Gulley and colleagues enrolled 26 patients and assigned them to monthly vaccinations with the PANVAC vaccine, which contains transgenes for MUC-1, CEA and three T cell costimulatory molecules.

These patients were already heavily pretreated, with 21 of them receiving at least three prior chemotherapy regimens.

Among the 12 patients with breast cancer, median time to progression was 2.5 months and median overall survival was 13.7 months. Four patients had stable disease.

For the 14 patients with ovarian cancer, median time to progression was two months and median overall survival was 15 months.

Following treatment, mild injection-site reactions were the most common side effect.

According to Gulley, interest in cancer vaccines is increasing and more study is needed to determine which vaccines will benefit which patients. “The sustained benefit seen in some patients in this study underscores the potential for therapeutic vaccines to impact clinical outcomes without toxicity,” he said. “However, more studies in the appropriate patient populations are required to adequately assess efficacy.”

The study was funded by the National Cancer Institute.

Provided by American Association for Cancer Research

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Led by CINJ epidemiologist Elisa Bandera, MD, PhD, a multidisciplinary team of investigators recently found detectable levels of these fungal compounds, known as mycoestrogens, in urine samples donated by girls participating in the Jersey Girl Study. The findings suggest that the presence of these mycoestrogens may delay height growth and the onset of breast development in young girls. The findings are scheduled to be published in the November 15 print edition of the journal Science of the Total Environment (doi:10.1016/j.scitotenv.2011.09.029).

Mycoestrogens are produced by fungi that are present in grains through contamination. They are also present in such foods as meat, eggs and dairy through contaminated animal feed or deliberate introduction of the synthetic mycoestrogen zeranol into livestock for the purpose of improved meat production. Zeranol is a non-steroid agent approved the by U.S. Food and Drug Administration to promote animal growth in beef production, but is banned for such use in the European Union and other countries.

The investigators measured zearalenone mycoestrogens and zeranol in the urine of 163 girls participating in the Jersey Girl Study and found detectable levels in 78 percent of the girls. More specifically, high levels of zearalenone mycoestrogens were found in 55 percent of the samples, while low levels of zeranol were found in more than 20 percent of the samples. Researchers also evaluated food sources for these mycoestrogens, and found that beef and popcorn intakes were strong predictors of detectable levels in urine. When researchers evaluated the association with growth and development, they found that girls with detectable urinary mycoestrogen levels tended to be shorter and less likely to have reached the onset of breast development.

“Because zearalenone mycoestrogens are widely distributed in the food supply, it is critical that we have a better understanding of their levels, their food sources and their effects on the development of young girls, which ultimately has important implications for their future breast cancer risk.” said Dr. Bandera, who is the lead author of the research and an associate professor of epidemiology at UMDNJ-Robert Wood Johnson Medical School. “To our knowledge this is the first study evaluating mycoestrogens in healthy girls. More studies are needed in this very important research area. This is just the beginning.”

In addition to researchers from CINJ, the Jersey Girl Study team includes experts in environmental health at the Environmental and Occupational Health Sciences Institute (EOHSI – jointly administered by UMDNJ-Robert Wood Johnson Medical School and Rutgers, The State University of New Jersey), pediatric endocrinology at UMDNJ-Robert Wood Johnson Medical School, and biostatistics at CINJ and UMDNJ-School of Public Health. Additional information about the Jersey Girl Study can be found at: http://cinjweb.umdnj.edu/jerseygirl.

Along with Bandera, the author team consists of Urmila Chandran, CINJ and UMDNJ-School of Public Health; Brian Buckley, CINJ and EOHSI; Yong Lin, CINJ and UMDNJ-School of Public Health; Sastry Isukapalli, EOHSI; Ian Marshall, UMDNJ-Robert Wood Johnson Medical School; Melony King, UMDNJ-School of Public Health; and Helmut Zarbl, CINJ and EOHSI.

The research was supported by CINJ, Komen Foundation Central and South Jersey Affiliate, the New Jersey Commission on Cancer Research, the National Institute of Environmental Health Sciences (P30ES005022), and the National Institutes of Health (K22CA138563).

About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey (www.cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center dedicated to improving the detection, treatment and care of patients with cancer, and serving as an education resource for cancer prevention. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. To make a tax-deductible gift to support CINJ, call 732-235-8614 or visit www.cinjfoundation.org. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School. Follow us on Facebook at www.facebook.com/TheCINJ.

The CINJ Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. System Partner: Meridian Health (Jersey Shore University Medical Center, Ocean Medical Center, Riverview Medical Center, Southern Ocean Medical Center, and Bayshore Community Hospital). Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Medical Center, Carol G. Simon Cancer Center at Overlook Medical Center, and Cooper University Hospital. Affiliate Hospitals: CentraState Healthcare System, JFK Medical Center, Mountainside Hospital, Robert Wood Johnson University Hospital Hamilton (CINJ Hamilton), Somerset Medical Center, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate

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The decision makes Blue Shield the largest insurer to stop coverage of Avastin. Three other regional insurers–Regence Blue Cross Blue Shield, Excellus, and Dakotacare–have already stopped covering Avastin for breast cancer, reports MedPageToday.

A federal advisory committee unanimously recommended in June that the Food and Drug Administration (FDA) rescind the drug’s approval as a treatment for breast cancer based on two studies showing it wasn’t effective and its risks outweighed benefits, according to the Dow Jones Newswires. The FDA hasn’t yet decided whether to continue Avastin’s approval and there’s no timeframe set for when that decision will be made.

Regardless of the FDA’s decision, Medicare said it will continue to pay for Avastin when it’s used to treat metastatic breast cancer

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The 1200.89 study is investigating the efficacy and safety of afatinib* for the treatment of patients with erbB2 (HER2)-overexpressing inflammatory breast cancer, one of the most aggressive forms of breast cancer.

The LUX-Breast 2 study, which started enrolling patients in May this year, is investigating the efficacy and safety of afatinib* in patients with erbB2 (HER2)-positive, metastatic breast cancer. The patients have progressed on currently available erbB2 (HER2) targeted treatments.

Afatinib* is also currently being investigated in a pivotal phase III clinical trial, called LUX-Breast 1. LUX-Breast 1 is a global trial in patients with metastatic erbB2 (HER2)-positive breast cancer after prior treatment with trastuzumab. The trial investigates whether treatment with afatinib* can extend the lives of these women before their cancer progresses (progression-free survival) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine. Both, the LUX-Breast 1 and study 1200.89 include thorough biomarker testing of tumour tissues.

Approximately 20-30% of women with breast cancer overexpress the erbB2 (HER2) receptor.2 This overexpression of the erbB2 (HER2) protein is associated with a more aggressive form of breast cancer and a greater risk of disease progression and death compared to women with erbB2 (HER2) negative tumours.3

“There is an urgent need for more treatment options for patients with aggressive erbB2 (HER2)-positive breast cancer. These studies are important because they will help us to further explore the potential of the novel compound afatinib to fill this gap in this difficult to treat group of patients”, said Professor Nadia Harbeck, Director of the Interdisciplinary Breast Centre, University Hospitals Cologne, Germany.

The initiation of these new studies represents yet another important milestone for Boehringer Ingelheim to broaden and further develop its oncology pipeline across a range of different cancers.

For more information:

About study 1200.75, LUX-Breast 1: Afatinib* in HER2-positive Metastatic Breast Cancer After One Prior Trastuzumab Treatment

http://clinicaltrials.gov/ct2/show/NCT01125566?term=LUX-Breast+1&rank=1

About study 1200.89: Afatinib* in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer

http://clinicaltrials.gov/ct2/show/NCT01325428?term=afatinib+1200.89&rank=1

If investigators are interested in becoming involved in the study and have potentially eligible patients, they should contact Boehringer Ingelheim at:
clintriage.rdg@boehringer-ingelheim.com

Notes to editors

About study LUX-Breast 1 (1200.75): Afatinib* in HER2-positive Metastatic Breast Cancer After One Prior Trastuzumab Treatment

http://clinicaltrials.gov/ct2/show/NCT01125566?term=LUX-Breast+1&rank=1

LUX-Breast 1 is an open-label, randomised phase III trial to investigate the efficacy and safety of oral afatinib* plus vinorelbine compared to trastuzumab plus vinorelbine in patients with metastatic erbB2 (HER2)-positive breast cancer who received one prior treatment with trastuzumab. The primary endpoint of this study is progression-free survival (PFS), defined as the time from the date of randomisation to the date of disease progression, or to the date of death. Secondary endpoints include best RECIST assessment during each treatment period, overall survival (OS), tumour shrinkage, time to deterioration, health-related quality of life and safety.

Inclusion criteria are as follows:

Histologically confirmed diagnosis of erbB2 (HER2)-overexpression breast cancer
Stage IV metastatic disease
Must have progressed on one prior trastuzumab treatment
No more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
Must have (archived) tumour tissue sample available for central re-assessment of erbB2 (HER2)-status

About study LUX-Breast 2 (1200.98): Afatinib* in HER2-Treatment Failures

http://clinicaltrials.gov/ct2/show/NCT01271725?term=afatinib+1200.98&rank=1

This non-randomised, open label study started in May 2011 and will recruit approximately 120 patients. The primary endpoint of the study is objective response. Secondary endpoints include best overall response (OR) during each treatment period, duration of OR, PFS and safety.

Inclusion criteria are as follows:

Female patients >18 years with proven diagnosis of erbB2 (HER2)-overexpressing, histologically confirmed breast cancer
Stage IV metastatic disease
At least one measurable lesion according to RECIST 1.1. Skin, bone and brain lesions are considered non-target lesions
Must have failed or progressed on either trastuzumab or lapatanib or trastuzumab and lapatanib treatment in the neoadjuvant and/or adjuvant setting

About study 1200.89: Afatinib* in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer

http://clinicaltrials.gov/ct2/show/NCT01325428?term=afatinib+1200.89&rank=1

This non-randomised, open label study is now open for recruitment of about 40 patients. The primary endpoint of the study is clinical benefit assessed by complete response, partial response and stable disease for at least 6 months. Secondary endpoints include overall response (OR), duration of OR, PFS and safety.

Inclusion criteria are as follows:

Female patients >18 years with proven diagnosis of erbB2 (HER2)-overexpressing, histologically confirmed breast cancer
Locally advanced or metastatic disease
Must have disease that can be evaluated according to RECIST 1.1
For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
Investigator-confirmed diagnosis of Inflammatory Breast Cancer
Must have biopsiable disease

Advancing Boehringer Ingelheim’s oncology pipeline:

In addition to breast cancer, afatinib* is also being investigated for non-small cell lung cancer (NSCLC) in phase III clinical trials, the most common type of cancer4. In the LUX-Lung clinical trial programme, one of the pivotal trials, LUX-Lung 3, evaluates the efficacy and safety of afatinib* compared to standard chemotherapy (cisplatin/pemetrexed) as a potential first-line treatment of patients with locally advanced or metastatic NSCLC with ErbB1(EGFR) mutations.

Afatinib* is just one of Boehringer Ingelheim’s most advanced oncology pipeline compounds. Another compound in Phase III development is BIBF 1120*, which is being investigated in NSCLC and ovarian cancer.

About Metastatic Breast Cancer

Metastatic breast cancer refers to the stage of the disease when cancer cells have broken away from the primary breast cancer site and spread to other parts of the body via the bloodstream or lymphatic system. Breast cancer is the most frequently diagnosed cancer and is the leading cause of cancer deaths among women worldwide, resulting in more than 450,000 deaths per year.5 Whilst mortality rates from breast cancer have decreased steadily in recent years thanks to advances in both early detection and adjuvant treatment, metastatic breast cancer still has a poor prognosis with a 5-year relative survival rate of about 23%.6

About Boehringer Ingelheim in Oncology

Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim is committed to discovering and developing novel cancer treatments. This commitment is underpinned by using advances in science to develop a range of targeted therapies in areas of medical need, including various solid tumours and haematological cancers.

The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Afatinib* is currently in phase III clinical development in NSCLC. The LUME-Lung 1 phase III clinical trial is investigating BIBF 1120* in combination with standard second-line chemotherapy for patients with advanced NSCLC. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1 (Plk1), volasertib*, a protein that is involved in the processes of cell division.

More than 400 employees around the world are dedicated to the discovery and development of new cancer treatments: 200 highly skilled and motivated scientists in Vienna, Austria at the dedicated, state-of-the-art Boehringer Ingelheim cancer research centre and more than 200 across the globe associated with oncology research and development.

Boehringer Ingelheim is committed to the clinical development of pioneering treatments for cancer through an extensive and diverse global study programme involving investigators and patients from around the world. This is supported by a significant financial investment from Boehringer Ingelheim, with the aim of developing treatments, which will make a difference to the lives of patients and their families. Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to the disease area.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion Euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

* Afatinib, BIBF 1120 and volasertib are investigational compounds. Their safety and efficacy have not yet been fully established

References

1 BI data on file

2 Penault-Llorca F et al. (2005) ‘Incidence and implications of HER2 and hormonal receptor overexpression in newly diagnosed metastatic breast cancer (MBC) Journal of Clinical Oncology vol.23 S69

3 Slamon D et al. (1987) ‘Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene’, Science, vol. 235, pp. 177-87

4 Metro G and Crinò (2011) ‘The LUX-Lung clinical trial program of afatinib for non-small-cell lung cancer.’ Expert Rev Anticancer Ther. vol.11 S673

5 Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; EPub Ahead of print.

6 Howlader N et al. SEER Cancer Statistics Review, 1975-2008, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2008/, based on November 2010 SEER data submission, posted to the SEER web site, 2011.

CONTACTS :
Boehringer Ingelheim
Corporate / Global Media Contact
Corporate Communications
Media + PR
Dr. Christina Janista
55216 Ingelheim/Germany
Phone: +49 6132 – 77 93640
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com or www.thewhiteroom.info/lux-breast

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Targeted Therapies in Breast Cancer - Oxford American Pocket Notes

The development of monoclonal antibodies and other inhibitors of specific molecules, fully utilizing the insights learned from molecular techniques such as comparative microarrays and protein expression patterns, has led to the development and FDA approval of several agents for the treatment of breast cancer, such as trastuzamab (Herceptin, targeting HER-2 positive tumors) and lapatinib (Tykerb, targeting tumors with mutated/overexpressed EGFR 1 and 2). Other agents specifically targeting the estrogen receptor, the aromatose pathway and microtubule dynamics, fulvestrant (Faslodex, targeting the ER specifically in breast cancer cells), and letrozole (Femara, targeting the aromatose pathway), raloxifene (Evista, a selective estrogen receptor modulator), ixabepilone (Ixempra, a ?-tubulin inhibitor) have also been approved for various stages and specific settings in breast cancer treatment. The current challenges in the field include further targeting of these agents as part of specific strategies for each patient (biomarker testing, pharmacogenetics, etc.), as well as follow-up and management of adverse events.
Part of the Oxford American Pocket Notes series, this volume provides clinicians with the ultra-concise, evidence-based, current information and insight on implementing the latest treatment strategies, including targeted agents, into clinical practice. This portable volume is intended to provide quick, easily accessible guidance for the practicing oncologist, oncology care staff (including nurses and PAs) as well as the primary care practitioner, on the mechanism of action, dosing and administration and adverse effects of the approved targeted agents.

About the Author
Harold J. Burstein, MD, PhD
Associate Professor of Medicine
Dana Farber Cancer Institute
Breast Oncology Center
Harvard Medical School
Boston, MA

Paperback: 64 pages
Publisher: Oxford University Press, USA; 1 edition (August 17, 2011)
Language: English
ISBN-10: 0199735670
ISBN-13: 978-0199735679
Targeted Therapies in Breast Cancer (Oxford American Pocket Notes)