CHICAGO—A new-format experiment conducted at the ASCO Annual Meeting has shown promising preliminary results according to some anecdotal evidence randomly collected here at the McCormick Convention Center.
The Trials in Progress (TIP) Poster Session was created to facilitate awareness and dialogue about open, ongoing clinical trials.
It was the first time ASCO provided a formal opportunity for clinical researchers to present information about their current trials without outcome data or results.
As ASCO CEO Allen S. Lichter, MD, told OT prior to the meeting (5/25/10 issue), the goal was to promote discussion among investigators, encourage recruitment of new investigators and sites, and foster dialogue about successor or confirmatory trials.
ASCO said the posters focused on the background of the science behind the trials, and encouraged the inclusion of preclinical or earlier-phase data.
When asked about the event, Patricia A. Ganz, MD, Director of the Division of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center at UCLA— who has held numerous voluntary leadership positions with ASCO and has received several awards from the society and elsewhere for her contributions to oncology, especially in prevention and survivorship—said the session made it possible for those without results to present their posters at the meeting.
But OT also found that presenters, and especially some of the younger investigators, were reaping a number of benefits that could likely translate into more effective trials.
Translational Breast Cancer Research Consortium
For example, Erica L. Mayer, MD, MPH, of the Breast Oncology Center at Dana-Farber Cancer Institute, presented a poster on behalf of the Translational Breast Cancer Research Consortium with the title, “ABCDE, a Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise after Preoperative Chemotherapy for Breast Cancer: TBCRC Trial 012.”
Dr. Mayer, who, I learned as we were talking, is also the daughter of Robert J. Mayer, MD, Director of Dana-Farber's Center for Gastrointestinal Oncology and a member of OT's Editorial Board, said that the randomized trial was a follow-up to a pilot study and involved women who had triple-negative or HR+/HER2- breast cancer, and had both treatment and lifestyle interventions. The lifestyle arm was used as “kind of a carrot,” she said, and was designed to learn more about the roles of diet and exercise.
She said that although she has presented at regular poster sessions, she found the Trials in Progress concept an interesting idea and was curious to see how it would turn out.
“This trial is looking at a very specific patient population who doctors across the country struggle with what to do with, and we always get consults about patients in this situation who still have residual disease and are at high risk, and physicians ask ‘what more can I do for my patient?’
“So we know this is a major clinical question, and I'm hoping that having my poster here and having people see that this is a large clinical trial addressing this difficult issue will heighten interest.”
She said the trial will be open at 10 sites across the country and she hoped that patients living near those sites might be interested in enrolling and that additional oncologists may want to join as investigators.
“This [poster session] is like a marketing tool for trials…. Trial accrual is the lifeblood of what we do, and if we can improve it by talking about what's going on and having more people know about it, then that's great.”
Chance to Improve the Research as Well as Meet New Collaborators
David M. Peereboom, MD, Associate Professor of Medicine at Cleveland Clinic Lerner College of Medicine, who works in the brain tumor and neuro-oncology department, presented a “Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients with 1-3 Newly Diagnosed Brain Metastases.”
He said that since only three patients were currently enrolled, the Trials in Progress session gave him the opportunity to get ideas to improve the study as well as to meet new collaborators who could enroll more patients.
Ernesto Bustinza-Linares, MD, an investigational cancer therapeutics fellow at the University of Texas MD Anderson Cancer Center, presented a “Phase I Trial of Sequential Azacitidine and Valproic Acid Plus Carboplatin in the Treatment of Patients with Advanced Malignancies”—the first study he has ever presented.
“I've gotten some good suggestions about how to design the second phase, and have found this session an excellent tool,” he said. “The more input you get, the more you can improve the research, and I've gotten cards and new contacts and ideas, which are important to a young researcher.”
Share Common Ideas, Strategies with Colleagues Worldwide
“Pharmacology of High-Dose Methotrexate in Patients with Primary CNS Lymphoma: a Pharmakinetic-Pharmacodynamic Analysis from the IELSG #20 Trial,” was the subject of the poster presented by Markus Joerger, MD, PhD, from St. Gallen, Switzerland.
He said he thought the trials in progress concept to be very helpful in sharing common ideas and strategies with colleagues from throughout the world.
“It's crucial at this early stage [to get feedback] to bring the research forward and help foresee pitfalls” he said.
Susan Love: ‘Recruiting Poster’
OT also spoke with a familiar figure in breast cancer, who was using the session for a slightly different purpose. Susan M. Love, MD, President and Medical Director of her self-named research foundation, said her poster, “A New Resource to Accelerate Research into the Cause and Prevention of Breast Cancer: The Love/Avon Army of Women,” was not technically an early-phase clinical trial, but more of a recruiting poster to add to the army of one-million women she was amassing as a resource for researchers who needed to access tissue samples and data to accelerate research.
The poster may not have fit ASCO's criteria perfectly, but it was another entry into what turned out to be a marketplace of collegial ideas and clinical trial recruitment.