Abstract | PURPOSE: MATERIALS AND METHODS: In a phase II study of patients with metastatic renal cell carcinoma the efficacy and toxicity of a treatment regimen were evaluated using interleukin-2 and interferon-alpha 2 subcutaneously in combination with intravenous 5-fluorouracil. The treatment protocol consisted of an 8-week cycle given on an outpatient basis, with 6 to 9 MU/m2. interferon-alpha given 1 to 3 times a week during the 8 weeks, and sequentially combined with 5 to 20 MU/m2. interleukin-2, 3 times a week for 4 weeks and 750 mg./m.2 5-fluorouracil once a week for 4 weeks. RESULTS: Among 25 consecutive men and 9 women treated 3 (9%) had a complete and 10 (29%) had a partial remission (overall objective response rate 38%). Median response duration (complete plus partial) was 12.5 months (range 3 to 20+). Stable disease lasting 3 to 24+ months was noted in 12 patients (35%). There were only minor side effects, for a maximum toxicity grade of I in 3 patients, II in 25 and III in 6 according to the World Health Organization classification. There were no dose limiting toxicities and no treatment related deaths. CONCLUSIONS: Triple drug immunochemotherapy resulted in a significant clinical effect comparable to an aggressive intravenous interleukin-2 treatment regimen but without significant toxicity.
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Authors | G Hofmockel, W Langer, M Theiss, A Gruss, H G Frohmüller |
Journal | The Journal of urology
(J Urol)
Vol. 156
Issue 1
Pg. 18-21
(Jul 1996)
ISSN: 0022-5347 [Print] United States |
PMID | 8648791
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Antimetabolites, Antineoplastic
- Antineoplastic Agents
- Interferon-alpha
- Interleukin-2
- Fluorouracil
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Topics |
- Adult
- Aged
- Antimetabolites, Antineoplastic
(therapeutic use)
- Antineoplastic Agents
(therapeutic use)
- Carcinoma, Renal Cell
(secondary, therapy)
- Combined Modality Therapy
- Female
- Fluorouracil
(therapeutic use)
- Follow-Up Studies
- Humans
- Interferon-alpha
(therapeutic use)
- Interleukin-2
(therapeutic use)
- Kidney Neoplasms
(pathology)
- Male
- Middle Aged
- Remission Induction
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