多柔比星和多西他赛初始全身治疗联合手术、放疗和根据临床及病理反应选择的环磷酰胺、甲氨蝶呤和 5-氟尿嘧啶辅助化疗治疗 IIB 期至 III 期乳腺癌的 II 期临床试验：来自德克萨斯大学 M.D.安德森癌症中心研究 ID97-099 的长期结果。

Phase 2 trial of primary systemic therapy with doxorubicin and docetaxel followed by surgery, radiotherapy, and adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil based on clinical and pathologic response in patients with stage IIB to III breast cancer : long-term results from the University of Texas M. D. Anderson Cancer Center Study ID97-099.

机构信息

Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.

出版信息

Cancer. 2010 Mar 1;116(5):1210-7. doi: 10.1002/cncr.24901.

DOI:10.1002/cncr.24901

PMID:20082452

Abstract

BACKGROUND

This study was performed to evaluate the outcomes of patients with locally advanced breast cancer (LABC) who were treated with a multidisciplinary approach including primary systemic chemotherapy and noncross-resistant adjuvant chemotherapy.

METHODS

Patients with LABC received 4 or 6 cycles of doxorubicin and docetaxel (DT) as primary systemic chemotherapy (PST) every 21 days. Patients with adequate response underwent surgery followed by adjuvant chemotherapy according to pathologic response: complete (pCR), 2 more cycles of DT; partial (pPR), 2 more cycles of DT followed by 6 cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (5-FU) (CMF); and minor (pMR), 6 cycles of CMF. Patients then received radiation and tamoxifen (hormone receptor-positive patients only).

RESULTS

Eighty-eight patients were evaluable. Seventy-four patients had an adequate response to DT and were considered operable, and 72 underwent surgery. Ten patients (13.9%) achieved a pCR, 22 (30.5%) achieved a pPR, and 40 achieved a pMR (55.5%). Fourteen patients were considered nonoperable after DT and underwent salvage CMF therapy. Five of these patients underwent surgery and 1 had achieved a pCR. The estimated 5-year recurrence-free survival (RFS) rates for patients with pCR, pPR, and pMR were 80%, 77%, and 59%, respectively, and the estimated 5-year overall survival (OS) rates were 90%, 91%, and 74%, respectively. The 5-year OS rates were 82% for initially operable and 21% for initially inoperable patients (P < or = .001)

CONCLUSIONS

Multidisciplinary therapy that includes PST with DT and adjuvant therapy with CMF administered according to the clinical and pathologic response is associated with high long-term RFS and OS rates in patients with LABC. Clinical or pathologic PR or CR to DT predicts improved RFS and OS.

摘要

背景

本研究旨在评估采用多学科方法治疗局部晚期乳腺癌（LABC）患者的疗效，该方法包括初始全身化疗和非交叉耐药辅助化疗。

方法

LABC 患者接受多西紫杉醇联合阿霉素（DT）4 或 6 个周期的化疗，每 21 天一次。对充分应答的患者进行手术，然后根据病理反应进行辅助化疗：完全缓解（pCR），再给予 2 个周期的 DT；部分缓解（pPR），再给予 2 个周期的 DT，然后给予环磷酰胺、甲氨蝶呤和 5-氟尿嘧啶（CMF）6 个周期；微小缓解（pMR），给予 CMF6 个周期。然后，所有患者接受放疗和他莫昔芬（仅激素受体阳性患者）治疗。

结果

共有 88 例患者可评估。74 例患者对 DT 有充分的反应，可考虑手术，72 例患者进行了手术。10 例患者（13.9%）达到 pCR，22 例（30.5%）达到 pPR，40 例达到 pMR（55.5%）。DT 后有 14 例患者被认为不能手术，接受挽救性 CMF 治疗。其中 5 例患者接受手术，1 例患者达到 pCR。pCR、pPR 和 pMR 患者的 5 年无复发生存率（RFS）估计分别为 80%、77%和 59%，5 年总生存率（OS）估计分别为 90%、91%和 74%。初始可手术患者的 5 年 OS 率为 82%，初始不可手术患者为 21%（P < 或 =.001）。