"There is a catchword for October among women who have been treated for or are living with breast cancer: Pinktober. The reason is on full display on television one Sunday afternoon as my boyfriend cheers on his NFL team: pink cleats, pink towels, pink goalposts, coaches with pink ribbons and a male announcer promoting the NFL’s “A Crucial Catch” campaign.
Yet I’m left to wonder, more than two years after my diagnosis and eight months out of active treatment for breast cancer: What is all the pink accomplishing?
After a wave of deaths in the young women’s breast cancer support group to which I belong, I am glum and petulant despite my boyfriend’s best efforts to alleviate my sour mood. I attempt to provide him with a snapshot of my pain: the deaths, my own fears at the blind luck of it all and my struggles to stay in the present.
Well beyond the 31 days of breast cancer awareness month, I am aware.
Getting up from my desk at work, my joints are stiff and achy, a side effect of the hormone therapy I will be on for 10 years. I hobble like a woman beyond my years until my hips, knees and ankles are warmed up and the discomfort dissipates. A colleague asks, “Did you hurt your leg?” “No, I’m okay,” I reply with an embarrassed half-smile.
We’ve seen kind of an explosion of requests—and I don’t think anybody really expected that,” Suparna B. Wedam, MD, Medical Officer at the U.S. Food and Drug Administration, said about the FDA’s four expedited programs, which she discussed here at the 2015 Breast Cancer Symposium in her talk “FDA Drug Approvals: Getting Drugs to Patients Sooner.” Those four programs include three designations (breakthrough therapy, priority review, and fast track designations) and one approval pathway (accelerated approval).
In an interview after the talk, she summed up these key points and elaborated on what these approval programs mean for the future of oncology drugs.
1. You spent a lot of time during the talk on breakthrough therapy designation, which is the newest program of the four—what should oncologists know about the designation?
“With breakthrough therapy designation, you have to have clinical evidence that this [drug] is substantially better than a significant endpoint, and for fast track designation, non-clinical data can be used. Having said that, we do not accept non-clinical data usually for oncology—typically we require at least some clinical data. Especially in oncology, we feel that [non-clinical] data that comes from cell lines or animals does not always translate well into humans.
“And the other part is the level of senior level involvement. Once a drug has the breakthrough therapy designation, it really is an all-hands-on-board situation from the top down, where the senior manager is helping with the whole process—so, it’s the intensity of involvement that differentiates it.”
"Medical oncologists empathize with their patients and feel responsible for providing them emotional/psychological support, but many experience the negative emotional impact of their work when treating women with metastatic breast cancer, according to survey results presented at the symposium.
Medical oncologists with less experience appeared to be more impacted by their emotions as compared to physicians with more experience, and the study authors noted that “acknowledging medical oncologists’ emotions is important and underscores their own need for psychological/emotional support.
Dr. Adam M. Brufsky, associate chief, division of hematology/oncology and codirector, Comprehensive Breast Cancer Center at the University of Pittsburgh, and his colleagues surveyed medical oncologists who treat five or more women per month with metastatic breast cancer, and surveys were also completed by patients with the disease. The goal of the study was to evaluate the emotional impact on the oncologist. The surveys were conducted from June to August 2014.
A total of 359 patients (median age 53 years) and 252 medical oncologists (median age 49 years and a median of 15 years in practice) completed the survey. "
"Although the cure rate for breast cancer has risen steadily in recent decades, recurrent or metastatic disease remains difficult to control. To fight metastatic breast cancer and forestall the recurrence of high-risk primary disease, researchers at The University of Texas MD Anderson Cancer Center are using various techniques to boost the body’s immune system. Clinical trials of many of these therapies are already under way.
Patients with metastatic breast cancer treated with standard chemotherapy followed by the STn-KLH vaccine who also received endocrine therapy (tamoxifen) had a longer median overall survival than did those treated with standard chemotherapy followed by a control vector. Adapted from Ibrahim NK, et al. J Cancer 2013;4:577–584.
Recent research findings have sparked interest in the role of immunotherapy in breast cancer treatment, said Elizabeth Mittendorf, M.D., Ph.D., an associate professor in the Department of Surgical Oncology. “For a very long time, breast cancers were not thought to be immunogenic,” she said. “But data published in the past 2 years have shown that there are immune cells, including T cells, in breast tumors. This suggests that breast tumors are indeed immunogenic.”
"A small, implantable device that researchers are calling a cancer “super-attractor” could eventually give doctors an early warning of relapse in breast cancer patients and even slow the disease’s spread to other organs in the body.
The sponge-like device developed at the University of Michigan is designed to attract the cancer cells that emerge in the bloodstream during the early stages of cancer’s recurrence—before tumors form elsewhere in the body. A new study in mice shows that the device attracts detectable numbers of cancer cells before they’re visible elsewhere in the body. It also shows that the cancer cells spread to the lungs 88 percent more slowly in the mice that received the implants. Cancer cells also spread more slowly to the liver and other organs. The team’s findings are reported in a new paper published in the journal Nature Communications.
Researchers envision the super-attractor being implanted just beneath the skin of breast cancer patients. Doctors could monitor it using a non-invasive scan and it could enable them to detect and treat relapse sooner. It also has the potential to be used as a preemptive measure in those who are at high risk for breast cancer.
“Breast cancer is a disease that can recur over a long period in a patient’s life, and a recurrence is often very difficult to detect until the cancer becomes established in another organ,” said Jacqueline Jeruss, an associate professor of surgery in the U-M Comprehensive Cancer Center and an author on the paper. “Something like this could be monitored for years and we could use it as an early indicator of recurrence.”
The very first educational video our CME group produced — entitled “Hormonal Manipulation for the 1980s” — featured a homemade animation from the nascent University of Miami audiovisual department depicting the mechanism of action of tamoxifen complete with side-by-side Pac-Man-like images of the drug and an estrogen molecule scooting across the cell membrane and racing to the nucleus to bind with a reverse-Pac-Man-looking estrogen receptor.
Back then this biology was very cool, and although we welcomed aromatase inhibitors (AIs) and fulvestrant to clinical practice, for a long time thereafter it seemed like there wasn’t much progress beyond this primitive concept of the very first form of targeted treatment of cancer. Instead the new target on the block, HER2, was generating considerably more interest as dashing figures like Dr Dennis Slamon regaled us with impressive science and trial results to match.
It was only in 2011 that research on endocrine treatment began to awaken from its long slumber, when data from the Phase III BOLERO-2 study demonstrated an impressive progression-free survival (PFS) hazard rate (HR) of 0.36 with the addition of the mTOR inhibitor everolimus to exemestane in patients with ER-positive advanced disease. Unfortunately, the toxicity of this agent, particularly mucositis, somewhat dulled our collective enthusiasm.
Breast Cancer Action is a national grassroots organization whose mission is to achieve health justice for all women at risk of and living with breast cancer. Our members below signed the following statement for the EPA's consideration before releasing the official version of the EPA's Assessment of the Potential Impacts of Hydraulic Fracturing for Oil and Gas on Drinking Water Resources:
Susan Zager's insight:
It only takes a moment to fill this out and tell the EPA to stop protecting the fracking industry and start protecting our public health.
(HealthDay News) —Needles beat pills for treating hot flashes in breast cancer survivors, according to a new trial that compared acupuncture, "sham" acupuncture, the medication gabapentin and a placebo pill.
"Many women with early-stage breast cancer can skip chemotherapy without hurting their odds of beating the disease — good news from a major study that shows the value of a gene-activity test to gauge each patient's risk.
The test accurately identified a group of women whose cancers are so likely to respond to hormone-blocking drugs that adding chemo would do little if any good while exposing them to side effects and other health risks. In the study, women who skipped chemo based on the test had less than a 1 percent chance of cancer recurring far away, such as the liver or lungs, within the next five years.
"You can't do better than that," said the study leader, Dr. Joseph Sparano of Montefiore Medical Center in New York.
An independent expert, Dr. Clifford Hudis of New York's Memorial Sloan Kettering Cancer Center, agreed.
"There is really no chance that chemotherapy could make that number better," he said. Using the gene test "lets us focus our chemotherapy more on the higher risk patients who do benefit" and spare others the ordeal.
The study was sponsored by the National Cancer Institute. Results were published online Monday by the New England Journal of Medicine and discussed at the European Cancer Congress in Vienna."
"Women diagnosed with ductal carcinoma in situ (DCIS) have been choosing mastectomy and even bilateral mastectomy more in recent years, but some of their decision-making may be based on risk estimates for local recurrence that are out of date. That was the conclusion of a retrospective study from researchers at Memorial Sloan Kettering Cancer Center scheduled to be reported here tomorrow at the Breast Cancer Symposium, which showed that patients with DCIS who were treated between 1999 and 2010 had a 40 percent lower risk of cancer recurrence than those treated in an earlier period, between 1978 and 1998.
Specifically, five-year recurrence rates fell from 13.6 to 6.6 percent over the course of these two periods.
Senior author Kimberly J. Van Zee, MD, Attending Surgeon in the Breast Service and Professor of Surgery at Weill Medical College of Cornell University, and colleagues evaluated a prospectively maintained database of 2,996 women who underwent lumpectomy at Memorial Sloan Kettering between 1978 and 2010."
"Recent news headlines have suggested that women with the earliest form of breast cancer should rethink undergoing treatment because it may not impact their long-term survival. But breast cancer experts interviewed for this article say the study results that spurred those headlines should not be interpreted as a message to forego or change standard treatment.
In the observational study, available online ahead of print in JAMA Oncology (doi:10.1001/jamaoncol.2015.2510), scientists at the Women's College Research Institute in Toronto analyzed data from the National Cancer Institute's Surveillance, Epidemiology, and End Results database, which included information on 108,196 women with ductal carcinoma in situ (DCIS) who were followed for 20 years.
DCIS is the presence of abnormal cells inside a milk duct in the breast, the earliest form of breast cancer, sometimes called Stage 0. The lead study author, Steven A. Narod, MD, Senior Scientist and Director of the Familial Breast Cancer Research Unit, explained in an interview that DCIS is usually discovered during a mammogram, and that three standard treatment courses are typically available: lumpectomy, lumpectomy with radiation, or mastectomy. Sometimes medication is also prescribed. All the women in the study had received some type of treatment, he said.
Narod is also Professor in the Dalla Lana School of Public Health and the Department of Medicine at the University of Toronto, as well as a Tier 1 Canada Research Chair in Breast Cancer. ".
Susan Zager's insight:
Great insight into understanding issues related to DCIS thanks to Dr. Don Dizon, Dr. Deanna Attai, JENNIFER LITTON, MD and others.
For many people diagnosed with cancer localized to the breast, prostate, or another organ, the outlook after treatment is really quite good. Still, most require follow-up testing because there remains a risk of the cancer recurring, particularly in the first five years after a tumor is removed. Catching recurrence at an early, treatable stage can…
"The inhibition of CDK 4/6 and PD-1 represent two of the most exciting developments in the field of metastatic breast cancer. Following an accelerated approval in February 2015, the CDK4/6 inhibitor palbociclib (Ibrance) has continued to make headlines as an exciting new agent for patients with HR-positive metastatic breast cancer. Additionally, PD-1 and PD-L1 inhibitors have shown early signs of promise for patients with metastatic triple-negative breast cancer (TNBC).
The phase II PALOMA-1 trial,1 which was the basis for the approval of palbociclib, found that the novel CDK 4/6 inhibitor in combination with letrozole (Femara) reduced the risk of disease progression by 51% compared with letrozole alone. The median progression-free survival (PFS) with palbociclib was 20.2 versus 10.2 months for letrozole alone (HR, 0.488; P = .0004).
At the 2015 ASCO Annual Meeting, the PALOMA-3 trial found that palbociclib plus fulvestrant (Faslodex) improved PFS compared with fulvestrant alone in women with HR-positive, HER2-negative metastatic breast cancer following progression on prior endocrine therapy.2 At the time of the interim analysis, the median PFS was 9.2 months for palbociclib plus fulvestrant and 3.8 months for placebo plus fulvestrant (HR, 0.422; 95% CI, 0.318-0.560; P <.0001).
In addition to this now FDA-approved approach, two early phase clinical trials have shown potential for PD-1/PD-L1 inhibition in pretreated patients with TNBC. In the KEYNOTE-012 trial,3 pembrolizumab demonstrated an overall response rate (ORR) of 18.5%. In a similar patient population, the PD-L1 inhibitor atezolizumab showed an ORR of 19%.4 Larger trials are now looking to confirm these findings.
Share In a nutshell The authors aimed to determine whether psychological therapy could relieve patients with fatigue (extreme tiredness) who are undergoing breast cancer radiation (uses high energy radiation to kill cancer cells by damaging their...
UC Davis researchers are harnessing the power of dogs’ innate sense of smell to detect cancer, especially at early stages of the disease. The team are training two puppies, each about 4 months old —Alfie, a Labradoodle and Charlie, a German Shepherd — who are undergoing a rigorous 12-month training program to develop their abilities to detect the scent of cancer in samples of saliva, breath and urine.
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