Ohnoa S, Toi M, Kuroi K, Nakamura S, Iwata H, Kusama M, Masuda N, Yamazaki K, Hisamatsu K, Sato Y, Takatsuka Y, Shin E, Kaise H, Kurozumi M, Tsuda H, Akiyama F
Japan Breast Cancer Research Group, c/o Komagome Hospital, Bunkyo-ku, Tokyo, Japan.
Biomed Pharmacother. 2005 Oct;59 Suppl 2:S323-4. doi: 10.1016/s0753-3322(05)80063-0.
This study has been initiated to evaluate the safety, clinical and pathologic response as well as the relation of response (pCR or non-pCR) and survival (overall and relapse-free) of fluorouracil, epirubicin and cyclophosphamide (FEC) followed by docetaxel (DOC) as preoperative chemotherapy in patients with operable breast cancer. Japanese patients with primary breast cancer, Tlc-3N0M0 or T1-3NIM0, age 20-60, PS 0-1 were included in this study. Preoperative chemotherapy consisted of 4 cycles of FEC (500 mg/m(2), 100 mg/m(2), 500 mg/m(2)) every 3 weeks followed by 4 cycles of DOC (75 mg/m(2)) every 3 weeks. Since June 2002, 200 patients were enrolled in this study, and the time of this interim analysis, 80 patients were evaluable for safety and clinical efficacy. The overall clinical response rate was 71.4% (14% CR, 44% PR, 42% SD/PD), and the only G3,4 toxicities, neutropenia and febrile neutropenia were observed in 54% and 14% of patients, respectively. Eighty nine patients were evaluable for pathologic response by central review. Pathologic response was evaluated among invasive tumors on multiple cross-section specimens based on a modified version of the Japanese grading system for Japanese Breast Cancer Society. The pathologic response rate was 17%. In this ongoing trial, FEC followed by DOC was active and well tolerated.
本研究旨在评估氟尿嘧啶、表柔比星和环磷酰胺（FEC）序贯多西他赛（DOC）作为可手术乳腺癌患者术前化疗的安全性、临床和病理反应，以及反应（pCR或非pCR）与生存（总生存和无复发生存）的关系。本研究纳入年龄20 - 60岁、PS 0 - 1、患有原发性乳腺癌（Tlc - 3N0M0或T1 - 3NIM0）的日本患者。术前化疗包括每3周进行4个周期的FEC（500 mg/m²、100 mg/m²、500 mg/m²），随后每3周进行4个周期的DOC（75 mg/m²）。自2002年6月起，200例患者入组本研究，至本次中期分析时，80例患者可评估安全性和临床疗效。总体临床缓解率为71.4%（14%为CR，44%为PR，42%为SD/PD），仅观察到54%的患者出现3/4级毒性，分别为中性粒细胞减少和发热性中性粒细胞减少，发生率分别为54%和14%。89例患者可通过中心评估进行病理反应评估。基于日本乳腺癌学会改良版日本分级系统，在多个横断面标本的浸润性肿瘤中评估病理反应。病理反应率为17%。在这项正在进行的试验中，FEC序贯DOC具有活性且耐受性良好。
