In a phase III trial (PANOVA-3) reported in the Journal of Clinical Oncology, Babiker et al examined the survival benefit of using tumor treating fields (TTFields) with gemcitabine/nab-paclitaxel in patients with unresectable locally advanced pancreatic adenocarcinoma.
Study Details
In the global open-label trial, 571 patients with newly diagnosed unresectable locally advanced pancreatic adenocarcinoma were randomly assigned between May 2018 and March 2023 to receive gemcitabine at 1,000 mg/m2 and nab-paclitaxel at 125 mg/m2 once daily on days 1, 8, and 15 of 28-day cycles with (n = 285) or without (n = 286) TTFields. The primary endpoint was overall survival.
Key Findings
Median overall survival was 16.2 months (95% confidence interval [CI] = 15.0–18.0 months) in the TTFields group vs 14.2 months (95% CI = 12.8–15.4 months) in the control group (hazard ratio [HR] = 0.82, 95% CI = 0.68–0.99, P = .039). Rates at 1 year were 68.1% vs 60.2% (P = .029).
Median pain-free survival was 15.2 months (95% CI = 10.3–22.8 months) in the TTFields group vs 9.1 months (95% CI = 7.4–12.7 months) in the control group (HR = 0.74, 95% CI = 0.56–0.97, P = .027). Median distant progression-free survival was 13.9 months (95% CI = 12.2–16.8 months) in the TTFields group vs 11.5 months (95% CI = 10.4–12.9 months) in the control group (HR = 0.74, 95% CI = 0.57–0.96, P = .022).
No significant benefit of TTFields was observed for progression-free survival (median = 10.6 vs 9.3 months, HR = 0.85, P = .137), local progression-free survival (median = 12.5 vs 10.4 months, HR = 0.84, P = .151), or objective response rate (36.1% vs 30.0%, P = .094).
Device-related skin adverse events of any grade occurred in 76.3% of the TTFields group; grade ≥ 3 events were seen in 7.7% of patients, most commonly dermatitis (2.9%), rash (1.5%), and maculopapular rash (1.1%). TTFields-related adverse events resulted in a discontinuation of treatment in 8.4% of patients; chemotherapy adverse events resulted in a discontinuation of treatment in 17.2% vs 15.8% of patients.
The investigators concluded: “This study demonstrated significant [overall survival], pain-free survival, and distant [progression-free survival] benefits for TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in patients with unresectable [locally advanced pancreatic adenocarcinoma], with no additive systemic toxicity.”
Hani M. Babiker, MD, of the Mayo Clinic, Jacksonville, Florida, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Novocure Inc. For full disclosures of all study authors, visit ascopubs.org.
