From the National Hospital Organization Osaka National Hospital, Osaka (N.M.), Hiroshima City Hiroshima Citizens Hospital, Hiroshima (S. Ohtani), Kyoto Prefectural University of Medicine (I.Y.), and Graduate School of Medicine, Kyoto University (M.T.), Kyoto, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital (K.K.), and Chuo University (Y.O.), Tokyo, Gunma Prefectural Cancer Center, Ota (Y.Y.), National Hospital Organization Kyushu Cancer Center, Fukuoka (S. Ohno), Hyogo Cancer Center, Akashi (S.T.), National Hospital Organization Shikoku Cancer Center, Matsuyama (K.A.), Aichi Cancer Center Hospital, Nagoya (H.I.), and Tohoku University, Sendai (H.S.) - all in Japan; and Yeungnam University Hospital, Daegu (S.-J.L.), Samsung Medical Center, Sungkyunkwan University School of Medicine (Y.-H.I.), Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine (S.-A.I.), Severance Hospital (B.-W.P.) and Gangnam Severance Hospital (J.J.), Yonsei University College of Medicine, Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Korea University Guro Hospital (A.K.), and Korea University Anam Hospital (K.-H.P.), Seoul, and National Cancer Center, Goyang-si (E.-S.L.) - all in South Korea.
N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.
BACKGROUND: Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS: We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS: The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P=0.01). Overall survival was longer in the capecitabine group than in the control group (89.2% vs. 83.6% of the patients were alive at 5 years; hazard ratio for death, 0.59; 95% CI, 0.39 to 0.90; P=0.01). Among patients with triple-negative disease, the rate of disease-free survival was 69.8% in the capecitabine group versus 56.1% in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95% CI, 0.39 to 0.87), and the overall survival rate was 78.8% versus 70.3% (hazard ratio for death, 0.52; 95% CI, 0.30 to 0.90). The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group. CONCLUSIONS: After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing. (Funded by the Advanced Clinical Research Organization and the Japan Breast Cancer Research Group; CREATE-X UMIN Clinical Trials Registry number, UMIN000000843 .).
背景：接受人表皮生长因子受体 2（HER2）阴性乳腺癌新辅助化疗后仍有残留浸润性癌的患者预后较差。这些患者辅助化疗的获益仍不明确。
方法：我们将 910 例接受新辅助化疗（含蒽环类药物、紫杉类药物或两者联合）后 HER2 阴性残留浸润性乳腺癌患者随机分配，接受卡培他滨辅助治疗或不接受（对照组）。主要终点为无病生存。次要终点包括总生存。
结果：预先设定的中期分析结果达到了主要终点，因此该试验提前终止。最终分析显示，卡培他滨组无病生存时间长于对照组（5 年时无复发或第二原发癌的患者比例分别为 74.1%和 67.6%；复发、第二原发癌或死亡的风险比为 0.70；95%置信区间[CI]为 0.53 至 0.92；P=0.01）。卡培他滨组总生存时间长于对照组（5 年时无死亡的患者比例分别为 89.2%和 83.6%；死亡风险比为 0.59；95%CI 为 0.39 至 0.90；P=0.01）。在三阴性疾病患者中，卡培他滨组的无病生存比例为 69.8%，对照组为 56.1%（复发、第二原发癌或死亡的风险比为 0.58；95%CI 为 0.39 至 0.87），总生存比例为 78.8%，对照组为 70.3%（死亡风险比为 0.52；95%CI 为 0.30 至 0.90）。卡培他滨最常见的不良反应手足综合征在卡培他滨组中发生在 73.4%的患者中。
结论：在标准的蒽环类药物、紫杉类药物或两者联合新辅助化疗后，辅助卡培他滨治疗可安全有效地延长 HER2 阴性乳腺癌患者的无病生存和总生存，这些患者在病理检查中仍有残留浸润性疾病。（由先进临床研究组织和日本乳腺癌研究组资助；CREATE-X UMIN 临床试验注册编号，UMIN000000843。）。
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