A Phase II Study of the Combination of Gemcitabine Plus Carboplatin as the Neoadjuvant Treatment in Locally Advanced Breast Cancer
Suthinee Ithimakin MD*, Adune Ratanawichitrasin MD**, Vutisiri Veerasarn MD***, Charuwan Akewanlop MD*, Nopadol Soparattanapaisarn MD*, Supakorn Rojananin MD**, Pornchai O-charoenrat MD, PhD**, Poramaporn Prasarttong-osoth MD**, Vichien Srimuninnimit MD*
Affiliation : * Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand ** Division of Head, Neck and Breast Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand *** Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Objective : Although anthracycline-based regimen is standard neoadjuvant chemotherapy (NAC) for locally advanced breast
cancer (LABC), there is some concern over its toxicities such as alopecia and cardiotoxicity. Gemcitabine is another active
agent in metastatic breast cancer after failure to anthracycline with less toxicity. The objective of the present study is to evaluate
the efficacy and safety of the combination of gemcitabine and carboplatin as NAC in LABC.
Material and Method: Patients with histologically confirmed LABC (T3, T4 or N2 and M0) were included. Patients were
scheduled to receive 3 cycles of neoadjuvant GC (gemcitabine 1,000 mg/m2 D1, D8 and carboplatin AUCx5 D1) every 21
days. Patients with clinical response underwent surgery and additional 3 cycles of adjuvant GC. Primary end point was
clinical response rate whereas secondary end points included pathological response, DFS, OS and toxicity.
Results : Between 2004 and 2007, 40 LABC patients were enrolled. Of 40 patients, 35 were evaluable for efficacy and 40 for
toxicity. Twenty-three out of 35 patients (65%) obtained cPR. Among 22 patients who had clinical response and who
underwent surgery, overall pathological response rate was 51.5% with 1-pCR (2.9%) and 17-pPR (48.5%). All 7 triple-
negative patients had pathological response (1-pCR, 6-pPR). At median follow-up of 59 months, median DFS and OS were
not reached. Five-year OS and DFS were 67% and 62%, respectively. Major adverse effect was myelosuppression without
fatal complications.
Conclusion : The combination GC was feasible and well-tolerated for LABC in neoadjuvant setting. Triple-negative subgroup
seems to have high response to GC.
Keywords : Carboplatin, Chemotherapy, Gemcitabine, Locally advanced breast cancer, Neoadjuvant therapy
