Clinics of Medical Oncology, HFR Fribourg Cantonal Hospital, Fribourg, Switzerland.
Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.
Chemotherapy-induced alopecia is very distressing for a patient and may have an impact on treatment decisions. On docetaxel-based therapy, alopecia occurs in a substantial proportion of patients. We aimed to investigate whether two different methods of scalp cooling can prevent hair loss.
In this open-label, prospective, nonrandomized trial, patients with solid tumors receiving docetaxel in a palliative setting were allocated according to patients' preference to short-term cooling (over 45 min postinfusion) with a Paxman PSC-2 machine (PAX), with cold cap (CC), or no cooling. The combined endpoint was alopecia World Health Organisation (WHO) III or IV or the necessity to wear a wig. Study identifier is Clinicaltrials.gov NCT01008774.
Two hundred thirty-eight patients were included in the trial (128 patients PAX, 71 CC, and 39 no cooling). Number of cycles (median 4) and median docetaxel doses were similar across groups (55-60 mg/day on weekly therapy, 135-140 mg/day on 3-weekly therapy). Alopecia occurred with PAX, CC, and no cooling under 3-weekly docetaxel in 23, 27, and 74% and under weekly docetaxel in 7, 8, and 17%, respectively. Overall, cooling (PAX and CC combined) reduced risk of alopecia by 78% (hazard ratio 0.22; 95% confidence interval 0.12 to 0.41). CC and PAX prophylaxis led to the same degree of prevention of alopecia. Adverse events (AE) were reported in 5% (most frequently, sensation of cold), and 30 patients (13%) discontinued cooling measures after cycle 1.
In this first comparison published to date, both PAX and CC offer efficacious protection against hair loss, in particular when docetaxel is administered in a 3-weekly interval.
化疗引起的脱发对患者来说非常痛苦，可能会影响治疗决策。在基于多西紫杉醇的治疗中，相当一部分患者会出现脱发。我们旨在研究两种不同的头皮冷却方法是否可以预防脱发。
在这项开放标签、前瞻性、非随机试验中，根据患者的偏好，将接受姑息性多西紫杉醇治疗的实体瘤患者分配至短期冷却组（输注后 45 分钟以上），使用 Paxman PSC-2 机器（PAX）、冷帽（CC）或不冷却。联合终点为脱发世界卫生组织（WHO）III 或 IV 级或需要戴假发。研究标识符为 Clinicaltrials.gov NCT01008774。
共有 238 名患者入组（PAX 组 128 例、CC 组 71 例、不冷却组 39 例）。各组的周期数（中位数为 4 个）和多西紫杉醇的中位数剂量相似（每周治疗时为 55-60mg/天，3 周治疗时为 135-140mg/天）。PAX、CC 和不冷却下，3 周多西紫杉醇治疗时脱发发生率分别为 23%、27%和 74%，每周多西紫杉醇治疗时脱发发生率分别为 7%、8%和 17%。总体而言，冷却（PAX 和 CC 联合）可使脱发风险降低 78%（风险比 0.22；95%置信区间 0.12 至 0.41）。CC 和 PAX 预防措施导致脱发的预防程度相同。不良反应（AE）发生率为 5%（最常见的是寒冷感），30 例（13%）患者在第 1 个周期后停止了冷却措施。
在迄今为止发表的首次比较中，PAX 和 CC 均能有效预防脱发，特别是当多西紫杉醇以 3 周间隔给药时。
