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
5638 - Incidence of Vascular Thromboembolism Events in Cancer Patients Receiving Immunotherapy: A Single Institution Experience.
Presenter: Laura Gutiérrez Sainz
Session: Poster Display session 1
Resources:
Abstract
5182 - High Incidence of Venous Thromboembolic Events (VTE) in Patients with Diffuse Large B-Cell Lymphoma.
Presenter: Alaa Abufara
Session: Poster Display session 1
Resources:
Abstract
1504 - Weight Loss over Time in Non-Small Cell Lung Cancer: Results from a Landmark Analysis of 800+ Prospectively-Treated Patients
Presenter: Jennifer Le-rademacher
Session: Poster Display session 1
Resources:
Abstract
3972 - The prognostic significance of preoperative nutritional status in resected pancreatic ductal adenocarcinoma (PDAC).
Presenter: Salvatore Paiella
Session: Poster Display session 1
Resources:
Abstract
2313 - Impact of Timing and Technique of Gastrostomy Placement on the Outcome of Patients (pts) with Head and Neck Cancer (HNC)
Presenter: M Julia Lostes Bardaji
Session: Poster Display session 1
Resources:
Abstract
5219 - Clinical & nutritional determinants of quality of life in patients with incurable cancer
Presenter: Louise Daly
Session: Poster Display session 1
Resources:
Abstract
4075 - Loss of skeletal muscle mass during palliative chemotherapy is a poor prognostic factor in patients with advanced gastric cancer
Presenter: In Gyu Hwang
Session: Poster Display session 1
Resources:
Abstract
4159 - Impact of nutritional derangement on treatment outcome in advanced non-small-cell lung cancer (A-NSCLC) patients (pts).
Presenter: Ilaria Trestini
Session: Poster Display session 1
Resources:
Abstract
1210 - Sarcopenia and pretreatment anemia as prognostic factors for patients with localized muscle invasive bladder cancer treated by neoadjuvant chemotherapy and radical cystectomy
Presenter: Emilien Billon
Session: Poster Display session 1
Resources:
Abstract
2490 - Gender effect on the pharmacokinetics (PK) and pharmacodynamics (PD) of anamorelin (ANAM) in healthy volunteers and cancer patients with cachexia
Presenter: Stein Kaasa
Session: Poster Display session 1
Resources:
Abstract