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SCCA Network News, Issue 1 Winter 2008

In this issue:

FES PET – The next wave of advanced imaging technology

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.

PET scans traditionally use a radio-labeled sugar tracer called 18F -fluorodeoxyglucose (FDG) that indicates tumor activity. The experimental FES tracer, however, 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 eschuber@u.washington.edu 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. 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 Effi cacy 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 Infl amatory 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 eschuber@u.washington.edu or (206) 288-6966.

Early assessment of response to targeted breast cancer therapy

Positron Emission Tomography (PET) is a helpful tool to understand tumor response to therapy. In this study, Dr. Hannah Linden, medical oncologist from Seattle Cancer Care Alliance, will use PET scans after the first two weeks of targeted therapy to predict response to treatment in people with breast cancer.

Study Purpose

The purpose of this study is to determine whether or not a PET scan can be used instead of a biopsy to evaluate a patient’s response to cancer treatment after only two weeks of treatment. “The early changes seen by PET FDG and biopsy will be correlated with response to determine if the early changes predict response,” Dr. Linden says.

Eligible patients will be receiving cancer treatment outside of this research study. This study does not offer treatment for cancer, but will compare the changes seen on a PET scan to the changes seen in a biopsy specimen, both taken after two weeks of cancer treatment. If the PET scan and the biopsy results match up, this will indicate that a PET scan may be used instead of a biopsy to evaluate a patient’s response to treatment.

Eligibility Criteria

Women 18 years and older with a new diagnosis of the following:
Hormone receptor positive breast cancer with a treatment plan that includes neoadjuvant aromatase inhibitor and ovarian suppression (if premenopausal)

  • Recurrent and/or metastatic hormone receptor positive breast cancer with a treatment plan that includes an aromatase inhibitor and ovarian suppression (if premenopausal)
  • Neoadjuvant or metastatic HER-2/neu positive breast cancer with a treatment plan that involves administration of trastuzumab
  • Recurrent HER-2/neu positive breast cancer with a treatment plan that involves neoadjuvant administration of trastuzumab

The women in this study will have a tumor that can be biopsied (unless contraindicated by their clinician), and their disease can be evaluated for response to treatment. She must also be a candidate for PET imaging.

Study Details

A biopsy and PET scan are required for this study before the participant begins treatment for her cancer. The biopsy may have already been performed (or scheduled) by the participant’s doctor. The PET scan needs to be done at SCCA. These procedures provide baseline information about the participant’s cancer. Study procedures will take place SCCA, the University of Washington Medical Center, or Harborview Medical Center. If hospitalization is needed, participants will be admitted to either UW Medical Center or Harborview Medical Center. About two weeks after the start of cancer treatment, the participant will have another PET scan and another biopsy (if acceptable to the participant and her doctor) for this research study. Results of the biopsies and PET scans will be shared with participants and their doctors. The cost of the procedures is charged to the study. If the participant has hormone receptor-positive cancer, she will be asked to have blood drawn three times during this study: once before hormone treatment for the cancer, and at three and six months after the start of the treatment. The results of the blood tests are for research purposes only and will not be shared with the participant or the participant’s doctor.

This study will last for about six months, during which we will monitor the participant’s progress. For more information about this study please contact the study coordinator, Kara Kendall at (206) 667-4376 or to refer your patient for the study, please contact SCCA Patient Intake at (206) 288-SCCA (7222).

SCCA Physician Profile: Renato Martins, MD

Medical Oncologist

“Lung cancer kills more people than colon, breast, and prostate cancers combined,” says Dr. Renato Martins, medical director of Thoracic and Head and Neck Oncology at SCCA.

Martins is committed to advancing the standard of care for lung cancer patients through clinical research trials. “Education and sharing decision making and responsibility allow the patient, staff, and me to form a more effective partnership to find the right solutions to wellness.”

Studies conducted at SCCA and the SCCA Network sites are discussed and approved by a number of specialists who believe the research may represent an improvement on the current standard regimens.

Martins completed medical school at Federal University of Rio de Janeiro and fellowships in Hematology and Oncology at Massachusetts General, Harvard Medical School. He holds a Masters degree in Public Health from Harvard University.

Providence Alaska Medical Center

In Alaska, cancer is the leading cause of death, one of eight states with that distinction. According to the American Cancer Society, one in three Alaskans is diagnosed with cancer in their lifetime. Alaska’s small population and geographic isolation make cancer care especially challenging. While many treatments have been available in Alaska for years, patients often had to travel outside of the state to access some forms of treatment.

Other patients choose to leave Alaska for treatment believing that they could find better care outside the state. In an effort to improve cancer statistics in Alaska and to provide Alaskans with more options for cancer treatment here at home, Providence Alaska Medical Center opened the first comprehensive cancer center in Alaska in December 2007.

Emphasizing a team approach to cancer care, the center offers a complete and total healing environment.

The 45,000-square-foot center occupies three floors offering services and programs such as genetic counseling, appearance support, healing arts, integrative health services, and the BP Cancer Resource Center for community education accessible to the public.

Providence Alaska Medical Center has been a Member of the SCCA Network since January 2008.

Physician Profile: Jeanne Anderson, MD

Medical Director, Providence Cancer Center

Dr. Jeanne Anderson, medical director of Providence Cancer Center, sees patients with all types of cancers, and has special interest in breast cancer and hematologic malignancies. She oversees research nurses enrolling patients in clinical trials and is developing an interdisciplinary breast consultation clinic that is due to begin seeing patients in 2009. She is also involved with other Alaska medical oncologists to put through a state bill that would require insurance companies to pay for routine medical costs of cancer patients on clinical trials.

Anderson supported the decision for Providence to join the SCCA Network. “The Network relationship helps communication at all levels,” she says. “It will help enhance it at the doctor level as well as the nursing level.”

Anderson is looking forward to being able to access more clinical trials at SCCA so her patients can stay in Anchorage for their treatment.

MultiCare Regional Cancer Center

MultiCare Regional Cancer Center has been an SCCA Network Member since January 2008. A large organization consisting of 8,300 employees, MultiCare has four hospitals, and many regional outpatient clinics, including pediatric oncology services at Mary Bridge Children’s Hospital.

Services include image guided intensity modulated radiation therapy, HDR, brachytherapy, and stereotactic cranial and body radiosurgery. There are plans to expand the Tacoma General oncology treatment center, which will open in 2010, to provide 40 chemotherapy chairs, three linear accelerators, complete radiosurgery services, a complete array of cancer imaging services, and a brachytherapy suite, all using the latest technology. Intraoperative radiotherapy will become feasible in the new facility, which is connected to recently modernized operating rooms.

MultiCare has added special patient navigators to support the four major disease site specific teams in neuro-oncology; breast cancer; urologic oncology; and thoracic/lung cancers, as well as general navigators for most other medical/radiation oncology patients. “The next big step is translational research. That is the mission of SCCA and our organization, and a major goal of the Network. We are excited to contribute to the academic mission of the University in this way,” MultiCare medical director John Rieke, MD, says.

Proud of their network affiliation, MultiCare “takes every opportunity to describe our relationship in the press and at local events,” Rieke says. “I have tremendous respect for SCCA and the University of Washington, and this is one of the best ways for the Alliance to serve our region.

 

John W. Rieke, MD

Medical Director, MultiCare Regional Cancer Center

Dr. John W. Rieke, is a radiation oncologist and the medical director of MultiCare Regional Cancer Center in Tacoma, Washington. He oversees the management of the cancer care services, including medical and radiation oncology, the patient care navigator program, and patient support services.

“I provide program and research support and generally plan for our growth with an absolutely wonderful team,” he says.

MultiCare has 8,300 employees, four hospitals, and many outpatient clinics in
the region.

“When I joined MultiCare, I was impressed by the similarity of our comprehensive care mission with that of University of Washington Medical Center, where I worked before,” Rieke says. MultiCare became an SCCA Network member in January 2008.