Medical oncologist Dr. Bernardo Goulart at the Seattle Cancer Care Alliance (SCCA) believes his latest clinical trial might be the most curative approach to treatment of pleural mesothelioma.
He also believes it could work.
Goulart is the principal investigator at SCCA, which has embraced a novel clinical trial that combines the immunotherapy drug Tecentriq (atezolizumab) with a multimodal regimen of chemotherapy, surgery and radiation.
“The trial design is very intense, requiring multidisciplinary involvement,” Goulart told The Mesothelioma Center at Asbestos.com. “I think it could provide insight into the next step of research that we will need to cure more people with this disease.”
SCCA — which includes the Fred Hutchinson Cancer Research Center and the University of Washington Medical Center — is one of multiple sites conducting the clinical trial. The study is sponsored by the National Cancer Institute (NCI).
Recruiting Patients to Participate
Researchers are hoping for 28 surgical candidates to enroll nationwide.
It will start with a chemotherapy and Tecentriq combination, then progress to aggressive surgery followed by possible radiation, and one year of Tecentriq follow-up maintenance.
The study will require a substantial commitment from patients and medical center staff — more than the typical clinical trial.
Those who undergo an extrapleural pneumonectomy (EPP) also will receive the high dose radiation.
Patients having a pleurectomy and decortication (P/D), which spares the lung, likely will not receive radiation treatment.
The pre-surgery phase includes four Tecentriq and chemotherapy infusions, once every 21 days. The post-surgery, or post-radiation phase, also involves a 60-minute infusion every 21 days for up to a year.
To be accepted for the trial, patients must have extended surgical staging that includes a mediastinoscopy along with video-assisted thoracoscopic surgery and a diagnostic laparoscopy to rule out any peritoneal disease spread.
Available at Many Specialty Centers
Here are some of the medical centers, cities and investigators hosting the trial:
- Ochsner Medical Center, New Orleans (Dr. Suma Satti)
- Mayo Clinic, Rochester, Minnesota (Dr. Helen Ross)
- University of California, Davis Comprehensive Cancer Center, Sacramento (Dr. David Cooke)
- The Medical University of South Carolina, Charleston, S.C. (Dr. John Wrangle)
- Bethesda North Hospital, Cincinnati (Dr. Mehmet Copur)
- MD Anderson Cancer Center, Houston (Dr. Anne Tsao)
- Seattle Cancer Care Alliance, Seattle (Dr. Bernardo Goulart)
- Missouri Baptist Medical Center, St. Louis (Dr. Bryan Faller)
- Mayo Clinic, Scottsdale, Arizona (Dr. Helen Ross)
- Mary Greeley Medical Center, Ames, Iowa (Dr. Joseph Merchant)
Only surgical patients with epithelioid or biphasic mesothelioma histology will be considered.
Typically, less than a third of patients diagnosed with mesothelioma are eligible for surgery.
“One of the goals of the trial is to prove that this intense regimen is feasible,” Goulart said. “It scares a lot of physicians and patients. It is testing a concept that aims at improving the probability of curative survival.”
Immunotherapy Is the Future
Tecentriq is an immunotherapy drug similar to Keytruda (pembrolizumab) and Opdivo (nivolumab).
All three target a specific protein that stops a body’s immune system from attacking cancer cells. By negating that protein, the immune system can more effectively destroy the tumor cells.
The U.S. Food and Drug Administration (FDA) approved Tecentriq for treatment of certain non-small cell lung and bladder cancers in 2016.
Common side effects include decreased appetite, fatigue and nausea. These are usually less serious than adverse effects that often come with chemotherapy.
Researchers believe using Tecentriq in combination with chemotherapy will produce a cooperative effect that can better reduce tumor burden before surgery.
They also believe the maintenance phase could reduce the chances of tumor recurrence.
In earlier clinical trials involving lung cancer, the combination of Tecentriq and chemotherapy proved more effective than using chemotherapy alone.
SCCA, in recent years, has accelerated its role as a mesothelioma specialty center, focusing on this aggressive cancer with no definitive cure.
The center is conducting six different clinical trials currently involving mesothelioma, including one with a combination of chemotherapy and durvalumab — another immunotherapy drug — aimed at unresectable tumor burden.
“We can offer options that other places can’t,” Goulart said. “We want people to know that we are a center dedicated to treatment of this disease. Immunotherapy is going to play a big role in improving outcomes for these patients.”