多西他赛联合卡培他滨或表柔比星一线治疗HER-2阴性晚期乳腺癌的临床观察

Clinical paired study of comparing docetaxel plus capecitabine versus docetaxel plus epirubicin as first-line treatment in women with HER-2 negative advanced breast cancer

目的比较多西他赛联合卡培他滨（TX）或表柔比星（TE）一线治疗HER-2阴性晚期乳腺癌的疗效。方法对46例TE方案一线治疗晚期乳腺癌进行TX方案配对研究，均为3周方案，TX（多西他赛75mg／m2，第1天；卡培他滨1000mg／m2，2次／d，第1～14天），TE（多西他赛75mg／m2，第1天；表柔比星75mg／m2，第1天）。观察其半年无进展率、中位疾病进展时间、客观有效率及毒副反应。结果TX组和TE组的疾病半年无进展率分别为78％、70％（P=0．477），中位肿瘤进展时间分别为10．2、8．7个月（P=0．128），客观有效率分别为72％、63％（P=0．505）。两组不良反应3／4级中性粒细胞减少TX组明显低于TE组（30％与70％，P〈0．001），发热性粒缺TX组亦低于TE组（2％与11％，P=0．004），手足综合征TX组明显高于TE组（37％与4％，P〈0．001），其余不良反应无明显差异。结论对于HER-2阴性晚期乳腺癌，TX和TE方案均是有效且可耐受的方案。

Objective To assess the efficacy of docetaxel plus capecitabine versus docetaxel plus epirubicin as first-line treatment in women with HER-2 negative advanced breast cancer. Methods A paired study was conducted for 92 cases with HER-2 negative advanced breast cancer. They received 3 weekly cycles of either TX （doeetaxel 75 mg/m2, day 1 ; eapeeitabine 1000 mg/m2 orally twice daily, clays 1 - 14） or TE （ doeetaxel 75 mg/m2, day 1 ; epirubiein 75 mg/m2, day 1 ）. The objective was to compare 6-month non-progression rate, time to progression（TTP）, overall response rate （ORR） and toxicities. Results The 6-month non-progression rates were 78% with TX versus 70% with TE （ P = 0. 477 ）. Medium TTP was 10. 2 versus 8.7 months （ P = 0. 128） and ORR was 72% and 63% respectively （P = 0. 505）. Severe toxicities included hand-foot syndrome （37% vs 4%, P 〈0. 001 ）, grade 3 -4 neutropenia （30% vs 70%, P 〈 O. 001 ） and febrile neutropenia （2% vs 11% , P = 0. 004 ） respectively. No relevant differences in other toxicities were observed in two arms. Conclusion Both regimens of TX and TE have similar efficacy and are well-tolerated as the first-line therapy for HER-2 negative advanced breast cancer.