Immune Analysis of On-Treatment Longitudinal Biopsies Predicts Response to Melanoma Immunotherapy

Excerpt:

“Immune response measured in tumor biopsies during the course of early treatment predicts which melanoma patients will benefit from specific immune checkpoint blockade drugs, researchers at The University of Texas MD Anderson Cancer Center report in the journal Cancer Discovery.

“Analysis of biopsies before treatment did not indicate who would respond in this unique longitudinal study of 53 melanoma patients treated with two immune checkpoint inhibitors between October 2011 and March 2015.

” ‘Before treatment, analyzing samples with a 12-marker immune panel or a 795-gene expression panel, you can’t tell who will respond with any degree of certainty. On treatment, there were night-and-day differences between responders and non-responders,’ said study senior author Jennifer Wargo, M.D., associate professor of Genomic Medicine and Surgical Oncology.”

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Shoddy Biopsies Deny Cancer Patients a Shot at Personalized Treatment

“A huge federal trial of personalized cancer medicine has run into an unexpected roadblock: Many of the tumor samples aren’t robust enough to be put through genetic analysis.

“The samples, taken from patients with advanced cancer, were collected by doctors in hundreds of clinics nationwide. When researchers checked them, they found as many as 1 in 5 didn’t have enough malignant cells to analyze, in most cases because the biopsy had been poorly done.

“The glitch raises troubling questions about the new era of precision medicine.”


New Diagnostic Tools for Prostate Cancer

“Dan Woska was weighing his treatment options after he was found to have prostate cancer two years ago when a friend mentioned a new genomic test that could gauge how lethal his tumor was.

“The test, called Oncotype DX, which looks at the expression of 17 genes in a tumor, cost about $4,000 and was not covered by Mr. Woska’s insurance. But through a patient assistance program, the company that created it, Genomic Health, ran it for him free, using a tiny grain of tissue left over from his biopsy. The results indicated there was an 81 percent probability that Mr. Woska’s tumor would not spread beyond the prostate. On an aggressiveness scale of zero to 100, the tumor was an indolent 15.

“Thrilled and relieved, Mr. Woska decided to forgo radiation and surgery.”


MRI-Ultrasound Fusion Improves Prostate Biopsy Cancer Detection

“Magnetic resonance imaging-ultrasound fusion targeted prostate biopsy (MRF-TB) improves detection and risk stratification of high-grade disease and limits detection of clinically insignificant prostate cancer, according to a study published in the December issue of the The Journal of Urology.

“Neil Mendhiratta, from the New York University Langone Medical Center in New York City, and colleagues reported clinical outcomes for 452 consecutive men presenting for primary . Participants underwent prebiopsy multiparametric magnetic resonance imaging followed by MRF-TB and systematic biopsy.”


Case for Testing Cancer in Blood Builds, One Study at a Time

“Two new studies published on Wednesday of patients with breast and prostate cancers add to growing evidence that detecting bits of cancer DNA circulating in the blood can guide patient treatment.

“Enthusiasm is building for ‘liquid biopsies,’ which offer a non-invasive alternative to standard tissue biopsies and are expected to be a multibillion-dollar market.

“But a key question remains: Do they really work?

“The stakes are high. At least 38 companies are working on liquid biopsies for cancer, according to analysts at investment bank PiperJaffray, who think the U.S. market alone could eventually reach $29 billion a year.”


Urine Biomarkers May Reduce Repeat Biopsies for Prostate Cancer

“Incorporating scores from two urine-based biomarker assays may reduce the number of biopsies men with clinically localized prostate cancer need to undergo without greatly affecting 10-year survival rates, according to the results of a decision analysis.

“ ‘Results from recent studies have demonstrated the potential clinical utility of the urine-based PROGENSA prostate cancer antigen 3 (PCA3) assay (Gen-Probe, Inc.) to predict repeat biopsy outcomes in men with elevated serum PSA levels and previous negative biopsy findings,’ Brian T. Denton, PhD, associate professor of industrial and operations engineering at University of Michigan, and colleagues wrote. ‘A recent literature review reported current evidence suggesting that the PCA3 test is clinically useful for selecting which patients should undergo repeat biopsy. Several studies have determined that urine assessment of [T2:ERG] is also associated with biopsy outcome and may be better at discriminating between low-grade and high-grade cancers.‘ “

“Denton and colleagues performed a decision analysis using a decision tree to evaluate the clinical value of using PCA3 and T2:ERG scores to determine the need for repeat biopsy in men with clinically localized prostate cancer who had at least one prior negative biopsy. Researchers estimated the probability for cancer by using the Prostate Cancer Prevention Trial Risk Calculator.”


PET Imaging Detects Fast-Growing Prostate Cancer

“A molecular imaging biomarker is able to detect fast-growing primary prostate cancer and distinguish it from benign prostate lesions, addressing an unmet clinical need. The new research, published in the July 2015 issue of The Journal of Nuclear Medicine, is significant for patients with suspected prostate cancer that has not been confirmed by standard biopsy.

” ‘We were able to demonstrate in our research that PSMA PET imaging was more specific than MR imaging for detection of clinically significant high-grade prostate cancer lesions, and importantly was able to distinguish benign prostate lesions from primary prostate cancer, currently a difficult diagnostic imaging task,’ stated Steven P. Rowe, MD, PhD, resident at Johns Hopkins Medical Institutions in Baltimore, Md. ‘Additionally, this work demonstrated a direct correlation between PSMA PET radiotracer activity in prostate cancer and prostate adenocarcinoma aggressiveness (Gleason score).’ “


Active Surveillance May Be Safe After Prostate Tumor Upgrade

“Men with low-risk prostate cancer on active surveillance whose tumors are upgraded after a biopsy might not have to rush into surgery, according to new research.

“In these men, the risk for further upgrading, should they choose to remain on surveillance for a while, is relatively low.

“What this study says is that for those who are on the fence or want some additional time to think about it, it’s likely safe to wait for treatment, said Christopher J. Welty, MD, a urology fellow at the University of California, San Francisco.

” ‘You don’t have to jump onto treatment right away just because of an upgrade,’ he told Medscape Medical News.”


Biodesix Launches GeneStrat Targeted Liquid Biopsy Mutation Test For Patients With Advanced Lung Cancer

“Biodesix, Inc. today announced the launch of GeneStrat™, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC). The blood test results are available within 72 hours, providing physicians actionable diagnostic information prior to making treatment decisions. GeneStrat is focused exclusively on the clinically actionable EGFR, KRAS, and BRAF mutations often used to guide targeted therapy treatment decisions. GeneStrat also captures the EGFR T790M mutation, which can be used for monitoring the emergence of the primary resistance mutation in the EGFR gene. It is anticipated that two drugs targeting the resistance mutation may be available later this year. GeneStrat uses the ddPCR platform to analyze cell-free tumor DNA and is highly concordant with tissue analysis, currently considered the gold standard.

“Roughly 30% of lung cancer patients either have insufficient biopsy tissue or are not candidates for a biopsy for tumor mutation profiling. Even in cases where tissue biopsy is available, the sense of urgency to treat is great, with one recent study showing that one out of four patients begin cancer treatment before receiving mutation test results. Requiring only a blood draw, GeneStrat offers a fast, minimally invasive alternative to a high-risk tissue biopsy or re-biopsy in patients with insufficient tissue.

“In addition to providing a minimally-invasive source of mutation status, liquid biopsy can be more cost-effective than traditional tissue biopsies. The mean cost of each tissue biopsy is $14,634 across all patients. The cost of a tissue biopsy can be up to four time higher in the 19.3% of patients who have complications associated with the biopsy. GeneStrat liquid biopsy can help avoid the cost and complications of repeat tissue biopsy.”