冷却头皮可预防化疗脱发

芝加哥——加拿大魁北克拉瓦尔大学的Julie Lemieux博士在美国临床肿瘤学会(ASCO)年会上报告了一项小型前瞻性队列研究结果：接受化疗的乳腺癌患者戴头皮冷却帽可减少头发脱落。接受头皮冷却治疗的患者，24%在完成化疗后不必戴假发或头巾，而这一比例在未使用头皮冷却装置的患者中仅为4%。而且前者的满意度也明显高于对照组。

研究者招募了110例接受头皮冷却治疗的乳腺癌患者，同时在一家不提供头皮冷却治疗的医院招募了26例乳腺癌患者作为对照。受试者的中位年龄介于51~55岁，主要为Ⅰ期或Ⅱ期激素受体阳性乳腺癌。头皮冷却组患者从化疗开始前20 min时开始佩戴头皮冷却装置，直至化疗输液结束后60~90 min再摘下。

为了更好地评价使用或不用头皮冷却装置的效果，研究者安排1名美发师在不知道患者分组的情况下比较患者试验前后的照片。如果化疗结束时与化疗开始时相比“完全没有脱发”、“稍有脱发”或“轻度脱发”，即视为护发成功；如果“大量脱发”、“完全脱发”或“头发剃光”，则视为护发失败。

结果根据美发师的判断，头皮冷却组有34%的患者护发成功，而对照组仅有9%的患者护发成功。头皮冷却组和对照组分别有49%和4%的患者自认为未出现明显脱发。头皮冷却组中有69%的患者认为该治疗利大于弊，78%声称将会推荐其他女性乳腺癌患者在接受化疗时使用这种头皮冷却装置。

Julie Lemieux博士

Lemieux博士介绍，这种头皮冷却装置已在加拿大获准用于减少脱发，但仍有不少肿瘤医生对该装置的安全性和对化疗疗效的潜在影响存有疑虑。她解释道：“冷却头皮会引起血管收缩，减少头皮的血流，这是该装置的主要作用机制。我们回顾分析了7项有关头皮冷却治疗的随机试验，结果未发现安全问题。本项试验招募了260例患者，涉及多种化疗方案，其中至少有1种方案尚未被发现可引起脱发。我们还进行了一项回顾性队列研究，发现不论是否使用头皮冷却装置，头皮转移率均为1%左右(Breast Cancer Res. Treat. 2009;118:547-52)。”此后，Lemieux博士及其同事还报告了2例以头皮为首发转移部位的病例，其转移分别发生于头皮冷却治疗后第7年和第9年(Breast Cancer Res. Treat. 2011;128:563-6)。Lemieux博士还曾在圣安东尼奥乳腺癌研讨会上报告一项回顾性研究结果：使用和不用头皮冷却装置的患者，生存率无差异。

该试验中使用的头皮冷却装置是在冰箱中冷冻过的冰帽，每20~30 min更换一顶冰帽。据称，新一代头皮冷却装置使用一台压缩机为冰帽不断注入冷水，因而可避免更换冰帽的麻烦。

这项试验由Fondations des Hôpitaux Enfant-Jésus et Saint-Sacrement、加拿大乳腺癌研究联盟和赛诺菲-安万特资助。Lemieux博士获得了由魁北克Fonds de la Recherche en Santé提供的研究资金。

爱思唯尔  版权所有

By: JANE SALODOF MACNEIL, Ob.Gyn. News Digital Network

CHICAGO – Wearing a scalp-cooling cap can reduce hair loss in women receiving chemotherapy for breast cancer, the results of a small prospective cohort study suggest.

Among women who used the cooling headgear starting 20 minutes before chemotherapy and continuing for 60-90 minutes after the infusion, 24% did not wear a wig or headband upon completion of chemotherapy, compared with 4% of a control group that did not have access to the device, investigators reported.

Further, patient satisfaction scores were higher than these numbers in a blinded assessment, according to Dr. Julie Lemieux of Laval University in Quebec City and her coinvestigators.

To grade the results with and without the cooling device, a hairdresser looked at before and after photos of women in the study, and was not told which women were in the scalp-cooling group. The criteria for successful hair preservation was characterization of hair loss as "not at all," "a little," or "moderate" from the beginning to the end of chemotherapy. The procedure was deemed a failure if the reviewer rated hair loss as "a lot," or "all," or "hair shaved."

The hairdresser graded the hair loss intervention as successful in 34% of the scalp-cooling group – as did 49% of the women who wore the caps. Only 9% of the control group received a successful grade from the hairdresser; even fewer, 4%, agreed they had not had substantial hair loss.

In all, 69% of women who tried scalp cooling said the advantages outweighed the disadvantages, and 78% said they would recommend it to other women receiving the same chemotherapy for breast cancer.

"When you look at patient evaluations, they are ... more optimistic than the hairdresser evaluations. They were more satisfied," Dr. Lemieux said in a poster-side interview at the annual meeting of the American Society of Clinical Oncology, where she displayed the results.

Scalp-cooling systems are approved for the reduction of alopecia in Canada, she said, but controversy persists among oncologists over safety and impact, if any, on the effectiveness of chemotherapy.

"If you cool the scalp there is vasoconstriction, so there is less blood that goes in the scalp ... that is the main mechanism," Dr. Lemieux explained. One concern is that scalp metastases could increase; another is that patients might receive less chemotherapy as a result.

Dr. Lemieux and her colleagues reviewed seven randomized trials of hair-cooling studies and found no safety signals. In all, 260 women were enrolled, and the studies covered a variety of chemotherapy regimens, including at least one that is not known to cause alopecia.

They also did a retrospective cohort study, and found that the incidence of scalp metastases was about 1% whether women used scalp cooling or not (Breast Cancer Res. Treat. 2009;118:547-52). Subsequently, they reported on two cases where the scalp was the first metastatic site, with metastases occurring 7 and 9 years after cooling (Breast Cancer Res. Treat. 2011;128:563-6).

At the San Antonio Breast Cancer Symposium, Dr. Lemieux and her associates reported on a retrospective study that found no difference in survival between patients who used scalp cooling and those who did not.

For the current study, the researchers compared outcomes in 110 patients at Centre des Maladies du Sein Deschênes-Fabia in Quebec City, which uses scalp cooling routinely, with those in 26 patients at the Centre Hospitalier Universitaire de Montréal, where scalp cooling is not available. The median patient age was in the early 50s, and most of the women had stage I or II, hormone receptor–positive breast cancer. A variety of neoadjuvant and adjuvant regimens were used.

The system tested in the study used a cap that is placed in a freezer and changed every 20-30 minutes, starting 20 minutes before chemotherapy and continuing for 60-90 minutes afterward. A new generation of scalp-cooling systems uses a compressor that circulates cold fluid in the cap, and it does not have to be changed.

Dr. Lemieux said the researchers conceived the study as a pilot for a larger randomized controlled trial that will address efficacy, cost, and quality of life issues. They are seeking to raise funds, as the companies that make the systems are too small to sponsor a large trial.

Cost is a concern, she noted, because of the additional time the women spend in the infusion room. "So you have to have that time available in the chemotherapy room," she said. "We also want to look at the cost of the system, of the extra time that women are in hospital, and at quality of life, too."

The trial was funded by the Fondations des Hôpitaux Enfant-Jésus et Saint-Sacrement, the Canadian Breast Cancer Research Alliance, and Sanofi-Aventis. Dr. Lemieux received a research grant from the Fonds de la Recherche en Santé du Québec.