Phase II trial of preoperative paclitaxel, gemcitabine, and trastuzumab combination therapy in HER2 positive stage II/III breast cancer: The Korean Cancer Study Group BR 07-01

• Published in: Breast cancer research and treatment 2012-04, Vol.132 (2), p.589-600
• Main Authors: Im, Seock-Ah, Lee, Keun Seok, Ro, Jungsil, Lee, Eun Sook, Kwon, Youngmee, Ahn, Jin-Hee, Ahn, Jin Seok, Kim, Jee Hyun, Kang, Han Sung, Shin, Kyung Hwan, Noh, Dong-Young, Park, In-Ae, Kim, Sung-Bae, Im, Young Hyuck, Ha, Sung Whan
• Format: Article
• Language: English
• Subjects: Adult; Anthracyclines; Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Biomarkers, Tumor - analysis; Breast cancer; Breast Neoplasms - chemistry; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Cancer; Cancer research; Cancer therapies; Cardiac patients; Care and treatment; Chemotherapy; Chemotherapy, Adjuvant; Chi-Square Distribution; Clinical Trial; Clinical trials; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Drug Administration Schedule; Female; Gynecology. Andrology. Obstetrics; Health aspects; Humans; Kaplan-Meier Estimate; Logistic Models; Mammary gland diseases; Mastectomy; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Multivariate Analysis; Neoadjuvant Therapy; Neoplasm Staging; Nuclear radiation; Oncology; Oncology, Experimental; Paclitaxel - administration & dosage; Product development; Radiotherapy, Adjuvant; Receptor, ErbB-2 - analysis; Republic of Korea; Risk Assessment; Risk Factors; Side effects; Time Factors; Trastuzumab; Treatment Outcome; Tumors
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-011-1852-0

An addition of trastuzumab preoperatively to chemotherapy for human epidermal growth factor receptor 2 (HER2) positive breast cancer improved relapse-free survival (RFS). This study was designed to evaluate the efficacy and safety of preoperative paclitaxel, gemcitabine, and trastuzumab (PGH) combination for HER2-positive breast caner. Pathologically, proven node positive stage II/III breast cancer patients with adequate organ function and no history of anti-cancer therapy were eligible. Patients received weekly trastuzumab with paclitaxel 80 mg/m 2 and gemcitabine 1,200 mg/m 2 on days 1 and 8, every 3 weeks for 6 cycles. Postoperatively, patients completed trastuzumab for 1 year and hormone therapy for 5 years if indicated. All patients received postoperative radiation therapy. Of 53 enrolled patients with a median tumor of 5.3 (range, 2.0 to >12) cm; 43.4%, T3/T4; 75.4%, N2/N3; and 45.3%, positive hormone receptors. The pathologic complete response (pCR) rate was 58.5% in both tumor and lymph nodes. Grade 3/4 adverse events were neutropenia (32%), febrile neutropenia (0.6%), and transient elevation of AST/ALT (1.6%) during a total of 318 cycles. All patients maintained normal cardiac function. With a median follow-up of 40 months, 3-year RFS rate was 84% with 91.7% distant metastasis-free survival rates. Remarkable pCR rate was obtained with non-anthracycline-based PGH therapy for HER2-positive stage II/III breast cancer. Adverse events were mild with few incidences of febrile neutropenia.