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
2728 - MicroRNA expression and DNA methylation profiles do not distinguish between primary and recurrent well-differentiated liposarcoma
Presenter: Melissa Vos
Session: Poster Display session 1
Resources:
Abstract
3197 - Genomic Alterations, Tumor Mutation Burden and Prognosis of Chinese Cardiac Sarcoma Patients
Presenter: Na Zhu
Session: Poster Display session 1
Resources:
Abstract
4214 - Evaluation of a peptide-conjugated alkylator melflufen in osteosarcoma preclinical models
Presenter: Konstantin Byrgazov
Session: Poster Display session 1
Resources:
Abstract
2654 - Expression analysis of NHEJ and HR genes in Ewing sarcomas: indications of DSB repair dysfunction
Presenter: Anastasios Kyriazoglou
Session: Poster Display session 1
Resources:
Abstract
4383 - Epidemiology of Synovial Sarcoma in EU28 countries
Presenter: Nedra Joseph
Session: Poster Display session 1
Resources:
Abstract
1937 - Resection Of High-Grade Large Soft Tissue Sarcoma With Adequate Wide Margin Can Lead To Good Local Control Without Adjuvant Radiotherapy
Presenter: Toshiyuki Kunisada
Session: Poster Display session 1
Resources:
Abstract
3757 - Influence of eribulin on proliferation, migration and invasion properties of leiomyosarcoma cell line models
Presenter: Marta Mendiola
Session: Poster Display session 1
Resources:
Abstract
1040 - EREMISS: Efficacy of regorafenib (REG) as maintenance therapy in non-adipocytic soft tissue sarcomas (STS) having received 1st-line doxorubicin-based chemotherapy (Doxo-CT)
Presenter: Nicolas Penel
Session: Poster Display session 1
Resources:
Abstract
1048 - A Phase 2 biomarker-driven study evaluating the clinical efficacy of an MDM2 inhibitor, milademetan, in patients with intimal sarcoma, a disease with a high unmet need
Presenter: Kan Yonemori
Session: Poster Display session 1
Resources:
Abstract
1511 - A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010)
Presenter: Herbert Loong
Session: Poster Display session 1
Resources:
Abstract