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.

Abstract

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.

• Authors: Seock-Ah Im, Keun Seok Lee, Jungsil Ro, Eun Sook Lee, Youngmee Kwon, Jin-Hee Ahn, Jin Seok Ahn, Jee Hyun Kim, Han Sung Kang, Kyung Hwan Shin, Dong-Young Noh, In-Ae Park, Sung-Bae Kim, Young Hyuck Im, Sung Whan Ha
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 132 Issue 2 Pg. 589-600 (Apr 2012) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 22094934 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Biomarkers, Tumor
• Deoxycytidine
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab
• Paclitaxel
• Gemcitabine

Topics

• Adult
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biomarkers, Tumor (analysis)
• Breast Neoplasms (chemistry, drug therapy, mortality, pathology, surgery)
• Chemotherapy, Adjuvant
• Chi-Square Distribution
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Kaplan-Meier Estimate
• Logistic Models
• Mastectomy
• Middle Aged
• Multivariate Analysis
• Neoadjuvant Therapy
• Neoplasm Staging
• Paclitaxel (administration & dosage)
• Radiotherapy, Adjuvant
• Receptor, ErbB-2 (analysis)
• Republic of Korea
• Risk Assessment
• Risk Factors
• Time Factors
• Trastuzumab
• Treatment Outcome
• Gemcitabine