Phase II study of primary chemotherapy with paclitaxel plus gemcitabine in patients with stage II and III breast cancer

Abstract

11080 Background: Adding taxane in the preoperative therapy increases both clinical and pathologic responses in pts with early breast cancer (BC). Clinical outcomes were superior by adding gemcitabine (G) to paclitaxel (P) compared with P alone in metastatic BC. This study evaluated clinical and pathological response rates and adverse events by primary chemotherapy with P and G in stage II and III BC. Methods: Patients (pts) with histologically confirmed stage II and III BC with positve axillary nodes by PET or positive FNA under sono guidance, age = 18 years, adequate organ functions and good PS were eligible. No prior hormonal or chemo-therapy, radiation, or surgery was allowed. Pts received P 80 mg/m2 and G 1,200 mg/m2, intravenously, d1/d8 every 3 weeks x 4. Postoperatively, doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously, d1 every 3 weeks x 4 were given followed by radiation therapy. Assessment for clinical response was majorly done by ultrasound. Results: All planned 44 pts were enrolled between September 2005 and April 2006. The median age was 43 years (range, 30–72 years), the median primary tumor size was 5.5 cm (range, 2.1 to 12.4 cm) with 27%, stage II and 73%, stage III BC. Thirty three tumors (75%) were multiple and 25 %, single. Thirty tumors (68 %) were ER or PR positive and 32 %, HER2 IHC 3+. The median relative dose intensities were 0.97 for both P and G . Clinical responses were 1-CR (2%), 34-PR (77%), 7-SD (16%) and 1-PD (2%). One pt did not return after 1st cycle (2%). 43 pts underwent surgery with 28 (64%) breast conserving surgery. Eight pts achieved pathologic CR in primary tumors (18%), 11 in axillary nodes (25%), and 5 in combined tumor and axillary nodes (11%). Grade III/IV toxicities were neutropenia (57%), leucopenia (14 %), febrile neutropenia (2%), and headache (2%). Conclusions: Preoperative P and G combination therapy given on d1/d8 every 3 weeks for 4 cycles is well tolerable and effective for stage II and III breast cancer. Supported in part by NCC Grant No. 06102240 and SHIN POONG PHARM CO., LTD. which provided paclitaxel and gemcitabine. No significant financial relationships to disclose.