A phase II study of docetaxel-carboplatin as first line therapy in the patients with visceral metastatic breast cancer: A Bangladesh experience

Abstract

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.