Frasci G, D'Aiuto G, Comella P, Thomas R, Botti G, Di Bonito M, De Rosa V, Iodice G, Rubulotta M R, Comella G
Giuseppe Frasci, Division of Medical Oncology A, National Tumor Institute, via Mariano Semmola 80131, Naples, Italy.
Br J Cancer. 2006 Oct 23;95(8):1005-12. doi: 10.1038/sj.bjc.6603395.
The present study aimed at evaluating whether a weekly cisplatin, epirubicin, and paclitaxel (PET) regimen could increase the pathological complete response (pCR) rate in comparison with a tri-weekly epirubicin and paclitaxel administration in locally advanced breast cancer (LABC) patients. Patients with stage IIIB disease were randomised to receive either 12 weekly cycles of cisplatin 30 mg m(-2), epirubicin 50 mg m(-2), and paclitaxel 120 mg m(-2) (PET) plus granulocyte-colony stimulating factor support, or four cycles of epirubicin 90 mg m(-2)+paclitaxel 175 mg m(-2) (ET) every 3 weeks. Overall, 200 patients (PET/ET=100/100) were included in this study. A pCR in both breast and axilla occurred in 16 (16%) PET patients and in six (6%) ET patients (P=0.02). The higher activity of PET was evident only in ER negative (27.5 vs 5.4%; P=0.026), and in HER/neu positive (31 vs 5%; P=0.037) tumours. The two arms yielded similar pCR rate in ER positive (PET/ET=7.5/7.1%) and HER/neu negative (PET/ET=10/6%) patients. At a 39 months median follow-up, 70 patients showed a progression or relapses (PET, 32 vs ET, 38). Anaemia, mucositis, peripheral neuropathy, and gastrointestinal toxicity were substantially more frequent in the PET arm. The PET weekly regimen is superior to ET in terms of pCR rate in LABC patients with ER negative and/or HER2 positive tumours Mature data in terms of disease-free and overall survival are needed to ascertain whether this approach could improve the prognosis of these subsets of LABC patients.
本研究旨在评估与每三周一次给予表柔比星和紫杉醇相比，每周一次给予顺铂、表柔比星和紫杉醇（PET）方案是否能提高局部晚期乳腺癌（LABC）患者的病理完全缓解（pCR）率。ⅢB期疾病患者被随机分为两组，一组接受12个周期的每周一次的顺铂30mg/m²、表柔比星50mg/m²和紫杉醇120mg/m²（PET）加粒细胞集落刺激因子支持治疗，另一组接受每三周一次的表柔比星90mg/m²+紫杉醇175mg/m²（ET）治疗。总体而言，本研究共纳入200例患者（PET/ET = 100/100）。16例（16%）PET组患者和6例（6%）ET组患者出现乳腺和腋窝的pCR（P = 0.02）。PET方案更高的活性仅在雌激素受体（ER）阴性（27.5%对5.4%；P = 0.026）以及人表皮生长因子受体2（HER/neu）阳性（31%对5%；P = 0.037）的肿瘤中明显。在ER阳性（PET/ET = 7.5/7.1%）和HER/neu阴性（PET/ET = 10/6%）的患者中，两组的pCR率相似。在中位随访39个月时，70例患者出现疾病进展或复发（PET组32例，ET组38例）。PET组的贫血、粘膜炎、周围神经病变和胃肠道毒性明显更常见。对于ER阴性和/或HER2阳性肿瘤的LABC患者，PET每周方案在pCR率方面优于ET方案。需要无病生存期和总生存期的成熟数据来确定这种方法是否能改善这些LABC患者亚组的预后。
