Wider Adoption of Droplet Digital PCR to Predict Cancer Treatment Response in Clinical Trials Highlighted at 2018 ASCO Annual Meeting

Date: 
2018-06-25
Wider Adoption of Droplet Digital PCR to Predict Cancer Treatment Response in Clinical Trials Highlighted at 2018 ASCO Annual Meeting

Research using Droplet Digital PCR technology from the labs of Alain Hendlisz (left) of the Jules Bordet Institute at the Université Libre de Bruxelles, Brussels, as well as François-Clément Bidard (middle) and Luc Cabel (right) of the Institut Curie, Paris, was presented at ASCO.

HERCULES, Calif. — June 25, 2018 — New studies highlighting the growing adoption of Bio-Rad’s Droplet Digital PCR (ddPCR) technology to predict cancer treatment outcomes in clinical trials were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 1–5. 

In these studies, cancer researchers used ddPCR technology to measure cell-free tumor (ctDNA) levels, which can indicate whether or not a cancer treatment is working. The results showed that ddPCR has increased precision, speed, and cost-effectiveness, particularly beneficial attributes for large-scale clinical trials. The presentations at ASCO this year also demonstrated that the use of ctDNA as a biomarker has expanded from pilot to clinical trials.

ctDNA Predicts Response to Therapy for Patients with Advanced Colorectal Cancer  

ctDNA levels at baseline and after two weeks of therapy may independently predict the response to therapy in patients with advanced colorectal cancer (aCRC), according to new findings presented by Alain Hendlisz, MD, PhD and his colleagues from the Jules Bordet Institute at the Université Libre de Bruxelles, Brussels. Dr. Hendlisz used a ddPCR ctDNA assay to monitor the evolution of mutation levels in genes associated with aCRC in 96 patients at baseline and 14 days post-regorafenib therapy in a phase II clinical trial.

Dr. Hendlisz’s group found that an increase of one or more tumor-specific mutations were associated with a poorer outcome for these patients, including worse median progression-free survival and worse median overall survival. He also found that the baseline ctDNA level itself predicted a patient’s benefit from treatment.

“Without ddPCR technology, we would not have been able to monitor tumor response to therapy so early in the course of treatment, nor would we be able to measure it so precisely throughout its administration,” said Dr. Hendlisz.

The researchers indicated that it may be possible to use ddPCR technology to predict a patient’s benefit from regorafenib therapy early during the course of treatment, or even before it is started.

Using ddPCR Technology to Reveal When Breast Cancer Patients Need to Switch Therapies

ddPCR technology’s high speed is helping researchers conduct large clinical trials on time-sensitive therapies. For example, some breast cancer patients may develop resistance to standard first-line therapies, which means they need to switch to a new treatment as soon as possible.

Dr. François-Clément Bidard, MD, PhD, at Institut Curie, Paris, and his colleagues are studying patients with breast cancer who have estrogen receptor positive, HER2 negative metastatic breast cancer and ESR1 mutations. They are trying to determine if ddPCR technology can rapidly detect the accumulation of mutated ESR1 in patients' blood and enable doctors to randomize patients to a different therapy, which is more likely to be effective in the presence of ESR1 mutations. By detecting rising ESR1 mutation levels in ctDNA months before tumor progression patients can receive an effective treatment sooner.

“We're planning on testing blood from more than 1,000 patients in real time, ten times each,” said Dr. Bidard. “This is the first effort to engage breast cancer on such a large scale, and it would be impossible to do so with a technology other than ddPCR technology, which is cost-effective and offers a shorter turnaround time,” he added. 

The phase III PADA-1 clinical trial is ongoing and as of May 2018 more than 650 patients have been enrolled.

HPV ctDNA as a Biomarker to Predict Relapse after Chemoradiotherapy 

Following cancer treatment, detecting ctDNA with ddPCR can also help predict relapse. Patients with locally advanced anal squamous cell carcinoma associated with human papilloma virus (HPV) are typically treated with chemoradiotherapy as the standard of care. But following treatment, some patients relapse.

In one proof-of-concept study, physicians used ddPCR technology to detect HPV ctDNA and established it as an effective biomarker for screening high-risk patients for further systemic therapy.

A team at Institut Curie led by Dr. Luc Cabel, MD, used ddPCR to detect HPV-16 and HPV-18 ctDNA levels before and after chemotherapy. They demonstrated that the absence of residual ctDNA levels at the end of chemoradiotherapy was strongly associated with relapse-free survival. 

“The liquid biopsy approach indicates the potential of using HPV ctDNA as an efficient, low-cost, prognostic tool to determine which patients are high risk and may deserve further adjuvant treatment, for example, immune therapy with anti-PD-1/PD-L1 antibodies,” said Dr. Cabel. “Other applications, such as immune therapy monitoring and screening, are also very promising, and we plan to further develop this technique based on ddPCR technology in HPV-related diseases at different stages.”

Please visit bio-rad.com/digitalPCR to learn more about Bio-Rad’s Droplet Digital PCR technology presented at ASCO.

Bio-Rad, Droplet Digital PCR and ddPCR are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions. 

About Bio-Rad

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