Neoadjuvant Weekly Paclitaxel with and without Trastuzumab in Locally Advanced or Metastatic Breast Cancer

• Published in: Anticancer research Vol. 29; no. 2; pp. 517 - 524
• Main Authors: HORIGUCHI, Jun, OYAMA, Tetsunari, ODAWARA, Hiroki, KIKUCHI, Mami, SATO, Ayako, IINO, Yuichi, TAKEYOSHI, Izumi, KOIBUCHI, Yukio, YOKOE, Takao, TAKATA, Daisuke, IKEDA, Fumihiro, NAGAOKA, Hiroshi, ROKUTANDA, Nana, NAGAOKA, Rin, ISHIKAWA, Yuko
• Format: Journal Article
• Language: English
• Published: Attiki International Institute of Anticancer Research 01.02.2009
• Subjects: Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - enzymology; Breast Neoplasms - pathology; Female; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Medical sciences; Middle Aged; Neoadjuvant Therapy; Neoplasm Metastasis; Neoplasm Staging; Paclitaxel - administration & dosage; Paclitaxel - therapeutic use; Receptor, ErbB-2 - biosynthesis; Trastuzumab; Tumors; Antineoplastic agent; Breast disease; Breast cancer; Monoclonal antibody; Malignant tumor; Metastasis; Neoadjuvant treatment; Mammary gland diseases; neoadjuvant chemotherapy; Chemotherapy; Treatment; Cancerology; Taxane derivatives; Paclitaxel; Advanced stage; Locally advanced stage; pathological response; Antimitotic; Trastuzumab; Cancer
• ISSN: 0250-7005; 1791-7530

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/m 2 (days 1, 8, 15) followed by a 1-week break for 4 cycles. Patients with HER2-positive tumors received weekly paclitaxel 80 mg/m 2 (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.