title: Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08).
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Breast Centre, St. Gallen, Switzerland. Electronic address: arnoud.templeton@kssg.ch.
authors.forename: Arnoud J
authors.initials: AJ
authors.lastname: Templeton
authors.affiliation: IBCSG, Bern, Switzerland.
authors.forename: Karin
authors.initials: K
authors.lastname: Ribi
authors.affiliation: Spirig Pharma Schweiz and Dermatologische Universitätsklinik, Basel, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Surber
authors.affiliation: Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
authors.forename: Hong
authors.initials: H
authors.lastname: Sun
authors.affiliation: Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
authors.forename: Shu-Fang
authors.initials: SF
authors.lastname: Hsu Schmitz
authors.affiliation: Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Beyeler
authors.affiliation: Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dietrich
authors.affiliation: Medical Oncology, Spitalzentrum AG, Biel, Switzerland.
authors.forename: Markus
authors.initials: M
authors.lastname: Borner
authors.affiliation: Medical Oncology, Spitalzentrum AG, Biel, Switzerland.
authors.forename: Annette
authors.initials: A
authors.lastname: Winkler
authors.affiliation: Medical Oncology, Kantonsspital Winterthur, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Müller
authors.affiliation: Medical Oncology, Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Lukas
authors.initials: L
authors.lastname: von Rohr
authors.affiliation: Medical Oncology, Luzerner Kantonsspital, Luzern, Switzerland.
authors.forename: Ralph C
authors.initials: RC
authors.lastname: Winterhalder
authors.affiliation: Medical Oncology, Universitätsspital, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Rochlitz
authors.affiliation: Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.
authors.forename: Roger
authors.initials: R
authors.lastname: von Moos
authors.affiliation: Medical Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: Khalil
authors.initials: K
authors.lastname: Zaman
authors.affiliation: Breast Centre, St. Gallen, Switzerland.
authors.forename: Beat J K
authors.initials: BJ
authors.lastname: Thürlimann
authors.affiliation: Breast Centre, St. Gallen, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruhstaller
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000536:Aluminum Hydroxide / Q000494:pharmacology / Q000627:therapeutic use; D051520:Antiperspirants / Q000494:pharmacology / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology; D002712:Chlorides / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D060831:Hand-Foot Syndrome / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D012720:Severity of Illness Index; D063465:Skin Cream; D016896:Treatment Outcome
chemical_list: D051520:Antiperspirants; D002712:Chlorides; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; C534453:aluminum sesquichlorohydrate; D000536:Aluminum Hydroxide; D004317:Doxorubicin
keywords: Antiperspirant; Breast cancer; Hand–foot syndrome; Palmar–plantar erythrodysesthesia; Pegylated liposomal doxorubicin; Prevention