Background: Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, utilizing low intensity alternating electric fields delivered non-invasively to the tumor using a portable medical device. TTFields are approved by the FDA for the treatment of glioblastoma and malignant pleural mesothelioma. In vitro and invivoTTFields at 150 kHz reduced the proliferative potential of hepatocelluar carcinoma (HCC) cell lines. Most HCC patients are not amenable to curative therapies and are treated with systemic chemotherapy following failure of local treatment options. The HEPANOVA Phase II trial (NCT03606590) is a prospective, single-arm study investigating the safety and efficacy of TTFields as a treatment option for advanced HCC concomitant with sorafenib in 25 patients. We present the interim saftey data of the HEPANOVA trial.
Methods: Incidence and severity of adverse events of the first nine patients who have been enrolled in the HEPANOVA Phase II trial were analyzed based on the MedDRA body system (system organ class) and preferred terms.
Results: The median age was 70 (range 63-85), all the patients were male, 3 (33.3%) patients had an ECOG score of 0. The median number of prior treatments was 2 (0-6) and median time from diagnosis was 9 (0-56) months. Five (55.6%) patients had Barcelona Clinic Liver Cancer (BCLC) stage B disease. The median treatment duration was 2 months for sorafenib and 3 months for TTFields. The total TTFields treatment duration for all nine patients was 29.1 months. Six (66.7%) patients had severe AEs (grade 3-4) and 3 (33.3%) had serious adverse events (SAE), none of which were related to TTFields. Mild-moderate skin toxicity was the only TTFields-related AE, reported in seven (78%) patients.
Conclusions: No unanticipated serious adverse device effects have been reported to date in the HEPANOVA study. The majority of AEs reported to date were expected and associated with the disease or chemotherapy. The most common adverse event reported was the expected TTFields-related dermatitis. In summary, these results emphasize the tolerably and safety of TTFields (150 kHz) concomitant with sorafenib in advanced hepatocellular carcinoma.
Citation Format: Eleni Gkika, Thomas Brunner, Robert Thimme, Anca-Ligia Grosu. HEPANOVA: Interim safety analysis from a phase 2 study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with sorafenib in advanced hepatocellular carcinoma (HCC) [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT186.