Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma.

BACKGROUND: Immunotherapy is generally ineffective in patients with sarcomatoid renal cell carcinoma (RCC) and in patients with rapidly progressive metastatic or locally recurrent disease, with a median time to progression of approximately 2 months and a median survival of 4-7 months. Gemcitabine-based regimens have modest antitumor activity, whereas doxorubicin is often used to treat sarcomatoid RCC. Based on the antitumor activity of doxorubicin and gemcitabine in collecting duct carcinoma of the kidney, the authors used this combination to treat selected patients with sarcomatoid or rapidly progressing RCC.

METHODS: Eighteen patients (11 males and 7 females; median age, 53 years; range, 31-81 years) with RCC (56% sarcomatoid; 44% other) were treated at 2 institutions in a collaborative study that was not institutional review board reviewed. Seven patients received previous treatment with interferon or interleukin-2. Sites of metastases included the lung, soft tissue, bone, liver, and brain with 88% of patients having > or = 3 sites of disease. Treatment consisted of doxorubicin (50 mg/m2) and gemcitabine (1500 or 2000 mg/m2) every 2-3 weeks with granulocyte-colony-stimulating factor support.

RESULTS: A median of 5 courses was administered (range, 2-12 cycles). Therapy was well tolerated with no Grade 4 toxicities. Two patients had a complete response, five had a partial response, three had a mixed response, and one had stable disease. The median duration of response was 5 months (range, 2-21+ months).

CONCLUSIONS: These data suggested that the combination of doxorubicin and gemcitabine has antitumor activity in patients with sarcomatoid RCC or with rapidly progressing RCC. A prospective investigation of this combination in RCC is warranted.