Just 3 percent adult cancer patients participate in clinical trials of treatments experimental. In a novel effort to increase that number, a national nonprofit organization is launching an unusual study – one that allows patients to easily move between several experimental therapies, without spending precious time trying to find and qualify for a new trial if the first does not help.
Once they are, they are.
“The system of ongoing clinical trials does not match what a patient needs,” said Julie Fleshman, president and CEO of the Network of Action Against Pancreatic cancer, which organized the platform $ 35 million ” precision Promise “, announced on Tuesday. “This is about doing that.”
The article continues after the announcement
The new approach raises some difficult questions. It may be more difficult, for example, to unravel the safety and efficacy of a treatment if patients are switched from one to another. The trial aims to achieve this obstacle by focusing on “progression free survival” or how long patients survive without the original tumor spread. They quickly switch to another treatment if the cancer begins to grow.
“It’s a complicated trial design and will be gray areas,” said Lynn Matrisian, head of research network pancreatic cancer. “This is a” signal search ‘test so we are willing to accept some imprecision in the data and finding a balance between rigor and the centrality of the patient. “
Precision Promise launched in the spring; It is expected to drug first large-scale precision test for pancreatic cancer. It is expected that about 42,000 people in the United States died of pancreatic cancer this year, making it the third leading cause of cancer death in the country. The prognosis is bad :. Only 8 percent of patients are still alive five years after diagnosis
Patients who enroll in the Promise accuracy is subject to the molecular characteristics of the tumor to identify mutations that drive malignant cells to proliferate. The hope is that researchers might find a home in targeted therapy in these mutations and stop the spread of cancer.
That’s a great “strength”.
Pancreatic cancer has not benefited from the targeted therapy how other diseases have. One reason: it is very difficult to get a good sample of cancer cells from a tumor of the pancreas. (Malignant cells tend to be few in number compared with inflammatory cells and others, so it is difficult to isolate.) As a result, relatively few dirigibles mutations allow mutations can only target for which there have been identified drugs, a study of 2015 found.
This lack of options is reflected in clinical trials for pancreatic cancer.
Although more than 600 are is on the basis of federal Clinicaltrials.gov data, the vast majority of the evidence standard treatments such as surgery, chemotherapy, radiation, or some combination. “The revolution we have seen in other cancers has been very slow to reach pancreatic cancer.”
In the assay precision Promise, a doctor will first determine which chemotherapy “backbone” is the best for each patient, based on the presence of other diseases, their ability to tolerate specific side effects and often you can come for treatment.
Here, the molecular profile of the tumor or characteristics of the area surrounding the tumor (the “microenvironment”) substudy determine which binds to a patient, said Dr. Robert Vonderheide Abramson Cancer Center of the University of Pennsylvania, who is leading the study of Penn. For example, if the have a mutation in BRCA2 gene, which could also be put on drugs called PARP inhibitors, which are used in other cancers.
The novel is part of what happens next. If a patient does not respond to first-line treatment or relapse after responding at first, she can switch to a different sub-study without having to qualify for another clinical trial – an expensive process that can often involve travel to a city different. whose center sees about 350 patients with pancreatic cancer each year. He hopes to enroll all the promise accuracy.
Traditionally, patients must meet several criteria to sign up for a new trial; if you have previously been treated with a similar or have additional features such as cardiovascular disease, who can not qualify disease drug. Accuracy Promise removes those barriers.
Precision Promise is starting with three experimental protocols, but will eventually have more, Matrisian said, including immunotherapies as transforming the treatment of melanoma and small-cell carcinoma.
“For the first time, in a very real sense, we will work with patients to cope with this disease together,” said Dr. Sunil Hingorani Research Center Fred Hutchinson Cancer, who will lead the study no. “Ultimately, we would like to see this as a template for how to take care of each patient of pancreatic cancer at all sites across the country.”