Abstract OT3-3-04: ALOPREV: first cooling scalp trial for prevention of persisting alopecia after docetaxel for early breast cancer patients.
Authors: Bourgeois H , Soulié P , Lucas B , Mercier Blas A , Zannetti A , Delecroix V , L'haridon T , Blot E , Delaloge S , Grudé F 
Published: August 2014

During SABCS 2009, Western France Observatory of Cancer has presented “ALOPERS” results from more than one hundred patients with persisting alopecia or suboptimal hair regrowth after chemotherapy for early breast cancer. Docetaxel 75–100 mg/msq was concerned for majority of patients. 43% of patients experienced alopecia more than 24 months after their last chemotherapy infusion. Optimal information of patients about alopecia and persisting alopecia appears to be mandatory before treatment: 47% of patients undergo a psychological shock during hair loss. Morevover, BCIRG 001 study (TAC versus FAC) led to the conclusion that docetaxel 75 mg/msq is responsible for persisting alopecia for 3% of patients. So, by extrapolating, in France, each year, docetaxel could induce a persisting alopecia in 300 patients. To confirm this figure, “ERALOP” study is in progress to evaluate precisely the incidence of persisting alopecia after docetaxel in early breast cancer patients and then theses data will be communicated to ANSM. It must be noticed that 8% of patients refused to be treated because of the risk of persistant alopecia (Trueb et al, 2010). That's why it is a worldwide public health problem, with personal and societal implications.

As alopecia is universal after FEC100 regimen, the cooling scalp has been supposed to be very effective during docetaxel 1 hour infusion and to allow a better hair regrowth but with a high risk in term of tolerance. Since 2012, a prospective clinical trial “ALOPREV” has begun in Western France to evaluate tolerance of cooling scalp, after 3–4 courses of FEC100 regimen and during 3–4 courses of docetaxel 100 mg/msq, for patients treated for early breast cancer. So, ALOPREV is designed as a safety trial. First, cooling scalp major toxicities (headache, neck pain, discomfort associated with cold, sinusitis) are evaluated during each docetaxel course by the patient. Then, auto-questionnary about hair loss and regrowth, nails disorders and others toxicities due to docetaxel and questionnary about quality of life (EORTC QLQ-C30 and BR-23 scales) is completed by the patients before, during and after treatment. Patients will be followed-up 12 months and final toxicities will be reported by physicians. According to our daily practice, it will demonstrate that 60% of patients could tolerate two consecutive cooling scalps during docetaxel infusion, and with statistical considerations (alpha-beta risks and 10% of ineligibility). So 160 patients must be included during inclusion period (18 months). 10 public or private care centers have been opened (45 investigators). This trial implicates particularly nurses teams and all patients will sign an informed consent before FEC100 courses. ALOPREV started two months ago and 25 patients are already enrolled.

In conclusion, cooling scalp is known to be safe, manageable and partially effective before hair loss. ALOPREV will evaluate safety and efficacy to avoid persisting alopecia after hair loss.

Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT3-3-04.