The approval of the Paxman Scalp Cooling System follows a randomized clinical trial, whose results were published in JAMA following an interim analysis.
The Paxman Scalp Cooling System, which reduces or prevents hair loss associated with chemotherapy treatment in women with breast cancer, is now FDA approved. The approval follows a randomized clinical trial, whose results were published in JAMA following an interim analysis.
Chemotherapy-associated alopecia, which drastically changes how a person looks and feels, can significantly impact a patient’s quality of life, over and above the physical exhaustion associated with their treatment. Studies have shown that for some patients, alopecia can rank just below nausea and vomiting as the most distressing side effect of cancer treatment.
Patients currently have access to several cold cap technologies, but the Paxman system is only the second to be FDA approved. Digitana Inc’s DigniCap Cooling System was the first such device to be approved back in December 2015.
In the JAMA study, 182 women receiving treatment with a taxane, anthracycline, or both, for stage I or II breast cancer at 7 sites within the United States, were enrolled between December 9, 2013, and September 30, 2016, and randomized to the scalp cooling (n = 119) or control (n = 63) cohort. The primary outcome of hair preservation was measured at the end of 4 cycles of chemotherapy, using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade 0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig] were considered to have hair preservation). Device safety was also a primary endpoint. Secondary endpoints included wig use and scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire—Core 30, Hospital Anxiety and Depression Scale, and a summary scale of the Body Image Scale.
Of the 142 evaluable patients at the time of the interim analysis, half the women who received scalp cooling (48 of 95) had successful hair preservation (95% CI, 40.7%-60.4%), compared with none in the control cohort (95% CI, 0%-7.6%). Fifty-four grade 1 and 2 device-related adverse events were reported.
Scalp-cooling devices are not without challenges. Nancy Marshall, cofounder of The Rapunzel Project, told Evidence-Based Oncology™ (EBO™) that patient tolerance for the cold caps can vary. “Exposed skin (such as forehead, ears, and scalp) can get freezer burn, but patients are taught to change hair part lines and protect other exposed skin with moleskin or similar covering.”
Another aspect is the cost associated with using the device. FDA approval does not automatically translate into reimbursement by health plans. Digitana told EBO™ that the company is working with third-party payers to establish coverage for use of their cooling device. Meanwhile, the cost sharing between the medical center and the patient can vary based on what the site decides. Aetna considers scalp cooling as “experimental” and UnitedHealth policy allows coverage for “ice-filled bags or bandages or other devices used for scalp hypothermia during chemotherapy,” as supplies but does not recognize them as a separate charge.
A blog post reports that the cost of using the system can vary anywhere from $300 to $500 per infusion session.
Study sites for the Paxman device included Baylor College of Medicine, the Memorial Sloan Kettering Cancer Center, the US Oncology Network, and the MD Anderson Cancer Center.