Research Unit of Medical Senology, European Institute of Oncology, Milan, Italy.
Clin Breast Cancer. 2010 Dec 1;10(6):483-8. doi: 10.3816/CBC.2010.n.064.
Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer.
We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ≥ 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination.
Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patients discontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity.
In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.
与阿霉素相比，多柔比星脂质体（PLD）在晚期乳腺癌中具有更好的疗效且毒性更低。鉴于其心脏毒性低，PLD 与曲妥珠单抗联合应用于治疗人表皮生长因子受体 2（HER2）阳性乳腺癌具有很大吸引力。
我们研究了 32 例初治或复发的 cT2-T4a-d、N0-3、M0 任何雌激素受体（ER）、HER2 阳性乳腺癌患者，接受 8 个周期 PLD 联合顺铂和持续输注氟尿嘧啶（CCF）加 3 周曲妥珠单抗治疗，以及联合来曲唑（如果绝经前还联合曲普瑞林）的疗效。主要终点是临床缓解率；次要终点是病理完全缓解率（pCR）和联合用药的心脏安全性。
该研究共纳入 32 例患者，所有患者均可评估疗效和毒性。15 例（47%）患者肿瘤 ER 阳性，15 例和 2 例患者 ER 阴性和 ER 弱阳性，分别为 15 例和 2 例。13 例（41%）患者为炎性乳腺癌（IBC），84%的患者临床淋巴结阳性。临床缓解率为 94%（95%CI，79%-99%），pCR 率为 41%（95%CI，24%-59%）。54%的 IBC 患者获得 pCR。11 例患者在计划完成 8 个周期前停止治疗。无患者发生相关心脏毒性。
在该系列非常局部晚期乳腺癌中，CCF 联合曲妥珠单抗具有非常高的活性，获得了令人印象深刻的 pCR 率，尤其是在 IBC 中，值得在更大系列中进一步研究。
