Focused ultrasound may enhance chemotherapy, survival outcomes for pancreatic cancer

A phase 2 clinical trial published in the European Journal of Cancer suggests that a novel form of focused ultrasound combined with standard FOLFIRINOX chemotherapy may improve tumor response and survival outcomes in patients with either borderline resectable pancreatic cancer or locally advanced pancreatic cancer, with a safety profile comparable to chemotherapy alone.

Led by Jae Young Lee, MD, Ph.D., and colleagues at Seoul National University Hospital in South Korea, the study enrolled 60 participants with borderline resectable pancreatic cancer or locally advanced pancreatic cancer. Fifty-six patients completed four cycles of focused ultrasound plus FOLFIRINOX and were compared with 56 patients from a propensity score–matched historical cohort treated with FOLFIRINOX alone.

Key findings included:

• Higher tumor response: Objective response rate (tumor shrinkage) was 64.3% for participants treated with FUS plus FOLFIRINOX versus 35.7% for those treated with FOLFIRINOX alone.
• Longer survival: Median overall survival was 24.0 months versus 17.0 months, and median progression-free survival was 16.0 months versus 11.0 months. Even modest gains in survival are considered meaningful for pancreatic cancer, one of the deadliest and most difficult-to-treat cancers.
• More patients became eligible for surgery: 52% of participants receiving the combination therapy went on to curative-intent surgery, compared with 30% of those receiving chemotherapy alone.
• Comparable safety: There were no focused ultrasound–related adverse events during posttreatment monitoring and no collateral organ injuries during follow-up.

Subgroup analysis showed a significant overall survival improvement in participants with borderline resectable pancreatic cancer (26.0 versus 20.0 months). Participants with locally advanced pancreatic cancer also had longer median overall survival with the combination therapy (19.0 versus 13.0 months), but this difference was not statistically significant.

“We are encouraged by these phase 2 results, which suggest that nonthermal, focused ultrasound may help improve the effectiveness of FOLFIRINOX without adding toxicity or side effects. For patients with borderline resectable or locally advanced pancreatic cancer, improving tumor response and creating more opportunities for curative-intent surgery can be clinically important,” said Lee. “These findings are an important step, and we are now focused on confirming the benefit in a randomized phase 3 clinical trial.”

“One of the greatest promises of this unique form of focused ultrasound is its ability to make existing therapies more effective without adding complications for patients,” said Neal F. Kassell, MD, founder and chairman of the Focused Ultrasound Foundation. “Lee’s results provide encouraging clinical evidence that this new form of focused ultrasound may enhance the delivery and effectiveness of chemotherapy for pancreatic cancer, bringing us closer to better outcomes for patients facing this devastating disease.”

The authors noted that the study was exploratory and used a propensity score–matched historical control rather than a randomized control group. They concluded that these findings support evaluation in a randomized phase 3 trial—which is currently being organized—to confirm the benefit and establish the clinical value of adding focused ultrasound to FOLFIRINOX for the treatment of pancreatic cancer.

Provided by
Focused Ultrasound Foundation

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Lisa Lock

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Robert Egan

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