多西他赛注射液对不同分子亚型乳腺癌患者的临床研究

Clinical trial of docetaxel injection in patients with different molecular subtypes of breast cancer

目的观察多西他赛注射液治疗不同分子亚型乳腺癌患者临床疗效。方法将130例乳腺癌患者随机分为试验组和对照组,每组65例。对照组予以10 mg·m^(-2)地塞米松,静脉注射1~3 d,75 mg·m^(-2)阿霉素,第4天后静脉注射,qd,共治疗3周。试验组在对照组的基础上予以75 mg·m^(-2)多西他赛,静脉注射,qd,共治疗3周。根据其人类表皮生长因子2、雌激素受体、Ki67以及孕激素受体表达的情况,将乳腺癌患者分为以下4种类型:HER2过表达型、Luminal A型、Luminal B型以及三阴型。按照以上分型比较组间的总缓解率、病理反应和不同乳腺癌类型的术后生存率。结果治疗后,试验组和对照组的总缓解率分别为98.46%(64例/65例)和96.92%(63例/65例),差异无统计学意义(P>0.05)。Luminal A型、Luminal B型、HER2型和三阴型的病理完全反应率分别为42.11%(8例/19例),33.33%(5例/15例),84.44%(38例/45例)和82.35%(42例/51例)。Logistic多因素回归分析结果表明,三阴型和HER2型的病理完全反应率高于Luminal A型和Luminal B型,差异均有统计学意义(均P<0.05)。随访结果显示,Luminal A型、Luminal B型、三阴型和HER2型乳腺癌患者的术后生存率分别为47.37%(9例/19例),60.0%(9例/15例),80.39%(41例/51例)和73.33%(33例/45例)。其中,三阴型和HER2型的术后生存率与Luminal A型和Luminal B型比较,差异均有统计学意义(均P<0.05)。结论不同分子亚型乳腺癌患者应用多西他赛注射液疗效差异明显,其可作为总体生存率、病理结果完全治愈率以及不同乳腺癌类型之间的术后生存时间的预测指标。

Objective To observe the clinical efficacy of docetaxel injection in patients with different molecular subtypes of breast cancer.Methods A total of 130 patients with breast cancer were randomly divided into the treatment group（n= 65 cases） and control group（n=65 cases）. The control group was treated with 10 mg · m^-2 of dexamethasone,intravenously injected for 1-3 d,75 mg·m^-2 of adriamycin,intravenously injected after 4 d,qd. The treatment group was given 75 mg·m^-2 of docetaxel,intravenous injection on the basis of the control group. Both groups were treated for 3 weeks. Patients with breast cancer were categorized into four subtypes（ HER2 over expression,Luminal A,Luminal B and triple negative subtype） according to the expression ofhuman epidermal growth factor 2,estrogen receptor,Ki67 and progesterone receptor. The overall remission rate,pathologic response rate and survival rates were compared between the different breast cancer subtypes according to the above typing and immunohistochemistry. Results After treatment,the overall remission rates of the treatment group and control group were 98.46%（64 cases/65 cases） and 96.92%（63 cases/65 cases）,without statistically significant difference（P〉0.05）. The overall remission rates of Luminal A,Luminal B,HER2 and triple negative subtype were42.11%（ 8 cases/19 cases）,33.33%（5 cases/15 cases）,84.44%（38 cases/45 cases） and 82.35%（42 cases/51 cases）,respectively. Logistic multivariate regression analysis showed that the pathological complete response rates of HER2 and triple negative subtype were significantly higher than those of Luminal A and Luminal B subtype（ P〈0.05）. The follow-up results showed that the postoperative survival of Luminal A,Luminal B,HER2 and triple negative subtype were 47.37%（9 cases/19 cases）,60.0%（ 9 cases/15 cases）,80.39%（ 41 cases/51 cases） and 73.33%（ 33 cases/45 cases）. Moreover,the survival rates of HER2 and triple negative subtype were significantly higher than those of Luminal A and Luminal B subtype（P〈0.05）. Conclusion The pathological response to docetaxel injection varied widely among different molecular subtypes of breast cancer,thus the subtypes can be used as the prediction indicators for overall remission rate,pathologic response rate and survival rates in patients with different molecular subtypes of breast cancer.