Oncology Learning NetworkFDA Approves Optune Pax® in Combination with Chemotherapy for Locally Advanced Pancreatic Cancer

The FDA approved Optune Pax (TTFields device) plus gemcitabine/nab-paclitaxel as first-line treatment for locally advanced pancreatic cancer, delivering a statistically significant 2-month overall survival gain over chemotherapy alone in 571 patients. This marks a meaningful new option in a disease with historically limited therapeutic progress.

🔬 CLINICAL CONSIDERATIONS

• Median OS improved from 14.2 to 16.2 months (ITT population; HR 0.82; P=.039): rising to 18.3 vs 15.1 months in protocol-adherent patients who received ≥28 days of device therapy
• 1-year survival increased from 60% to 68% in the ITT population, which is a clinically meaningful improvement for patients and families navigating treatment decisions
• Time to pain progression nearly doubled — 15.2 vs 9.1 months — a critical quality-of-life advantage in a symptom-heavy disease
• Skin adverse events affected 76% of patients under device arrays, with 7.7% reaching Grade ≥3, requiring proactive monitoring and patient preparation
• PFS, objective response rate, and tumor resectability showed no significant differences between arms: survival and pain benefits occur without enhanced tumor response

🎯 PRACTICE APPLICATIONS

• Identify eligible locally advanced pancreatic cancer patients initiating gemcitabine/nab-paclitaxel for Optune Pax candidacy assessment
• Counsel patients on the 76% skin AE rate under device arrays before initiating therapy to set realistic expectations
• Establish skin monitoring protocols for patients on TTFields to detect and manage Grade ≥3 dermatologic events early
• Frame the survival benefit accurately: device compliance (≥28 days) correlates with stronger outcomes in per-protocol analyses

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