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

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.