Abstract
We report on the clinical course of 15 patients with metastatic renal cell carcinoma (RCC) who were treated with recombinant beta-interferon as part of a phase I-II study. There were no objective responders among the 15 patients treated with recombinant beta-interferon at an i.v. dose escalating from 90 x 106 to 720 x 106 U given three times a week until there was documented disease progression or complete response (CR). Overall median survival was 24 months. One patient refused further treatment after 7 weeks. The major side effects of treatment included cardiovascular events (20%), mental status change requiring cessation of drug (6.7%), and grade 3 headaches/myalgias (26.7%). There were no life-threatening side effects observed; however, cardiac events led to the termination of treatment in three patients. Other minor toxicities included fatigue (46.7%), proteinuria (60%), diarrhea (6.7%), nausea and vomiting (13.3%), persistent fever (6.7%), and transient visual disturbance (6.7%). Thus, at our institution, in a cohort of 15 patients with metastatic RCC, recombinant beta-interferon when given i.v. at a dose ≤720 x 106 U three times per week, yielded no clinical antitumor activity. A review of the literature on the use of beta-interferon for metastatic RCC suggests that there may be some efficacy, but our experience with escalating i.v. doses ≤720 x 106 U given three times a week does not support it. Moreover, at these doses, one may find serious cardiovascular events although further studies need to be done in order to clearly define dose-related side effects as well as optimal efficacy-to-toxicity ratio.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 187-189 |
| Number of pages | 3 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 19 |
| Issue number | 2 |
| DOIs | |
| State | Published - Apr 1996 |
| Externally published | Yes |
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Keywords
- Beta-interferon
- Renal cell carcinoma
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
Recombinant beta-interferon in the treatment of patients with metastatic renal cell carcinoma. / Mani, Sridhar; Todd, Mary; Poo, Wen Jen.
In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 19, No. 2, 04.1996, p. 187-189.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Recombinant beta-interferon in the treatment of patients with metastatic renal cell carcinoma
AU - Mani, Sridhar
AU - Todd, Mary
AU - Poo, Wen Jen
PY - 1996/4
Y1 - 1996/4
N2 - We report on the clinical course of 15 patients with metastatic renal cell carcinoma (RCC) who were treated with recombinant beta-interferon as part of a phase I-II study. There were no objective responders among the 15 patients treated with recombinant beta-interferon at an i.v. dose escalating from 90 x 106 to 720 x 106 U given three times a week until there was documented disease progression or complete response (CR). Overall median survival was 24 months. One patient refused further treatment after 7 weeks. The major side effects of treatment included cardiovascular events (20%), mental status change requiring cessation of drug (6.7%), and grade 3 headaches/myalgias (26.7%). There were no life-threatening side effects observed; however, cardiac events led to the termination of treatment in three patients. Other minor toxicities included fatigue (46.7%), proteinuria (60%), diarrhea (6.7%), nausea and vomiting (13.3%), persistent fever (6.7%), and transient visual disturbance (6.7%). Thus, at our institution, in a cohort of 15 patients with metastatic RCC, recombinant beta-interferon when given i.v. at a dose ≤720 x 106 U three times per week, yielded no clinical antitumor activity. A review of the literature on the use of beta-interferon for metastatic RCC suggests that there may be some efficacy, but our experience with escalating i.v. doses ≤720 x 106 U given three times a week does not support it. Moreover, at these doses, one may find serious cardiovascular events although further studies need to be done in order to clearly define dose-related side effects as well as optimal efficacy-to-toxicity ratio.
AB - We report on the clinical course of 15 patients with metastatic renal cell carcinoma (RCC) who were treated with recombinant beta-interferon as part of a phase I-II study. There were no objective responders among the 15 patients treated with recombinant beta-interferon at an i.v. dose escalating from 90 x 106 to 720 x 106 U given three times a week until there was documented disease progression or complete response (CR). Overall median survival was 24 months. One patient refused further treatment after 7 weeks. The major side effects of treatment included cardiovascular events (20%), mental status change requiring cessation of drug (6.7%), and grade 3 headaches/myalgias (26.7%). There were no life-threatening side effects observed; however, cardiac events led to the termination of treatment in three patients. Other minor toxicities included fatigue (46.7%), proteinuria (60%), diarrhea (6.7%), nausea and vomiting (13.3%), persistent fever (6.7%), and transient visual disturbance (6.7%). Thus, at our institution, in a cohort of 15 patients with metastatic RCC, recombinant beta-interferon when given i.v. at a dose ≤720 x 106 U three times per week, yielded no clinical antitumor activity. A review of the literature on the use of beta-interferon for metastatic RCC suggests that there may be some efficacy, but our experience with escalating i.v. doses ≤720 x 106 U given three times a week does not support it. Moreover, at these doses, one may find serious cardiovascular events although further studies need to be done in order to clearly define dose-related side effects as well as optimal efficacy-to-toxicity ratio.
KW - Beta-interferon
KW - Renal cell carcinoma
UR - http://www.scopus.com/inward/record.url?scp=0029921871&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029921871&partnerID=8YFLogxK
U2 - 10.1097/00000421-199604000-00020
DO - 10.1097/00000421-199604000-00020
M3 - Article
C2 - 8610647
AN - SCOPUS:0029921871
VL - 19
SP - 187
EP - 189
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 2
ER -