Pafolacianine (Cytalux), an intraoperative molecular imaging agent, has demonstrated a favorable safety profile in patients undergoing surgery for lung cancer, with no serious adverse effects observed to date. According to Colleen Gaughan, MD, a thoracic surgeon and chief of surgery at AdventHealth Celebration, the agent's safety has been consistent throughout its evaluation.
The agent comprises a folate analog and a dye, both of which are commonly used in other medical applications. The folate analog binds to folate receptors, while the dye facilitates visualization during surgery.
Most adverse effects associated with pafolacianine are mild and manageable. Common toxicities include injection site reactions such as flushing or itching, which are typically treated with diphenhydramine. Nausea, another reported side effect, is managed with anti-nausea medication. Importantly, no serious treatment-related adverse events have been observed since pafolacianine was first evaluated in lung cancer surgery patients.
ELUCIDATE Trial Safety Data
Safety data from the phase 3 ELUCIDATE trial, which included 112 patients with lung cancer, further supports the favorable safety profile of pafolacianine. The trial found no treatment-related serious adverse events associated with the use of pafolacianine.
Clinical Experience
"We are fortunate with the patients whom we have treated so far that we have not seen any serious adverse effects," Dr. Gaughan noted. "At this point, the medication has been used in over 700 patients in both clinical trials and in clinical practice…and we have not seen any serious adverse effects."
