Journal of Clinical Oncology, Vol 10, 414-421, Copyright © 1992 by American Society of Clinical Oncology
Concomitant administration of recombinant human interleukin-2 and recombinant interferon alfa-2A: an active outpatient regimen in metastatic renal cell carcinoma
RA Figlin, A Belldegrun, N Moldawer, J Zeffren and J deKernion
Department of Medicine, University of California, School of Medicine, Los Angeles.
PURPOSE: A phase II trial of interleukin-2 (IL-2) and interferon alfa
(IFN-alpha) in metastatic renal cell carcinoma (RCCa) was conducted. A
lower dosage of IL-2 was given via continuous intravenous (IV) infusion, a
route with documented tumor activity associated with less toxicity, with
the purpose of improving the therapeutic index of this treatment in an
outpatient setting. PATIENTS AND METHODS: Thirty patients with metastatic
RCCa were treated with the combination of IL-2 and IFN-alpha-2A. IL-2 was
administered on days 1 through 4 of each treatment week, as a continuous IV
infusion at a dose of 2 x 10(6) U/m2/d. IFN-alpha-2A was administered
intramuscularly or subcutaneously on days 1 and 4 of each treatment week,
at a dose of 6 x 10(6) U/m2/d. One treatment course included 4 weeks of
treatment followed by a 2-week rest. Patients received therapy as
outpatients except for the first 4 days of treatment, cycle 1 only. All
patients were assessable for toxicity and response assessment. A total of
105 courses of therapy were administered, 51% at full dose. RESULTS:
Sixteen patients experienced toxicities resulting in dosage modification.
The major treatment-limiting toxicities were gastrointestinal, neurologic,
and fatigue. Nine patients (30%) had partial remissions (PRs) with a median
duration of responses of 12+ months. The median time to response was 11
weeks. Two partial responders whose sites of metastatic disease were renal
fossa and mediastinal lymph nodes (LN), respectively, were found to have
achieved a pathologic complete remission (pCR) after surgery. A third
patient with a pCR of axillary LN was rendered into a surgical complete
remission (sCR) with salvage nephrectomy. Median survival of patients
obtaining a PR has not been reached with a median follow-up time of 19+
months. CONCLUSION: IL-2 and IFN-alpha-2A is well tolerated in the
outpatient treatment setting and demonstrates significant clinical activity
against RCCa.
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