Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08).

Détails

ID Serval
serval:BIB_90D8595437E8
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08).
Périodique
Breast (edinburgh, Scotland)
Auteur(s)
Templeton A.J., Ribi K., Surber C., Sun H., Hsu Schmitz S.F., Beyeler M., Dietrich D., Borner M., Winkler A., Müller A., von Rohr L., Winterhalder R.C., Rochlitz C., von Moos R., Zaman K., Thürlimann B.J., Ruhstaller T.
Collaborateur(s)
Swiss Group for Clinical Cancer Research (SAKK) Coordinating Center
ISSN
1532-3080 (Electronic)
ISSN-L
0960-9776
Statut éditorial
Publié
Date de publication
2014
Peer-reviewed
Oui
Volume
23
Numéro
3
Pages
244-249
Langue
anglais
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
Résumé
BACKGROUND: Elevated concentrations of doxorubicin are found in eccrine sweat glands of the palms and soles. We therefore evaluated an antiperspirant as preventive treatment for palmar-plantar erythrodysesthesia (hand-foot syndrome) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin.
PATIENTS AND METHODS: An antiperspirant containing aluminum chlorohydrate or placebo cream was applied to the left or right hand and foot in a double-blinded manner (intra-patient randomization). The primary endpoint was the rate of grade 2 or 3 palmar-plantar erythrodysesthesia. A secondary endpoint was the patient-reported symptom burden (tingling, numbness, pain, or skin problems). Using McNemar's matched pairs design, 53 patients were needed to detect a 20% difference between the treatment and placebo sides with a significance level of 5% and power of 90%.
RESULTS: Grade 2 or 3 PPE occurred in 30 (58%) of 52 evaluable patients; in six patients adverse effects occurred on the placebo side but not on the treatment side, whereas one patient developed palmar-plantar erythrodysesthesia on the treatment side only (P = 0.07). Four patients developed grade 2 or 3 palmar-plantar erythrodysesthesia on their foot on the placebo side but not on the treatment side (P = 0.05). In the cohort with grade 2 or 3 palmar-plantar erythrodysesthesia there was a trend towards fewer dermatologic symptomatologies with the active treatment (P = 0.05), and no difference for other adverse events.
CONCLUSION: Using topical aluminum chlorohydrate as an antiperspirant appears to reduce the incidence of grade 2 or 3 palmar-plantar erythrodysesthesia following pegylated liposomal doxorubicin chemotherapy for metastatic breast cancer.
Mots-clé
Administration, Topical, Aged, Aluminum Hydroxide/pharmacology, Aluminum Hydroxide/therapeutic use, Antiperspirants/pharmacology, Antiperspirants/therapeutic use, Breast Neoplasms/drug therapy, Breast Neoplasms/pathology, Chlorides/pharmacology, Chlorides/therapeutic use, Double-Blind Method, Doxorubicin/administration & dosage, Doxorubicin/adverse effects, Drug Monitoring/methods, Female, Hand-Foot Syndrome/prevention & control, Humans, Middle Aged, Neoplasm Staging, Polyethylene Glycols/administration & dosage, Polyethylene Glycols/adverse effects, Severity of Illness Index, Skin Cream, Treatment Outcome
Pubmed
Web of science
Création de la notice
18/10/2016 16:21
Dernière modification de la notice
02/10/2018 6:26
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