The study results also showed that fatigue and hand-foot syndrome, the two most common toxicities, were significantly decreased when patients were switched from the 4/2 schedule to the 2/1 schedule (Table 1). In addition, the study showed that the median overall treatment duration was 13.5 months on the 4/2 schedule compared to 24.4 months on the 2/1 schedule.

“What matters is giving an adequate dose but balancing that with minimizing toxicity.  I think the 2/1 schedule does this, but more prospective investigation is needed,” said Dr. Rini in an interview with  “Other retrospective data have shown similar things, maybe not exactly the same schedule, but the same concept.  This will be very clinically relevant if we can show this schedule preserves efficacy and reduces toxicity.”

Continue Reading

The More Options for Patients, the Better

The latest data presented at the Genitourinary Cancers Symposium are suggesting that certain agents may be favorable for one patient but not for another. While the agents have unique safety profiles, but one drug may be more appropriate for in certain patients because of the drug-related adverse side effects.  Administering these agents in a specific sequence may also provide benefit.

Table 1. Comparison of Toxicities Experienced on a 4-weeks-on/2-weeks-off Schedule of Sunitinib Versus a 2-weeks-on/1-week-off Schedule 

Toxicity 4/2 Schedule (% of patients) 2/1 Schedule (% of patients)
Fatigue, all grades 52% 33%
Grade 3 fatigue 33% 14%
Hand-foot Syndrome, all grades  33% 14%
Grade 3 hand-foot syndrome 29% 0%

“We have found that some patients benefit from receiving one drug after another and the overall effect is to improve their survival,” said Robert Motzer, MD, who is attending physician at Memorial Sloan-Kettering Cancer Center, New York, NY.

Dr. Motzer presented new data on the efficacy and safety of tivozanib hydrochloride, an investigational agent for the treatment of mRCC, after disease has progressed on sorafenib.  Tivozanib is a potent, selective, tyrosine kinase inhibitor of all three vascular endothelial growth factor (VEG-F) receptors.2  In a phase III trial in patients with advanced RCC, tivozanib has been shown to have superior efficacy in terms of progression-free survival (PFS) as first-line therapy compared with sorafenib.3  In this trial, patients whose disease had progressed on sorafenib could receive tivozanib in an open-label, prospective multicenter extension of this study (TIVO-1).

Dr. Motzer reported preliminary efficacy and safety data for 156 patients who received tivozanib after disease progression on sorafenib.4  The group consisted of 111 men and 45 women, and the mean age was 60 years (range, 23-86 years).

“What we found in this population of patients was that there were responses, and most patients had some degree of tumor shrinkage with a median progression-free survival of patients on tivozanib after sorafenib at 8.4 months,” said Dr. Motzer told