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MO_16_2864 - Safety of TTFields applied to the torso: Meta-analysis of 176 patients from four phase I-II trials

Monday, October 22
10:45 AM - 12:15 PM
Location: Innovation Hub, Exhibit Hall 3

Safety of TTFields applied to the torso: Meta-analysis of 176 patients from four phase I-II trials
I. Vergote1, M. Benavides2, M. Pless3, and G. Ceresoli4; 1Universitaire Ziekenhuizen Leuven, Leuven, Belgium, 2Hospital Universitario Regional y Virgen de la Victoria, Andalucía, Spain, 3Chefarzt Medizinische Onkologie, Winterthur, Switzerland, 4Istituto Clinico Humanitas IRCCS, Rozzano (MI), Italy

Purpose/Objective(s): Tumor Treating Fields (TTFields) is a non-invasive, loco-regional, antimitotic treatment modality, approved for glioblastoma. TTFields are delivered to the tumor through transducer arrays applied non-invasively to the tumor region. In a phase 3 trial in newly diagnosed glioblastoma (GBM), TTFields added to temozolomide was not associated with any significant increase in systemic adverse events (AEs) versus temozolomide alone. The only treatment-related AE seen in TTFields-treated patients was localized dermatitis underneath the arrays. Mild-moderate dermatitis was reported in 52% of patients (2% had grade 3 skin toxicity). The safety of TTFields was investigated in four phase I-II studies in non-small-cell lung cancer (NSCLC), mesothelioma, pancreatic cancer and ovarian cancer.

Materials/Methods: TTFields studies included in analysis: EF-15 (n=41, advanced NSCLC; plus pemetrexed), PANOVA (n=40, advanced pancreatic adenocarcinoma; plus gemcitabine with or without nab-paclitaxel), STELLAR (n=64, malignant pleural mesothelioma; plus platinum and pemetrexed) and INNOVATE (n=31, recurrent ovarian carcinoma; combined with weekly paclitaxel). TTFields were applied 12 - 18 hours/day at frequency of 150-200 kHz per tumor histology. All patients received standard of care systemic chemotherapy for their disease in addition to TTFields. Severity and frequency of AEs, and association with TTFields treatment were evaluated (CTCAE criteria).

Results: The median age of patients was 69 (range: 41-81), 73 (49-81), 68 (43-78) and 60 (45-77) for EF-15, PANOVA, STELLAR and INNOVATE, respectively. Patients had an ECOG score of 0-1; 7 patients in the EF-15 study had ECOG 2. The incidence of grade 1-2 gastrointestinal (GI) toxicities was ≥5%: constipation (16%), diarrhea (14%), nausea (27%) and vomiting (13%). Grade 1-2 general disorders such as asthenia, fatigue and anorexia were common (<20%). Grade 3-4 dyspnea (6%) was reported in patients with lung tumors. These AEs were related to standard chemotherapy or underlying disease. The incidence of arrhythmias was ≤2% and none were severe. The only common TTFields-related adverse event was dermatitis beneath the transducer arrays. 50% patients had dermatological AEs: Grade 1-2 dermatitis in 50% of and grade 3 dermatitis in 6% of patients. 7% of patients complained of grade 1-2 pruritus. Dermatologic AEs were managed using published guidelines leading to full resolution in all cases.

Conclusion: Treatment of solid tumors with TTFields at 150-200 kHz to the lungs, abdomen and upper pelvis did not result in serious AEs or treatment related pulmonary, cardiac, hematological or gastrointestinal toxicity. Expected dermatological toxicity beneath the device transducer arrays was seen in 50% patients, and resolved after treatment termination.

Author Disclosure: I. Vergote: Consultant; Novocure, Amgen, Astra Zeneca, BMS, Eli Lilly. M. Benavides: None. M. Pless: None. G. Ceresoli: None.

Ignance Vergote

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