KEY TAKEAWAYS
- The phase 2 trial aimed to investigate the safety and efficacy of combining FOLFIRINOX with HIFU in patients with LAPC/BRPC.
- Researchers noticed a promising partial response rate with FOLFIRINOX plus HIFU treatment for LAPC/BRPC patients.
FOLFIRINOX, a standard regimen for locally advanced pancreatic cancer (LAPC) and borderline resectable pancreatic cancer (BRPC), is often utilized for palliation and neoadjuvant treatment, respectively. Animal studies suggest that concurrent high-intensity focused ultrasound (HIFU) and chemotherapy may improve drug delivery to target tissues.
Dong Ho Lee and the team aimed to assess the safety and therapeutic efficacy of combining FOLFIRINOX with HIFU in LAPC or BRPC patients.
Researchers performed an inclusive analysis in a prospective single-center trial, enrolling 60 patients (M: F=35:25; median age, 67.0 years old) with LAPC (n=23) or BRPC (n=37). The median tumor size was 4.0 cm (IQR 2.7-4.6).
All patients were treated with FOLFIRINOX (oxaliplatin, 85mg/m2 of body-surface area; irinotecan, 180mg/m2; leucovorin, 400 mg/m2; and fluorouracil, 400 mg/m2 given as a bolus followed by 2400 mg/m2 given as a 46-hour continuous infusion) every 2 weeks until disease progression.
They combined HIFU in the first 4 cycles of chemotherapy with considering parameters such as intensity of 2.0 kw/cm2, duty cycle of 1%, exposure time of 3 seconds, and PRF of 10Hz. Follow-up contrast-enhanced CT was taken every 4 cycles for the response evaluation using response evaluation criteria for solid tumor 1.1. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. All analyses were intention-to-treat.
About 2 patients withdrew consent, and 2 patients could not complete the planned 4 cycles of FOLFIRINOX plus HIFU treatment due to sepsis from severe neutropenia related to chemotherapy. Among 56 patients who completed the 4 cycles of FOLFIRINOX plus HIFU and continued chemotherapy, partial response was achieved in 36 patients (60.0%, 36/60) and stable disease in 20 patients.
Regarding adverse effects (AE), 32 of 60 patients experienced grade 3 (n=22) or grade 4 (n=10) AE, all related to FOLFIRINOX chemotherapy. No AE related to HIFU was observed. The estimated OS was 94.8%, 75.9%, and 67.6% at 6-, 12-, and 18-months, respectively. The PFS of 6-, 12-, and 18-month PFS were 91.9%, 70.3%, and 56.2%, respectively.
The study concluded that FOLFIRINOX plus HIFU represents a safe and effective treatment for LAPC/BRPC, yielding a notable partial response rate of 60.0% without any additional AE related to chemotherapy.
The study was sponsored by Seoul National University Hospital
Source: https://meetings.asco.org/abstracts-presentations/229625
Clinical Trial: https://clinicaltrials.gov/study/NCT05262452
Lee D H, Lee J Y, Lee S H, et al. (2024). “FOLFIRINOX plus high intensity focused ultrasound for locally advanced/borderline resectable pancreatic ductal adenocarcinoma: A prospective single arm phase II trial.” Presented at ASCO GI 2024, Abstract(670).
