Multiinstitutional home-therapy trial of recombinant human interleukin-2 and interferon alfa-2 in progressive metastatic renal cell carcinoma.
OBJECTIVE
In a phase II multiinstitutional outpatient trial, patients with progressive metastatic renal cell carcinoma were treated with a combination of subcutaneous (SC) recombinant interleukin-2 (rIL-2) and recombinant interferon alfa-2 (rIFN alpha 2).


METHODS
One hundred fifty-two patients with metastatic renal cell carcinoma were treated. Treatment courses consisted of SC rIL-2 at 20 x 10(6) IU/m2 three times per week in weeks 1 and 4, and at 5 x 10(6) IU/m2 three times per week in weeks 2, 3, 5, and 6. Additionally, patients received SC rIFN alpha 2 6 x 10(6) U/m2 once per week in weeks 1 and 4, and three times per week in weeks 2, 3, 5, and 6.


RESULTS
There were nine (6%) complete responses (CRs) and 29 (19%) partial responses (PRs), for an overall response rate of 25% (95% confidence interval, 19% to 32%). The median duration of responses for CRs and PRs was 16+ and 9 months, respectively. Additionally, 55 patients (36%) had stable disease (SD). Fifty-nine patients (39%) had continued disease progression (PD) despite treatment, or went off study after less than 4 weeks of therapy. The majority of patients treated experienced fever, chills, malaise, nausea, vomiting, and anorexia, side effects that were mostly limited to World Health Organization (WHO) grade 1 and 2. However, one patient developed grade 4 CNS toxicity with extended somnolence. On cessation of therapy, the neurologic symptoms in this patient were fully reversible, with no neurologic deficiency.


CONCLUSIONS
In summary, this multiinstitutional home-therapy setting of SC rIL-2 and SC rIFN alpha 2 in patients with progressive metastatic renal cell carcinoma demonstrated drastically reduced systemic toxicity, while it confirmed the therapeutic efficacy of the low-dose SC immunotherapy combination schedule.
Division of Hematology and Oncology, Medizinische Hochschule Hannover, Germany.
J
J
Atzpodien
E
E
Lopez Hänninen
H
H
Kirchner
H
H
Bodenstein
M
M
Pfreundschuh
U
U
Rebmann
B
B
Metzner
H J
HJ
Illiger
G
G
Jakse
T
T
Niesel
D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007370:Interferon Type I / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D007668:Kidney / Q000187:drug effects; D007680:Kidney Neoplasms / Q000628:therapy*; D008099:Liver / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010045:Outpatients; D011994:Recombinant Proteins; D012449:Safety; D013997:Time Factors; D016896:Treatment Outcome
D007370:Interferon Type I; D007376:Interleukin-2; D011994:Recombinant Proteins