Meta-analysis of toxicity data in thoracic and abdominal malignancies from: Clinical trials in tumor treating fields.

Ignace Vergote BGOG and University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium info_outline Ignace Vergote, Fernando Rivera, Miklos Pless, Giovanni L. Ceresoli

Authors Ignace Vergote BGOG and University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium info_outline Ignace Vergote, Fernando Rivera, Miklos Pless, Giovanni L. Ceresoli Organizations BGOG and University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium, Hospital Universitario Marqués de Valdecilla, Santander, Spain, Department of Oncology, Kantonsspital Winterthur, Winterthur, Switzerland, Istituto Clinico Humanitas IRCCS, Rozzano (mi), Italy Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: Tumor Treating Fields (TTFields) are a non-invasive, loco-regional, antimitotic treatment modality, which has been approved for the treatment of glioblastoma (GBM) by the FDA. Mild-moderate localized dermatitis was reported in 52% of newly diagnosed GBM patients treated in the EF-14 [NCT0091640] phase 3 trial (with only 2% having Grade 3 skin toxicity). The toxicity of TTFields has been investigated in a number of pilot studies for malignancies located outside of the brain, and here we present a meta-analysis of toxicities reported in them. Methods: A total of 192 patients from four pilot clinical studies in the following malignancies were included: Advanced lung cancer, advanced pancreatic cancer, pleural mesothelioma and recurrent ovarian cancer. All patients received chemotherapy in addition to TTFields. Adverse events (AEs) and their association with the treatment were evaluated using CTCAE Criteria. Toxicities were reported as incidence by body system and MedDRA term out of the number of patients who received any amount of TTFields treatment. Results: The median age of patients was 63 (range: 44-78), 73 (49-81), 67 (27-78) and 60 (45-77) for EF-15 [NCT00749346], PANOVA [NCT01971281], STELLAR [NCT02397928] and INNOVATE [NCT02244502], respectively. The incidence of several low grade gastrointestinal (GI) toxicities was ≥5%: constipation (16%), diarrhea (14%), nausea (27%), vomiting (13%). None of the GI toxicities was associated with TTFields. Low grade general disorders such as asthenia (12%) and fatigue (18%) were common but not associated with TTFields. The incidence of arrhythmias was ≤2%. 58% of the patients had dermatological AEs, but only 6% had grade 3 dermatitis. 9% of patients had low grade pruritus. Conclusions: No new safety signals associated with TTFields were identified in this meta-analysis. The incidence of TTFields-related skin toxicity was similar to that reported in glioblastoma patients. The application of TTFields to the torso is safe. Clinical trial information: [NCT00749346], [NCT01971281], [NCT02397928], [NCT02244502].