HER 2 NEU METASTATIC BREAST CANCER;

LOW DOSE SEQUENTIAL DOCETAXEL - CAPECITABINE CHEMOTHERAPY AS FIRST LINE TREATMENT. A CLINICAL TRIAL OF CANCER RESEARCH GROUP PAKISTAN

Abstract

Objective: To evaluate the efficacy and toxicity of low dose sequential docetaxel-capecitabine chemotherapy as first line treatment of HER 2 negative metastatic breast cancer (MBC). Design: Experimental Study, Clinical Trial. Setting: Three different oncology centers, collaborating under the Cancer Research Group Pakistan. Period: From June 2006 to December 2007. Methods: Female breast cancer patients with visceral or visceral and bone metastases and a KPS > 70 were eligible. Results: 38 patients were enrolled. Median age
was 49 years (Range 32-70). With docetaxel treatment, CR was seen in 06 (16%) patients and PR in 20 (53%) with an overall response rate of 69%. Stable disease was seen in 10 (26%) and PD in 02 (05%). Four out of six complete responses were in patients with liver metastases. Thirty six patients received capecitabine. Thirty were evaluable for response. Capecitabine added one CR (3.33%) and six partial responses (20%).
Two patients (6.67 %) who had a partial response to docetaxel relapsed during capecitabine treatment. As a result at the completion of the therapy CR was seen in 07 patients (18.42%), PR in 23 patients (60.53%) with SD and PD in, 4 patients (10.53%) each. An overall RR of 78.94 % was seen. Median time to progression was 10.9 months (range, 3-22 months) and at a median follow up time of 24 months (range, 16 -34
months) 13 patients have died with an overall survival probability of docetaxel –capecitabine sequential therapy of 0.68. Significant docetaxel specific grade 3/4 toxicities included neutropenia and diarrhea in 14 (36.84%) and 03 (07.89%) respectively. Febrile neutropenia was seen in 06 (15.79%). Capecitabine specific significant grade 3 toxicities included hand-foot syndrome in three patients (8.33%) and diarrhea in 2
(5.56%). Stomatitis, dermatitis, fatigue was seen in one patient (2.78 %) each. Conclusions: This treatment schedule of low dose sequential docetaxel - capecitabine is an effective first line treatment of HER 2 negative MBC that provides good overall response rate, manageable toxicity and improved survival.