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Sorafenib Safe and Effective in Elderly Patients With Metastatic Renal Cell Carcinoma: Presented at EMUC

By Chris Berrie

BARCELONA, Spain -- December 1, 2009 -- Sorafenib therapy is safe and effective, with evidence of long-lasting disease control in elderly patients with metastatic renal cell carcinoma (mRCC), according to research presented at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC).

On the basis of increasing incidence of RCC with age, the objective of this retrospective, subset analysis was to assess the safety and efficacy of sorafenib in patients older than 65 years of age with mRCC, noted principal investigator Angela Gernone, MD, Universitaria Azienda Ospedaliera Policlinico, Bari, Italy, speaking here on November 27.

Twenty-two elderly patients (male, 82%) had a median age of 72 years and Eastern Cooperative Oncology Group performance status of 1, with 86% having undergone prior nephrectomy. The locations of metastases were varied (bone, 18%; lymph nodes, 23%; lung, 36%; liver, 27%), with about 50% of patients having a single site of metastasis, and about 20% with 3 or more sites.

Dr. Gernone noted that "many of our patients had been treated before with chemotherapy and immunotherapy."

All of these patients underwent comprehensive geriatric assessment according to risk stratification to determine them "fit," "unfit," or "frail," with 12 patients being considered "fit" and 10 "unfit."

During initial continuous dosing with sorafenib 400 mg twice daily, subjects were assessed every 3 months by computed tomography. For continuing sorafenib therapy, 32% remained on 400 mg twice daily, with 27% on 600 mg twice daily, and 18% on 200 mg twice daily.

The first primary endpoint of response rate according to Response Evaluation Criteria in Solid Tumours saw no complete responses; 13 (59%) partial responses were seen, however, and a further 6 (27%) patients had stable disease, providing a clinical benefit of 86%.

The second primary endpoint was time to progression. The partial and stable responses showed median durations of 22 months and 23 months, respectively. Indeed, as Dr. Gernone stressed, "We have very long stabilisation of the disease, and this is good for people who have been treated before."

In the safety assessment, the main grade 1/2 drug-related adverse events seen were fatigue (27%), hand-foot skin reaction (22%), rash/desquamation (18%), hypertension (13%), and diarrhoea and bleeding (9% each). Three patients died following disease progression without responding to therapy, and 2 discontinued treatment due to hand-foot skin reaction.

"In the younger patients, we had many problems, with the toxicity very high, but in older people, the drug is safe, and the quality of life is good considering that they are metastatic patients," Dr. Gernone noted. He concluded that sorafenib is considered a useful treatment for both fit and unfit elderly patients with mRCC.

EMUC was co-organised by the European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), and the European Society for Therapeutic Radiology and Oncology (ESTRO).

[Presentation title: Efficacy and Safety of Long-Term Use of Sorafenib (SOR) in Elderly Patients (pts) With Metastatic Renal Cell Carcinoma (mRCC). Abstract 090]

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