Alopecia is one of the most dreaded adverse effects associated with the use of chemotherapy. It can adversely affect a patient's quality of life. In April 2017, the FDA approved scalp cooling (SC) as a method to try to reduce hair loss. Studies have produced mixed results as to the benefit of this practice for preventing hair loss in breast cancer (BC) patients.
The Hair Safe Study was a prospective, interventional, single-center study to evaluate the efficacy of SC for different chemotherapy regimens used during BC treatment and to assess SC's long-term effects on hair recovery from both a patient and clinician perspective. It was conducted between May 2018 and February 2021 and included patients aged 18 years or older receiving at least four cycles of a taxane- or anthracycline-based regimen. Patients were excluded if they had a history of migraines, Raynaud syndrome or cold allergy, hematological malignancies, scalp metastases, preexisting alopecia, overt cognitive impairment, or could not communicate in German.
The primary endpoint was hair preservation (HP) (i.e., grade 0-1 alopecia). The secondary endpoints were patient satisfaction and quality of life. The third endpoint was hair regrowth (HR) as determined by medical experts at 3 and 6 to 9 months postchemotherapy. Grading of hair loss was based on the CTCAEv4.0 grading system with grade 0 representing no hair loss, grade 1 signifying hair loss up to 50%, and grade 2 defined as hair loss of >50%. This assessment was based on five standardized photographs taken by a professional photographer and evaluated by three health experts.
A total of 128 patients were recruited for the study with 88 being enrolled in the SC arm (median age: 51 years) and 40 in the non-SC arm (median age: 54.5 years). In the SC arm, 11 patients withdrew, and in the non-SC arm, two patients dropped out of the clinical trial. Of the remaining 77 patients in the SC arm, 24% of patients (n = 17; 6 were treated with taxane monotherapy and 11 were treated with taxane and anthracycline combination therapy) reported hair loss as grade 1; no one reported grade 0 (i.e., no hair loss) and 76% (59 patients) reported grade 2 hair loss, the most severe type. No patients in the non-SC group reported grade 0-1 alopecia; 100% reported grade 2 hair loss. These differences between the groups were statistically significant (P = .001).
On the contrary, expert opinion stated that 13% had grade 0, 59% had grade 1, and only 28% had grade 2 alopecia in the SC group, indicating that 72% had no hair loss or less than 50% hair loss. All clinicians reported the non-SC group had grade 2 hair loss. That indicated severe alopecia.
A significant difference was observed for SC for preventing alopecia based on the chemotherapeutic regimen administered and the patient's perspective.
Patients rated SC as being more effective for taxane monotherapy than for the combination of taxane and an anthracycline. Fifty percent of patients rated taxane monotherapy as causing only grade 1 alopecia, and the combination regimen was associated with grade 1 alopecia in only 17.2% of patients. That implied most patients had more severe alopecia (P = .018).
The clinicians indicated that 17% of patients on taxane monotherapy and 7.9% on taxane-anthracycline combination therapy had no hair loss (grade 0). They also reported that grade 1 alopecia occurred in 42% on taxane monotherapy and in 49% receiving the taxane-anthracycline combination. However, the differences in these expert ratings were not statistically significant. The sequencing of the taxane and anthracycline chemotherapy did not affect outcome.
Of the 77 patients in the SC group, 71% discontinued SC therapy, with the most common reason (in three-quarters of patients) being hair loss. Nine percent discontinued because of adverse effects (i.e., headache, scalp pain, and extreme sensation of feeling cold). SC also did not improve quality of life. There was no difference between the SC and non-SC group regarding HR at 3 and 6 to 9 months.
While the outcome of the use of SC was rater dependent with health professionals having a more optimistic view about the minimization of hair loss compared with patients, pharmacists need to provide BC patients with realistic expectations of the limitations of this treatment modality.
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