The Lynx Group

Axitinib Promising Second-Line Treatment for Advanced Renal Carcinoma

December 2011, Vol 2, No 7

This is the first phase 3 clinical trial to compare the effectiveness of 2 second- generation antiangiogenic agents —axitinib and sorafenib—for meta - static renal-cell cancer, showing great promise for the investigational drug axitinib (Rini BI, et al. Lancet. 2011;378: 1931-1939).

This randomized trial included 723 patients (from 175 sites in 22 countries) with renal-cell carcinoma that had progressed despite the use of first-line therapy with sunitinib, bevacizumab plus interferon-alfa, temsirolimus, or cytokines. Patients were randomized to axitinib 5 mg initially and titrated up to 10 mg twice daily (N = 361) or to sorafenib 400 mg twice daily (N = 362).

The primary end point was progression- free survival (PFS). Secondary end points were overall survival (OS), objective response rate, response duration, and time to deterioration.

The median PFS was significantly (42%) longer with axitinib (6.7 months) than with sorafenib (4.7 months). In those who had previously received cytokines, the median PFS was 12.1 months with axitinib compared with 6.5 months sorafenib; in those who had previously received sunitinib it was 4.8 months versus 3.4 months, respectively.

The objective response rate was 19% with axitinib versus 9% with sorafenib. A total of 14 (4%) of the 359 patients who received axitinib and 29 (8%) of the 355 patients who received sorafenib discontinued treatment because of adverse effects. The most common adverse events reported were diarrhea, hypertension, and fatigue in the axitinib group and diarrhea, palmar- plantar erythrodysesthesia, and alopecia in the sorafenib group.

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