| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 3944154 | Gynecologic Oncology | 2010 | 6 Pages |
BackgroundFor the adjuvant setting of advanced ovarian cancer (AOC) after primary radical surgery the combination of paclitaxel and platinum in a 3-week schedule has emerged as the current standard. In preclinical studies additional anti-angiogenic effects of low dose paclitaxel infusion were demonstrated. A sequential schedule of carboplatin and paclitaxel has the potential to improve the therapeutic index.MethodsIn this multicenter phase II trial four cycles of carboplatin at a dose of AUC 5 (d1/q21d) followed by 12 cycles of weekly paclitaxel at a dose of 80 mg/m2 (d1/q7d) were applied after primary radical surgery. Eligible were all optimally or sub-optimally debulked patients with FIGO IA–IV ovarian cancer. All patients with hemoglobin levels < 12 mg/dl received erythropoietin additionally.ResultsBetween July 2003 and May 2005, 105 patients from 27 institutions were enrolled. The median age was 60 years (range: 23–80 years). A median number of 16 courses (range 1–16) were applied. The incidence of non-hematological toxicities was very low. Only 41% of patients experienced alopecia (grade 1–2). Neurotoxicity (grade 3—4) was not observed. Grade 3–4 hematological toxicity (43% of all patients) included thrombocytopenia (17%), anemia (3%), leucopenia (23%), and neutropenic fever (0%).Ninety-seven percent received erythropoietin. Thromboembolic events (4%) were not increased in patients who received erythropoietin. After a median time of 23 months (range: 1–42 months) 32 patients had died, and the median overall survival was not reached. The progression-free survival was 25.4 months (95% CI: 18.8–40+).ConclusionThese results suggest that this sequential regimen using weekly paclitaxel represents an efficacious and well-tolerated regimen. A randomized study comparing this new schedule with the conventional 3-week protocol is warranted.
