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Phase I study of transforming growth factor-beta3 mouthwashes for prevention of chemotherapy-induced mucositis.
Clin Cancer Res. 1999 Jun; 5(6):1363-8.CC

Abstract

The purpose of this study was to establish the safety and tolerability of recombinant transforming growth factor-beta3 (TGF-beta3; CGP 46614) mouthwashes intended for prevention of chemotherapy-induced mucositis. Local effects were especially analyzed by objective and subjective measurements of mucositis. Secondary aims were analysis of potential systemic exposure and development of anti-TGF-beta3-antibodies. Eleven breast cancer patients received chemotherapy with 1.5 g/m2 cyclophosphamide i.v., 80 mg/m2 epirubicin i.v., and 1.0 g/m2 5-fluorouracil i.v. (n = 8) or 1.6 g/m2 carboplatin i.v., 480 mg/m2 thiotepa i.v., and 6 g/m2 cyclophosphamide i.v. divided over 4 days (n = 3). TGF-beta3 mouthwashes (10 ml; provided by Novartis, Basel, Switzerland) were administered for 4 days, four times a day, starting 1 day before chemotherapy. The dose was escalated in following patients from 25 microg/ml (n = 3) to 50 microg/ml (n = 3) and 100 microg/ml (n = 5). Clinically, the mucosa was scored objectively and according to WHO criteria. The percentage of viable oral epithelial cells was determined by trypan blue dye exclusion. Morphology of cells was assessed in buccal smears. Plasma samples were collected for determination of TGF-beta3 levels and anti-TGF-beta3-antibodies. Adverse events were recorded by the patient in a diary. Mouthwashes with TGF-beta3 were well tolerated. Three patients scored for mucositis > grade 0 (WHO grading criteria). The percentage of viable oral epithelial cells in patients treated with 1.5 g/m2 cyclophosphamide i.v., 80 mg/m2 epirubicin i.v., and 1.0 g/m2 5-fluorouracil i.v. was stable, whereas in patients treated with 1.6 g/m2 carboplatin i.v., 480 mg/m2 thiotepa i.v., and 6 g/m2 cyclophosphamide i.v. divided over 4 days, an increase was observed. The morphology of buccal cells showed a transient shift from mature to immature cells in the first week. Neither systemic absorption of TGF-beta3 nor development of TGF-beta3-antibodies was observed. TGF-beta3 mouthwashes were well tolerated and deserve further study in preventing chemotherapy-induced mucositis.

Authors+Show Affiliations

Department of Internal Medicine, University Hospital Groningen, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Journal Article

Language

eng

PubMed ID

10389920

Citation

Wymenga, A N., et al. "Phase I Study of Transforming Growth Factor-beta3 Mouthwashes for Prevention of Chemotherapy-induced Mucositis." Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, vol. 5, no. 6, 1999, pp. 1363-8.
Wymenga AN, van der Graaf WT, Hofstra LS, et al. Phase I study of transforming growth factor-beta3 mouthwashes for prevention of chemotherapy-induced mucositis. Clin Cancer Res. 1999;5(6):1363-8.
Wymenga, A. N., van der Graaf, W. T., Hofstra, L. S., Spijkervet, F. K., Timens, W., Timmer-Bosscha, H., Sluiter, W. J., van Buuren, A. H., Mulder, N. H., & de Vries, E. G. (1999). Phase I study of transforming growth factor-beta3 mouthwashes for prevention of chemotherapy-induced mucositis. Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, 5(6), 1363-8.
Wymenga AN, et al. Phase I Study of Transforming Growth Factor-beta3 Mouthwashes for Prevention of Chemotherapy-induced Mucositis. Clin Cancer Res. 1999;5(6):1363-8. PubMed PMID: 10389920.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase I study of transforming growth factor-beta3 mouthwashes for prevention of chemotherapy-induced mucositis. AU - Wymenga,A N, AU - van der Graaf,W T, AU - Hofstra,L S, AU - Spijkervet,F K, AU - Timens,W, AU - Timmer-Bosscha,H, AU - Sluiter,W J, AU - van Buuren,A H, AU - Mulder,N H, AU - de Vries,E G, PY - 1999/7/2/pubmed PY - 1999/7/2/medline PY - 1999/7/2/entrez SP - 1363 EP - 8 JF - Clinical cancer research : an official journal of the American Association for Cancer Research JO - Clin Cancer Res VL - 5 IS - 6 N2 - The purpose of this study was to establish the safety and tolerability of recombinant transforming growth factor-beta3 (TGF-beta3; CGP 46614) mouthwashes intended for prevention of chemotherapy-induced mucositis. Local effects were especially analyzed by objective and subjective measurements of mucositis. Secondary aims were analysis of potential systemic exposure and development of anti-TGF-beta3-antibodies. Eleven breast cancer patients received chemotherapy with 1.5 g/m2 cyclophosphamide i.v., 80 mg/m2 epirubicin i.v., and 1.0 g/m2 5-fluorouracil i.v. (n = 8) or 1.6 g/m2 carboplatin i.v., 480 mg/m2 thiotepa i.v., and 6 g/m2 cyclophosphamide i.v. divided over 4 days (n = 3). TGF-beta3 mouthwashes (10 ml; provided by Novartis, Basel, Switzerland) were administered for 4 days, four times a day, starting 1 day before chemotherapy. The dose was escalated in following patients from 25 microg/ml (n = 3) to 50 microg/ml (n = 3) and 100 microg/ml (n = 5). Clinically, the mucosa was scored objectively and according to WHO criteria. The percentage of viable oral epithelial cells was determined by trypan blue dye exclusion. Morphology of cells was assessed in buccal smears. Plasma samples were collected for determination of TGF-beta3 levels and anti-TGF-beta3-antibodies. Adverse events were recorded by the patient in a diary. Mouthwashes with TGF-beta3 were well tolerated. Three patients scored for mucositis > grade 0 (WHO grading criteria). The percentage of viable oral epithelial cells in patients treated with 1.5 g/m2 cyclophosphamide i.v., 80 mg/m2 epirubicin i.v., and 1.0 g/m2 5-fluorouracil i.v. was stable, whereas in patients treated with 1.6 g/m2 carboplatin i.v., 480 mg/m2 thiotepa i.v., and 6 g/m2 cyclophosphamide i.v. divided over 4 days, an increase was observed. The morphology of buccal cells showed a transient shift from mature to immature cells in the first week. Neither systemic absorption of TGF-beta3 nor development of TGF-beta3-antibodies was observed. TGF-beta3 mouthwashes were well tolerated and deserve further study in preventing chemotherapy-induced mucositis. SN - 1078-0432 UR - https://www.unboundmedicine.com/medline/citation/10389920/Phase_I_study_of_transforming_growth_factor_beta3_mouthwashes_for_prevention_of_chemotherapy_induced_mucositis_ L2 - http://clincancerres.aacrjournals.org/cgi/pmidlookup?view=long&pmid=10389920 DB - PRIME DP - Unbound Medicine ER -