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Sorafenib improved progression, no effect on survival in lung cancer
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More than half of patients with non–small cell lung cancer and KRAS mutation assigned to sorafenib had no progression at 6 weeks, but that did not translate into improved survival, according to recently released results from a single-arm phase 2 study.
The reported rate of non-progression at 6 weeks was 52.6% for patients assigned to daily sorafenib (Nexavar, Bayer). Median PFS was 2.3 months, and median OS was 4.9 months.
“There is a great need for targeted treatment options for patients with non–small cell lung cancer with a KRAS mutation,” Wouter W. Mellema, MD, said in a press release. “Sorafenib could be a useful drug in this patient population by inhibiting the growth-stimulating signal of the RAS protein. However, although sorafenib showed relevant activity, the outcome was unsatisfactory.”
Mellema, a doctoral candidate at VU University Medical Center in Amsterdam, presented the results at the AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer: Biology, Therapy and Personalized Medicine in San Diego.
In the study, 57 patients were assigned to 400 mg daily sorafenib. The median duration of treatment was 9 weeks, and the median duration of response was 32 weeks.
Twenty-one patients required dose modifications, four of whom discontinued treatment. Fifteen patients discontinued treatment before 6 weeks, 10 of those for clinical progression.
Mellema said two patients were still on treatment and 14 were still alive.
Five patients reported grade-3 skin toxicity, four had grade-3 gastrointestinal toxicity and one patient had both grade-3 metabolic abnormalities and a grade-3 pneumonitis. The most common adverse events included fatigue (6.4%), hand-foot reaction (5.7%) and dyspnea (5.6%).
For more information:
- Mellema WW. #PR5. Presented at: the 2011 AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer: Biology, Therapy and Personalized Medicine; Jan. 8-11, 2012; San Diego.
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In the absence of a placebo or chemotherapy control group, we cannot say that progression was, in fact, delayed. The data in PFS and OS, especially in the absence of RECIST criteria responses, does not encourage further study of sorafenib as a single agent in this setting.
Miguel A. Villalona, MD
Director of Solid Tumor Experimental Therapeutics
Division Director of Medical Oncology
The Ohio State University
Comprehensive Cancer Center
Disclosure: Dr. Villalona reported receiving past research funding from Onyx Pharmaceuticals.
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