Phase II trial of 5-fluorouracil, interferon-α and continuous infusion interleukin-2 for patients with metastatic renal cell carcinoma

✍ Scribed by Julie A. Ellerhorst; Avishay Sella; Robert J. Amato; Shi-Ming Tu; Randall E. Millikan; Laury D. Finn; Marie Banks; Christopher J. Logothetis

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 90 KB
• Volume: 80
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19971201)80:11<2128::aid-cncr12>3.0.co;2-0

✦ Synopsis

RESULTS.

Fifty-five patients were enrolled in the trial and 52 were evaluable for ogy, The University of Texas M. D. Anderson response. All patients experienced fever and flu-like symptoms. Grade 3 or 4 nonhe-Cancer Center, Houston, Texas.

matologic toxic effects included hypertension (48%), dermatitis (12%), stomatitis 2 Beilinson Medical Center, Department of On-(11%), and altered mental status (9%). There was one toxic death. Four complete cology, Petah-Tikva, Israel.

responses and 12 partial responses were observed for a total response rate of 31% (95% confidence interval, 18-46%). The survival of responding patients was significantly better than that of nonresponding patients. The improvement in survival was even more significant when comparing patients with at least stable disease with those who progressed through treatment.

CONCLUSIONS.

The three-drug combination described in this study demonstrates activity. However, it appears to be more toxic than other regimens with similar response rates and cannot be recommended for standard practice. Changing the interleukin-2 route to subcutaneous administration may permit more continuous administration with less toxic effects.