Journal article
Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08).
- Templeton AJ Breast Centre, St. Gallen, Switzerland. Electronic address: arnoud.templeton@kssg.ch.
- Ribi K IBCSG, Bern, Switzerland.
- Surber C Spirig Pharma Schweiz and Dermatologische Universitätsklinik, Basel, Switzerland.
- Sun H Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
- Hsu Schmitz SF Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
- Beyeler M Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
- Dietrich D Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
- Borner M Medical Oncology, Spitalzentrum AG, Biel, Switzerland.
- Winkler A Medical Oncology, Spitalzentrum AG, Biel, Switzerland.
- Müller A Medical Oncology, Kantonsspital Winterthur, Switzerland.
- von Rohr L Medical Oncology, Kantonsspital Aarau, Aarau, Switzerland.
- Winterhalder RC Medical Oncology, Luzerner Kantonsspital, Luzern, Switzerland.
- Rochlitz C Medical Oncology, Universitätsspital, Basel, Switzerland.
- von Moos R Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.
- Zaman K Medical Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
- Thürlimann BJ Breast Centre, St. Gallen, Switzerland.
- Ruhstaller T Breast Centre, St. Gallen, Switzerland.
- 2014-03-25
Published in:
- Breast (Edinburgh, Scotland). - 2014
Antiperspirant
Breast cancer
Hand–foot syndrome
Palmar–plantar erythrodysesthesia
Pegylated liposomal doxorubicin
Prevention
Administration, Topical
Aged
Aluminum Hydroxide
Antiperspirants
Breast Neoplasms
Chlorides
Double-Blind Method
Doxorubicin
Drug Monitoring
Female
Hand-Foot Syndrome
Humans
Middle Aged
Neoplasm Staging
Polyethylene Glycols
Severity of Illness Index
Skin Cream
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.breast.2014.02.005
- PMID 24656636
- Persistent URL
- https://sonar.ch/global/documents/270091
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