A phase II trial of weekly one hour paclitaxel as second-line therapy for endometrial and cervical cancer

Autor: G. Lowendowski, A. A. Elbendary, L. Vaccarello, Howard D. Homesley
Rok vydání: 2006
Předmět:
Zdroj: Journal of Clinical Oncology. 24:15013-15013
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2006.24.18_suppl.15013
Popis: 15013 Background: The antitumor activity of other regimens of paclitaxel (from Bristol-Myers Squibb Oncology, Bristol-Myers Squibb Company, Princeton, NJ, U. S. A.) has been identified in both cervical and endometrial cancer. A less toxic and better tolerated regimen for paclitaxel is a one hour infusion every 7 days. The primary aim of this study was to assess the activity of weekly paclitaxel in patients with recurrent or refractory endometrial cancer or squamous cell cancer of the cervix who had failed one prior chemotherapy regimen and had measurable disease. The nature and degree of toxicity of paclitaxel administered in this schedule in this group of patients was assessed. Methods: Eligible patients had initial histologic diagnosis. All patients presented with persistent or recurrent measurable disease with no more than one prior chemotherapeutic regimen and a GOG Performance Status of 2 or better. At entry hematologic and all other labs were within normal limits. Patients received paclitaxel 80 mg/m2 over one hour every 7 days. One cycle consisted of four weeks and patients had to receive at least two cycles of therapy to be evaluable for response unless progression occurred during the first eight weeks of the trial. Response by measurable disease change and survival were the endpoints of the trial. Results: Forty-three patients were registered. Evaluable for response were 15/16 patients with endometrial cancer and 20/29 patients with advanced cervical cancer. For the endometrial cancer patients 4 of 15 responded. Two of four responders had complete responses with durations of response of 16 to 23 weeks. Stable disease was present in 33%. There were two responders (one a complete response) in the 20 evaluable patients with cervical cancer while 35% had stable disease. Adverse effects were minimal and easily managed with dose adjustments as needed. Conclusions: In this trial, weekly paclitaxel as second line therapy had a response rate of 27% (4/15) in endometrial carcinoma but only 10% in advanced cervical cancer (2/20). Although confirmatory larger trials are needed, weekly paclitaxel appears promising for advanced endometrial carcinoma but not for squamous cell carcinoma of the cervix. [Table: see text]
Databáze: OpenAIRE