George W. Sledge, Jr, MD

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Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer

December 1st 2003

Gemcitabine (Gemzar) and paclitaxel show good activity as singleagents and combined in metastatic breast cancer, and the combinationof paclitaxel/trastuzumab (Herceptin) has been shown to prolong timeto disease progression and survival significantly in this setting. Preclinicaldata indicate additive or synergistic effects of gemcitabine andtrastuzumab in HER2-positive human breast cancer cell lines. In aphase II trial, patients with HER2-overexpressing metastatic breastcancer who had received no prior chemotherapy for metastatic diseasereceived gemcitabine at 1,200 mg/m2 on days 1 and 8 and paclitaxel at175 mg/m2 on day 1 every 21 days for six cycles plus trastuzumab at aninitial loading dose of 4 mg/kg followed by 2 mg/kg weekly; patientswithout progressive disease after six cycles continued to receivetrastuzumab until disease progression. Overall, objective response wasobserved in 28 (67%) of 42 evaluable patients, including complete responsein 4 (10%) and partial response in 24 (57%); stable disease wasobserved in 7 (17%) and progressive disease was observed in 6 (14%).Median time to treatment failure was 9+ months. Median overall survivalhas not yet been reached, but is estimated at approximately 27months. Significant toxicities apart from neutropenia were uncommon.The triplet combination of gemcitabine, paclitaxel, and trastuzumab ishighly active and well tolerated in patients with HER2-overexpressingmetastatic breast cancer.