MD News Magazine
September-October 2006 Cover Story

Think about medical research. What do you envision? Probably an academic medical center, a university or a major pharmaceutical corporation comes to mind. It is unlikely that a specialty center at a local health care network is on the top of your mental list.

The staff at The Lacks Cancer Center at Saint Mary’s Health Care in Grand Rapids is working to change that image.

“Everybody is familiar with the story of our care – our holistic mind, body, spirit approach,” says Susan Hoppough, PhD, RN, director of cancer control at Lacks. “What we want them to know is that we also have top-level technology and scientists, and we’re working with local, regional and national partners to develop original medical breakthroughs.”

Hoppough is an integral part of that effort, doing her own behavioral research while helping her colleagues with the complexities of clinical trials. She was recently awarded a quarter-million-dollar grant from the Susan G. Komen Breast Cancer Foundation. “It’s unusual to have a PhD in a non-academically affiliated medical center,” she says. “The hospital has 324 beds, so we are not the largest provider in the area. But having me on board is one way Saint Mary’s is demonstrating the commitment they’ve made to research. From bench to translational research – with partners like Van Andel Institute, the National Institutes of Health and private companies – studies are being done here that have the potential to dramatically influence how oncology is practiced every day at the bedside.”

Studies Underway
Researchers at The Lacks Cancer Center are currently working on 12 clinical studies. (See “Oncology Studies Underway at Saint Mary’s.”) In addition to these, Saint Mary’s is the beta test site for Hill-Rom beds, helping to assess new surfaces and software. The beds, installed when The Lacks Cancer Center was being furnished, contain built-in smart technology. It is hoped they will help to reduce falls, limit pressure ulcers and reduce staff injuries.

To support its research efforts, Saint Mary’s joined the Grand Rapids Clinical Oncology Program (GRCOP) many years ago. This membership allows patients access to all of the oncology clinical trials that are available through the National Cancer Institute.

“We’re very interested in developing evidence-based practices,” says Hoppough. “We’re trying out many new technologies and patient care approaches here at Lacks, but they have to be based on solid research. In everything we do, we’re trying to answer fundamental questions about oncology care: What can we do to minimize the side effects of treatment? How can we limit what the family physician has to deal with? How can we practice more safely? What can we do to reduce readmissions after discharge? How can we reduce the cost while taking even better care of our patients? These are some of the outcomes we’re trying to address in our oncology research program.”

Partial Breast Radiation Study
Gilbert Padula, MD, a radiation oncologist at The Lacks Cancer Center, is the principal investigator for one of the current oncology research efforts at Saint Mary’s. The RTOG/ NSABP B-39 study (see “Glossary”) is designed to evaluate the efficacy of whole breast radiation versus partial breast radiation in early-stage cancer therapy.

This new Phase III trial is being funded by the National Cancer Institute. The Lacks Cancer Center is one of several sites across the nation that has patients enrolled in the study. Saint Mary’s joined the study and began recruiting participants in early 2006.

“This is one of the most controversial areas in radiation oncology research,” explains Dr. Padula. “Historically, if a woman had a lumpectomy for breast cancer, we would also treat the whole breast with radiation therapy for six weeks. This offered survival rates comparable to mastectomy, but without the disfigurement. However, this combination of lumpectomy and radiation is not accessible to all people – especially women who don’t have the physical access or financial ability to get six weeks of radiation therapy.

“Some oncologists postulated that it might be possible to give radiation twice a day for a week and just treat the lumpectomy site,” he continues. “This partial breast radiation could be accomplished using an indwelling MammoSite catheterâ or through external beam radiation therapy. It is potentially a highly localized, breast-conserving approach that will allow us to give treatment more quickly – making the entire process much more available and convenient for the patient.”

According to Dr. Padula, this partial breast radiation approach began with some successful single-institution studies. But, he points out, the only true test of its efficacy is to conduct a Phase III randomized, longitudinal clinical trial.

Enrollment is underway in participating institutions across the country, including Saint Mary’s. Half of the women are receiving conventional six-week, full breast radiation therapy and half are receiving the partial breast treatment. It will take several years before the results of this study are published. In the meantime, the standard of care is still whole breast radiation therapy for six weeks.

“Partial breast radiation therapy, even if it ultimately proves to be a valuable treatment option, is not appropriate for all patients with breast cancer,” Dr. Padula states. “Patients who have early stage tumors are typically good candidates – those who have small tumors with little lymph node involvement.” Dr. Padula says he is actively seeking participants for the RTOG/ NSABP B-39 study.

“We have many clinical studies going on at Saint Mary’s all the time,” he concludes. “We do an amazing amount of research for a (OLD phrase was “community hospital”) local health care network, (Phrase in red is my suggested revision.) and our focus is always on answering the question, ‘What will be best for our patients?’”

Susan K. Hoppough, PhD, RN, is director of cancer control at The Lacks Cancer Center at Saint Mary’s Health Care in Grand Rapids, Mich. Dr. Hoppough received her PhD in Family Studies and an MSN with an emphasis in gerontology from Michigan State University.

Gilbert D. A. Padula, MD, is an attending radiation oncologist at The Lacks Cancer Center. He also is a clinical instructor with the Michigan State University College of Human Medicine. Board certified in radiation oncology, Dr. Padula received his medical degree from MSU and completed his residency at Memorial Sloan-Kettering Cancer Center in New York.

Oncology Studies Underway at Saint Mary’s

In addition to Dr. Gilbert Padula’s study related to partial breast radiation therapy, the team at The Lacks Cancer Center at Saint Mary’s Health Care currently has 11 other clinical research studies underway. Some of them include:

1. Prediction of Late Toxocity in Patients Undergoing Radiotherapy. Development of a clinical blood test that can be used to determine, prior to radiation, which patients are most likely to experience late radiation side effects. Co-PI’s: James Kane, Jr., MD, The Lacks Cancer Center; Nigel Crompton, PhD, Cornerstone University; Rick Hay, PhD, Van Andel Research Institute.

2. Role of Excreted Proteins in Screening for Colorectal Cancer. A pilot study to identify new protein markers unique to colorectal cancers in the stool that can be used to detect early stage disease. Co-PI’s: Timothy Fitzgerald, MD, Saint Mary’s Health Care; Craig Webb, PhD, Van Andel Research Institute.

3. Open-Label, Multi-Dose Study of Intracavitary Administered 131ITM-601. A Phase II study examining the use of a radiolabeled targeted therapy given directly into the brain cavity to block surface growth factors on tumor cells. PI: Thomas Gribbin, MD, The Lacks Cancer Center. Study Coordinator: Shannon Ikiri, RN MSN, Cancer Hematology Centers of West Michigan.

4. Dosimetric Characterization of a Compact Doorless High Energy Linear Accelerator Vault. A study to identify the components in the doorless vault design that are most efficient at stopping radiation from exiting the room. PI: Tewfik Bichay, PhD, The Lacks Cancer Center. Study Partners: Richard Rogow, MS, Wayne State University; Joe Meadows, MS, and Chen Chen, MS, The Lacks Cancer Center.