.

Dose Dense Chemo Better for Hormone-Negative

Dose-dense chemotherapy—chemo every two weeks—yields better results than standard chemo for hormone-receptive negative breast cancer, according to a meta-analysis using The Cochrane Cancer Network register of trials, The Cochrane Library, and LILACS and MEDLINE databases from January 1966 to January 2010. Researchers, however, say the studies they analyzed were inconsistent and they recommend randomized control trials. Read the full article, in the December 15, 2010 Journal of the National Cancer Institute.

Abdominal Fat Related to Estrogen-Negative Risk in Premenopausal Women

Abdominal fat is associated with risk of estrogen-negative breast cancer in premenopausal women, according to a study published in the December 15, 2010 issue of Journal of the National Cancer Institute. Because this type of fat distribution is also associated with pre-diabetes, researchers say these findings may point to a role of insulin in the risk of estrogen-negative.

The news release is below:

Body fat distribution does not play an important role in the incidence of every subtype of premenopausal breast cancer, but is associated with an increased risk for estrogen receptor (ER)–negative breast cancer, according to a study published December 15 in The Journal of the National Cancer Institute.

Previous studies have shown that the association between body mass index (BMI) and the risk of breast cancer varies with menopausal status: a higher BMI is positively associated with risk of postmenopausal breast cancer but inversely associated with risk of premenopausal breast cancer. Intra-abdominal fat that surrounds organs has been associated with metabolic and hormonal changes that have been associated with premenopausal breast cancer risk, although prospective studies have produced conflicting results, and none have examined the role of hormone receptor status.

To determine the relation between body fat distribution and premenopausal breast cancer risk, Holly R. Harris, Sc.D., of Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues, conducted a prospective analysis among women in the Nurses' Health Study II, a cohort of 116,430 women who have been followed up since 1989. In 1993 the researchers sent women in that study a questionnaire in which the women were asked to measure and report their waist and hip circumference.

The researchers found no statistically significant associations between waist circumference, hip circumference, or the waist to hip ratio and overall risk of breast cancer. But they did find that abdominal adiposity, or waist circumference and the waist to hip ratio, was more strongly associated with risk of ER-negative breast cancer than with the risk of ER-positive breast cancer.

Furthermore, the fact that body fat distribution was more strongly associated with ER-negative breast cancer than with ER-positive breast cancer suggests that body fat may influence breast cancer risk through sex hormone–independent pathways. Specifically, the researchers note that abdominal fat is associated with hyperinsulinemia, or pre-diabetes, and that insulin receptors are expressed in most breast cancers and have been shown to stimulate the growth of breast cancer cells in vitro.

"These findings may suggest that an insulin-related pathway of abdominal adiposity is involved in the etiology of premenopausal breast cancer," the authors write.

Tuesday, December 14, 2010

New Research Links Obesity to HR+, but not HR-

Obesity is linked to worse survival rates for hormone-positive, but not for hormone-negative breast cancers, according to research presented at the San Antonio Breast Cancer Symposium. Preliminary results of three studies were presented. One study showed no relationship between obesity and survival rates. MedPage Today covered the story.

Brazil Sees Nearly Twice the TNBC Cases as Ten Years Ago

From the San Antonio Breast Cancer Symposium, Via the Peer Review Media Guide:

TNBC cases in Brazil have nearly doubled in the past ten years. Researchers analyzed data of 439 women diagnosed with breast cancer at the Núcleo Mama Moinhos breast cancer clinic from 2000 to 2010 and compared patient characteristics in two 5-year periods: 2000 to 2005 and 2006 to 2010. They discovered that cases of hormone-positive had decreased, while triple-negative had increased. TNBC cases in women older than 50 increased and tumors were larger at diagnosis.

"We have no idea why we are seeing more of these cases," said Maira Caleffi, MD, PhD, Associação Hospitalar Moinhos de Vento, Porto Alegre, Brazil, on December 10. "The increase in triple-negative and hormone-negative tumours in women older than 50 is worrisome and does not reflect the common sense that the large majority of cases in this age group are hormone sensible."

Read the entire article here.

Monday, December 13, 2010

HRT Increases risk of TNBC

Combined hormonal replacement therapy—using estrogen plus progestin—is associated with a 78 percent increase in triple-negative cancers, a twofold increase in HER2-positive tumors, and a 37 percent increase in HER2-negative tumors, according to Women’s Health Initiative results presented at the San Antonia Breast Cancer Symposium. And it nearly doubles the risk of death from breast cancer. In the past, HRT was associated strongly with hormone-positive cancers, but not hormone-negative.

Data were from WHI randomized trials after 11 years of follow-up.

Read the entire story from Internal Medicine News.

More Good News on PARP Inhibitors for TNBC

From the San Antonio Breast Cancer Symposium, via Medpage Today:

A novel agent that inhibits DNA repair in cancer cells appears to be promising for safety and efficacy given along with chemotherapy using irinotecan (Camptosar), according to early-phase clinical trial results reported here.

The phase Ib trial conducted among 34 metastatic breast cancer patients found that the experimental drug iniparib yielded partial or complete responses in up to 31.8% of the patients when combined with irinotecan, Stacy Moulder, MD, MSCI, of MD Anderson Cancer Center in Houston, and colleagues found. Read more.

Mixed News on Avastin

From the 33rd Annual San Antonio Breast Cancer Symposium:

Avastin (
Bevacizumab) may be successful in fighting triple-negative, but shows no benefit for early breast cancer in other patients. The FDA is expected to announce later this month whether it will continue to approve use of the drug. Read the full story on Medscape Today.

Sunday, December 12, 2010

Memorial: Ruth Bressan

Ruth stood in her sunny kitchen cutting peaches and gesturing with the knife as she told us about the headless rattlesnake that had snapped at her. Her sons had captured it, beheaded it, and put it in the sink. Instinctively, the creature coiled and sprang at her, even though its head was long gone and its fangs with it.

She was making us dessert, cutting fresh Colorado peaches to put on vanilla ice cream. So far it had taken her 45 minutes to cut three peaches. They were beautiful minutes, though, full of stories of Ruth’s life as a young wife and mother, then a grandmother, and finally a great grandmother, all spent in the shadow of Colorado’s Spanish Peaks, twin mountains called Wahatoya, or breasts of the earth, by native Americans.

She laughed, a tinkling giggle, her bright blue eyes blinking with delight in her memories.

Ruth lived in a house built by her husband Arthur, a comfy 1950’s ranch with a picture window in the living room that framed a stunning scene of the peaks. They raised six kids there—Dave, Doug, Don, Daryl, Debbie, and Dana.

Her kitchen has corner windows that looked the opposite direction, toward one of the dikes—volcanic walls—that are unique to this neck of the Southern Colorado woods, south of Walsenburg and east of La Veta. Outside those windows, dogs, horses, cows, and who knows what other unknown beasts roamed the high dessert.

And rattlesnakes. As Ruth told it the Bressan family had a close relationship with these snakes, which liked to nest in the rocks of the dikes.

Still gesturing with her knife, still cutting the peaches, Ruth tells us about the time she and her dog went for a walk in the autumn and heard hissing all around them. Both froze—smart dog—until the snakes lost interest and moved.

We were her neighbors and were at her house on one of the two or three visits we made every year. Although our land adjoined hers, it took us about half an hour to drive to her house. So we did not visit as much as we wanted. Each visit, though, was a treat.

This time, my brother Ed, his wife Gwyn, and my husband Joe were all visiting. Finally, Ed got up and helped Ruth finish the peaches. We sat down and had our tasty dessert. But the real luxury was time with Ruth.

Usually, Gwyn and I visited without our husbands. Two years ago, we went driving around the nearby Boy Scout camp her family helped build. I drove my Toyota 4Runner and Ruth encouraged me up one steep hill after another, as though we were driving to the mall. At one point, we ended up on the narrow ridge we often hiked. She suggested that I drive along the ridge but I suggested otherwise. Each time I hike that ridge I chuckle at Ruth, so glibly telling me how I could just turn and keep driving on a cow path. She would have.

The year before that, we had hiked close to Ruth’s home, to a formation she called the Birdbath. It is probably a 20X20-foot flat rock with a pool at one corner into which water puddles. It was a hidden wonder, a little mountain treasure we would never have known without Ruth.

Afterward, we shared peanut butter and jelly sandwiches.

The last meal I shared with Ruth was in her cozy dining room with her son Dave. We brought part of the meal and Ruth and Dave added fabulous cheese plus strawberries with melted chocolate. And wine. Ruth loved Yellow Tail. We talked about gas drilling in the area, we heard more stories of the Bressan family, we laughed, we talked politics. We were kindred political souls—Ruth and Dave even had a fish named Obama.

And we left. I hugged Ruth and told her I would see her next year. We are fair weather neighbors, in the mountains only in the summer. Ruth waved goodbye, her grey hair in its perky little ponytail, her tiny frame tucked into her jeans.

That was my last view of her. She died last Friday, of a cancer that came on ferociously—adenocarcinoma, which affects the lining of the internal organs— and stole her right from under us in a matter of weeks.

I only met Ruth eight years ago—ironically, we got to know one another over a lawsuit with a troublesome common neighbor. And I only saw her a few times a year. Yet I am as bereft as if I had seen her every day. Partly it’s because I did not get to spend as much time as I wanted with her—it’s like our friendship was just getting started. There was so much I wanted to know, so many stories I wanted to hear.

Largely, though, it’s because she was an American original—the kind of person whose life stories belong in a book, whose world was larger than the rest of us can even imagine. And who made us larger by sharing it.

Wednesday, December 8, 2010

The Pill and Cancer: Correction

Thanks to my reader Jojo, I am offering a more thorough perspective on the risk of oral contraceptives than the update I posted several days ago, which inflated that risk. I greatly appreciate my eagle-eyed readers who keep me honest when I occasionally drop the ball. In all my other work as a journalist, I have an editor to run things past. Here, it's me, myself, and I. Sometimes that is not enough. Thanks again, Jojo.

Check out the National Cancer Institute's Fact Sheet on Oral Contraceptive and Cancer Risk.

Our Role in Elizabeth Edwards’ Deadly Hesitation

When Elizabeth Edwards felt a lump in her breast in 2004, she waited until after the election to get the treatment she needed. She knew her health would become the story rather than the issues she felt passionate about, the issues that fueled her support for her husband as a vice-presidential candidate.

This is more than the usual wife who puts her wellbeing on hold to care for her husband. It was a woman living her life under a magnifying glass who knew that, should she shine light on that glass, it would scorch her and her family.

So the cancer grew and spread and by the time she got treatment, it was already stage III.

There are already people saying God killed her in retribution for her husband’s infidelity. Somebody has even blamed it on Obama. In the words of Pogo, "We have met the enemy, and he is us."

Most of us who discover a lump can head to the doctor, get tested, possibly get the bad news, and then figure out how to tell our family and friends. No so Elizabeth Edwards. She could not quietly take time off the campaign and discreetly go to the doctor. Some reporter, blogger, or unpaid busybody would have leaked the story and the woman’s pain would become the country’s gossip.

As it did. I am writing this in the middle of the night in the middle of Iowa, and you are reading it. My opinion is already out there, swirling around cyberspace. I think it is a fairly well reasoned opinion, but even if it weren’t, it still has legs.

Lucky for us, Elizabeth was a thoughtful, articulate woman who turned her negative into our positive, educating us on the ferocity of this disease and on how to deal with it under pressure. She wrote two books, advocated for better treatment for others with cancer, and was a gifted spokeswoman and role model for women throughout the world dealing with a similar diagnosis.

And with that came public support and affection. And criticism. When her cancer returned in the 2008 presidential campaign, critics said John should pull out of the race, that he and Elizabeth were putting politics ahead of her health. And when John’s affair was made public, some blamed Elizabeth for a laundry list of reasons that were nobody else’s business.

The adulation itself can be oppressive, of course. I met Elizabeth—see how I call her by her first name because we’re so close?—once during the 2008 campaign. Politics are retail in Iowa, where we get to meet candidates personally. I introduced myself and told her I’d also had breast cancer. She smiled wearily—it was the end of the day and she was no doubt exhausted and had been dealing with God-only-knows-what. I suspect she thought, “Oh my, another one.”

She could not get away from cancer, or from us.

And the misinformation lingers. In discussion boards, women say she had triple negative breast cancer—negative for estrogen and progesterone receptors, and for the human epidermal growth factor receptor, Her2. This probably grew from the fact that TNBC can be an aggressive form of cancer, and Elizabeth’s certainly seemed aggressive. But hers was estrogen and progesterone positive—the most common kind. While statistically less deadly, it still kills.

A 24/7 news cycle means that public figures never have a minute off, never a second of downtime. Add to that the option of Internet anonymity that allows us to spit even our most evil thoughts into the public well, plus commentators who make things up for a living, and public scrutiny can make even the most thoughtful person second-guess basic decisions—like when to go to the doctor.

That is the environment in which Elizabeth Edwards faced the reality of her illness. No wonder she avoided initial treatment for that lump. And shame on us for making her hesitate for fear of what we might do.

But good for her for becoming the face of reason against an unreasonable disease and unfathomable public scrutiny. If she whined, she did so in what little privacy she had left.

Tuesday, December 7, 2010

Elizabeth Edwards: A Good Life

"Elizabeth did not want people to say she lost her battle with cancer. The battle was about living a good life and that she won." Read more.

Elizabeth Edwards Has Hormone-Responsive Breast Cancer

Several readers have come to this site by Googling questions on whether Elizabeth Edwards has triple-negative breast cancer. She does not. Hers is responsive to both estrogen and progesterone. In its archives, WebMD has an interview in which Edwards talked about her cancer, its diagnosis, and her treatment.

Monday, December 6, 2010

Elizabeth Edwards Losing Her Cancer Battle

Elizabeth Edwards announced today that her cancer is now incurable and that doctors have stopped medication. She is now resting at her home in Chapel Hill, North Carolina. On her Facebook page, she wrote:

The days of our lives, for all of us, are numbered,” she wrote. “We know that. And yes, there are certainly times when we aren’t able to muster as much strength and patience as we would like. It’s called being human. But I have found that in the simple act of living with hope, and in the daily effort to have a positive impact in the world, the days I do have are made all the more meaningful and precious. And for that I am grateful.”

The Associated Press covered the family’s announcement today.

Elizabeth did a great deal to improve out understanding of the reality of breast cancer. Her story is worth a whole basketful of pink ribbons.