"TAIPEI--Taiwan-based OBI Pharma (浩鼎生技) announced Monday that its phase 2/3 stage clinical trial for a therapy for metastatic breast cancer, designated OBI-822, has met the goal of collecting 342 patients.
OBI Pharma Chairman Michael N. Chang (張念慈) said that the OBI-822 project has progressed more smoothly than expected, and the completion of the collection was a major milestone.
The company will analyze the data after the last patient completes the treatment process.
According to OBI Pharma General Manager Amy Huang (黃秀美), breast cancer is the most common form of cancer among women and the biggest killer of women's health.
The five-year survival rate for metastatic breast cancer is only 24.3 percent, Huang said, stressing that developing this first-class immunotherapy can hopefully satisfy this unmet medical need.
Susan Zager's insight:
According Huang, " the concept behind OBI-822, is to use the human body's immune system to fight cancer with few side effects, unlike chemotherapy and radiation therapy that harm good cells as well as cancerous cells."
(HealthDay)—Researchers have identified genes that may help predict whether a patient with estrogen receptor (ER)-positive breast cancer is likely to benefit from tamoxifen therapy, according to a study published in the July 15 issue of Cancer Research.
Hendrika M. Oosterkamp, M.D., of The Netherlands Cancer Institute in Amsterdam, and colleagues conducted a large-scale loss-of-function genetic screen in ZR-75-1 luminal breast cancer cells to identify candidate genes for tamoxifen resistance.
The researchers found that loss of function in the deubiquitinase USP9X prevented proliferation arrest by tamoxifen, but not by the ER downregulator fulvestrant. RNAi-mediated attenuation of USP9X stabilized ERα on chromatin in the presence of tamoxifen, and this caused a global activation of ERα-responsive genes driven by tamoxifen. A gene signature defined by differential expression after USP9X attenuation in the presence of tamoxifen was used to identify patients with ERα-positive breast cancer experiencing a poor outcome after adjuvant therapy with tamoxifen. Correlation of the gene signature with survival was not observed in patients with breast cancer who did not receive endocrine therapy.
"Overall, our findings identify a gene signature as a candidate biomarker of response to tamoxifen in breast cancer," the authors write.
"LBBC designed this conference so that participants can easily access information that is relevant to their specific situation," says LBBC CEO Jean Sachs, MSS, MLSP. "Our attendees can follow one of our breast-cancer-specific tracks or they can attend sessions on topics of their choosing. These will include workshops and discussion groups for young women, women at high risk for developing breast cancer, and healthcare providers seeking to better understand the psychosocial needs of people impacted by the disease."
"The conference design recognizes a trend we have been seeing in individuals wanting specific information about their diagnoses and treatments," says Catherine Ormerod, MSS, MLSP, LBBC's vice president of programs and partnerships. "At the same time, they also want to network with others and share the experiences that are common to all attendees."
The day will therefore feature social time for attendees, and a closing general session that will bring conference goers together for an interactive conversation with Weiss and Borges. The two will explore quality of life issues across the breast cancer spectrum during "Thriving! A Discussion on Living Well: Body, Mind and Soul."
Complete conference details including how to register, travel grant and fee waiver eligibility, general session and breakout session descriptions and information on the conference's speakers are available at lbbc.org/fallconference or by calling (855) 807-6386.
Transcripts, video and MP3 podcasts of select presentations will also be available online following the conference.
Tell Secretary Sebelius to adopt a legislation requiring insurance companies to provide coverage for BRCA gene mutation testing.
Mutation of the BRCA1 and BRCA2 genes have been linked to the development of hereditary breast and ovarian cancer. According to the National Cancer Institute, about 12% of women in the general population will develop breast cancer sometime during their lives, compared with about 60% of women who have inherited a harmful mutation in BRCA1 or BRCA2 genes. Genetic testing can reveal an inherited BRCA1 or BRCA2 mutation.
Although insurance companies often cover genetic testing, coverage is not guaranteed. Take action today - urge Secretary of the Department of Health and Human Services Kathleen Sebelius to adopt legislation requiring insurance companies to cover genetic counseling and testing for the BRAC1 and BRAC2 mutations upon medical recommendation."
Susan Zager's insight:
All women who have a risk of carrying a BRCA gene mutation have a right to testing covered by insurance. SIGN today-IT's easy and pre-written.
Women with early-stage breast cancer may now receive a one-dose radiation treatment at the same time as lumpectomy surgery, eliminating the need to return to the hospital daily for up to six weeks for post surgical radiation treatments. The relatively new treatment option, intraoperative radiation therapy (IORT), delivers one precise, concentrated dose of radiation to the tumor site immediately following surgical removal of the cancer.
Susan Zager's insight:
It will be interesting to see if this is done more in the US. Cutting down radiation time (up to 6 weeks) and doing the treatment at the same time (IORT) as the lumpectomy surgery will be welcomed if the treatment is just as effective as standard radiation.
"Among the seven billion people on planet Earth, one-half million die prematurely every year because of breast cancer. It is one of the most common cancers to affect women and in 2008 almost 1.4 million women were diagnosed. At the current rate of growth, one prediction has this number climbing another 50 percent – to 2.1 million by 2030.
Global breast cancer survival rates vary greatly, from below 40 percent in low-income countries to more than 80 percent in Sweden, Japan and North America. However no matter where people are, experts say survival rates could exceed 90 percent with the introduction of widespread, better and earlier detection. Indeed, the lower rates of survival in lesser-developed countries are attributed almost entirely to a lack of early detection programs. With women presenting jn later-stages of the disease and a general lack of adequate diagnostic centers, experts contend that survival rates are much lower than they need to be.
A new test from EventusDx, an Israeli life sciences company, aims to assist. With the recent completion of an eight-year project, the company now produces and distributes a relatively simple blood test that detects cancer. Although the company insists that its Octava Pink analysis should be used only as an adjunct to traditional mammographies, it nevertheless holds the potential to circumvent expensive and not-always-accessible mammograms. The lower cost and portability of the Octava Pink test could make breast cancer assessments available to untold numbers of people currently without access. Octava Pink is now available in Israel and Italy and currently under review by the U.S. Food and Drug Administration."
Susan Zager's insight:
This looks very promising and will be interesting to follow and see if this gets approval in other countries besides Israel and Italy. The FDA is currently reviewing Octava Pink.
"Scientists at the Penn State College of Medicine have discovered that a virus that is harmless to humans will kill triple-negative breast cancer cells and tumour cells in mice when applied to cancers.
Breast cancer is the leading cause of cancer death in women in the world, and triple-negative breast cancer is the hardest type of breast cancer to treat.
Some types of tumours contain protein receptors that are activated by one of three proteins – namely the human epidermal growth factor receptor 2 (HER2), the hormone oestrogen or the hormone progesterone.
Chemotherapies usually target one of these three receptors, but since triple-negative cancers do not express these genes, doctors have to treat them with a combination of therapies.
"Treatment of breast cancer remains difficult because there are multiple signalling pathways that promote tumour growth and develop resistance to treatment," said Craig Meyers, a professor of Microbiology and Immunology at Penn State.
"There is an urgent and ongoing need for the development of novel therapies which efficiently target triple-negative breast cancers."
"The suppression of two genes reduces breast cancer tumor formation and spread by interfering with blood vessel formation and recruitment, according to new research from Houston Methodist, Weill Cornell Medical College and other institutions. The findings in the Proceedings of the National Academy of Sciences may help medical researchers identify effective drug targets for triple negative breast cancer (TNBC).
The genes, MLF2 (myeloid leukemia factor 2) and RPL39 (a ribosomal protein), were found to most profoundly affect the production of nitric oxide synthase, which helps regulate blood vessel behavior and could be crucial to the recruitment of new blood vessels to growing tumors. These genes influence the spread of TNBC throughout the body, and have not so far been linked with breast cancer.
"We have found two unique genes that may affect the most lethal type of breast cancer," said principal investigator and Houston Methodist Cancer Center Director Dr. Jenny Chang, who is also a professor of medicine at Weill Cornell Medical College. "Most importantly, by knowing how these genes function, we have drugs that can block nitric oxide signaling."
About 42,000 new cases of triple negative breast cancer are diagnosed in the United States each year, about 20 percent of all breast cancer diagnoses. Patients typically relapse within one to three years of being treated. TNBC is distinguished from other breast cancers in that it does not express the genes for estrogen receptors, progesterone receptors, and Her2/neu and is frequently harder to treat than other forms of the disease.
By suppressing close to 500 TNBC-related genes, Chang's group found interference was strongest with MLF2 and RPL39 in triple negative breast cancer model tissue. The scientists also learned that mutations in these genes in human patients were associated with worse survival in triple negative breast cancer patients."
Among patients with early-stage HER2-positive breast cancer, disease-free survival (DFS) at 4 years was no better with the combination of HER2-targeted agents, lapatinib and trastuzumab than with trastuzumab alone (Abstract LBA4). The long-awaited results from the phase III ALTTO trial were presented by Dr. Edith A. Perez at Sunday’s Plenary Session.
"Researchers have found that young women with breast cancer were able to better preserve their fertility during cancer treatments by using hormone-blocking drug injections that put them into temporary menopause. The results announced today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago are from the Prevention of Early Menopause Study (POEMS), a clinical trial sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (ASCO late breaking abstract #505). Women receiving the injections were only about one-third as likely to experience ovarian failure, a common long-term toxicity of chemotherapy treatments, and were more than twice as likely to have a normal pregnancy after their cancer treatment compared to women in the trial who did not receive the injections.
In POEMS, premenopausal women with hormone-receptor negative breast cancer ages 18 to 49 were randomly assigned to receive standard chemotherapy with or without goserelin every four weeks. Goserelin is a drug that disrupts the body’s hormonal feedback systems, resulting in reduced estrogen production, which puts the women into a chemical menopause. Under usual use, that chemical menopause is reversible; POEMS was carried out to see if the treatment allowed the women to recover fertility after cancer treatment while not interfering with the cancer treatment itself.
The researchers compared the ovarian failure rate of the women two years after entering the study and found that 22 percent of patients on the standard therapy had ovarian failure (15 of 69 patients) compared to 8 percent of those who also had goserelin treatment (5 of 66 patients). Of the 218 patients enrolled in the trial, 12 patients on the standard arm (11 percent) became pregnant vs 22 patients on the goserelin treatment arm (21 percent). "
"A joint analysis of two phase III trials involving a total of 4690 premenopausal women with hormone-receptor–positive (HR+) breast cancer demonstrated that adjuvant use of the aromatase inhibitor (AI), exemestane, reduced relative risk of developing subsequent invasive cancer by 28% compared with tamoxifen when both agents were combined with ovarian function suppression (OFS). The exemestane + OFS treatment arm also showed a relative reduction in risk of breast cancer recurrence of 34%. “The trials demonstrate that an aromatase inhibitor, previously recommended only for postmenopausal women is also effective for premenopausal women when combined with ovarian function suppression,” said Olivia Pagani, MD, of the Institute of Oncology of Southern Switzerland, who presented the combined results on behalf of the International Breast Cancer Study Group (IBCSG), June 1, 2014 at the 50th Annual Meeting of ASCO. “As a physician who routinely recommends ovarian function suppression as adjuvant therapy for some young patients, these results will change my practice. I will combine ovarian function suppression with an aromatase inhibitor rather than with tamoxifen.” “Tamoxifen, for at least 5 years, with the option of adding OFS has been the standard treatment,” Pagani said regarding premenopausal woman with HR+ breast cancer. Using adjuvant AIs for 5 years is a more effective treatment strategy than 5 years of tamoxifen in many postmenopausal women, according to Pagani; however, this AI treatment was not available to premenopausal women, because AIs require the low estrogen levels that occur after menopause, and these levels can only be achieved in young women with OFS. "
"Women with metastatic breast cancer to the bone may be able to receive bisphosphonates, the bone-targeting class of drugs like zoledronic acid, less often after the first year of monthly administration. With that practice change, women may also reduce their risk of serious side effects, according to a study led by researchers at The University of Texas MD Anderson Cancer Center. The research was presented at the American Society of Clinical Oncology 2014 Annual Meeting by MD Anderson's Gabriel Hortobagyi, MD, professor, Breast Medical Oncology. The study found that receiving zoledronic acid every 12 weeks after one year of monthly administration was as efficacious as continuing to receive it monthly.
Findings from the OPTIMIZE-2 study could have an impact not just in the setting of metastatic breast cancer, but other solid tumors, as well as multiple myeloma, where monthly intravenous bisphosphonates are used to prevent skeletal related events and the loss of bone mass.
According to the American Cancer Society, 232,670 women will be diagnosed with breast cancer in 2014 and 40,000 will die from the disease. The overwhelming majority of metastatic breast cancer patients will develop a bone metastasis at some point during their care, says Hortobagyi."
"A new study in East Asian women has identified three genetic changes linked to an increased risk of breast cancer. The research, led by Vanderbilt University investigators, was published online July 20 in Nature Genetics.
While breast cancer is one of the most common malignancies among women worldwide, most studies of the genetic risk factors for the disease have focused on women of European ancestry.
Given the differences in genetic heritage and environmental exposures between East Asian women and those of European ancestry, the investigators decided to conduct a study in East Asians to search for genetic changes that are linked to breast cancer development. The current study was conducted as part of the Asia Breast Cancer Consortium led by Wei Zheng, M.D., Ph.D., MPH, Ingram Professor of Cancer Research at Vanderbilt.
First author Qiuyin Cai, M.D., Ph.D., associate professor of Medicine, and colleagues performed a genome-wide association study of 22,780 women with breast cancer, and 24,181 control subjects who were recruited in 14 studies in Asian countries, including China, Japan, Korea, Malaysia and Singapore.
DNA for the gene assays was obtained through blood samples or buccal cells from mouthwash.
"We found DNA sequence changes in two genes, PRC1 and ZC3H11A, and a change near the ARRDC3 gene were associated with breast cancer risk and we identified a possible association with a fourth gene locus," said Cai. "Two of those sequence changes are in parts of the genome that regulate the expression of nearby genes."
"CHICAGO—Drs. Edith A. Perez and Martine Piccart-Gebhart shared the unenviable task of reporting final, negative results from the randomized, Phase III ALTTO trial, in presentations here at the American Society of Clinical Oncology Annual Meeting (Abstract LBA4).
The long-awaited results showed that adding lapatinib to adjuvant trastuzumab, either concurrently or sequentially, does not increase disease-free survival compared with use of trastuzumab alone in women with early-stage HER2-positive breast cancer.
At 4.5 years, the disease-free survival rate was 86 percent for the group receiving trastuzumab alone, 88 percent for those receiving concurrent treatment of the two drugs, and 87 percent for patients in the sequential-treatment arm.
Beyond the study's impact on the development of lapatinib, the report will have profound long-term implications on drug development and approval in this country, experts said. If the results had been positive, they would have validated the U.S. Food and Drug Administration's Accelerated Approval process, which is based on the assumption that pathological complete response (pCR) after neoadjuvant treatment would translate into an improvement in long-term disease-free survival.
"The summer solstice is finally here, which means to most of you that summer has arrived. But, to me, it means my son is 21-and-a-half. He, of course, was born on the winter solstice. It's kind of fun to have these little extra things to celebrate in life.
Even though he is 21, he still reminded me about his birthday. It shows that tradition has value. He remembers the cupcakes and little celebrations we used to do. Oh, those good old, cancer-free days.
I have been appointed to the CDMRP in Washington, D.C., which is the Congressionally Directed Medical Research Program.
I will be required to attend three-day meetings with scientists, four times a year, to review proposals submitted by other scientists who are applying for funding for their breast cancer research studies."
Susan Zager's insight:
Noreen Frasier is doing so many exciting things and helping so many people. What a lovely article. She is such an inspiration and so accomplished. She will be a great addition to the CDMRP (Congressionally Directed Medical Research Program). For more information about Noreen and the Noreen Fraser Foundation got to: http://www.noreenfraserfoundation.org/.
"When Joan Lunden was diagnosed with triple negative breast cancer, or TNBC – a rare and aggressive form of the disease – the former Good Morning America co-host was initially "shell-shocked." But Lunden turned a corner quickly and is focusing on finding strength through the love and support of her family, fans and colleagues.
After finishing her second chemotherapy treatment on June 26, "she was expected to start losing her hair in the coming week," a close family friend tells PEOPLE. "So she took matters into her own hands and shaved her head. She wanted to do it on her own terms, and she looks stunning."
Lunden, 63, first revealed that she was battling breast cancer on June 24 during a sit-down with Robin Roberts on Good Morning America, where she spent 17 years as an anchor. "
Susan Zager's insight:
I think it's really great that Joan Lunden is being so open about her treatment and the details of her breast cancer being that she is triple negative.
"A test of tumor microenvironment of metastasis (TMEM) predicted risk of distant metastasis in estrogen receptor–positive and HER2-negative breast cancer, according to a new study. The test may help in guiding treatment decisions and in preventing overtreatment.
"Tests assessing metastatic risk can help doctors identify which patients should receive aggressive therapy and which patients should be spared," said lead and corresponding author Thomas Rohan, MD, PhD, professor and chair of Epidemiology & Population Health at Einstein and Montefiore. The study was led by researchers at the National Cancer Institute (NCI)─designated Albert Einstein Cancer Center of Albert Einstein College of Medicine of Yeshiva University and Montefiore Einstein Center for Cancer Care, in Bronx, New York. It was published in the Journal of the National Cancer Institute (2014; doi:10.1093/jnci/dju136).
To measure the effectiveness of the test, the researchers used it on about 500 breast tumor specimens that had been collected over a 20-year period. The test proved more accurate in predicting the risk of distant tumor spread than a test closely resembling the leading breast cancer prognostic indicator on the market."
"MedicalResearch.com: What are the main findings of the study?
Answer: Triple-negative breast cancer (TNBC) could be classified into 7 subtypes: basal-like 1 (BL1), basal-like 2 (BL2), immunomodulatory (IM), mesenchymal (M),mesenchymal stem-like (MSL), luminal androgen receptor (LAR), and unstable (UNS).
Using cluster analysis, Lehmann and Bauer et al. identified these TNBC subtypes in 21 public mRNA gene expression profiles of breast cancer. However, the clinical relevancy of these novel molecular subtypes has not been established. To establish the clinical relevancy, we determined if the subtypes of TNBC have different rates of pathological complete response (pCR) to standard neoadjuvant chemotherapy regimens. In this study, we confirmed that TNBC is heterogeneous and that pCR differs by TNBC subtype using the algorithm proposed by Lehmann and Bauer et al. The BL1 subtype had the highest pCR rate (52%), and BL2 and LAR had the lowest pCR rates (0% and 10%, respectively). TNBC subtype was an independent predictor of pCR status (P=0.022) via a likelihood ratio test. To our knowledge, this was the first study to show that the TNBC subtype can serve as an independent predictor of pCR status in patients who received standard chemotherapy regimens.
This confirms the possible clinical relevance of the 7 molecular subtypes, and these subtypes may lead to innovative clinical trials of personalized medicine for patients with TNBC."
Dr. Monica Morrow describes the dramatic changes that have transformed breast cancer care in the last 50 years, a period in which, “the landscape of breast cancer management across the spectrum . . . has changed so dramatically as to be virtually unrecognizable.” Her expert editorial is an overview of the major advances in risk assessment and prevention, surgery, radiation, and adjuvant systemic therapy that have resulted in decreased mortality and morbidity among patients with breast cancer.
"One in four young Australian women diagnosed with non-metastatic cancer will see their cancer spread within five years, researchers say. Their retrospective study of nearly all NSW women diagnosed with localised or regional breast cancer between 2001 and 2007 showed those under 40 had an almost threefold greater five-year risk of progressing to metastatic disease. However once metastatic breast cancer had been diagnosed, overall survival for younger and older women was similar (18 vs 14 months), the authors from the University of Sydney found."
"After eight years of painstaking research, Israeli life-sciences company Eventus Diagnostics (EventusDx) has produced a blood test for the early detection of breast cancer.
The Octava Pink test is now available in Israel and Italy, and is undergoing clinical trials to receive US Food and Drug Administration approval.
This is the first blood test ever that can reveal cancer, not merely markers that might indicate cancer or something else. Its innovation also lies in its examination of antibodies in the blood to pinpoint this specific cancer.
Molecular biologist Galit Yahalom — who heads the research team at the EventusDx offices and lab, located in Moshav Ora outside of Jerusalem – explains the breakthrough to ISRAEL21c.
“For the last decade, we have known that there is a connection between cancer and the immune system,” says Yahalom, a 43-year-old mother of two from Modi’in who has been working on this project since its inception.
“We know that it recognizes cancer as an external enemy that must be destroyed. It is possible that each of us has had instances of cancer we were unaware of, because our immune systems killed it when it was still very small. For whatever reason, the immune system of people with cancer is not functioning properly.”