PMID- 10732744
OWN - NLM
STAT- MEDLINE
DCOM- 20000405
LR  - 20181113
IS  - 0007-0920 (Print)
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Linking)
VI  - 82
IP  - 4
DP  - 2000 Feb
TI  - Immunochemotherapy with interleukin-2, interferon-alpha and 5-fluorouracil for 
      progressive metastatic renal cell carcinoma: a multicenter phase II study. Dutch 
      Immunotherapy Working Party.
PG  - 772-6
AB  - In patients with metastatic renal cell carcinoma response rates of 7-26% have 
      been achieved with immunotherapy. A high response rate of 48% in 35 patients has 
      been reported for treatment with the combination of interferon-alpha (IFN-alpha), 
      interleukin-2 (IL-2) and 5-fluorouracil (5-FU) (Atzpodien et al (1993a) Eur J 
      Cancer29A: S6-8). We conducted a multicentre phase II study to confirm these 
      results. Metastatic renal cell carcinoma patients were treated as outpatients 
      with an 8-week treatment cycle. Recombinant human IL-2 20 MU m(-2) was 
      administered subcutaneously (s.c.) three times a week (t.i.w) in weeks 1 and 4 
      and 5 MU m(-2) t.i.w. in weeks 2 and 3. Recombinant human IFN-alpha 2a 6 MU m(-2) 
      was administered s.c. once in weeks 1 and 4 and t.i.w. in weeks 2 and 3, and 9 MU 
      m(-2) t.i.w. in weeks 5-8. 5-FU (750 mg m(-2)) was given as a bolus injection 
      intravenous once a week in weeks 5-8. The treatment cycle was repeated once in 
      case of response or minor response. Fifty-two patients entered the study. All had 
      undergone a nephrectomy and had progressive metastatic disease. The median 
      WHO-performance status was 1, the median number of metastatic sites was 2 (range 
      1-5) and the median time between the diagnosis of the primary tumour and the 
      start of treatment was 12.9 months (range 1-153). Among the 51 patients, 
      including four patients with early progressive disease, who were evaluable for 
      response, the response rate was 11.8% (95% confidence interval (CI) 2.9-20.7%), 
      with no complete responses. Median duration of response was 8.3 (range 3.8-22.4+) 
      months. Median survival was 16.5 (range 1.8-30.5+) months. Grade 3/4 toxicity 
      (WHO) occurred in 29/52 (55.8%) of the patients in cycle 1 and in 6/16 (37.5%) of 
      the patients in cycle 2. It consisted mainly of anorexia, fatigue, nausea, fever 
      and leucocytopenia. We cannot confirm the high response rate in patients with 
      metastatic renal cell carcinoma treated with the combination of IFN-alpha, IL-2 
      and 5-FU, as described by Atzpodien et al.
FAU - van Herpen, C M
AU  - van Herpen CM
AD  - Department of Medical Oncology, University Hospital Nijmegen, The Netherlands.
FAU - Jansen, R L
AU  - Jansen RL
FAU - Kruit, W H
AU  - Kruit WH
FAU - Hoekman, K
AU  - Hoekman K
FAU - Groenewegen, G
AU  - Groenewegen G
FAU - Osanto, S
AU  - Osanto S
FAU - De Mulder, P H
AU  - De Mulder PH
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Interferon-alpha)
RN  - 0 (Interleukin-2)
RN  - 0 (Recombinant Proteins)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy
MH  - Fluorouracil/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Interferon-alpha/administration & dosage/adverse effects/*therapeutic use
MH  - Interleukin-2/administration & dosage/adverse effects/*therapeutic use
MH  - Kidney Neoplasms/*drug therapy
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Recombinant Proteins/administration & dosage/adverse effects/therapeutic use
PMC - PMC2374413
EDAT- 2000/03/25 00:00
MHDA- 2000/03/25 00:01
CRDT- 2000/03/25 00:00
PHST- 2000/03/25 00:00 [pubmed]
PHST- 2000/03/25 00:01 [medline]
PHST- 2000/03/25 00:00 [entrez]
AID - S0007092099909977 [pii]
AID - 10.1054/bjoc.1999.0997 [doi]
PST - ppublish
SO  - Br J Cancer. 2000 Feb;82(4):772-6. doi: 10.1054/bjoc.1999.0997.