Horiguchi Jun, Oyama Tetsunari, Koibuchi Yukio, Yokoe Takao, Takata Daisuke, Ikeda Fumihiro, Nagaoka Hiroshi, Rokutanda Nana, Nagaoka Rin, Ishikawa Yuko, Odawara Hiroki, Kikuchi Mami, Sato Ayako, Iino Yuichi, Takeyoshi Izumi
Department of Surgery, Gunma University Faculty of Medicine, Gunma, Japan.
Anticancer Res. 2009 Feb;29(2):517-24.
A phase II clinical trial was conducted to examine the clinical and pathologic efficacy and safety of neoadjuvant paclitaxel with or without trastuzumab in women with advanced or metastatic breast cancer. A total of 49 patients with advanced or metastatic breast cancer (clinical stage IIB -IV) were included. Patients with HER2-negative tumors received weekly paclitaxel 80 mg/m2 (days 1, 8, 15) followed by a 1-week break for 4 cycles. Patients with HER2-positive tumors received weekly paclitaxel 80 mg/m2 (days 1, 8, 15) followed by a 1-week break and a trastuzumab 4 mg/kg loading dose, intravenously, followed by 2 mg/kg weekly for 4 cycles. The age of the patients was 51.6 +/- 1.6 years (mean +/- SE) and the size of their tumors was 5.8 +/- 0.4 cm (mean +/- SE). Thirty-two patients had HER2-negative tumors and 17 had HER2-positive tumors. Of 49 patients, 13 (26.5%) had a clinical complete response and 24 (49.0%) had a clinical partial response. Five (10.2%) patients had a pathological complete response (pCR) and three (6.1%) patients had a near pCR in the breast. A total of eight (16.3%) patients had a pCR or near pCR in the breast. The pCR or near pCR rate was 3.1% in the HER2-negative group and 41.2% in the HER2-positive group. With a median follow-up of 28 months (range, 1-45), the 3-year overall survival was 88%. Clinical responders showed a significantly better overall survival than non-responders (p < 0.01). Pathological responders showed a better overall survival than non-responders. There was no significant difference in overall survival between patients with HER2-positive and -negative tumors. In conclusion, combined neoadjuvant weekly paclitaxel and trastuzumab achieved high clinical and pathological response rates for HER2 -overexpressing breast cancers, despite the omission of an anthracycline.
开展了一项II期临床试验，以研究新辅助紫杉醇联合或不联合曲妥珠单抗治疗晚期或转移性乳腺癌女性患者的临床及病理疗效和安全性。共纳入49例晚期或转移性乳腺癌（临床分期IIB-IV）患者。HER2阴性肿瘤患者接受每周一次紫杉醇80mg/m²（第1、8、15天）治疗，随后休息1周，共进行4个周期。HER2阳性肿瘤患者接受每周一次紫杉醇80mg/m²（第1、8、15天）治疗，随后休息1周，静脉注射曲妥珠单抗4mg/kg负荷剂量，之后每周2mg/kg，共进行4个周期。患者年龄为51.6±1.6岁（均值±标准误），肿瘤大小为5.8±0.4cm（均值±标准误）。32例患者为HER2阴性肿瘤，17例为HER2阳性肿瘤。49例患者中，13例（26.5%）获得临床完全缓解，24例（49.0%）获得临床部分缓解。5例（10.2%）患者达到病理完全缓解（pCR），3例（6.1%）患者乳腺达到接近pCR。共有8例（16.3%）患者乳腺达到pCR或接近pCR。HER2阴性组的pCR或接近pCR率为3.1%，HER2阳性组为41.2%。中位随访28个月（范围1-45个月），3年总生存率为88%。临床缓解者的总生存率显著高于未缓解者（p<0.01）。病理缓解者的总生存率高于未缓解者。HER2阳性和阴性肿瘤患者的总生存率无显著差异。总之，尽管未使用蒽环类药物，但新辅助每周一次紫杉醇联合曲妥珠单抗治疗HER2过表达乳腺癌可获得较高的临床和病理缓解率。
