In this issue of The Leading Edge newsletter, we've highlighted new topics to give you the latest news on leading-edge research and therapies that SCCA physicians are offering.
FES PET – It’s the new wave of advanced imaging technology
After more than 10 years of effort, SCCA and University of Washington physicians now have FDA approval for an imaging protocol that uses a radio-labeled estradiol tracer called 18F-fluroestradiol (FES) in a PET scan. Read more about this exciting research.
Outcomes Research a new focus at SCCA Prostate Cancer Center
Dr. Bruce Dalkin joined SCCA in 2008 bringing with him eight years of outcomes study experience. Prospective quality-of-life studies before and after prostate cancer surgery reveals how good techniques and physicians really are regarding quality of life after treatment.
New T-cell lymphoma project at SCCA
A collaborative effort between basic research and clinical science at SCCA will provide peripheral and cutaneous T-cell lymphoma patients with a growing number of clinical trials. Read more about this project and other Study News.
First-line treatment of extensive stage small-cell lung cancer
SCCA’s Dr. Laurie Carr evaluates the latest treatment advances for first-line therapies for this disease.
Representing more than 10 years of effort, Drs. David Mankoff and Hannah Linden from Seattle Cancer Care Alliance, and University of Washington radio-chemists Drs. Jeanne Link and Ken Krohn now have FDA approval for an imaging protocol that uses a radio-labeled estradiol tracer called 18F-fluoroestradiol (FES) in a PET scan.
Where clinically used PET scans traditionally use a radio-labeled sugar tracer called 18F -fluorodeoxyglucose (FDG) that indicates tumor activity, this experimental tracer is one of the first of its kind to study the presence of a specific target for breast cancer therapy, in this case estrogen receptors in breast cancer tumors.
“The idea is that these FES PET images can tell us how a tumor is built,” says Dr. David Mankoff, UW professor of radiology and nuclear medicine specialist at SCCA. “Breast cancers with estrogen receptors behave differently and respond differently to specific therapies than those without.”
PET imaging will never replace the biopsy for primary breast cancers, but where it will really count is in metastatic disease where tumors have recurred or spread and are in hard-to-biopsy locations, like the bone, or are too numerous to biopsy.
This observational study is sponsored by the National Cancer Institute and is called A Phase 2 Study of [18F]fluoroestradiol (FES) as a marker of hormone sensitivity of metastatic breast cancer” (IRB# 6590) . It is open to patients who have had treatment for a primary cancer, including surgery, but now have a recurrence that has spread outside the breast and lymph nodes and is yet untreated. These patients will have tumors that were estrogen receptor positive originally and may have completed chemotherapy and endocrine therapy for their primary cancer, but have not been previously treated for metastatic breast cancer.
For this study, patients will have a clinical FDG PET and experimental FES PET imaging before they begin treatment for their metastatic disease and then they will be imaged again with clinical FDG PET and other clinical scans (such as bone scan, CT scan or MRI) six months later to see the response of their treatment.
“It’s important that the patient’s physician decides to use endocrine therapy to treat the metastasis before entering this study,” Mankoff says. “We are not using FES PET to direct treatment in this early trial; imaging is purely observational. If we show that FES PET predicts response, there will be impetus for further study to use imaging in making treatment decisions.”
This new trial comes from a retrospective study conducted at the University of Washington and recently published in the Journal of Clinical Oncology that looked at advanced metastatic cancer data for patients who may have failed other endocrine therapies (salvage endocrine therapy) to show that FES PET predicted outcomes. Many patients from the Seattle Cancer Care Alliance Network Member hospitals participated in this study.
“We now have authority to do a prospective observational study,” Mankoff says. “We’ve designed this study so the next trial will help make treatment recommendations.”
Study participant requirements:
- • Biopsied metastatic disease
- SCCA access to biopsy material for staining
- One site of disease outside bone and liver that is measurable by RECIST criteria
- Able to tolerate PET scan
- Planned endocrine therapy
Patients will receive treatment with their oncologist and only need to come to SCCA/UWMC for the FDG PET and FES PET scans and two blood tests to check hormone levels.
To inquire about enrolling your patients into this study, please contact study coordinator Erin Schubert at email@example.com or (206) 288-6966.
Other PET Imaging Trials
Other PET imaging studies open to breast cancer patients include:
- "Positron Emission Tomography (PET) for Evaluation of Breast Cancer Metastases to Bone with F18 Fluoride" (IRB# 6337): a fluoride PET imaging study to evaluate treatment response for breast cancer bone metastasis. Funded with a grant from the National Institutes of Health, patients currently in treatment for bone dominant breast cancer can participate in this study, however, must be about to change to a new treatment or have just begun a new treatment regimen.
- "DCE-MRI and FDG PET with Kinetic Analysis to Monitor Breast Cancer Response to Neoadjuvant Sunitinib and Metronomic Chemotherapy" ( IRB #6489)- a combination trial for locally advanced breast cancers that combines PET and MRI to evaluate treatment response with a treatment study "A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Malate in Combination with Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer" ( IRB# 6488) using chemotherapy and antiangiogenic therapy
To inquire about enrolling your patients into these studies, please contact study coordinator Erin Schubert at firstname.lastname@example.org or (206) 288-6966.
Urologic Oncologist Looks at Outcomes Research
Bruce Dalkin is a urologic oncologist interested in health-related quality-of-life outcomes research.
“Eight years ago I decided that I wanted to more accurately learn about what happens to people after surgery for prostate cancer, find out how well I was doing for my patients, and then be able to tell future patients what to truly expect,” Dr. Dalkin says. Working as an associate professor of surgery at the University of Arizona at the time, he initiated a prospective quality-of-life survey study of his patients before and after surgery, and followed them for up to eight years. The surveys were completed anonymously by the participants, and the capture rate has been over 90 percent.
“The interview questionnaire looked at things like sexual and urinary health – big issues for men after this type of surgery,” he says. Two scientific journals have published the results of Dalkin’s research currently.
“We cheat at how we define success,” Dalkin says. “This study is an optimal way to find out if we really are doing OK.”
Fortunately for him and his colleagues, the answer was yes. His patients fare very well after surgery, according to the study results. However, if they had not, modifications to treatment and/or surgical approaches would have been examined and refined.
A well-designed study will help improve medical care and outcomes, according to Dalkin. He would like to see all prostate cancer physicians participate in this sort of study, to accurately define the true outcomes of surgery, radiation therapy, and medical oncologic treatments “to better educate men on expected outcomes, and our treatment impact,” he says.
“It is likely that not all physicians have equal outcomes, and if we can define the differences, then teach all to perform well, it would lead to more cost-effective outcome-based medicine, and better results for patients,” Dalkin says.
Coming to University of Washington Medical Center will provide Dalkin with a larger patient volume from which to continue his research. He hopes to utilize a similar study here and define outcomes over the next three to five years.
“Robotic surgery has not been shown to have any advantages to well done open surgery with regards to recovery, urinary continence, and sexual health,” Dalkin says. “There has been some recent concern about cancer control issues and robotic surgery. Also, there have not been any well-designed quality-of-life survey studies with robotic surgery to see if it’s any better than traditional techniques,” Dalkin says. “Seattle is the perfect city to look at all the different surgeons and surgical methods in a high quality study.”
A city-based assessment would be ideal to define how urology in general is doing for patients’ outcomes and quality of life.
Dalkin believes there have been few studies to date of this nature because “If you end up not being good, there’s a big problem, and it’s not good for patient referrals. But, our field needs to look beyond this concern, define what the problems are if they do exist, then define how to correct them if possible. This will eventually improve outcomes for all prostate cancer patients.”
Surveys in Dalkin’s study are completed anonymously by the patients and collected and tabulated by an independent third party.
“This is how quality-of-life outcomes research should be done,” Dalkin says. “We would all be better off, physicians and patients.”
Dr. Dalkin received his medical degree and residency training in general surgery and urology at Northwestern University in Chicago. He served as a urologic oncologist at the University of Arizona for 12 years, and the director of Urologic Oncology at the Arizona Cancer Center for seven years. He also worked in private practice in Tucson for six years prior to beginning his position at the University of Washington.
The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.
Read about important outcomes research at the Hutchinson Center that may benefit your patients.
Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.
Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.