Scientists reported constructive Section 1 trial outcomes of their “intratumoral microdevice” in sufferers with glioma tumors
Right here is an instance of latest microtechnology which has the potential to enormously shorten the time and enhance the flexibility of physicians to find out which anti-cancer drug is only for a person affected person’s glioblastoma. As it’s additional developed, this know-how might give anatomic pathologists and medical laboratories an elevated function in assessing the info produced by microdevices and serving to physicians decide essentially the most acceptable anti-cancer drug for particular sufferers.
In a information launch, researchers at Brigham and Girls’s Hospital (BWH) in Boston stated they’ve developed an implantable “intratumoral microdevice” (IMD) that capabilities as a “lab in a affected person,” able to gauging the effectiveness of a number of medicine that concentrate on mind tumors. In a Section 1 medical trial, they examined the IMD on six sufferers with glioma tumors.
“So as to make the best influence on how we deal with these tumors, we’d like to have the ability to perceive, early on, which drug works greatest for any given affected person,” research co-author Pier Paolo Peruzzi, MD, PhD, instructed the Harvard Gazette. “The issue is that the instruments which are at the moment obtainable to reply this query are simply not adequate. So, we got here up with the concept of constructing every affected person their very own lab, through the use of a tool which may straight interrogate the dwelling tumor and provides us the data that we’d like.”
Peruzzi is Principal Investigator on the Harvey Cushing Neuro-Oncology Laboratories and Assistant Professor of Neurosurgery at Harvard Medical Faculty.
The researchers revealed their findings within the journal Science Translational Drugs titled, “Intratumoral Drug-Releasing Microdevices Enable In Situ Excessive-Throughput Pharmaco Phenotyping in Sufferers with Gliomas.” [PHOTO OF PERUZZI HERE
“Our goal is for the placement of these devices to become an integral part of tumor surgery,” said Pier Paolo Peruzzi, MD PhD (above) of Brigham and Women’s Hospital and Harvard Medical School in an article he co-wrote for Healio. “Then, with the data that we have from these microdevices, we can choose the best systemic chemotherapy to give to that patient.” Pathologists and clinical laboratories may soon play a role in helping doctors interpret data gathered by implantable microdevices and choose the best therapies for their patients. (Photo copyright: Dana-Farber Cancer Institute.)
New Perspective on Tumor Treatments
In a news story he co-wrote for Healio, Peruzzi explained that the microdevice—about the size and shape of a grain of rice—contains up to 30 tiny reservoirs that the researchers fill with the drugs they want to test. Surgeons implant the device during a procedure to remove the tumors.
The surgery takes two to three hours to perform, and during that time, the device releases “nanodoses” of the drugs into confined areas of the tumor. Near the end of the procedure, the device is removed along with tissue specimens. The researchers can then analyze the tissue to determine the effectiveness of each drug.
“This is not in the lab, and not in a petri dish,” Peruzzi told Harvard Gazette. “It’s actually in real patients in real time, which gives us a whole new perspective on how these tumors respond to treatment.”
The Healio story notes that gliomas are “among the deadliest brain cancers and are notoriously difficult to treat.” With current approaches, testing different therapies has posed a challenge, Peruzzi wrote.
“Right now, the only way these drugs are tested in patients is through what are called window-of-opportunity studies, where we give one drug to the patient before we resect the tumor and analyze the effect of the drug,” he said. “We can only do this with one drug at a time.”
Determining Safety of Procedure
The primary goal of the Phase 1 trial was to determine the safety of the procedure, Peruzzi noted. “To be in compliance with standard clinical practice and minimize risks to the patients, we needed to integrate the placement and retrieval of the device during an otherwise standard operation.”
The trial consisted of three men and three women ranging from 27 to 86 years old, with a median age of 76. Five were diagnosed with glioblastoma and one with grade 4 astrocytoma.
“None of the six enrolled patients experienced adverse events related to the IMD, and the exposed tissue was usable for downstream analysis for 11 out of 12 retrieved specimens,” the researchers wrote in Science Translational Medicine. They noted that application of the IMD added about 32 minutes to the time required for the surgery, equating to a cost increase of $7,800.
One drug they tested was temozolomide (TMZ), “the most widely used agent in this patient population,” they wrote. “Several patients in our trial received it systemically, either before or after IMD insertion, as part of the standard of care. Thus, although our trial was not designed to choose chemotherapy agents based on IMD data, we still could compare the observed clinical-radiological response to systemic TMZ with the patient-specific response to TMZ in the IMD-exposed tissue.”
One patient, the researchers noted, had not benefited from the drug “in concordance with the poor tissue response observed in the IMD analysis.” But in another patient, a 72-year-old woman, “IMD analysis showed a marked response to TMZ,” and she survived for 20 months after receiving the treatment “with radiological evidence of tumor response. This was despite having a subtotal tumor resection, in itself an unfavorable prognostic factor. The patient expired because of an unrelated cardiovascular event, although she had remained neurologically stable.”
Drug Duration Limitation
One limitation of the study was that testing the device during the tumor removal procedure limited the duration of the drug treatments, Peruzzi said. The Harvard Gazette noted that following their initial study, the researchers were testing a variation of the procedure in which the device is implanted three days before the main surgery in a minimally invasive technique. This gives the drugs more time to work.
Cancer researchers have theorized that common treatments for tumors can impair the immune system, Peruzzi wrote in Healio. “One thing we want to look at is which drugs can kill the tumor without killing the immune system as well,” he noted.
Future studies will determine the effectiveness of implanting microdevices into tumors to test therapies in vivo. Should they become viable, clinical laboratories and anatomic pathologists will likely be involved in receiving, interpreting, storing, and transmitting the data gathered by these devices to the patient’s doctors.
—Stephen Beale
Related Information:
Microdevices Implanted into Tumors Offer New Way to Treat Brain Cancer
Microdevices Turn Brain Tumors into Tiny Labs
Devices Implanted into Brain Tumors During Surgery May Guide Treatment
Human Brain Tumor Implant Could Guide Personalized Therapies Tiny Implanted Devices Give Insights for Treating Brain Tumors
