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Targeted Oncology

, Volume 12, Issue 6, pp 795–803 | Cite as

Validation of a Simple Scoring System to Predict Sorafenib Effectiveness in Patients with Hepatocellular Carcinoma

  • Giovan Giuseppe Di Costanzo
  • Andrea Casadei Gardini
  • Giorgia Marisi
  • Francesco Giuseppe Foschi
  • Mario Scartozzi
  • Rocco Granata
  • Luca Faloppi
  • Stefano Cascinu
  • Nicola Silvestris
  • Oronzo Brunetti
  • Vincenzo Ostilio Palmieri
  • Giorgio Ercolani
  • Raffaella Tortora
Original Research Article

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.

Notes

Author’s Contribution

G.G.D. and R.T. designed the study’s concept. R.T, A.C.G., G.M., F.G.F., L.P., S.C., N.S., V.O.P, G.E., and O.B. contributed to the data collection and analysis. G.G.D. drafted the manuscript. G.G.D. and R.G. revised the manuscript.

Compliance with Ethical Standards

Funding

No funding was received for the preparation of this article.

Conflicts of Interest

The authors declare no conflicts of interest.

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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Giovan Giuseppe Di Costanzo
    • 1
  • Andrea Casadei Gardini
    • 2
  • Giorgia Marisi
    • 3
  • Francesco Giuseppe Foschi
    • 4
  • Mario Scartozzi
    • 5
  • Rocco Granata
    • 1
  • Luca Faloppi
    • 5
  • Stefano Cascinu
    • 6
  • Nicola Silvestris
    • 7
  • Oronzo Brunetti
    • 7
  • Vincenzo Ostilio Palmieri
    • 8
  • Giorgio Ercolani
    • 9
  • Raffaella Tortora
    • 1
  1. 1.Department of Transplantation – Liver UnitCardarelli HospitalNaplesItaly
  2. 2.Department of Medical OncologyIstituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCSMeldolaItaly
  3. 3.Biosciences Laboratory, IRST IRCCSMeldolaItaly
  4. 4.DPT Internal MedicineFaenza HospitalFaenzaItaly
  5. 5.Department of Medical OncologyUniversity Hospital CagliariCagliariItaly
  6. 6.Department of Hematology and OncologyUniversity Hospital, University of Modena and Reggio EmiliaModenaItaly
  7. 7.Medical Oncology UnitCancer Institute “Giovanni Paolo II”BariItaly
  8. 8.Biomedical Sciences and Human OncologyUniversity of BariBariItaly
  9. 9.Surgical OncologyGeneral Hospital Morgagni-PierantoniForlìItaly

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