Use of paclitaxel for advanced ovarian cancer in clinical practice: analysis of 541 patients. Results from a German multi-centre observational study.

UNLABELLED: Paclitaxel is one of the most common antitumour agents paclitaxel for the treatment of primary and relapsed ovarian cancer. Based on a German multicentre observational study, this article reflects the use of paclitaxel in German daily clinical practice. PATIENTS AND METHODS: Data for a total of 541 patients in Germany were analysed, including 315 patients with primary ovarian cancer and 226 patients treated with paclitaxel with relapsed ovarian cancer.
RESULTS: The mean age was 61.2 years, ranging from 22 to 85 years. No unexpected toxicities were ascertained. In general, grade III/IV haematological toxicities were rare. Only 15% of the patients suffered from grade III/IV leucopenia and 5% from thrombocytopenia. Alopecia and polyneuropathy were the most frequent non-haematological side-effects noticed. Response evaluation was provided in 183 patients with primary ovarian cancer (CR 39.8%, of these achieved a complete response (CR), and 27.9% a partial response (PR), resulting in an overall response rate (ORR) of 67.7%. In 13.7%, stable disease (SD) and in 19.7%, tumour progression (PD) were documented. In 196 patients with recurrent ovarian cancer, response evaluation was provided. A total of 28.6% of the patients achieved a CR, and 31.6% a PR, which produced an ORR of 60.2%. In 33.2%, SD and in 6.6%, PD were documented.
CONCLUSION: Paclitaxel is broadly used in the management of patients with primary and relapsed ovarian cancer. The toxicity profile observed seems to be within the range of the results of clinical phase-III studies. The doses applied and the schedules based on the official recommendation of the working groups seem to have been influenced by international studies.