Abstract
Purpose
Chemotherapy-induced alopecia is very distressing for a patient and may have an impact on treatment decisions. On docetaxel-based therapy, alopecia occurs in a substantial proportion of patients. We aimed to investigate whether two different methods of scalp cooling can prevent hair loss.
Methods
In this open-label, prospective, nonrandomized trial, patients with solid tumors receiving docetaxel in a palliative setting were allocated according to patients’ preference to short-term cooling (over 45 min postinfusion) with a Paxman® PSC-2 machine (PAX), with cold cap (CC), or no cooling. The combined endpoint was alopecia World Health Organisation (WHO) III or IV or the necessity to wear a wig. Study identifier is Clinicaltrials.gov NCT01008774.
Results
Two hundred thirty-eight patients were included in the trial (128 patients PAX, 71 CC, and 39 no cooling). Number of cycles (median 4) and median docetaxel doses were similar across groups (55–60 mg/day on weekly therapy, 135–140 mg/day on 3-weekly therapy). Alopecia occurred with PAX, CC, and no cooling under 3-weekly docetaxel in 23, 27, and 74 % and under weekly docetaxel in 7, 8, and 17 %, respectively. Overall, cooling (PAX and CC combined) reduced risk of alopecia by 78 % (hazard ratio 0.22; 95 % confidence interval 0.12 to 0.41). CC and PAX prophylaxis led to the same degree of prevention of alopecia. Adverse events (AE) were reported in 5 % (most frequently, sensation of cold), and 30 patients (13 %) discontinued cooling measures after cycle 1.
Conclusions
In this first comparison published to date, both PAX and CC offer efficacious protection against hair loss, in particular when docetaxel is administered in a 3-weekly interval.
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Acknowledgments
Christian Schmidhauser, Ph.D., (la volta statistics, Zurich, Switzerland) performed the statistical analyses. David Pittrow, MD, advised on contents of the manuscript and interpretation of data.
We appreciate the support of Frank Verholen, MD (Sanofi-Aventis (Suisse) SA) and Danièle Brack (Sanofi-Aventis (Suisse) SA) as well as the contribution of the investigators of the participating centers in Switzerland (listed in alphabetical order):
Prof. Dr. med. Markus Borner
Chefarzt, Medizinische Onkologie,Spitalzentrum, Im Vogelsang 84, 2502 Biel/Bienne, Switzerland
Email: markus.borner@szb-chb.ch
Tel.: +41-32-3242424
Dott. med. Antonello Calderoni
FMH Oncologia Medica, Via Fogazzaro 3, 6900 Lugano, Switzerland
Email: antonello.calderoni@swissoncology.com
Tel.: +41-91-9226988
Dr. med. Clemens Caspar
Chefarzt Onkologie, Medizinische Klinik, Kantonsspital Baden AG, 5404 Baden, Switzerland
Email: clemens.caspar@ksb.ch
Tel.: +41-56-4862111
Dr. med. Corinne Cescato-Wenger
Oberärztin, Medizinische Abteilung, St. Claraspital, Kleinriehenstrasse 30, 4058 Basel, Switzerland
Email: corinne.cescato@claraspital.ch
Tel.: +41-61-6858585
Dr. Petr Cech
FMH Oncologie Médicale, Route de Villars 37, 1700 Fribourg, Switzerland
Email: pcech@worldcom.ch
Tel.: +41-26-3474305
Dr. med. Manuel Jeschko
FMH Medizinische Onkologie, Onkologie Länggasse, Fabrikstrasse 24b, 3012 Bern, Switzerland
Email: manuel.jeschko@hin.ch
Tel.: +41-31-3005090
Dr. Claudius Irlé
FMH Oncologie Médicale, Avenue J.-D.-Maillard 11, 1217 Meyrin, Switzerland
Email: djazira.irle@bluewin.ch
Tel.: +41-22-7830500/+41-62-8367830
Dr. med. Martin F. Hagen
FMH Medizinische Onkologie, Seestrasse 80, 8810 Horgen, Switzerland
Email: mfhagen@bluewin.ch
Tel.: +41-44-7277727
Dr. Volker Kirchner
FMH Oncologie Médicale, Clinique de Genolier, Route du Muids 3, 1272 Genolier, Switzerland
Email: vkirchner@genolier.net
Tel.: +41-22-3669000
Dr. med. Meinrad Mannhart-Harms
FMH Medizinische Onkologie, OHZ Zug, Andreas Klinik, Rigistrasse 1, 6330 Cham, Switzerland
Email: meinrad.mannhart@hirslanden.ch
Tel.: +41-41-7840884
Dr. med. Razvan Andrei Popescu
FMH Medizinische Onkologie, Tumor Zentrum, Hirslanden Medical Center, Rain 34, 5000 Aarau, Switzerland
Eamil: razvan.popescu@hirslanden.ch
Tel.: +41-62-8367830
Dr. med. Martin Wernli
Chefarzt, Onkologie, Kantonsspital, Tellstrasse, 5001 Aarau, Switzerland
Email: martin.wernli@ksa.ch
Tel.: +41-62-8384141
Dr. med. Lucas Andreas Widmer
FMH Medizinische Onkologie, Onkozentrum Hirslanden, Klinik Hirslanden, Postfach, 8032 Zürich, Switzerland
Email: lwidmer@onkozentrum.ch
Tel.: +41-44-3873780
Dr. med. Ralph Winterhalder
Leitender Arzt, Medizinische Klinik, Luzerner Kantonsspital, Spitalstrasse, 6004 Luzern, Switzerland
Email: ralph.winterhalder@luks.ch
Tel.: +41-41-2051111
Dr. med. Reinhard Zenhäusern
Onkologie, Spitalzentrum Oberwallis, Überlandstrasse 14, 3900 Brig, Switzerland
Email: reinhard.zenhaeusern@hopitalvs.ch
Tel.: +41-27-9703333
Conflict of interest
Sanofi-Aventis Suisse funded this study. Sereina Bodenmann and Vera Bühler are full-time employees of Sanofi-Aventis Suisse. The rest of the authors declare no conflict of interest related to this study. The authors had full control of all primary data. The authors agree to allow the journal to review their data if requested.
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Betticher, D.C., Delmore, G., Breitenstein, U. et al. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer 21, 2565–2573 (2013). https://doi.org/10.1007/s00520-013-1804-9
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DOI: https://doi.org/10.1007/s00520-013-1804-9