Oral Taxane Shows Potent Antitumour Activity as First-Line Metastatic Breast Cancer Therapy: Presented at SABCS
By Alex Morrisson
SAN ANTONIO -- December 13, 2011 -- About 50% of women with metastatic breast cancer showed an objective response when treated with the investigational oral taxane, tesetaxel, researchers reported here at the 34th Annual San Antonio Breast Cancer Symposium (SABCS).
“We have seen good activity with this drug, which has an advantage over other taxanes because it is has an oral rather than parenteral administration,” said Hassan Danesi, MD, Genta Incorporated, Berkeley Heights, New Jersey.
In the phase 2b, open-label study, women diagnosed with metastatic breast cancer were treated with tesetaxel at a starting dose of 27 mg/m2 once every 3 weeks, and were titrated to 35 mg/m2 as tolerated.
The use of tesetaxel in first-line therapy followed previous studies in which treatment in second-line therapy showed favourable activity, Dr. Danesi said in his poster presentation on December 9.
Among the 24 evaluable patients, progressive disease was observed in 4 women. Eight women showed improvements but that improvement did not reach criteria for being reported as a partial response. Twelve women achieved either a partial response or a complete response.
Dr. Danesi said that the most frequent adverse event was grade 3 and 4 neutropenia that was seen in 42% of the patients, but febrile neutropenia occurred in 2 patients (6%).
The trial enrolled 33 patients, with a goal of enrolling 45 in this stage of development.
The mean age of the women in the study was 57.9 years, 67% were white, and 27% were black. The mean time from initial diagnosis of breast cancer to metastasis was 5.8 years.
The most common sites for metastases were the lungs, lymph nodes, liver, and bone. About 76% of the women had prior adjuvant chemotherapy, and about 58% of these women had previously been treated with taxanes. About 61% of the women had undergone hormonal therapy -- mainly tamoxifen and anastrozole.
“Tesetaxel as a single agent has potent antitumour activity in first-line breast cancer [therapy],” Dr. Danesi said.
Funding for this study was provided by Genta Incorporated.
[Presentation title: Tesetaxel, an Oral Taxane, as First-Line Therapy for Women With Metastatic Breast Cancer. Abstract P5-19-11]
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