Subcutaneous interleukin-2 and interferon α in the treatment of patients with metastatic renal cell carcinoma—Less efficacy compared with intravenous interleukin-2 and interferon α : Results of a multicenter Phase II trial from the Groupe Français d'Immunothérapie

✍ Scribed by Alain Ravaud; Rémy Delva; Fréderic Gomez; Christine Chevreau; Jean-Yves Douillard; Jean Peny; Bruno Coudert; Sylvie Négrier

• Publisher: John Wiley and Sons
• Year: 2002
• Tongue: English
• Weight: 88 KB
• Volume: 95
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.10968

✦ Synopsis

Background:

The main objective of this trial was to evaluate the combination of subcutaneous (sc) interleukin-2 (il-2) with interferon alpha-2a (ifn-alpha) in the treatment of patients with metastatic renal cell carcinoma (mrcc) compared with a previous trial that used continuous-infusion il-2 and ifn-alpha with identical schedules and dosages.

Methods:

Between april, 1997 and january, 1998, 66 patients with mrcc received sc il-2 at a dose of 9 x 10(6) iu/m(2) twice daily for 5 days during 2 induction cycles and during 4 additional cycles, with a 3-week rest between cycles. each induction cycle consisted of two 5-day courses of il-2 separated by a 9-day break. ifn-alpha at a dose of 6 x 10(6) iu per day three times per week was given during induction cycles and additional cycles.

Results:

All patients were assessable for response and toxicity. the median follow-up was 43 months. thirty-five patients (51%) and 43 patients (63%) received >or= 80% of the planned induction doses of il-2 and ifn-alpha, respectively. five patients achieved objective responses (7.6%; 95% confidence interval [95%ci], 2.5-16.8%), with two complete responses. the median survival was 14 months (95%ci, 11.3-16.7 months). fifty-three patients (80%) had at least one episode of grade 3 toxicity related to treatment. twenty-two patients developed grade 4 toxicities, which included hypotension (24% of patients), decreased performance status (6% of patients), dyspnea (3% of patients), and mucositis (3% patients) as well as fever, ventricular tachycardia, and anemia.

Conclusions:

The current results seem to indicate reduced efficacy and higher toxicity rates with sc il-2 plus ifn-alpha compared with the results from a previous trial that used an identical regimen with iv il-2 administration. although sc il-2 regimens are used widely, their interest remains to be determined.