Sorafenib Provides Safe, Long-Lasting Control in Older Patients With Renal Cell Carcinoma: Presented at ASCO-GU
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Sorafenib Provides Safe, Long-Lasting Control in Older Patients With Renal Cell Carcinoma: Presented at ASCO-GU

By Fred Gebhart

SAN FRANCISCO -- March 9, 2010 -- Earlier findings that sorafenib is safe and effective in older patients with renal cell carcinoma were confirmed by new data presented here at the 2010 ASCO Genitourinary Cancers Symposium (ASCO-GU).

Results from the small study also indicate that sorafenib gives long-lasting disease control in this age group.

“We have had very good responses to sorafenib in elderly patients,” said Angela Gernone, MD, Oncology Unit, Azienda Ospedaliera Policlinico Bari, Bari, Italy, on March 7. “The drug seems to be safer in older patients than it is in young people, or at least elderly patients tolerate the side effects better. These elderly patients take their drug more regularly, so the treatment benefit lasts longer.”

Dr. Gernone and colleagues performed an open-label study with 24 patients with metastatic renal cell carcinoma (age, >=65 y). Researchers followed patients from February 2007 through September 2009. Within the group, 11 patients were fit, 10 were unfit, and 3 were frail based on comprehensive geriatric assessment scores. Nineteen of the patients had a prior nephrectomy.

After 3 months of treatment, 14 patients (58%) showed a partial response, with a median duration of 20 months. Of the 14 responders, 6 (55%) were fit, 7 (70%) were unfit, and 1 (33%) was frail. The median duration of response was 21 months for fit patients, 23 months for unfit patients, and 16 months for the frail patient.

Seven patients (29%) had stable disease for a median of 22 months. Of the patients with stable disease, 3 (27%) were fit, 2 (20%) were unfit, and 2 (66%) were frail. Only 3 patients progressed, 2 fit (18%) and 1 unfit (10%), with a median time to progression of 9 months.

No grade 3 or 4 toxicities were found. Grade 1 and 2 toxicities included rash/desquamation, fatigue, hand-foot skin reaction, hypertension, diarrhoea, and bleeding. Three patients discontinued treatment because of hand-foot skin reactions. Seven patients reduced their dose from the standard 800 to 600 mg/day (21%) or to 400 mg/day (8%).

As of December 2009, 13 of the original 24 patients remained on sorafenib. Seven fit patients were taking the full 800-mg/day dose, 3 unfit patients were taking 800 mg/day, 2 unfit patients were taking 600 mg/day, and 1 frail patient was taking 400 mg/day.

“This appears to be a very good drug, even for some frail patients,” Dr. Gernone said. “Looking at the entire group, we saw a clinical benefit in 87% of patients. That is better than you will see in many younger patients.”

The conference is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO).

[Presentation title: Efficacy and Safety of Long-Term Use of Sorafenib (SOR) in Elderly Patients (pts) With Metastatic Renal Cell Carcinoma (mRCC). Abstract 412]

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