Fabian Finkelmeier1, Carolin Czauderna2, Lukas Perkhofer3, Thomas J Ettrich3, Jörg Trojan4, Arndt Weinmann2, Jens U Marquardt2, Johannes Vermehren4, Oliver Waidmann4. 1. Department of Gastroenterology, Hepatology and Endocrinology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany. fabian.finkelmeier@kgu.de. 2. Department of Gastroenterology and Hepatology, University Hospital Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. 3. Medical Clinic I, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. 4. Department of Gastroenterology, Hepatology and Endocrinology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.
Abstract
INTRODUCTION: Nivolumab is the first checkpoint-inhibitor approved for the treatment of advanced HCC patients. Real-life experience data of nivolumab treatment in HCC patients, especially those with advanced liver disease, is scarce. MATERIALS AND METHODS: All patients with confirmed advanced HCC and nivolumab treatment from three large German centers were retrospectively analyzed. Clinical parameters and outcome were assessed. RESULTS: A total of 34 patients were included. At the time of treatment initiation 5 patients (14.7%) were classified as stage BCLC B and 29 (85.3%) BCLC C, respectively. 25 (73.5) patients had received prior sorafenib treatment. All patients presented with cirrhosis, namely Child-Pugh stages A (56%) or B (41%), respectively. At time of patient's assessment, 20 out of 34 (58.8%) patients had died. Grade 3 toxicities occurred in two patients (5.9%). Best overall responses were partial response in four patients (11.8%) and stable disease in eight patients (23.5%). The median overall survival of the whole cohort was 7.5 weeks (range 0-46). Child-Pugh B stage disease at treatment start was significantly associated with poor outcome. DISCUSSION: Nivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.
INTRODUCTION:Nivolumab is the first checkpoint-inhibitor approved for the treatment of advanced HCC patients. Real-life experience data of nivolumab treatment in HCC patients, especially those with advanced liver disease, is scarce. MATERIALS AND METHODS: All patients with confirmed advanced HCC and nivolumab treatment from three large German centers were retrospectively analyzed. Clinical parameters and outcome were assessed. RESULTS: A total of 34 patients were included. At the time of treatment initiation 5 patients (14.7%) were classified as stage BCLC B and 29 (85.3%) BCLC C, respectively. 25 (73.5) patients had received prior sorafenib treatment. All patients presented with cirrhosis, namely Child-Pugh stages A (56%) or B (41%), respectively. At time of patient's assessment, 20 out of 34 (58.8%) patients had died. Grade 3 toxicities occurred in two patients (5.9%). Best overall responses were partial response in four patients (11.8%) and stable disease in eight patients (23.5%). The median overall survival of the whole cohort was 7.5 weeks (range 0-46). Child-Pugh B stage disease at treatment start was significantly associated with poor outcome. DISCUSSION: Nivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.
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