Triple negative breast cancer drug one step closer to approval

BY SUSAN MCCLURE | DECEMBER 13, 2009

On Friday, sanofi-aventis announced that the FDA has granted fast track approval to their investigational PARP1 inhibitor, BSI-201, and that accruals for their phase 3 clinical trial is on schedule and meeting expectations on patient accrual and trial site coverage in the United States. Investigators have enrolled 214 of their target number of 420 patients.

The "fast rack" process is designed to expedite the review of drugs being developed for serious diseases with the potential to address an unmet medical need.

BSI-201 entered a phase 3 clinical trial in the United States in July 2009 and is being evaluated in combination with chemotherapy in patients with metastatice triple-negative breast cancer (mTNBC), a condition defined by tumors lacking expression of estrogen, progesterone receptors and without overexpression of HER2. BSI-201 is a novel investigational targeted therapy that inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.

The decision to commence with the phase 3 study in July was based on the encouraging phase 2 study results presented at ASCO on May 31, 2009. In the phase 2 clinical trial, women with mTNBC were randomly assigned to receive gemcitabine and carboplatin (GC) in combination with the investigational agent BSI-201 or GC alone. Updated phase 2 data including overall survival were presented on Friday at a poster session during the San Antonio Breast Cancer Symposium.

The addition of BSI-201 to GC improved median overall survival from 7.7 months to 12.2 months. BSI-201 did not add to the frequency or severity of adverse events associated with chemotherapy. This is not a final analysis of the phase 2 data, but an updated analysis of overall survival. Median survival hasn't yet been reached in the BSI-201 arm, therefore the data cut-off period for the phase 2 trial was from September to November.

"The updated analysis from the phase 2 program, including data on overall survival, are consistent with the positive results presented earlier this year at ASCO," declared Marc Cluzel, executive vice president, R&D, sanofi-aventis. "We are very encouraged by the fast recruitment of patients in phase 3 trial. We hope the findings will lead to emerging strategy that may help women with metastatic triple negative breast cancer."

New mammography guidelines continue to spark debate

BY SUSAN MCCLURE | DECEMBER 12, 2009

You'll recall the public outcry that occurred in October when the U.S. Preventive Services Task Force issued a report that recommended significant changes to existing mammography guidelines. The debate continues among physicians, scientists, and advocates here in San Antonio.

Back in October, the 16-member committee recommended that most women in their 40s should not routinely get mammograms. Additionally, women 50 to 74 should get mammograms every other year until they turn 75, after which the risks and benefits are unknown. Women 75 and older should not get regular screening. The committee is also against teaching women to do regular self exams because "the value of breast exams by doctors is unknown and breast self exams are of no value."

The American Association for Cancer Research (AACR) released a response to the new guidelines which stated that they recognize that these are complex issues that encompass a broad range of areas - medical, scientific, public health, economic and sociological - and that the interpretation of these data can result in legitimate disagreement among respected leaders in their fields. Decisions on the delivery of screening methods and treatment of cancer should be evidence based and that the "state of the art" in the field is evolving and will continue to change as our understanding of the biology and genetics of cancer is better understood. They also recognized that mortality rates from breast cancer have been falling since the mid-1990, and they believe that this is attributable at least in part to the more widespread utilization of mammography screening and other factors. Their statement concluded by saying that the issues are simply too complex to make a clear statement at this time supporting either the existing guidelines or those proposed by the USPTF.

To me, that response equates to issuing a "no comment."

The Breast Cancer Network of Strength took a much more definitive stance. Margaret Kirk, the foundation's President and CEO said, "We know that earlier diagnosis and treatment of breast cancer leads to better outcomes. As an organization that hears from tens of thousands of women through our 24/7 YourShoes support center, we would be disappointed if this new recommendation became yet another barrier that women will have to overcome to get the care they need."

Over 7,000 people have sounded off about the new mammogram guidelines by signing Breast Cancer Network of Strength's petition. You can too by clicking here.

I was 35 when I found my lump and had it confirmed via mammography and biopsy. It's important to note that my mammogram was considered diagnostic and would still be covered under the new recommendations. However, had I done the mammogram two months earlier, when my doctor recommended it at my annual check up, it wouldn't have been because the tumor hadn't been detected then. At 35, and with no family history, I felt invinsible. I procrastinated.

I salute Margaret Kirk and the Breast Cancer Network of Strength for keeping the public's voice at the forefront of this issue.

Federal task force says women need fewer mammograms. Sound reasoning or rationing?

BY SUSAN MCCLURE | NOVEMBER 17, 2009

Bewilderment. That's the only word I can use to describe how I felt upon reading an article in my daily newspaper this morning (Yes, I still read the daily paper). The story reported on an influential federal task force's recommendation that women have fewer mammograms. "We're not saying that women shouldn't get screened. Screening saves lives," said Diana Petitti, vice chairman of the U.S. Preventive Services Task Force. "But we are recommending against routine screening. There are important and serious negatives or harms that need to be considered carefully." The recommendations of this committee would set the standards for preventative health care services under health care reform and would be used to determine which tests would be covered by insurance plans. These guidelines are for the general population, not for those at high risk of breast cancer.

The 16-member committee recommended that most women in their 40s should not routinely get mammograms. Additionally, women 50 to 74 should get mammograms every other year until they turn 75, after which the risks and benefits are unknown. Women 75 and older should not get regular screening. The committee is also against teaching women to do regular self exams because "the value of breast exams by doctors is unknown and breast self exams are of no value."

Those who side with the task force's findings say that more testing, exams, and treatment are not always beneficial and may cause harm to patients. The article stated that in about 10 percent of cases, false positive results caused anxiety among patients and lead to unnecessary procedures such as disfiguring biopsies and in some cases, surgery, chemotherapy, and radiation.

Those on the opposing side said that this is a huge step in the wrong direction. Daniel Kopans, a radiology professor at Harvard Medical School said, "Tens of thousands of lives are being saved by mammography screening, and these idiots want to do away with it." Dr. Phil Evans, director of the Center for Breast Care at UT Southwestern Medical Center in Dallas predicted that conducting fewer mammograms would be a mistake. "Mammography is not a perfect test, but it's still the best test for finding breast cancer early," argued Evans.

The most ominous quote in the article came from Dr. Michael Grant, my breast surgeon at Baylor University Medical Center at Dallas. He said that the timing of this made him suspicious. "Ultimately, this may be how we provide rationale for rationing. They're not saying it isn't worth it -- just that the number of lives it saves is not counter balanced by the cost and trouble of doing it," said Grant. Roughly 39 million women in the U.S. have mammograms each year, costing the healthcare system more than $5 billion annually.

I think I need to dust off my old copy of George Orwell's, Animal Farm. This arguement is sounding vaguely familiar. "All animals are equal-- just some are more equal than others."

Finally, good news for triple negative breast cancer patients!

BY SUSAN MCCLURE | JUNE 9, 2009

During ASCO's annual meeting this year, I was thrilled to learn that a new drug class is offering promise to patients with triple negative breast cancer. PARP inhibitors--experimental targeted therapy medicines, may make chemotherapy work better against aggressive forms of breast cancer (see Debu Tripathy's blog for the details). For years, I've been happy to see great advancements in the treatment of breast cancer, but have selfishly been concerned that no real progress was being made to better understand triple-negative cancers.

When I was diagnosed with breast cancer back in 1994, the term "triple-negative" breast cancer didn't exist. Diagnostic tests weren't as sophisticated as they are today. I did know that I was estrogen receptor-negative and that while my cancer was aggressive, it hadn't spread to my lymph nodes. I had surgery, chemotherapy, and radiation. Within six months my treatment was over, and I was told to get on with my life. Six months of treatment and I was done. So why were some of my friends, also estrogen receptor-negative, not so fortunate?

It was years later, during a routine check up with my oncologist that I asked him to review my pathology report to see if he thought that I might have fallen into the triple-negative camp. After close examination, he shrugged his shoulders and said that, most likely, I did. To be sure, they'd have to go down to the basement of Baylor, find my 12-year-old tumor, and run it through the gauntlet of diagnostic tests now available to determine such things. Eeek.

I've been cancer free for twelve years. I've lived with never really knowing what caused my cancer. I've lived with the fear that it might return--as we all do. I've lost friends with triple-negative breast cancer who ran out of treatment options far before they ran out of hope. For me, this new development honors their memory.

Mom and teen home, but debate rages on...

BY SUSAN MCCLURE | MAY 29, 2009

I'm sure many of you have been following the plight of Daniel Hauser, the 13-year-old Minnesota boy who scrambled to the Mexico border with his mom in order to avoid undergoing court ordered chemotherapy. For those of you who haven't, let me catch you up. In January Daniel was diagnosed with Hodgkin's Lymphoma-- what experts are calling "a highly curable disease". He had one round of chemotherapy before his parents told doctors that he wasn't going to have any further treatment. The first treatment resulted in a reduction of cancer, but because Daniel hasn't had another treatment since, his cancer has returned to pre-treatment levels. The doctors were very concerned. So concerned in fact, they turned the matter over to the courts. They said Daniel has a good chance of achieving a complete remission if he resumes treatment. They felt that Daniel's life was in jeopardy and that his parents weren't acting in his best interest. Knowing that the courts were likely to force Daniel into chemotherapy, he and his mom fled town. Well, they're home now, less than a week since their life on the run began. Daniel's parents have told the judge that they will abide by whatever ruling is made--even if that means undergoing more chemotherapy.

But why did the Hausers decide against such a proven treatment plan in the first place? Like most issues related to cancer, it's complicated. The family is Roman Catholic, but they belong to a group called the Nemenhah Band, which promotes a "Do no harm" philosophy. They believe in natural healing methods advocated by some American Indians as an alternative to traditional treatment. In fact, Daniel and his mother believe that the treatment for his cancer is what will end up killing him-- not the cancer itself. They were seeking "less toxic" options to treat his cancer.

That decision resulted in a heated national debate surrounding the government's right to intervene in cases such as this. According to a recent MSNBC poll in which participants were asked if parents should be allowed to refuse cancer treatments for their sick children, public opinion was split. Of the 77,276 people who responded as of May 28th, 55% said "Yes, families should be allowed to make their own decisions in every aspect of medical care", and 45% said "No, refusing care that could save someone's life is a form of medical neglect". Many who answered "yes" said that while they did believe that the parents were putting the child at risk, this is America and we have a little document called The Bill of Rights that protect people in cases such as this. Those who answered "no" said that this was just another form of child abuse and that refusing to render medical aid to a sick child is unjustifiable.

I was thinking about my own cancer treatment and wondered how I would feel if someone told me that I had no right to refuse a particular therapy. Granted, I was 35 when I was diagnosed--not 13. What do you think? I'm looking forward to your comments.