Phase II study of sorafenib in patients with relapsed or refractory lymphoma

Anna Guidetti, Carmelo Carlo-Stella, Silvia L. Locatelli, Walter Malorni, Marina Pierdominici, Cristiana Barbati, Roberta Mortarini, Lilli Devizzi, Paola Matteucci, Alfonso Marchianò, Rodolfo Lanocita, Lucia Farina, Anna Dodero, Corrado Tarella, Massimo Di Nicola, Paolo Corradini, Andrea Anichini, Alessandro M. Gianni

Research output: Contribution to journalArticlepeer-review


The safety and activity of the multikinase inhibitor sorafenib were investigated in patients with relapsed or refractory lymphoproliferative disorders who received sorafenib (400 mg) twice daily until disease progression or appearance of significant clinical toxicity. The primary endpoint was overall response rate (ORR). Biomarkers of sorafenib activity were analysed at baseline and during treatment. Thirty patients (median age, 61 years; range, 18-74) received a median of 4 months of therapy. Grade 3-4 toxicities included hand/foot skin reactions (20%), infections (12%), neutropenia (20%) and thrombocytopenia (14%). Two patients achieved complete remission (CR), and two achieved partial remission (PR) for an ORR of 13%. Stable disease (SD) and progressive disease (PD) was observed in 15 (50%) and 11 patients (37%), respectively. The median overall survival (OS) for all patients was 16 months. For patients who achieved CR, PR and SD, the median time to progression and OS was 5 and 24 months, respectively. Compared with patients with PD, responsive patients had significantly higher baseline levels of extracellular signal-regulated kinase phosphorylation and autophagy and presented a significant reduction of these parameters after 1 month of therapy. Sorafenib was well tolerated and had a clinical activity that warrants development of combination regimens.

Original languageEnglish
Pages (from-to)108-119
Number of pages12
JournalBritish Journal of Haematology
Issue number1
Publication statusPublished - Jul 2012


  • Biomarkers
  • Lymphoma
  • Sorafenib
  • Targeted therapy
  • Tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Hematology


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