TY - JOUR
T1 - Association between use of a scalp cooling device and alopecia after chemotherapy for breast cancer
AU - Rugo, Hope S.
AU - Klein, Paula
AU - Melin, Susan Anitra
AU - Hurvitz, Sara A.
AU - Melisko, Michelle E.
AU - Moore, Anne
AU - Park, Glen
AU - Mitchel, Jules
AU - Bågeman, Erika
AU - D'Agostino, Ralph B.
AU - Ver Hoeve, Elizabeth S.
AU - Esserman, Laura
AU - Cigler, Tessa
PY - 2017/2/14
Y1 - 2017/2/14
N2 - IMPORTANCE Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited. OBJECTIVES To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life. DESIGN, SETTING, AND PARTICIPANTS A prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years. EXPOSURES Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3?C (37?F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. MAIN OUTCOMES AND MEASURES Self-estimated hair loss using the Dean scalewas assessed 4weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. ADean scale score of0to 2 (≤50%hair loss)was defined as treatment success.Apositive association between scalp cooling and reduced risk of hair losswould be demonstrated if50%or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95%CI greater than40%of the success proportion. Quality of lifewas assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-upwas 29.5 months. RESULTS Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0%were white, 9.0%were black, and 10.7%were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95%CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3%(95%CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3%(95%CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold. CONCLUSIONS AND RELEVANCE Amongwomen undergoing non-anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is needed to assess outcomes after patients receive anthracycline regimens, longer-term measures of alopecia, and adverse effects.
AB - IMPORTANCE Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited. OBJECTIVES To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life. DESIGN, SETTING, AND PARTICIPANTS A prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years. EXPOSURES Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3?C (37?F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. MAIN OUTCOMES AND MEASURES Self-estimated hair loss using the Dean scalewas assessed 4weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. ADean scale score of0to 2 (≤50%hair loss)was defined as treatment success.Apositive association between scalp cooling and reduced risk of hair losswould be demonstrated if50%or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95%CI greater than40%of the success proportion. Quality of lifewas assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-upwas 29.5 months. RESULTS Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0%were white, 9.0%were black, and 10.7%were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95%CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3%(95%CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3%(95%CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold. CONCLUSIONS AND RELEVANCE Amongwomen undergoing non-anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is needed to assess outcomes after patients receive anthracycline regimens, longer-term measures of alopecia, and adverse effects.
UR - http://www.scopus.com/inward/record.url?scp=85014650556&partnerID=8YFLogxK
U2 - 10.1001/jama.2016.21038
DO - 10.1001/jama.2016.21038
M3 - Article
C2 - 28196257
AN - SCOPUS:85014650556
SN - 0098-7484
VL - 317
SP - 606
EP - 614
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 6
ER -