Program Backs PBSC Protocols in Community

SAN DIEGO--Not wishing to be a self-contained island of clinical research in a region with a wealth of private cancer specialists, the Fred Hutchinson Cancer Research Center established a community outreach program to involve more oncologists in clinical trials, a program that now includes autologous transplants of peripheral blood stem cells (PBSCs), Leona Holmberg, MD, an associate in the clinical division at Hutch-inson, said at a conference sponsored by the University of California, San Diego.

Founded in 1986, the initial mission of the Puget Sound Oncology Consortium (PSOC) included encouraging and facilitating the entry of patients into clinical trials by providing private physicians with information and access to protocols; acting as a forum for the development of pilot studies that might ultimately become national in scope; and sponsoring educational meetings.

The mission expanded in 1994, Dr. Holmberg said, when the academic physicians concluded that cancer specialists in the community would be doing autologous transplants at their institutions. The PSOC decided to provide guidance to these local physicians and offer protocols to better ensure safe treatment.

The PSOC began enrolling patients in its autologous PBSC transplant protocol in 1994. During that year, physicians affiliated with PSOC did 23 autologous transplants. In 1995, this rose to 112, and in 1996 and 1997, to 127 and 126, respectively. To put these numbers in perspective, Hutchinson physicians performed 148 such transplants in 1997.

There are 16 active PSOC transplant centers throughout the northwestern United States, including Washington state, Oregon, Montana, Idaho, and northern California, as well as Hawaii.

The arrangement offers benefits for both the cancer research center and the community. At Hutchinson, for example, it has increased the referral base for transplants as well as other oncology services. In the community, the program allows physicians to expand their treatment capabilities with quality protocols.

For patients, the arrangement provides continuity of care. In the past, many patients had been hesitant to leave their homes to receive transplants. Dr. Holmberg said that transplant candidates in Redding, Calif, for example, in the past had been referred to Stanford University’s program, but patients often balked at making the trip. Now Redding physicians affiliated with the PSOC can perform the transplant locally.

The data also indicate that patients need not worry that they are sacrificing quality of care by not making the trek to Seattle or elsewhere. "The toxicity rates in the community have been identical to what we see at our center, so we are observing a high quality of care," she said.

There are some negatives to this cooperative effort, she said. Hutchinson loses some referrals each year for its phase I trials, as patients opt to join the PSOC protocol closer to home. The institution also incurs certain expenses. Hutchinson physicians constantly monitor the community programs for quality of care and toxicity, and all data submitted to PSOC are reviewed before being coded. The center also spends money to train the community physicians in blood banking, apheresis, and PBSC collection, and provides on-site lectures on patient care.

To continue in the program, a group must perform a minimum of five transplants a year, pay for a data manager, and submit data in a timely fashion. On very rare occasions, she said, Hutchinson has had to put a group on probation for failing to do so, but this action has always resulted in quick compliance.