199P - Safety meta-analysis of clinical trials delivering TTFields to the upper torso

Date 05 April 2019
Event European Lung Cancer Congress 2019
Topics Mesothelioma
Radiation Oncology
Presenter Giovanni Luca Ceresoli
Citation Annals of Oncology (2019) 30 (suppl_2): ii72-ii73. 10.1093/annonc/mdz069
Authors G.L. Ceresoli1, M. Pless2
  • 1Humanitas Gavazzeni, 24125 - Bergamo/IT
  • 2Kantonsspital Winterthur, 8401 - Winterthur/CH

Abstract

Background

Tumor Treating Fields (TTFields), a non-invasive, loco-regional, antimitotic treatment approved for glioblastoma (GBM), are delivered via transducer arrays to tumor region. Localized dermatitis underneath the arrays were main adverse events (AEs) reported in phase 3 GBM trials. The safety of TTFields was analyzed in two phase I-II studies in non-small-cell lung cancer (NSCLC) [EF-15, NCT00749346] and malignant pleural mesothelioma (MPM) [STELLAR, NCT02397928].

Methods

TTFields studies in this pooled analysis were EF-15 (n=41, advanced NSCLC; plus pemetrexed) and STELLAR (n=80, MPM; plus platinum and pemetrexed). TTFields were applied 12 - 18 hours/day at a frequency of 150 kHz. 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 version 4.0).

Results

Patients were aged 27-78 years: STELLAR: 67 (27-78) and EF-15: 63 (44-78), ECOG 0-1; 7 patients in EF-15 had ECOG 2. The incidence of grade 1-2 gastrointestinal (GI) toxicities was 35%. The most common low grade GI toxicities were: nausea (17%), vomiting (6%), constipation (10%) and diarrhea (6%). Grade 1-2 general disorders (16% fatigue and 11% asthenia) were common. Dyspnea Grade 1-2 (12%) and Grade 3-4 (5%) were considered related to standard chemotherapy or underlying disease. Grade 1-2 cardiovascular AEs were 7%; one case of severe arrhythmia (atrial flutter) was unrelated to TTFields. The only common TTFields-related adverse event was dermatitis below the transducer arrays. 59% patients had dermatological AEs: 53% Grade 1-2 dermatitis, 4% grade 3 dermatitis and 11% Grade 1-2 pruritus.

Conclusions

Treatment of solid tumors with TTFields 150 kHz to the thorax did not result in serious AEs or treatment-related pulmonary, cardiac, hematological or gastrointestinal toxicities. Expected dermatological toxicity beneath the device transducer arrays was seen in 59% patients, and resolved after a short treatment break or termination of treatment. These safety results and encouraging survival outcomes support the potential use of TTFields therapy in NSCLC and mesothelioma.

Clinical trial identification

NCT00749346 and NCT02397928.

Editorial acknowledgement

Legal entity responsible for the study

Novocure.

Funding

Novocure.

Disclosure

G.L. Ceresoli: Travel support: Novocure. All other authors have declared no conflicts of interest.