Abstract P5-21-05: ERALOP study: Post adjuvant FEC - docetaxel chemotherapy for early breast cancer: Hair regrowth in the real life
Authors: Bourgeois Hugues Pierre , Jamet Aurélie , Grudé Françoise , Adounkpe Carole , Kerbrat Pierre , Delva Remy , Simon Hélène , Deguiral Philippe , Diquet Bertrand , Lainé Pascale , Septans Anne-Lise 
Published: May 2015

Abstract
Background : during 2008 we have collected one hundred observations of persistent significant alopecia (PSA). FEC 100-docetaxel 100 mg/msq regimen was mostly concerned. We therefore decided to evaluate exact incidence of this relevant side effect through women points of view.
Methods : ERALOP is a retrospective study using a self-questionnaire targeting patients (pts) treated with this sequential regimen from 2008 to 2009. The primary objective was to estimate the incidence of a PSA at 6 months after last course of docetaxel with CTCAE 4.0 classification : grade 1 : hair loss of up to 50% not obvious from a distance, a different hair style may be required to cover the hair loss, grade 2 : hair loss &gt; 50% with a psychosocial impact. The sample size calculation of 635 patients took into account : PSA incidence of 3.2% (TAC regimen), precision of 0.015, α risk at 0.05, 20% patients lost for follow up. ERALOP study was approved by local ethic comitee.
Results: from July 2012 to October 2012, 829 pts received a self-questionnaire. 176 pts (21%) did not answer and were considered as without PSA. 653 (79%) answers with medical data fully documented were collected. Median age of patients was 56 years. Six months after last docetaxel course, PSA incidence grade 2 : 8.6% (71 pts), grade 1 : 32.6% (271 pts), grade 0 : 56% (466 pts), NA : 2.5% (21 pts). 73% of pts with PSA received hormonotherapy. At the time of the inquiry (median follow up of 3.7 years), PSA incidence grade 2 was 3.5% (29 pts), grade 1 : 30% (248 pts), grade 0 : 63,8% (529 pts), for a global PSA incidence of 33.4%. Between 6 months after last course of docetaxel and time of the inquiry, it appears slight or total regrowth for 40 pts with PSA grade 2 and 187 with PSA grade 1.Three pts still wore a wig, and many pts had suboptimal regrowth of eyelash (31%), eyebrow (47%), pubic hair (27%), and nail disorders (27%). A multivariate analysis was performed to look for PSA risk factors. All the oral treatments, including dexpanthenol, biotin, methionine cysteine and cystin-vitamin B6 proved to have no efficacy. Treatment by topical minoxidil could have a little efficacy. Impairment of health-related quality of life will be assesed by Dermatology Life Quality Index (DLQI) and alopecia grade will be evaluated at the end of hormonotherapy.
Conclusions: Physicians and patients should be aware of this new distressing side-effect. This high level of PSA lead us to conduct ALOPREV trial to investigate, in spite of FEC induced alopecia, the properties of cooling cap prevention trial during docetaxel infusion. Preliminary results are encouraging and this option could be considered.
Citation Format: Hugues Pierre Bourgeois, Aurélie Jamet, Françoise Grudé, Carole Adounkpe, Pierre Kerbrat, Remy Delva, Hélène Simon, Philippe Deguiral, Bertrand Diquet, Pascale Lainé, Anne-Lise Septans. ERALOP study: Post adjuvant FEC - docetaxel chemotherapy for early breast cancer: Hair regrowth in the real life [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-21-05.