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Molecular profiling yielded clinical benefit in refractory cancer
AACR 100th Annual Meeting
Molecular profiling to look for possible treatment targets in patients with refractory metastatic cancer yielded a positive clinical benefit after treatment with subsequent chemotherapy regimens, according to the results of a nine-center pilot study.
Daniel Von Hoff, MD, physician-in-chief at TGen and chief scientific officer of Scottsdale Healthcare and U.S. Oncology Research, and colleagues enrolled patients with metastatic cancer who had failed at least two prior lines of therapy. One hundred and six patients signed consent for participation; 40 did not go forward with profiling.
The study endpoint was a comparison of progression-free survival using the treatment regimen selected based on molecular profiling compared with progression-free survival for the most recent regimen on which the patient had progressed.
Molecular profiling was done through immunohistochemistry, fluorescence in situ hybridization and microarray analyses. Ninety-eight percent of patients who underwent molecular profiling yielded a treatment target.
“For example, in some patients with breast cancer we found ER,” Von Hoff said. “Some of these patients had been on an ER antagonist and we were surprised to find [ER].”
Of the 66 patients who underwent molecular profiling, 18 (27%) had a longer time to progression on the treatment regimen selected through molecular profiling compared with prior treatment regimens. In addition, six patients had dramatic shrinkage of the tumor, and 45% of patients had some shrinkage of the tumor.
At four months there was one complete response and five partial responses for an overall response rate of 10%. Twenty-one percent of patients did not have progression at four months.
Von Hoff said to interpret these results with caution because of the lack of experience with progression-free survival ratio, where patients are their own control, as a clinical trial endpoint.
“We don’t feel this is ready for prime time in patients without prior treatment,” Von Hoff said. “If there is something that has already improved patient survival, then you should treat patients with that regimen. But in patients where you are sort of scratching your head, when you don’t have something that is working to improve survivorship, this becomes a possibility, not only for standard agents but for investigational agents.” – by Leah Lawrence
I think this is an excellent idea. If allowable — and these are very early, very intriguing results — what we should do is move this to a larger study. These are patients that failed multiple therapies. We encounter these as clinicians all the time. These are people who want to live, who want to try investigational agents. It's getting easier and more cost-effective to do the kind of studies that Dr. Von Hoff's team did to look for new targets. We could likely identify a series of targets for each of the histologies based on the data he has. I'm very enthusiastic about it. It points to the personalization that is becoming easier to do not only with clinical sciences but with technologies that we have.
– Michael Caligiuri, MD
Director and CEO of the Comprehensive Cancer
Center
James Cancer Hospital, The Ohio State University
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