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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)。

结论

包括多西紫杉醇联合阿霉素初始全身化疗和根据临床及病理反应给予 CMF 辅助化疗的多学科治疗,可使局部晚期乳腺癌患者获得较高的长期 RFS 和 OS 率。DT 的临床或病理部分缓解或完全缓解预测 RFS 和 OS 改善。

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