Kawaguchi H, Masuda N, Nakayama T, Aogi K, Anan K, Ito Y, Ohtani S, Sato N, Saji S, Tokunaga E, Nakamura S, Hasegawa Y, Hattori M, Fujisawa T, Morita S, Yamaguchi M, Yamashita T, Yamamoto Y, Ohno S, Toi M
Department of Breast Surgery, Matsuyama Red Cross Hospital, 1 Bunkyo-cho, Matsuyama, Ehime, 790-8524, Japan.
Department of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, 540-0006, Japan.
Breast Cancer Res Treat. 2017 Jun;163(3):545-554. doi: 10.1007/s10549-017-4212-x. Epub 2017 Mar 23.
This retrospective study evaluated the effect of clinical background and treatment line on time to treatment failure (TTF) in advanced/metastatic breast cancer (AMBC) patients receiving F500 in Japan (UMIN 000015168).
Patients who commenced F500 treatment were registered at 16 sites in Japan. Correlations between baseline clinicopathological factors, treatment line, and TTF were investigated by Kaplan-Meier analysis. TTF data were analyzed using univariate analysis and multivariate analysis with a Cox proportional hazards model.
Data for 1072 patients were available; 1031 patients (96.2%) were evaluable for efficacy. F500 was administered as first-line treatment in 2.0%, second-line in 22.7%, third-line in 26.7%, and ≥fourth-line in 48.6% patients. Median TTF was 5.4 months. Multivariate analysis found that earlier F500 use (first and second vs. third vs. ≥fourth line; hazard ratio (HR) = 0.80, 95% confidence interval (CI) 0.74-0.86; P < 0.001), longer period from AMBC diagnosis to F500 use (≥3 vs. <3 years; HR 0.60, 95% CI 0.51-0.70; P < 0.001), and no prior palliative chemotherapy administered for unresectable or metastatic breast cancer (no vs. yes; HR 0.69, 95% CI 0.60-0.80; P < 0.001) were associated with significantly longer TTF. Among 691 patients, where information on histologic/nuclear grade was available, a low grade was also associated with a longer TTF, but this finding was not maintained among patients with recurrent breast cancer (N = 558). Among women with recurrent breast cancer, a longer DFI between a patient's initial breast cancer diagnosis and their recurrence was associated with a longer TTF on F500 therapy.
Our study showed that treatment period of F500 was longer when used in earlier-line treatment. For patients on F500, TTF was also longer for patients who had not received prior palliative chemotherapy and for those who had a longer period from their AMBC diagnosis to F500 use.
本回顾性研究评估了临床背景和治疗线数对在日本接受F500治疗的晚期/转移性乳腺癌（AMBC）患者治疗失败时间（TTF）的影响（UMIN 000015168）。
开始F500治疗的患者在日本的16个地点进行登记。通过Kaplan-Meier分析研究基线临床病理因素、治疗线数和TTF之间的相关性。使用单因素分析和Cox比例风险模型进行多因素分析来分析TTF数据。
有1072例患者的数据可用；1031例患者（96.2%）可进行疗效评估。F500作为一线治疗给药的患者占2.0%，二线治疗的占22.7%，三线治疗的占26.7%，≥四线治疗的占48.6%。中位TTF为5.4个月。多因素分析发现，F500使用时间越早（一线和二线vs.三线vs.≥四线；风险比（HR）=0.80，95%置信区间（CI）0.74 - 0.86；P<0.001）、从AMBC诊断到使用F500的时间间隔越长（≥3年vs.<3年；HR 0.60，95%CI 0.51 - 0.7）、以及未接受过针对不可切除或转移性乳腺癌的姑息化疗（未接受vs.接受；HR 0.69，95%CI 0.60 - 0.80；P<0.001）均与TTF显著延长相关。在691例可获得组织学/核分级信息的患者中，低分级也与TTF延长相关，但这一发现在复发性乳腺癌患者（n = 558）中未得到维持。在复发性乳腺癌女性中，患者初始乳腺癌诊断与其复发之间的无病间期（DFI）越长，F500治疗的TTF越长。
我们的研究表明，F500用于早期治疗时治疗期更长。对于接受F500治疗的患者，未接受过姑息化疗的患者以及从AMBC诊断到使用F500时间间隔较长的患者TTF也更长。
