Universitats-Frauenklinik, Magdeburg, German.
J Clin Oncol. 2010 Jan 1;28(1):83-91. doi: 10.1200/JCO.2009.23.5101. Epub 2009 Nov 9.
PURPOSE Neoadjuvant chemotherapy followed by mastectomy is the treatment of choice in patients with inflammatory breast cancer (IBC) or locally advanced breast cancer (LABC), but it is considered less effective in these diseases than in operable breast cancer (OBC). We report a prospective comparison of the GeparTrio trial of patients with IBC (cT4 days) or LABC (cT4a-c or cN3; stage IIIB or IIIC) and patients with OBC (cT2-3). PATIENTS AND METHODS Participants were stratified by stage and were randomly assigned to six or eight cycles of docetaxel/doxorubicin/cyclophosphamide (TAC) or to two cycles of TAC followed by four cycles of vinorelbine/capecitabine. We present results of a secondary aim of the study, which was to compare pathologic complete response (pCR; ie, no remaining invasive/noninvasive tumor in breast and lymph nodes) in different stage groups. Results A total of 287 patients with IBC (n = 93) or LABC (n = 194) and 1,777 patients with OBC were entered onto the trial. At baseline, parameters were as follows for the three types of cancer, respectively: median tumor sizes: 8.0 cm, 7.0 cm, and 4.0 cm (P < .001); multiple lesions: 31.2%, 27.3%, and 19.6% (P < .001); nodal involvement: 86.6%, 71.2%, and 51.6% (P < .001); grade 3: 44.4%, 30.4%, and 39.9% (P = .178); lobular-invasive type: 7.5%, 17.5%, and 13.3% (P = .673); negative hormone receptor status: 38.0%, 20.0%, and 36.4% (P = .008); and positive human growth factor receptor 2 status: 45.1%, 38.9%, and 35.7% (P = .158). Response rates for IBC, LABC, and OBC, respectively, were 8.6%, 11.3%, and 17.7% for pCR (P = .002); 71.0%, 69.6%, and 83.4% for overall response by physical or sonographic examination (P < .001); and 12.9%, 33.0%, and 69.9% for breast conservation (P < .001). All P values were for IBC and LABC versus OBC. However, tumor stage itself was not an independent predictor for pCR in multivariable analysis (odds ratio, 1.51; 95% CI, 0.88 to 2.59; P = .13). CONCLUSION No evidence of a difference in response to neoadjuvant chemotherapy was found by tumor stage when analysis was adjusted for baseline characteristics.
新辅助化疗后行乳房切除术是炎性乳腺癌（IBC）或局部晚期乳腺癌（LABC）患者的首选治疗方法，但与可手术乳腺癌（OBC）相比，这种方法在这些疾病中的效果较差。我们报告了一项 GeparTrio 试验的前瞻性比较，该试验纳入了 IBC（cT4d）或 LABC（cT4a-c 或 cN3；III 期或 IIIC 期）患者以及 OBC 患者（cT2-3）。
根据分期对参与者进行分层，并随机分配至六或八周期多西他赛/多柔比星/环磷酰胺（TAC）或两周期 TAC 序贯四周期长春瑞滨/卡培他滨治疗。我们报告了该研究的次要目标结果，旨在比较不同分期组的病理完全缓解（pCR；即乳房和淋巴结中无残留浸润/非浸润性肿瘤）。
共有 287 例 IBC（n = 93）或 LABC（n = 194）患者和 1777 例 OBC 患者入组该试验。入组时，三种类型癌症的基线参数分别为：中位肿瘤大小：8.0cm、7.0cm 和 4.0cm（P <.001）；多发病灶：31.2%、27.3%和 19.6%（P <.001）；淋巴结受累：86.6%、71.2%和 51.6%（P <.001）；G3：44.4%、30.4%和 39.9%（P =.178）；小叶-浸润型：7.5%、17.5%和 13.3%（P =.673）；激素受体阴性：38.0%、20.0%和 36.4%（P =.008）；人表皮生长因子受体 2 阳性：45.1%、38.9%和 35.7%（P =.158）。IBC、LABC 和 OBC 的 pCR 缓解率分别为 8.6%、11.3%和 17.7%（P =.002）；体格检查或超声检查的总缓解率分别为 71.0%、69.6%和 83.4%（P <.001）；乳房保留率分别为 12.9%、33.0%和 69.9%（P <.001）。所有 P 值均为 IBC 和 LABC 与 OBC 比较。然而，多变量分析并未发现肿瘤分期是 pCR 的独立预测因素（比值比，1.51；95%CI，0.88 至 2.59；P =.13）。
在调整基线特征后，未发现肿瘤分期对新辅助化疗反应有差异。
