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Titolo:
Topical transforming growth factor-beta 3 in the prevention or alleviationof chemotherapy-induced oral mucositis in patients with lymphomas or solidtumors
Autore:
Foncuberta, MC; Cagnoni, PJ; Brandts, CH; Mandanas, R; Fields, K; Derigs, HG; Reed, E; Sonis, ST; Fay, J; LeVeque, F; Pouillart, P; Schrezenmeier, H; Emmons, R; Thiel, E;
Indirizzi:
Novartis Pharma AG, CRD CME, CH-4002 Basel, Switzerland Novartis Pharma AG Basel Switzerland CH-4002 CH-4002 Basel, Switzerland Inst Alexander Fleming, Buenos Aires, DF, Argentina Inst Alexander Fleming Buenos Aires DF Argentina os Aires, DF, Argentina Univ Colorado Hlth Sci, Denver, CO USA Univ Colorado Hlth Sci Denver CO USA v Colorado Hlth Sci, Denver, CO USA Univ Klinikum Benjamin Franklin, Berlin, Germany Univ Klinikum Benjamin Franklin Berlin Germany ranklin, Berlin, Germany Univ Oklahoma, Hlth Sci Ctr, Oklahoma City, OK USA Univ Oklahoma OklahomaCity OK USA , Hlth Sci Ctr, Oklahoma City, OK USA Univ S Florida, H Lee Moffitt Canc Ctr, Tampa, FL 33682 USA Univ S Florida Tampa FL USA 33682 e Moffitt Canc Ctr, Tampa, FL 33682 USA Med Klin, Mainz, Germany Med Klin Mainz GermanyMed Klin, Mainz, Germany Univ Nebraska, Omaha, NE 68182 USA Univ Nebraska Omaha NE USA 68182Univ Nebraska, Omaha, NE 68182 USA Brigham & Womens Hosp, Boston, MA 02115 USA Brigham & Womens Hosp Boston MA USA 02115 mens Hosp, Boston, MA 02115 USA Baylor Univ, Med Ctr, Dallas, TX USA Baylor Univ Dallas TX USABaylor Univ, Med Ctr, Dallas, TX USA Harper Grace Hosp, Detroit, MI USA Harper Grace Hosp Detroit MI USAHarper Grace Hosp, Detroit, MI USA Inst Curie, Paris, France Inst Curie Paris FranceInst Curie, Paris, France Univ Ulm, Med Klin, Ulm, Germany Univ Ulm Ulm GermanyUniv Ulm, Med Klin, Ulm, Germany
Titolo Testata:
JOURNAL OF IMMUNOTHERAPY
fascicolo: 4, volume: 24, anno: 2001,
pagine: 384 - 388
SICI:
1524-9557(200107/08)24:4<384:TTGF3I>2.0.ZU;2-Z
Fonte:
ISI
Lingua:
ENG
Soggetto:
BONE-MARROW TRANSPLANTATION; COLONY-STIMULATING FACTOR; HIGH-DOSE THERAPY; BREAST-CANCER; NECK-CANCER; CELL CARCINOMA; HEAD; MANAGEMENT; ADJUVANT;
Keywords:
oral mucositis; high-dose chemotherapy; objective scoring system for oral mucositis;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
28
Recensione:
Indirizzi per estratti:
Indirizzo: Emmons, R Novartis Pharma AG, CRD CME, WSJ 027-5-73, CH-4002 Basel, Switzerland Novartis Pharma AG WSJ 027-5-73 Basel Switzerland CH-4002 rland
Citazione:
M.C. Foncuberta et al., "Topical transforming growth factor-beta 3 in the prevention or alleviationof chemotherapy-induced oral mucositis in patients with lymphomas or solidtumors", J IMMUNOTH, 24(4), 2001, pp. 384-388

Abstract

Transforming growth factor (TGF)-beta3 has been hypothesized to prevent oralleviate oral mucositis (OM) in cancer patients receiving high-dose chemotherapy (CT). Two double-blind, placebo-controlled, multicenter, phase II Studies of TGF-beta3 were initiated in the United States, Europe, and Argentina in patients with lymphomas or solid tumors who were receiving highly stomatotoxic CT regimens. Patients were to apply 10-mL mouthwash applicationsof TGF-beta3 (25 mug/mL) or placebo four times daily (or twice daily) I day before and all days during CT. The patients were subsequently evaluated for OM incidence, severity, and duration using National Institute of Cancer Common Toxicity Criteria (NCI-CTC) criteria and an objective scoring system( 1). After the start of the trials, negative results from new preclinicalStudies suggesting suboptimal formulation and/or dosing led to an interim analysis of the ongoing clinical trials. One hundred fifty-two patients from the combined studies were included ill the interim analysis, with 116 patients on the TGF-beta3 four times daily and placebo arms. Most (72%) patients had breast cancer, 22% had lymphomas, and 6% had other solid tumors. Although 98% (149 of 152) of patients experienced adverse events, only 14% (22of 152) experienced events that were judged as possibly or probably related to the study drug (primarily gastrointestinal symptoms). No clinically relevant differences were seen between the treatment and placebo arms regarding safety, nor was there evidence for systemic absorption of TGF-beta3. Finally, there was no advantage of' TGF-beta3 treatment regarding the incidence (TGF-R3 four times daily versus placebo [46% versus 47%]), onset, or duration of NCI-CTC grade 3 or 4 OM. For this dose, formulation, regimen, and patient population, TGF-beta3 was not effective in the prevention or alleviation of CT-induced OM.

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Documento generato il 23/01/20 alle ore 03:24:22