10792 Background: Metastatic breast cancer is heterogeneous and treatment decisions are influenced by multiple factors. Docetaxel remains as the standard chemotherapy agent in the management of metastatic breast cancer. We conducted a phase II study to examine the efficacy and tolerability of docetaxel with carboplatin in the treatment of visceral metastatic breast cancer patients. Methods: From July 2000 to December 2004, 32 patients with; histologically/cytologically proven, bidimensionally measurable visceral (pulmonary & hepatic) metastatic breast cancer, age 18–75 years with ECOG performance status 0–3, no prior chemotherapy, life expectancy > 3 months, adequate bone marrow, renal, hepatic and hematological values were enrolled. It was an open-labeled, non-randomized, single-centered and prospective study. The patients received docetaxel (75 mg/m2) and carboplatin AUC 5 on day 1 at an interval of 3 weeks. Outcome measures were response rates and tolerability was measured by adverse events and laboratory blood values. Results: This study consisted of 30 female and only 2 male patients. Median age was 55 years. 18 patients (56.25%) were presented with pulmonary metastases, where as there were 12 patients (66.67%) with single lung and the remaining 6 patients (33.34%) with bilateral lung metastases.14 patients (43.75%) had hepatic metastases. In total, 168 cycles chemotherapy were administered with a median of 5.25 cycles per patient, and 29/32 patients were evaluable for responses. The overall response was 62.07% with 8 complete responses and 10 partial responses. 6 patients (20.69%) had stable disease and only 5 patients (17.24%) had progressive disease. Grade 3 hematological toxicities were observed as follows: neutropenia (24%) and anemia (15.6%). Some non-hematological toxicities (including nausea, vomiting, fluid retention and peripheral neuropathy) in 15 patients (51.72%) were observed. No severe febrile neutropenia and no fatal events were observed. Conclusions: This phase II study supports the use of docetaxel-carboplatin combination in chemo naïve visceral metastatic breast cancer patients due to its very promising effects with well tolerated toxicities in Bangladeshi population. No significant financial relationships to disclose.
Phase II Study of Celecoxib and Trastuzumab in Metastatic Breast Cancer Patients Who Have Progressed after Prior Trastuzumab-Based Treatments
