A Phase II trial of dosage escalation of sorafenib in Asian patients with metastatic renal cell carcinoma
Abstract
ABSTRACT
Aim: To investigate the role of sorafenib dosage escalation in Asian patients with metastatic renal cell carcinoma that had progressed after routine dosages. Patients & methods: Sorafenib dosage escalation to 600 or 800 mg twice a day was offered to 41 patients with metastatic renal cell carcinoma who had progressed on normal dosages. Clinical outcome, toxicity and favorable clinical covariables for progression-free survival (PFS) were evaluated. Results: The median PFS with dosage-escalated therapy was 7 months. Drug-related adverse events were tolerable. The pre-escalation Karnofsky performance status, serum calcium concentration, neutrophil/lymphocyte ratio, PFS and the highest toxicity grade at the routine dosage were associated with a longer PFS in the dosage-escalation period. Conclusion: Sorafenib dosage escalation was efficacious and tolerable in Asian patients. Trial registration: Chinese Clinical Trial Registry (no. ChiCTR-ONRC-12002088).
Papers of special note have been highlighted as: • of interest; •• of considerable interest.
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