Giovan Giuseppe Di Costanzo1, Andrea Casadei Gardini2, Giorgia Marisi3, Francesco Giuseppe Foschi4, Mario Scartozzi5, Rocco Granata6, Luca Faloppi5, Stefano Cascinu7, Nicola Silvestris8, Oronzo Brunetti8, Vincenzo Ostilio Palmieri9, Giorgio Ercolani10, Raffaella Tortora6. 1. Department of Transplantation - Liver Unit, Cardarelli Hospital, via A. Cardarelli 9, 80131, Naples, Italy. dicostanzogg@gmail.com. 2. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 3. Biosciences Laboratory, IRST IRCCS, Meldola, Italy. 4. DPT Internal Medicine, Faenza Hospital, AUSL Romagna, Forli, Faenza, Italy. 5. Department of Medical Oncology, University Hospital Cagliari, Cagliari, Italy. 6. Department of Transplantation - Liver Unit, Cardarelli Hospital, via A. Cardarelli 9, 80131, Naples, Italy. 7. Department of Hematology and Oncology, University Hospital, University of Modena and Reggio Emilia, Modena, Italy. 8. Medical Oncology Unit, Cancer Institute "Giovanni Paolo II", Bari, Italy. 9. Biomedical Sciences and Human Oncology, University of Bari, Bari, Italy. 10. Surgical Oncology, General Hospital Morgagni-Pierantoni, Forlì, Italy.
Abstract
BACKGROUND: Sorafenib is recommended for the treatment of advanced-stage hepatocellular carcinoma (HCC). Nonetheless, it is expensive, effective in few patients, and may cause significant adverse effects. Therefore, accurate selection of patients is needed. In a previous study, we constructed a simple scoring system to predict patients' outcomes based on the occurrence of sorafenib adverse effects. OBJECTIVE: The present study aimed to validate this scoring system in a real-life cohort of HCC patients. PATIENTS AND METHODS: Clinical records of 279 outpatients treated with sorafenib in eight Italian centers were retrospectively analyzed. Adverse effects considered to calculate the score were skin toxicity, diarrhea, and arterial hypertension, occurring during the first month of therapy. For each adverse effect, 1 point was assigned if present; and 0 points if absent (resulting in a total score between 0 and 3). RESULTS: Median overall survival (OS) was 10.8 months and median time to progression (TTP) was 5.1 months. At multivariate analysis, performance status, α-fetoprotein (AFP), and Child-Pugh score were independently associated with TTP and OS. A progressive increase of OS and TTP was observed in patients with scores from 0 to 3 (p < 0.001). Six-, 12-, and 24-month survival probabilities were 55.1, 24.5, and 7.9% in score 0 patients, and 100, 80.9, and 46.2% in score 3 patients, respectively. Complete response was observed in one patient (0.4%), partial responses in 41 (15.2%), and stable disease in 117 (43.5%). The disease control rate in patients with scores of 0, 1, 2, and 3 was 34.3, 51.6, 80.9, and 96.3%, respectively (p < 0.001). Complete or partial responses were not observed in score 0 patients. CONCLUSIONS: We have validated a useful scoring system to predict outcomes in sorafenib-treated HCC patients. This score is easy to calculate and suitable for implementation in daily clinical practice.
BACKGROUND: Sorafenib is recommended for the treatment of advanced-stage hepatocellular carcinoma (HCC). Nonetheless, it is expensive, effective in few patients, and may cause significant adverse effects. Therefore, accurate selection of patients is needed. In a previous study, we constructed a simple scoring system to predict patients' outcomes based on the occurrence of sorafenib adverse effects. OBJECTIVE: The present study aimed to validate this scoring system in a real-life cohort of HCC patients. PATIENTS AND METHODS: Clinical records of 279 outpatients treated with sorafenib in eight Italian centers were retrospectively analyzed. Adverse effects considered to calculate the score were skin toxicity, diarrhea, and arterial hypertension, occurring during the first month of therapy. For each adverse effect, 1 point was assigned if present; and 0 points if absent (resulting in a total score between 0 and 3). RESULTS: Median overall survival (OS) was 10.8 months and median time to progression (TTP) was 5.1 months. At multivariate analysis, performance status, α-fetoprotein (AFP), and Child-Pugh score were independently associated with TTP and OS. A progressive increase of OS and TTP was observed in patients with scores from 0 to 3 (p < 0.001). Six-, 12-, and 24-month survival probabilities were 55.1, 24.5, and 7.9% in score 0 patients, and 100, 80.9, and 46.2% in score 3 patients, respectively. Complete response was observed in one patient (0.4%), partial responses in 41 (15.2%), and stable disease in 117 (43.5%). The disease control rate in patients with scores of 0, 1, 2, and 3 was 34.3, 51.6, 80.9, and 96.3%, respectively (p < 0.001). Complete or partial responses were not observed in score 0 patients. CONCLUSIONS: We have validated a useful scoring system to predict outcomes in sorafenib-treated HCC patients. This score is easy to calculate and suitable for implementation in daily clinical practice.
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