Effect of Scalp-Cooling Device on Hair Loss in Women Receiving Chemotherapy for Breast Cancer
An interim analysis of the SCALP trial, reported in JAMA by Nangia et al, showed that use of a scalp-cooling device significantly reduced hair loss in women receiving chemotherapy for stage I or II breast cancer compared with no scalp cooling. The study was stopped early on the basis of efficacy.
Study Details
In the study, 182 women from seven U.S. sites who required chemotherapy were randomized 2:1 between December 2013 and September 2016 to scalp cooling (n = 119) or no scalp cooling (n = 63). All patients were planned to receive at least four cycles of taxane- and/or anthracycline-based chemotherapy for curative intent. Scalp cooling was performed using a cap scalp-cooling device for 30 minutes prior to, during, and for 90 minutes after each chemotherapy infusion.
The primary efficacy endpoint was successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale, with preservation defined as grade 0 (no hair loss) or grade 1 alopecia (< 50% hair loss not requiring a wig) at the end of four cycles of chemotherapy. Outcome was assessed by a clinician unaware of treatment assignment. At the time of the preplanned interim analysis, 142 patients (95 in the cooling group and 47 in the control group) had completed four cycles of chemotherapy and were evaluable for the primary endpoint (modified intent-to-treat population).
For the cooling and control groups in the modified intent-to-treat population: median age was 53 and 55 years; 75% and 82% were white; all had grade 0 alopecia at baseline; major chemotherapy type was anthracycline in 34% and 40% and taxane in 66% and 60%; disease stage was I in 40% and II in 60% in both; and the most common scheduled chemotherapy regimens were doxorubicin at 60 mg/m2 plus cyclophosphamide at 600 mg/m2 in 32% and 36%, docetaxel at 75 mg/m2 plus cyclophosphamide at 600 mg/m2 in 36% and 19%, and docetaxel at 75 mg/m2 with carboplatin target AUC = 6 mg x min/mL and standard-dose trastuzumab (Herceptin) in 22% and 23%.
Rates of Hair Preservation
At interim analysis, successful hair preservation was observed in 48 of 95 women in the cooling group (50.5%, 95% confidence interval [CI] = 40.7%–60.4%) vs 0 of 47 women in the control group (0%, 95% CI = 0%–7.6%), yielding a success rate difference of 50.5% (95% CI = 40.5%–60.6%, P < .001). Since the P value crossed the interim analysis superiority boundary (P = .0061), the data and safety monitoring board recommended study termination in September 2016. Hair preservation in the cooling group consisted of grade 0 alopecia in 5 patients (5.3%) and grade 1 alopecia in 43 patients (45.3%). Rates of hair retention were 50.5% vs 0% as assessed by patients and 55.8% vs 0% as assessed by oncologists. Wigs or head wraps were used by 63% vs 100% of patients.
Differences in the rates of hair preservation in the cooling group were observed according to study site and drug treatment. Rates of hair reservation ranged from 0% at a site enrolling only 1 patient to 68.6% at a site enrolling 51 patients. Overall, success was reported in 7 of 32 patients (22%) receiving anthracycline-based treatment and in 41 of 63 patients (65%) receiving taxane-based treatment. In an exploratory post hoc analysis accounting for site effects, estimated rates of hair preservation were 16% with anthracycline-based treatment and 59% with taxane-based treatment.
Adverse Events
Adverse events were collected only for the cooling group. A total of 54 adverse events were reported, with all being grade 1 (n = 46) or 2 (n = 8). Adverse events included chills, dizziness, headache, nausea, paresthesia, pruritus, sinus pain, skin and subcutaneous tissue disorders, and skin ulceration. The most common adverse events were headache, which occurred in 11.9%, 10.7%, 1.5%, and 6.5% during chemotherapy cycles 1 through 4, and nausea, which occurred in 4.0%, 2.4%, 1.5%, and 1.6% during cycles 1 through 4. Of the eight grade 2 adverse events, seven were headache and one was scalp pain. No serious adverse events were reported.
No statistically significant differences were observed between groups in changes from baseline in quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire–Core 30, Hospital Anxiety and Depression Scale, and summary scale of the Body Image Scale.
A final analysis of the trial including an additional 60 enrolled patients is planned. The last patient was expected to complete chemotherapy in February of 2017.
The investigators concluded: “Among women with stage I to II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss after the fourth chemotherapy cycle compared with those who received no scalp cooling. Further research is needed to assess longer-term efficacy and adverse effects.”
The study was supported by Paxman Coolers Ltd, which contracted with Baylor College of Medicine to conduct the study.
Julie Nangia, MD, of Baylor College of Medicine, is the corresponding author of the JAMA article.
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