Frasci G, Comella P, Rinaldo M, Iodice G, Di Bonito M, D'Aiuto M, Petrillo A, Lastoria S, Siani C, Comella G, D'Aiuto G
Department of Senology, Unit of Preoperative Treatments, National Cancer Institute of Naples, Naples, Italy.
Ann Oncol. 2009 Jul;20(7):1185-92. doi: 10.1093/annonc/mdn748. Epub 2009 Feb 13.
Findings from our previously published phase II study showed a high pathologic complete remission (pCR) rate in patients with triple-negative large operable breast cancer after the administration of eight cisplatin-epirubicin-paclitaxel (PET) weekly cycles. The safety and efficacy data of the initial population were updated, with inclusion of additional experience with the same therapy.
Patients with triple-negative large operable breast cancer (T2-T3 N0-1; T > 3 cm) received eight preoperative weekly cycles of cisplatin 30 mg/m2, epirubicin 50 mg/m2, paclitaxel (Taxol) 120 mg/m2, with granulocyte colony-stimulating factor (5 microg/kg days 3-5) support.
Overall 74 consecutive patients (T2/T3 = 35/39; N0/N+ = 26/48) were treated, from May 1999 to May 2008. At pathological assessment, 46 women (62%; 95% confidence interval 50-73) showed pCR in both breast and axilla. At a 41-month median follow-up (range 3-119), 13 events (nine distant metastases) had occurred, 5-year projected disease-free survival (DFS) and distant disease-free survival being 76% and 84%, respectively. Five-year DFS was 90% and 56% in pCRs and non-pCRs, respectively. Severe neutropenia and anemia occurred in 23 (31%) and eight (10.8%) patients, respectively. Severe non-hematological toxicity was recorded in <20% of patients. Peripheral neuropathy was quite frequent but never severe.
Eight weekly PET cycles are a highly effective primary treatment in women with triple-negative large operable breast cancer. This approach results in a very promising long-term DFS in this poor prognosis population. This triplet regimen is worthy of evaluation in phase III trials.
我们之前发表的II期研究结果显示，三阴性可手术性大乳腺癌患者在接受8个周期的顺铂-表柔比星-紫杉醇（PET）每周方案治疗后，病理完全缓解（pCR）率很高。纳入了更多相同治疗的经验后，对初始人群的安全性和疗效数据进行了更新。
三阴性可手术性大乳腺癌（T2-T3 N0-1；T>3 cm）患者接受8个术前每周周期的顺铂30 mg/m2、表柔比星50 mg/m2、紫杉醇（泰素）120 mg/m2治疗，并给予粒细胞集落刺激因子（第3-5天5 μg/kg）支持。
从1999年5月至2008年5月，共连续治疗了74例患者（T2/T3 = 35/39；N0/N+ = 26/48）。在病理评估中，46名女性（62%；95%置信区间50-73）在乳腺和腋窝均显示pCR。在中位随访41个月（范围3-119个月）时，发生了13起事件（9例远处转移），预计5年无病生存率（DFS）和远处无病生存率分别为76%和84%。pCR患者和非pCR患者的5年DFS分别为90%和56%。分别有23例（31%）和8例（10.8%）患者发生严重中性粒细胞减少和贫血。<20%的患者记录到严重非血液学毒性。周围神经病变相当常见，但从未严重。
8个每周PET周期是三阴性可手术性大乳腺癌女性患者的一种高效初始治疗方法。这种方法在这个预后不良的人群中产生了非常有前景的长期DFS。这种三联方案值得在III期试验中进行评估。
