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Clinical Response, Hypotension, And Oliguria Independent Prognostic Factors In Renal Cell Carcinoma Patients Treated With Interleukin-2

Metastatic renal cell carcinoma (RCC), once considered an incurable disease, can be successfully treated now in some patients with recombinant interleukin-2 (rIL-2), which can produce complete, long lasting remissions, according to an Italian study.

RCC is one of the few tumours for which a clear benefit of immunotherapy has been demonstrated. Among biological response modifiers, interleukins, interferons, and tumour necrosis factor currently provide a larger clinical impact.

To evaluate the long-term survival of patients, response rate, and other new possible prognostic and predictive factors, Massimo Libra of the Centro di Riferimento Oncologico, IRCCS, Aviano, and colleagues performed a retrospective analysis of 56 consecutive metastatic RCC patients treated in a single institution with high-dose of rIL-2.

All patients had metastatic progressive disease without brain metastasis, and received rIL-2 by continuous infusion according to the West protocol. Evaluation of treatment response was performed according to World Health Organization (WHO) criteria, and treatment was interrupted if WHO G3 or greater toxicity occurred.

Survival was measured from the first day of treatment until death or last contact with the patients, and the Kaplan and Meier method was used to estimate survival curves. Prognostic factors were assessed by univariate and multivariate analyses of survival (Cox proportional hazard ratio model).

Overall, 26.8% of patients had objective responses, 28.6% had stable disease, 32.1% had disease progression, and 12.5% were not evaluable for response. Median overall survival was 20 months, and probability of 2- and 5-year survival was 41% and 21%, respectively.

Eastern Cooperative Oncology Group (ECOG) performance status (PS), clinical response and dose were statistically significant prognostic factors at the univariate analysis and at multivariate analysis, clinical response, hypotension, and oliguria were significant prognostic factors.

Forty-eight patients died while 8 were still alive at follow-up. Among the 8 surviving patients, 5 were disease free.

"Our study confirms the activity of IL-2 based immunotherapy in renal cell carcinoma," conclude the researchers. "Moreover, ECOG performance status, clinical response, hypotension and oliguria toxicity resulted as independent survival prognostic factors."

Tumori 2003 Jul-Aug;89:4:400-4. "Long-term survival in patients with metastatic renal cell carcinoma treated with continuous intravenous infusion of recombinant interleukin-2: the experience of a single institution"

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