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Titolo:
NEUROTOXICITY OF INTERFERON-ALPHA IN MELANOMA THERAPY - RESULTS FROM A RANDOMIZED CONTROLLED TRIAL
Autore:
CARACENI A; GANGERI L; MARTINI C; BELLI F; BRUNELLI C; BALDINI M; MASCHERONI L; LENISA L; CASCINELLI N;
Indirizzi:
NATL CANC INST,PAIN THERAPY & PALLIAT CARE DIV,NEUROL UNIT,VIA VENEZIAN 1 I-20133 MILAN ITALY NATL CANC INST,PSYCHOL DIV I-20133 MILAN ITALY NATL CANC INST,SURG ONCOL DIV B I-20133 MILAN ITALY
Titolo Testata:
Cancer
fascicolo: 3, volume: 83, anno: 1998,
pagine: 482 - 489
SICI:
0008-543X(1998)83:3<482:NOIIMT>2.0.ZU;2-R
Fonte:
ISI
Lingua:
ENG
Soggetto:
CENTRAL-NERVOUS-SYSTEM; OF-LIFE ASSESSMENT; ADJUVANT THERAPY; BREAST-CANCER; DISEASE; PAIN; RISK;
Keywords:
MALIGNANT MELANOMA; INTERFERON-ALPHA; ADJUVANT IMMUNOTHERAPY; NEUROLOGIC SIDE EFFECTS; QUALITY OF LIFE;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
31
Recensione:
Indirizzi per estratti:
Citazione:
A. Caraceni et al., "NEUROTOXICITY OF INTERFERON-ALPHA IN MELANOMA THERAPY - RESULTS FROM A RANDOMIZED CONTROLLED TRIAL", Cancer, 83(3), 1998, pp. 482-489

Abstract

BACKGROUND. The objective of this study was to evaluate the neurologic and quality of life impact of low dose adjuvant interferon (IFN)-alpha immunotherapy in patients with malignant melanoma metastatic to regional lymph nodes after radical surgery. METHODS, One hundred and thirteen patients were randomized to receive IFN-a, 3 x 10(6) IU three times weekly by subcutaneous injection for 36 months or until melanoma recurrence (IFN group), or to act as controls (CTR group). Seventy-five of these patients (66%) entered the toxicity study and underwent formal neurologic, neuropsychologic, psychologic, and quality of life assessments. Patients were assessed at baseline and after 1, 3, 6, and 12 months of follow-up. For each variable, maximum worsening of symptoms from baseline was considered as a response variable. The differences between the two groups regarding this variable were evaluated by means of the Hodges-Lehmann median unbiased point estimates and their 95% confidence interval. RESULTS. A significant degree of action tremor was found in eight patients in the IFN group and in none of the controls. No differences were found during psychiatric evaluation and for cognitive tests. There was a greater increase in anxiety in the IFN group on both trait and stare anxiety. With regard to quality of life the analysis showed a significant worsening of at most one level on only three questionnaire items and on the fatigue scale. CONCLUSIONS. Neurologic dysfunction associated with IFN therapy was mild. Psychiatric symptomsand neuropsychologic impairment were not found. Levels of fatigue andanxiety were increased in the IFN group but without a sizable impact on quality of life measures. Cancer 1998;83:482-9. (C) 1998 American Cancer Society.

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Documento generato il 02/12/20 alle ore 18:16:12