Neal Meropol MD discusses FDA decision to remove Avastin for breast cancer treatment
The New York Times
As a medical student and later during my residency, I trained for some time in a medical center known for its research and clinical trials. Every week, patients with rare diseases and cancers that had not responded to standard therapy arrived from all over the country, eager to try something new, even if the efficacy of the treatments had not yet been proven.
But placed in the context of early-phase clinical cancer trials, unrealistic optimism results in a perfect ethical storm. “You have oncology, a field of medicine that is strongly evidence-based and research-intensive, and you have a population of patients who are experiencing an immediate threat to their lives,” said Dr. Neal J. Meropol, a researcher who has done extensive work on the ethics of early-phase cancer trials and chief of the division of hematology and oncology at University Hospitals Case Medical Center and Case Western Reserve University in Cleveland.
“Patients almost invariably take part in early-phase clinical trials because they believe they will personally benefit.”
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In a first-of-its-kind clinical trial, physician-scientists are exploring a new method to potentially prevent recurrence of an early stage, aggressive type of breast cancer.
The pilot study, conducted by Joe Baar, MD, Professor, Division of Hematology Oncology, Director of Breast Cancer Research at UH Case Medical Center’s Seidman Cancer Center, is recruiting patients with HER-2 neu+ breast cancer. “This study has the potential to change the standard of care for women with this type of breast cancer, which tends to spread very quickly,” says Dr. Baar, who is also Associate Professor of Medicine at Case Western Reserve University School of Medicine.
Read the full article :: Medical News Today
Life Technologies Corporation (Nasdaq: LIFE) announced it has received FDA 510(k) clearance for StemPro® MSC SFM a first for this next-generation stem cell culture medium that is now cleared as a medical device and satisfies a crucial requirement for researchers involved in clinical trials in the United States…”
An FDA-cleared, serum-free medium certainly provides a positive step toward moving away from mostly animal-based products for growing mesenchymal stem cells,” said Stanton L. Gerson, MD, Professor, Division of Hematology Oncology in the Department of Medicine, Director, University Hospitals Seidman Cancer Center and the National Center for Regenerative Medicine, at Case Western Reserve University, a pioneer in the use of adult stem cells to treat cancer and heart disease who is also part of a team conducting early phase clinical trials with MSCs to treat graft-versus-host disease and multiple sclerosis. “Growth media that is better defined can facilitate regulatory requirements. Ultimately, clinical trials will determine whether it benefits patients.”
Tuesday, March 08
In a first-of-its-kind clinical trial, physician-scientists at University Hospitals (UH) Case Medical Center are exploring a new method to potentially prevent recurrence of an early stage, aggressive type of breast cancer. The pilot study, conducted by Joe Baar, MD, Director of Breast Cancer Research at UH Case Medical Center’s Seidman Cancer Center, is recruiting patients with HER-2 neu+ breast cancer.
Patients with this form of breast cancer typically have a higher recurrence rate of nearly 25% following initial treatment. This novel study aims to improve outcomes through performing bone barrow biopsies to identify if patients’ cancer has spread and adding an additional cancer-targeting drug to standard therapy.
“This study has the potential to change the standard of care for women with this type of breast cancer, which tends to spread very quickly,” says Dr. Baar, who is also Associate Professor of Medicine at Case Western Reserve University School of Medicine. “A small number of HER-2 neu+ breast cancer patients do not do well following standard therapy. We are hoping to identify these high-risk patients and stop the cancer before it progresses to other parts of the body.”
Impact of Oncotype DX Test on Quality-Adjusted Life Expectancy & Costs in Patients with Stage II Colon Cancer
In an independent study led by co-author, Neal Meropol, University Hospital Seidman Cancer Center and Case Western Research University, results showed that clinical use of the Oncotype DX Recurrence Score to assess risk of recurrence in T3 stage II colon cancers with intact mismatch repair (MMR-P) is likely to improve quality-adjusted life expectancy and be cost-saving from a societal perspective. Patient age and adverse effects associated with chemotherapy are important considerations in adjuvant treatment decisions. The study, “Use of a multigene prognostic assay for selection of adjuvant chemotherapy in patients with stage II colon cancer: Impact on quality-adjusted life expectancy and costs” (N. J. Meropol et al, Abstract #491), will be presented in a poster on Saturday, January 22.
“Our data support the notion that use of a genomic test like the Recurrence Score Assay may potentially reduce chemotherapy use, improve quality adjusted survival, and save health care costs,” said Neal J. Meropol, M.D., Chief of the Division of Hematology and Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve University.
Impact of Oncotype DX Test on Quality-Adjusted Life Expectancy & Costs in Patients with Stage II Colon Cancer
In an independent study led by Neal Meropol, University Hospital Seidman Cancer Center and Case Western Research University results showed that clinical use of the Oncotype DX Recurrence Score to assess risk of recurrence in T3 stage II colon cancers with intact mismatch repair (MMR-P) is likely to improve quality-adjusted life expectancy and be cost-saving from a societal perspective. Patient age and adverse effects associated with chemotherapy are important considerations in adjuvant treatment decisions.
The study, “Use of a multigene prognostic assay for selection of adjuvant chemotherapy in patients with stage II colon cancer: Impact on quality-adjusted life expectancy and costs” (N. J. Meropol et al, Abstract #491), will be presented in a poster on Saturday, January 22.
“Our data support the notion that use of a genomic test like the Recurrence Score Assay may potentially reduce chemotherapy use, improve quality adjusted survival, and save health care costs,” said Neal J. Meropol, M.D., Chief of the Division of Hematology and Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve University.
UH Case Medical Center’s Dr. Joseph Baar explains his hopes for the Avastin, which the FDA will rule on for use in late stage breast cancer patients.
Jane and Lee Seidman Donate $42 Million to University Hospitals
Jane and Lee Seidman have donated $42 million to University Hospitals (UH) – the largest gift in the Cleveland-based health system’s history. In recognition of this unprecedented generosity, UH is naming the “Jane and Lee Seidman Cancer Center” in their honor.
UH’s new freestanding cancer hospital, the only in Northeast Ohio and one of 12 in the nation, is scheduled to open in spring 2011 on the UH Case Medical Center campus. Beginning today, the new hospital will be named the University Hospitals Seidman Cancer Center. In addition, the health system’s integrated network of nine outpatient cancer programs throughout the region will now be called University Hospitals Seidman Cancer Center.
UH Chief Executive Officer Thomas F. Zenty III made the historic announcement to more than 1,000 community leaders, UH physicians, employees, board members, benefactors and volunteers. “The Seidmans’ extraordinary gift to University Hospitals marks a pivotal moment in our history and their generosity will have a lasting legacy,” says Mr. Zenty. “Through their remarkable philanthropic spirit, Jane and Lee have demonstrated their passion for our cancer program and the entire Northeast Ohio community. We are additionally pleased to announce that their gift launches our $1 billion fundraising campaign that will build on the success of our new facilities and further strengthen University Hospitals’ unparalleled commitment to patient-centered care.”
Jane and Lee Seidman are lifelong philanthropists who have also been ardent supporters of University Hospitals and cancer care. “Jane and I have been fortunate with a successful business and that, coupled with the tradition of giving passed along to us by our parents, has provided us the inspiration to give back,” says Mr. Seidman. “Cancer has impacted many of our loved ones and we are overjoyed to make this gift that may lead to finding cures for cancer.”
Lee Seidman founded The Motorcars Group in 1958 and led the company to become one of the nation’s largest networks of auto dealerships. The Seidmans’ relationship with UH has been enduring — both were born at UH MacDonald Women’s Hospital– and The Motorcars Group has been a strong supporter of UH Rainbow Babies & Children’s Hospital through the Children’s Miracle Network. In 2008, they donated $1 million to UH Rainbow Babies & Children’s Hospital, establishing the Jane and Lee Seidman Chair in Pediatric Cancer Innovation.
“We are so pleased by Jane and Lee’s magnanimous support of Vision 2010 and our cancer hospital,” says Fred C. Rothstein, MD, President of UH Case Medical Center. “Their commitment to UH will change the face of cancer care for all of our patients today and into the future. We are extraordinarily proud that our cancer hospital, which will offer patients the most advanced treatments and technology in the country, will bear the Seidmans’ name.”
Lifelong Clevelanders, Mr. and Mrs. Seidman grew up in families with a strong charitable focus. As a teenager, the importance of supporting health care became significant to Jane when she joined her mother to help actor Danny Thomas raise money for what became St. Jude Children’s Research Hospital. After giving regularly to more than four dozen worthy causes, the couple recently began to narrow their focus to make a more significant impact by concentrating their philanthropic efforts on health care.
“From when we were children, our parents instilled in us the importance of giving back and advancing the mission of health care,” says Mrs. Seidman. “My mother was a hospital volunteer most of her life and Lee’s mother spent her evenings transcribing books into Braille while he did his homework. This gift is truly from our hearts. We really wanted to make an impact in our community and support UH’s outstanding cancer program as this magnificent new cancer hospital opens.”
The $260 million, 375,000-square-foot facility, with a capacity of 150 beds, will triple the square footage that cancer services currently encompass at UH Case Medical Center and will bring all facets of cancer care under one roof. The cancer hospital will be home to the latest treatment protocols and the most advanced imaging, therapeutic and information technologies. The patient-centered design features overnight accommodations for families, inpatient exercise areas, abundant natural light and a healing garden. Clinical care areas will focus on multidisciplinary cancer care, and the design also incorporates space for clinical trials, diagnostics, outpatient and inpatient treatment, surgery, patient education programs, radiation oncology, infusion therapy and teaching space.
“Jane and Lee’s inspirational gift to University Hospitals has created a lasting legacy in Northeast Ohio,” says Stan Gerson, MD, Director of the newly named UH Seidman Cancer Center. “UH has had a renowned cancer program dating back to our hospital’s earliest days and the Seidman Cancer Center will build upon that strong foundation to further establish our position as one of the premier cancer programs in the nation.”