Chronic administration of single-agent paclitaxel in gynecologic malignancies

There are currently limited published data available on the safety and feasibility of the prolonged administration of paclitaxel. The goal of this study was to review the cumulative toxicity associated with the continuous long-term administration of this agent to women with gynecologic cancers.

Eleven patients with gynecologic malignancies of varying histologic subtypes who received >15 consecutive courses of paclitaxel were identified in a retrospective review of individuals treated between 1994 and 1999 in the Gynecologic Oncology Program of the Cleveland Clinic Taussig Cancer Center. The analysis excluded paclitaxel delivered as a component of an initial chemotherapy regimen for the cancer. Paclitaxel was administered at doses ranging from 80 to 175 mg/m(2) every 3-4 weeks as a 3-h infusion.

In general, the patients included in this report were heavily pretreated and were continued on therapy either as a result of documentation of an objective response or with evidence of stabilization of disease (e.g., physical examination, radiographic evaluation, CA-125 antigen level) and the maintenance of a satisfactory quality of life. In the 11 patients, the median duration of therapy was 20 cycles (range: 16-36 cycles). Alopecia was observed in all patients. A single patient experienced grade 3 anemia and grade 4 neutropenia. Of note, there was 1 case of grade 2 and no cases of grade 3 peripheral neuropathy in this population.

Prolonged delivery of paclitaxel for >15 consecutive cycles can be safely administered to carefully selected patients with persistent or recurrent advanced gynecologic cancers.