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Clinical performance of the DigniCap system, a scalp hypothermia system, in preventing chemotherapy-induced alopecia.
Background: Alopecia is an emotionally traumatic side effect for breast cancer (BC) patients (pts) undergoing adjuvant chemotherapy (CTX). The DigniCap System is the first scalp cooling system studied under a clinical trial approved by the Food and Drug Administration (FDA) to minimize alopecia. Methods: This prospective trial evaluated the clinical performance of the DigniCap System in women with early stage BC receiving adjuvant CTX. The primary endpoint was efficacy evaluated by pt self-assessment of 5 photographs of the head using the Dean scale to estimate hair loss one month after the end of chemotherapy. A score of 0-2 ( ≤ 50% hair loss) was defined as treatment success. Tolerability was defined as the percentage of patients who completed all planned CTX cycles using the DigniCap System and by the Patient Symptoms Survey. Eligibility included women with stage I/II BC scheduled to receive adjuvant CTX, excluding sequential anthracycline/taxane regimens. With 100 pts enrolled, there was 90% power to detect the difference between the null hypothesis treatment success proportion of less than 40% versus an alternative proportion of 56%. Pts who chose not to undergo scalp cooling were enrolled in a control group. Results: 101 pts used the DigniCap System and were evaluable for the primary endpoint. CTX regimens included docetaxel (D)/ cyclophosphamide (76%), D/carboplatin (12%) & weekly paclitaxel (12%); trastuzumab and pertuzumab were allowed. Treatment success was seen in 71 (70.3%; 95% CI, 60.4 - 79.0%; p < 0.001), compared to 0/16 in the control group. Minimal or no hair loss (Dean score 0-1) was seen in 39 pts (39%). Toxicity included grade 1/2 headache (4), pruritus (1), pain of skin (1) and head discomfort (1). Three pts discontinued cooling, primarily from feeling cold. Conclusions: Use of the DigniCap System prevented significant hair loss in 70.3% of pts with breast cancer receiving adjuvant CTX, compared to control where 94% had > 75% hair loss. Treatment was well tolerated and there has been no evidence of scalp metastases. Pts will be followed for long-term safety. The DigniCap System is highly effective in reducing chemotherapy-induced alopecia with a clinically meaningful benefit. Clinical trial information: NCT01831024
Abstracts by Hope S. Rugo:
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