Tumor Treating Fields Concomitant with Sorafenib in Advanced Hepatocellular Cancer: Results of the HEPANOVA Phase II Study

Cancers

Eleni Gkika¹  Anca-Ligia Grosu¹  Monika Pazgan-Simon²  Thomas Seufferlein³  Antonio Cubillo Gracián⁴  Teresa Macarulla Mercade⁵  Michael Schultheiß⁶  Thomas B. Brunner⁷  Yann Touchefeu⁸ 

[1] Department for Radiation Oncology, University Medical Centre Freiburg, Robert-Koch-Straße 3, 79106 Freiburg, Germany;Department of Infectious Diseases and Hepatology, Wroclaw Medical University, 50-367 Wrocław, Poland;Department of Internal Medicine, University Hospital Ulm, 89081 Ulm, Germany;Department of Medical Oncology, Centro Integral Oncológico Clara Campal HM CIOCC, Hospital Universitario HM Sanchinarro, 28050 Madrid, Spain;Department of Medical Oncology, Vall d’Hebrón University Hospital and Vall d’Hebrón Institute of Oncology, 08035 Barcelona, Spain;Department of Medicine II, University Hospital Freiburg, 79106 Freiberg, Germany;Department of Radiotherapy, University Hospital Magdeburg, 39120 Magdeburg, Germany;Nantes Université, CHU Nantes, Institut des Maladies de l’Appareil Digestif (IMAD), Hépato-Gastroentérologie, Inserm CIC 1413, F-44000 Nantes, France;

关键词: hepatocellular carcinoma (HCC);    liver cancer;    solid tumor;    sorafenib;    TTFields;   

DOI  :  10.3390/cancers14061568

来源: DOAJ

【 摘 要 】

Advanced hepatocellular carcinoma (HCC) is an aggressive disease associated with poor prognosis. Tumor Treating Fields (TTFields) therapy is a non-invasive, loco-regional treatment approved for glioblastoma and malignant pleural mesothelioma. HCC preclinical and abdominal simulation data, together with clinical results in other solid tumors, provide a rationale for investigating TTFields with sorafenib in this patient population. HEPANOVA was a phase II, single arm, historical control study in adults with advanced HCC (NCT03606590). Patients received TTFields (150 kHz) for ≥18 h/day concomitant with sorafenib (400 mg BID). Imaging assessments occurred every 12 weeks until disease progression. The primary endpoint was the overall response rate (ORR). Safety was also evaluated. Patients (n = 27 enrolled; n = 21 evaluable) had a poor prognosis; >50% were Child–Turcotte–Pugh class B and >20% had a baseline Eastern Clinical Oncology Group performance status (ECOG PS) of 2. The ORR was higher, but not statistically significant, for TTFields/sorafenib vs. historical controls: 9.5% vs. 4.5% (p = 0.24), respectively; all responses were partial. Among patients (n = 11) with ≥12 weeks of TTFields/sorafenib, ORR was 18%. Common adverse events (AEs) were diarrhea (n = 15/27, 56%) and asthenia (n = 11/27, 40%). Overall, 19/27 (70%) patients had TTFields-related skin AEs; none were serious. TTFields/sorafenib improved response rates vs. historical controls in patients with advanced HCC, with no new safety concerns or related systemic toxicity.

【 授权许可】

Unknown