Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08)
| Autor: | Roger von Moos, Shu-Fang Hsu Schmitz, Annette Winkler, Markus Borner, Daniel Dietrich, Khalil Zaman, Thomas Ruhstaller, A. Müller, Lukas von Rohr, H. Sun, Karin Ribi, Arnoud J. Templeton, Michael Beyeler, Christoph Rochlitz, Beat Thürlimann, Christian Surber, Ralph Winterhalder |
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| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Randomization medicine.medical_treatment Administration Topical Skin Cream Aluminum Hydroxide Breast Neoplasms Placebo Severity of Illness Index Polyethylene Glycols Breast cancer Chlorides Double-Blind Method Antiperspirants Clinical endpoint Medicine Humans Doxorubicin Adverse effect Aged Neoplasm Staging Chemotherapy business.industry General Medicine Middle Aged medicine.disease Dermatology Metastatic breast cancer Surgery body regions Treatment Outcome Female Hand-Foot Syndrome Drug Monitoring business medicine.drug |
| Zdroj: | Breast (Edinburgh, Scotland). 23(3) |
| ISSN: | 1532-3080 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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