Abstract | BACKGROUND: METHODS: We included 85 patients from June, 1995, to July, 1998: two (one per group) were ineligible. 42 of the 83 participants were randomly assigned combined treatment (study group) and 43 immunotherapy alone (controls). All patients had metastatic renal-cell carcinoma that had been histologically confirmed and was progressive at entry. In study patients, surgery was done within 4 weeks of randomisation, and immunotherapy (5x10(6) IU/m(2) subcutaneously three times per week) started 2-4 weeks later. In controls, immunotherapy was started within 1 working day of randomisation. Follow-up visits were monthly. All analyses were by intention to treat. FINDINGS: 40 (53%) of 75 patients received at least 16 weeks of interferon-alfa treatment, which was also the median duration of treatment. Time to progression (5 vs 3 months, hazard ratio 0.60, 95% CI 0.36-0.97) and median duration of survival were significantly better in study patients than in controls (17 vs 7 months, 0.54, 0.31-0.94). Five patients responded completely to combined treatment, and one to interferon alfa alone. Dose modification was necessary in 32% of patients, most commonly because of non-haematological side-effects. INTERPRETATION:
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Authors | G H Mickisch, A Garin, H van Poppel, L de Prijck, R Sylvester, European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group |
Journal | Lancet (London, England)
(Lancet)
Vol. 358
Issue 9286
Pg. 966-70
(Sep 22 2001)
ISSN: 0140-6736 [Print] England |
PMID | 11583750
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Antineoplastic Agents
- Interferon alpha-2
- Interferon-alpha
- Recombinant Proteins
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Topics |
- Adult
- Aged
- Antineoplastic Agents
(therapeutic use)
- Carcinoma, Renal Cell
(mortality, pathology, secondary, surgery, therapy)
- Female
- Humans
- Immunotherapy
- Interferon alpha-2
- Interferon-alpha
(therapeutic use)
- Kidney Neoplasms
(mortality, pathology, secondary, surgery, therapy)
- Male
- Middle Aged
- Nephrectomy
- Recombinant Proteins
- Survival Analysis
- Treatment Outcome
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