Scientists in Switzerland
Massey researchers travel to Switzerland to lead discussions on phase 1 clinical trials in cancer
In July, VCU Massey Cancer Center scientists traveled to Hermance, Switzerland, to lead discussions at the Brocher Foundation Symposium titled, “Recent developments in phase 1 oncology trials: Implications for ethics, palliative care and society.” The symposium brought together researchers, oncologists, ethicists and palliative care specialists from all over the world, including the Netherlands, Germany, Sweden, the United Kingdom, Switzerland, Spain and the United States, to examine phase 1 clinical trials in cancer.
Phase 1 trials are key translational steps in developing new therapies. In these studies, researchers are testing a new drug or treatment in a small group of people, for the first time, to evaluate its safety, determine a safe dosage range and identify side effects. In recent years, three trends have unfolded in phase 1 trials. First, large-scale reviews of hundreds of phase 1 trials have indicated that there is a relatively low risk of serious harm and some prospect of clinical benefit for patients. Second, the introduction of targeted therapies that are less toxic, and an increase in phase 1 trials that combine two or more agents in a novel way, have changed some of the expectations of these trials and decreased patients’ fears and apprehensions about participation. Third, the field of palliative and supportive care in cancer has expanded greatly, offering symptom management to early-stage and late-stage cancer patients and demonstrating that the use of palliative care is not mutually exclusive to disease-targeted therapies or clinical research.
“This symposium provided a unique opportunity for experts to share and react to these new trends,” said J. Brian Cassel, Ph.D., symposium co-director, member of the Cancer Prevention and Control research program at Massey and assistant professor in the Division of Hematology, Oncology and Palliative Care at VCU School of Medicine. Cassel was awarded a grant to organize this symposium from the Brocher Foundation in Geneva, Switzerland, where the symposium was held.
Two of the speakers were Massey physician-researchers Andrew Poklepovic, M.D., medical hematologist-oncologist and member of the Developmental Therapeutics research program at Massey as well as assistant professor in the VCU Division of Hematology, Oncology and Palliative Care, and Egidio Del Fabbro, M.D., program director of palliative care and member of the Developmental Therapeutics research program at Massey as well as associate professor in the VCU Division of Hematology, Oncology and Palliative Care.
“Franklin Miller, Ph.D., [symposium co-director and senior faculty of bioethics at the National Institutes of Health] and I selected speakers from the three fields of phase 1 clinical trials, palliative care and ethics,” explained Cassel. “We chose two speakers from Massey because Massey is a unique cancer center in that it has a long-standing reputation for innovation in palliative care and is increasingly recognized for its translational, investigator-initiated early phase clinical trials.”
Poklepovic led a talk titled, “Evolution of phase 1 design and nature of agents being tested,” in which he discussed the establishment of routine genomic profiling for tumors and the advent of successful immune therapy strategies.
“As a clinician who has participated and developed phase 1 trials in a variety of solid tumors, I recognize the important role that early drug development plays in advancing cancer research and offering new options to patients,” he said. “I also know that balancing the needs of patients with advanced cancer requires collaboration between medical oncologists and supportive care specialists. This collaboration can help patients to be in the best shape possible in order to be able to participate in the next generation of early phase clinical trials.”
Del Fabbro elaborated on this collaboration in his talk titled, “Palliative care and phase 1 programs: the potential for partnership.”
“I discussed the integration of cancer treatment with supportive and palliative care. Patients and families no longer have to make a choice between receiving treatment for cancer or opting for palliative care. Simultaneously, treatment that improves symptoms and quality of life can be combined with new investigational therapies against cancer,” said Del Fabbro.
Overall, the symposium led to vigorous panel discussions and positive feedback from both speakers and attendees. “It is very gratifying to hear from recognized experts in these fields that this symposium was valuable and an important step forward for cancer care and research that spans departments, disciplines and nations,” said Cassel.