Introduction: The best outcomes for multiple myeloma include the use of high-dose melphalan and autologous peripheral blood stem cell (PBSC) transplantation. Melphalan given prior to the reinfusion of stem cells causes nearly complete hair loss in all patients at the doses used, (CTCAE v5 Grade 2). This outcome is widely expected and leads some patients to avoid doing an otherwise life sustaining procedure. In those that do proceed with the transplant, the alopecia can be emotionally traumatic. Oral cryotherapy is commonly used to reduce melphalan side effects in the GI tract during stem cell transplantation (Lilleby et.al. 2006). We, thus, initiated a trial to determine if scalp cooling done on both days of melphalan administration would minimize or even completely prevent hair loss.
Methods: Thirty patients with multiple myeloma or AL amyloidosis undergoing an autologous PBSC transplantation had cryotherapy using the Penguin Cold Cap starting 60 minutes prior to each melphalan administration. All patients received either 70 or 100 mg/m2 of melphalan on 2 consecutive days. The cold caps were applied using manufacturer recommended guidelines (penguincoldcaps.com) and kept on for ~5 hours after melphalan was started. Questionnaires were given to patients at Day 0 and 90 during the transplant process to determine tolerability and patient perceived benefit. Photographs were taken at Day -2, 7, 14, 30, 60 and 90 days after the transplant to grade hair loss using the CTCAE v5 guidelines.
Results: All 30 patients have been treated and 25 have reached the 90-day completion date. Median cold cap application time was 409 minutes (range 350-490). Median age was 66, (range 50-79), and while most patients were women (17), 13 men enrolled. Patient stated race was as follows: White (6 Hispanic, 18 non-Hispanic), Black (2), Asian (2), and Other (4). Hair loss was minimal to non-existent in all patients with no patients having Grade 1 or 2 hair loss. The procedure was well tolerated with the main complaint being scalp discomfort due to cold. No skin reactions or toxicity was observed. At 90 days, patient described hair loss was a median of 2% (range 0 - 74%). Photographs show minimal difference between pre- and post-transplant time points with essentially no hair loss noticed except at some areas where the scalp cooling device may not have touched the skin. Questionnaires of the 25 patients to date document that all but one patient would do the procedure again. While 5 patients thought family members would notice (3) or may notice (2) a difference in their hair appearance, the other 20 did not think family members would notice a change in their hair. All 25 patients stated that strangers would not suspect that they had received chemotherapy by looking at their hair. One plasma cell leukemia patient has already relapsed but without visible scalp or disproportionate skull involvement.
Conclusions: The Penguin Scalp cooling device can prevent nearly any detectable hair loss in patients with multiple myeloma undergoing high-dose melphalan chemotherapy and an autologous peripheral blood stem cell transplantation. This result was in marked contrast to the near universal Grade 2 hair loss in transplanted patients treated without scalp cooling historically. The process is simple, and the patients were overall very pleased with the results. Even some male patients with moderate alopecia to begin with opted for and were generally pleased with the ability to maintain the appearance of their hair post-transplant. The short 80-minute half-life of melphalan likely explains the better outcomes for multiple myeloma compared to breast cancer patients. This better cosmetic outcome should broaden the usage of high-dose chemotherapy and thus improve overall quality and quantity of life. The theoretical concern of excess tumor recurrence in the treated scalp was discussed with the patients who enrolled. Since multiple myeloma is rarely curable, only rarely involves the skin at early stages, and is treated in general with maintenance therapy afterwards, it is hoped and assumed that the risk of higher tumor recurrence locally in the scalp and skull will be minimal. Final results of the trial including photographs and questionnaire results will be available in time for the conference.
Vescio:Janssen: Speakers Bureau; Alnylam: Speakers Bureau; Karyopharm: Speakers Bureau; Amgen: Speakers Bureau; Bristol Myers Squibb: Speakers Bureau. Oveisi:Janssen: Consultancy, Research Funding; Pfizer: Honoraria. Solomon:Penguin Cold Caps: Current Employment.
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