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术后辅助化疗是高风险早期乳腺癌患者的标准治疗。剂量密集应该作为首选给药方案，不过其对生活质量的长期影响尚不明确。 2020年3月31日，施普林格自然旗下《乳腺癌研究与治疗》在线发表瑞典卡罗林学院、卡罗林大学医院、奥地利维也纳医科大学、帕拉塞尔苏斯大学萨尔茨堡医院、德国法兰克福大学的PANTHER研究报告，对两种现有乳腺癌术后辅助化疗方案随访长达16个月的健康相关生活质量进行了前瞻比较。 PANTHER (A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients):A Randomized Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel (dtEC→dtT) Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel (FEC→T) in Lymph Node Positive or High Risk Lymph Node Negative Breast Cancer Patients (NCT00798070) 该国际多中心非盲随机对照三期临床研究于2007年2月～2011年9月从86个瑞典、德国、奥地利临床研究中心入组淋巴结阳性或高风险淋巴结阴性早期乳腺癌术后年龄≤65岁女性760例，按1∶1的比例随机分为两组：
在所有瑞典临床研究中心通过欧洲癌症研究与治疗组织（EORTC）生活质量问卷（QLQ）核心30项（C30）和乳腺癌23项（BR23）对随机分组后0、2、4、8、12、16个月时的健康相关生活结局进行评定。 结果，问卷反馈率最高为0个月时93%、最低为16个月时74%。 治疗期间，两组患者健康相关生活质量均下降。 4个月治疗结束时，密集化疗组与标准化疗组相比，患者报告的整体健康状态、生理评分、心理评分、社交评分、疲劳、性评分、全身治疗影响评分等健康相关生活质量显著较低（P<0.001）。不过，情绪评分、身体意象评分、手臂症状评分、乳房症状评分相似。 8、12、16个月随访时，密集化疗组与标准化疗组相比，健康相关生活质量各项评分相似。 16个月随访时与入组时相比，健康相关生活质量各项评分相似。 因此，该研究结果表明，对于高风险早期乳腺癌术后女性，剂量密集＋定制剂量辅助化疗策略对于治疗期间健康相关生活质量的不利影响显著。不过，一旦治疗结束，健康相关生活质量可恢复至治疗前。 相关链接 Breast Cancer Res Treat. 2020 Mar 31. [Epub ahead of print] Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer. Yvonne Brandberg, Hemming Johansson, Mats Hellstrom, Michael Gnant, Volker Mobus, Richard Greil, Theodoros Foukakis, Jonas Bergh; Swedish Breast Cancer Group; Austrian Breast, Colorectal Cancer Study Group; German Breast Cancer Group. Karolinska Institutet, Stockholm, Sweden; Karolinska University Hospital, Stockholm, Sweden; Medical University of Vienna, Vienna, Austria; Goethe University Frankfurt, Frankfurt, Germany; Medical University Hospital, Salzburg, Austria. PURPOSE: To prospectively compare HRQoL effects of two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16 months after random assignment. METHODS: The open-label, randomized, Phase 3 "Panther trial" was conducted between February 2007 and September 2011. 760 women, aged 65 years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer were randomized 1:1 to the experimental group (four cycles of tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2 weeks followed by four cycles of tailored dose-dense docetaxel/2 weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3 weeks followed by three cycles of docetaxel/3 weeks). HRQoL was assessed at all Swedish centres using EORTC QLQ-C30 and EORTC QLQ-BR23 at six points during 16 months before randomization. RESULTS: Response rates to questionnaires were highest at baseline 728/780 (93%) and lowest 16 months after randomization, 557/750 (74%). HRQoL declined during treatment in both groups. At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P<0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects. No differences were found for emotional functioning, body image, and arm and breast symptoms. There were no statistically significant differences between the groups at the first follow-up and at subsequent assessments. HRQoL levels at the 16-month follow-up were similar to baseline values. CONCLUSIONS: Negative HRQoL impact of the dose-dense and tailored strategy appears to be prominent during treatment, but HRQoL recover once treatment ends. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665. KEYWORDS: Breast cancer, Adjuvant, Dose dense, Health-related quality of life, Randomized trial DOI: 10.1007/s10549-020-05602-9
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