PMID- 8293417
OWN - NLM
STAT- MEDLINE
DCOM- 19940225
LR  - 20190620
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 73
IP  - 2
DP  - 1994 Jan 15
TI  - Treatment of primary or relapsing limb cancer by isolation perfusion with 
      high-dose alpha-tumor necrosis factor, gamma-interferon, and melphalan.
PG  - 483-92
AB  - BACKGROUND: Utilization of alpha-tumor necrosis factor (alpha-TNF) in clinical 
      practice is limited by severe general side effects. Very promising results with 
      low toxicity were reported with administration of alpha-TNF by isolation 
      perfusion in extracorporeal circulation. METHODS: From December 1991 to November 
      1992, 14 patients underwent perfusion with alpha-TNF (2-4 mg, total dose), 
      gamma-interferon (1.5 x 10(6) IU), and melphalan (10 mg/l/perfused limb). Twelve 
      patients presented in-transit metastases of the limbs, one patient, a clear cell 
      sarcoma of the hand, and one patient, a wide spindle cell carcinoma of the thigh. 
      Perfusion lasted 90 minutes and was conducted in mild hyperthermia (38-40.5 
      degrees C, muscle temperature). RESULTS: Nine complete regressions and four 
      stable diseases were recorded. In one case, a reliable evaluation of response was 
      not possible for diffused tissue necrosis. Five patients relapsed or progressed 
      locally from 3 to 4 months after surgery, five presented distant localizations 
      from 2 to 7 months after surgery, and one died of disease 6 months after 
      perfusion. Twelve patients are alive, seven without evidence of disease. A 
      septic-like shock syndrome was observed in all patients and required 
      administration of dopamine, dobutamine, or noradrenaline. One patient died 30 
      days after perfusion from a multiorgan-failure syndrome, likely due to alpha-TNF. 
      The follow-up time ranges from 4 to 15 months (median, 6). CONCLUSIONS: The 
      preliminary, impressive results reported in other series were not completely 
      confirmed in this study adopting the same treatment scheme. Further clinical 
      experience and biologic data are needed to state the real efficacy of the 
      approach and to reduce the severe general toxicity consistently associated with 
      this type of treatment.
FAU - Vaglini, M
AU  - Vaglini M
AD  - Department of Surgical Oncology B, National Cancer Institute, Milan, Italy.
FAU - Belli, F
AU  - Belli F
FAU - Ammatuna, M
AU  - Ammatuna M
FAU - Inglese, M G
AU  - Inglese MG
FAU - Manzi, R
AU  - Manzi R
FAU - Prada, A
AU  - Prada A
FAU - Persiani, L
AU  - Persiani L
FAU - Santinami, M
AU  - Santinami M
FAU - Santoro, N
AU  - Santoro N
FAU - Cascinelli, N
AU  - Cascinelli N
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - 82115-62-6 (Interferon-gamma)
RN  - Q41OR9510P (Melphalan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - *Arm
MH  - Carcinoma/drug therapy
MH  - Chemotherapy, Cancer, Regional Perfusion
MH  - Female
MH  - Humans
MH  - Interferon-gamma/*administration & dosage
MH  - *Leg
MH  - Male
MH  - Melanoma/drug therapy
MH  - Melphalan/*administration & dosage
MH  - Middle Aged
MH  - Pilot Projects
MH  - Sarcoma/drug therapy
MH  - Skin Neoplasms/drug therapy
MH  - Soft Tissue Neoplasms/*drug therapy
MH  - Tumor Necrosis Factor-alpha/*administration & dosage
EDAT- 1994/01/15 00:00
MHDA- 1994/01/15 00:01
CRDT- 1994/01/15 00:00
PHST- 1994/01/15 00:00 [pubmed]
PHST- 1994/01/15 00:01 [medline]
PHST- 1994/01/15 00:00 [entrez]
AID - 10.1002/1097-0142(19940115)73:2<483::aid-cncr2820730238>3.0.co;2-s [doi]
PST - ppublish
SO  - Cancer. 1994 Jan 15;73(2):483-92. doi: 
      10.1002/1097-0142(19940115)73:2<483::aid-cncr2820730238>3.0.co;2-s.