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Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment

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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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Correspondence to Daniel C. Betticher.

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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

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