In a recent study, a combination of multiple drugs in addition to chemotherapy showed positive results on breast cancer patients with an advanced disease. The promising results now have to be part of a phase-3 trial to possible replicate the results.
During the medical trial, a total of 72 patients were randomly assigned to receive the veliparib-carboplatin therapy, while 44 other patients were concurrently assigned to the control group, according to the study published Thursday in the New England Journal of Medicine.
When finished the chemotherapy sessions in the two groups, it was found that the estimated of pathological complete response in the triple-negative population were off 51 percent, compared to the 26 percent of the control group. This means that in the half of the patients with the drug, cancer spread stopped.
Also, Neratinib halted the spread of cancer by 56 percent in women with HER2-positive, a hormone-receptor-negative type of cancer. The results were compared with the control group, who experienced just a 33 percent reduction.
However, the team found that the toxicity of veliparib-carboplatin was greater in their patients when compared to the control groups, researchers noted in the results. As a conclusion, the process used in the trial showed, according to the team, that veliparib-carboplatin added to standard therapy resulted in higher rates of positive results rather than the traditional one by itself.
The drugs were the first ones to come out of the I-SPY clinical trials, a joined effort between multiple organizations intended to streamline drug testing by better guiding treatment to those who would benefit from them, as reported by UPI.
The unconventional medical trial used genetic information from its patients to steer them to experimental drugs that are most likely to work, according to study author Dr. Laura Esserman, a director of breast cancer care at the University of California.
Adaptive design is also used. It is a process in which doctors use early data from current patients to steer treatment for the next patients in line, Esserman commented. For instance, a patient might be given a different drug in the trial that is working better in women with her particular type of breast cancer, she added.
“The whole idea of the framework is to allow us to be more innovative and thoughtful, and to drive faster to combinations that might make a huge difference in the response to these agents in women who need them most,” Esserman noted.
A wave of the future
According to Dr. Otis Brawley, chief medical officer for the American Cancer Society, the adaptive design that I-SPY is currently exploring is the wave of the future for clinical trials of cancer drugs.
The I-SPY trials are a joined venture between QuantumLeap Healthcare Collaborative, Foundation for the National Institutes of Health, the U.S. Food and Drug Administration, the U.S. National Cancer Institute, 16 leading academic centers and the Safeway Foundation
Genetic research has provided a bevy of new ways to attack cancer, by finding very specific targets against which different drugs can be utilized, Brawley told U.S. News. Unfortunately, traditional clinical trial design cannot keep up with the pace of genetic revelations concerning cancer, he added.
Brawley commented as well that the I-SPY team is using a 70-gene panel to determine which drugs might be the right ones for a particular patient. Testing each gene or combination of genes with individual drugs would be costly and time-consuming, he said.
“The real aim here is to use the smallest number of people in the shortest period of time to figure out if a drug works,” Brawley said. “It is especially important to do that as we learn that the number of diseases that we are going to be testing these drugs on is increasing exponentially as we better understand and define cancer genomically.”
The conventional trials
As for the standard approach in most of the current clinical trials, they only focus on a single drug or combination of medicines and compare them to the traditional care for the disease. According to Esserman, this amounts to a costly “educated guess” of the experimental treatment’s effectiveness and leaves no chance to change something until the trial is finished.
A typical trial cost more than $2 billion and takes between 12 and 15 years with a massive involvement of patients, from 2,000 to 8,000. This is all the road to be taken if a drug wanted to be introduced to the market. However, besides all the time, money and effort, 60 to 70 percent of those clinical trials failed, according to I-SPY.
Within the I-SPY medical trial, Esserman assured that this had included 12 different experimental drugs in the stable of options available to patients. The treatments are cycled in and out of the trials, with about four or five active at the same time, he said.
Source: New England Journal of Medicine