Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, Leiden, 2300 RC Leiden, The Netherlands.
Department of Research & Development, The Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.
Support Care Cancer. 2022 Aug;30(8):6641-6648. doi: 10.1007/s00520-022-07090-7. Epub 2022 May 2.
Scalp cooling can prevent chemotherapy-induced alopecia (CIA). Previously, the post-infusion cooling time (PICT) could be successfully reduced in docetaxel-treated patients from 90 to 45 and 20 min. Therefore, it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well.
Patients treated with weekly paclitaxel were included in this multi-centre trial and randomly assigned to a PICT of 45 or 20 min. The results were compared to a standard PICT of 90 min, derived from prospective collected data from the Dutch Scalp Cooling Registry. The primary endpoint was the percentage of patients who decide to not wear a wig or head covering. Secondary endpoints were the degree of CIA assessed with the Dean scale for assessment of hair loss; alopecia graded according to NCI CTC toxicity version 4.03 (CTCAE4.03); tolerance of scalp cooling and perceived distress of CIA.
Ninety-one patients were enrolled in this study; 74 patients were evaluable for hair loss. Hair preservation was successful in 27 patients (75%) with a PICT of 45 min and in 31 patients (82%) with a PICT of 20 min. There was no difference in success rate with the standard PICT of 90 min (85%, p = 0.29). Similar success rates were seen when using the Dean scale and CTCAE assessment, with no differences between groups (p = 0.12 and p = 0.38).
A 20 min PICT is as effective as 45 and 90 min to prevent weekly paclitaxel-induced alopecia and should be the new standard of care.
ClinicalTrials.gov Identifier: NCT03266185.
头皮冷却可预防化疗引起的脱发（CIA）。先前，在接受多西他赛治疗的患者中，输注后冷却时间（PICT）可成功从 90 分钟缩短至 45 分钟和 20 分钟。因此，对于接受紫杉醇治疗的患者，PICT 似乎也可以缩短。
本多中心试验纳入接受每周紫杉醇治疗的患者，并随机分为 PICT 45 分钟或 20 分钟组。结果与来自荷兰头皮冷却登记处前瞻性收集数据的标准 PICT（90 分钟）进行比较。主要终点是决定不戴假发或头饰的患者比例。次要终点是使用脱发评估的 Dean 量表评估 CIA 的程度；根据 NCI CTC 毒性版本 4.03（CTCAE4.03）分级的脱发程度；头皮冷却的耐受性和 CIA 所致的痛苦程度。
本研究纳入 91 例患者；74 例患者可评估脱发。45 分钟 PICT 组有 27 例（75%）患者头发保留成功，20 分钟 PICT 组有 31 例（82%）患者头发保留成功。标准 90 分钟 PICT 的成功率无差异（85%，p=0.29）。使用 Dean 量表和 CTCAE 评估时，成功率相似，组间无差异（p=0.12 和 p=0.38）。
20 分钟 PICT 与 45 分钟和 90 分钟一样有效，可预防每周紫杉醇引起的脱发，应成为新的护理标准。
ClinicalTrials.gov 标识符：NCT03266185。
