Published in:
01-02-2008 | Original Article
Weekly paclitaxel and carboplatin (PC-W) for patients with primary advanced ovarian cancer: results of a multicenter phase-II study of the NOGGO
Authors:
Jalid Sehouli, Dirk Stengel, Alexander Mustea, Oumar Camara, Elke Keil, Dirk Elling, Peter Ledwon, Bernd Christiansen, Peter Klare, Gerhard Gebauer, Marina Schwarz, Werner Lichtenegger, on behalf of the Ovarian Cancer Study Group of the Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO)
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 2/2008
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Abstract
Objectives
To study the toxicity and efficacy of weekly paclitaxel and carboplatin (PC-W) in women with primary ovarian cancer
Methods
This investigation extended a phase-I dose finding study and was approved by the institutional review boards of all participating institutions. Between 1999 and 2003, women with radically resected ovarian cancer of FIGO stages II B to IV were enrolled at 17 German centres. Patients received weekly paclitaxel at a dose of 100 mg/m2, followed by carboplatin AUC 2. After a first treatment block consisting of six cycles of chemotherapy, patients had a treatment-free interval of 14 days, followed by a second block of six cycles. Treatment was completed by a 28-days break and a final block of six cycles.
Results
Altogether, 129 women with a mean age of 59 ± standard deviation 11 years entered the study. Most patients (82.9%) had serous papillary carcinoma of FIGO stage III (72.9%) and IV (20.9%). Participants received 1,851 cycles of chemotherapy; averaging 14.3 ± 4.3 cycles each patient. PC-W produced low rates of peripheral neuropathy (grade 3: 2.3%, 95% confidence interval [CI] 0.5–6.6%), with rapid recovery after 3 months. However, 72 patients had grade III/IV anaemia (55.8%, 95% CI 46.8–64.5%). There were 36 events of grade III/IV leukopenia (27.9%, 95% CI 20.4–36.5%). One patient sustained neutropenic fever. CA-125- and objective response was noted in 73.9% (95% CI 64.7–81.8%) and 55.6% (95% CI 41.4–69.1%) of patients. Median progression free and overall survival was 21 and 43 months, respectively.
Conclusions
PC-W is feasible; a randomized study is warranted to compare this new regimen with conventional 3-weekly treatment.