Abstract 4368
Background
Tumor Treating Fields (TTFields) are a non-invasive, antimitotic therapy delivered to the tumor via transducer arrays applied to the skin at tumor site. The only TTFields-related adverse event (AE) reported in clinical trials was localized dermatitis beneath the arrays. The safety of TTFields has also been investigated in glioblastoma, non-small-cell lung cancer (NSCLC), mesothelioma, pancreatic and ovarian cancer. This meta-analysis reported AEs in clinical studies with TTFields torso delivery.
Methods
192 patients from 4 pilot studies were included in the analysis: EF-15 (n = 41, advanced NSCLC), PANOVA-2 (n = 40, advanced pancreatic adenocarcinoma), STELLAR (n = 80, malignant pleural mesothelioma) and INNOVATE (n = 31, recurrent ovarian carcinoma). The frequency of TTFields applied was 150 kHz in all except 200 kHz in the INNOVATE study. All patients received standard of care systemic chemotherapy for their disease in addition to TTFields. Severity and frequency, of AEs were reported using CTCAE Version 4 and CTCAE 3 in EF-15. AEs were reported as incidence by body system and MedDRA terms.
Results
The median age was 63 (range: 44-78), 73 (49-81), 67 (27-78) and 60 (45-77) for EF-15, PANOVA-2, STELLAR and INNOVATE, respectively. Patients had an ECOG score of 0-1, except for 7 patients in the EF-15 study with ECOG score of 2. Low grade gastrointestinal (GI) toxicities reported with an incidence ≥5%: constipation (16%), diarrhea (14%), nausea (27%), vomiting (13%). None of the GI toxicities was associated with TTFields, and the incidence of high-grade GI toxicities did not reach 10%. Low grade disorders such as asthenia (12%), fatigue (18%) and anorexia (2%) were common (<20%) but not associated with TTFields. Both low and high grade dyspnea (11% and 5%, respectively) were reported. The incidence of arrhythmia was <2%. 58% of the patients had dermatological AE. Low grade dermatitis was reported in 53% and high grade in only 6%. 9% of patients reported low grade pruritus.
Conclusions
This meta-analysis detected no new safety signals in clinical studies where TTFields were applied to the torso. 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 identification
NCT: 01971281, 02244502; 02397928; 00749346.
Editorial acknowledgement
Legal entity responsible for the study
Novocure.
Funding
Novocure.
Disclosure
F. Grosso: Travel / Accommodation / Expenses: Novocure. G.L. Ceresoli: Travel / Accommodation / Expenses: Novocure. All other authors have declared no conflicts of interest.
Resources from the same session
3887 - First Real Life Data on Durvalumab after definitive concomitant ChemoRadiotherapy (cCRT) in unresectable Stage (St) III Non-Small Cell Lung Cancer (NSCLC) in France: Analysis of 591 patients (pts) enrolled in the French cohort (c) Temporary Authorization of Use (ATU)
Presenter: Virginie Avrillon
Session: Poster Display session 1
Resources:
Abstract
682 - EGFR Inhibitor Versus Chemotherapy as Adjuvant Treatment for Locally-advanced EGFR-mutant Non-Small Cell Lung Cancer
Presenter: Peng Xie
Session: Poster Display session 1
Resources:
Abstract
2509 - Afatinib in EGFR TKI-naïve patients with EGFR mutation-positive (EGFRm+) NSCLC: interim analysis of a Phase IIIb, multi-national, open-label study
Presenter: Filippo de Marinis
Session: Poster Display session 1
Resources:
Abstract
3300 - First-line ceritinib versus chemotherapy in patients (pts) with advanced ALK rearranged (ALK+) non-small cell lung cancer (NSCLC): ASCEND-4 Asian subgroup analysis
Presenter: Daniel SW Tan
Session: Poster Display session 1
Resources:
Abstract
2653 - A combined analysis of two Phase IIIb studies of afatinib in EGFR TKI-naïve patients (pts) with EGFR mutation-positive (EGFRm+) NSCLC
Presenter: Filippo de Marinis
Session: Poster Display session 1
Resources:
Abstract
3663 - Impact of plasma EGFR mutation fractions on response to first generation tyrosine-kinase inhibitor in treatment of naïve non-small cell lung cancer patients
Presenter: Xiaohong Wang
Session: Poster Display session 1
Resources:
Abstract
5921 - Definition of an afatinib trough concentration threshold in the treatment of NSCLC
Presenter: Stephane Bouchet
Session: Poster Display session 1
Resources:
Abstract
2852 - A Phase Ib Trial of Neoadjuvant Chemoradiotherapy and Durvalumab(MEDI4736) for Potentially Resectable stage III Non-Small Cell Lung Cancer (NSCLC)
Presenter: Beung chul AHN
Session: Poster Display session 1
Resources:
Abstract
3273 - Low expression of Notch1 and combined Notch1/HES1 are associated with adverse survival factor for limited stage small cell lung cancer
Presenter: Jinsoo Lee
Session: Poster Display session 1
Resources:
Abstract
5141 - Mutational profiling of tumor tissue and sequential plasma illustrates emergent clones during treatment in late stage small cell lung cancer (SCLC)
Presenter: Stephanie Yaung
Session: Poster Display session 1
Resources:
Abstract