Weekly dose-dense paclitaxel and carboplatin in recurrent ovarian carcinoma : a phase II trial

الملخص EN

Purpose : The aim of this study was to investigate efficacy and toxicity of the dose-dense weekly paclitaxel (T) and carboplatin (C) in the management of platinum-resistant / sensitive recurrent epithelial ovarian cancer (EOC) previously treated with 3 weekly paclitaxel / carboplatin.

Methods : Thirty two patients with recurrent EOC who had received 3 weekly TC before were enrolled.

Nine patients relapsed within 6 months (platinum-resistant), 13 patients relapsed after 12 months (platinum-sensitive) and in 10 patients recurrence occurred between 6 and 12 months (intermediate platinum-sensitive).

Weekly (T) at a dose of 80 mg / m2, followed by weekly (C) AUC 2 on day 1, 8, and 15 of a 28-day cycle for 6 planned cycles were administrated.

End-points were overall response rate (ORR), progression free survival (PFS), overall survival (OS) and toxicity.

Results : The ORR was 62.5 %.

For the platinum-resistant, intermediate platinum-sensitive and platinum-sensitive patients the ORR was 44.4 % (4 / 9), 60 % (6 / 10) and 76.9 % (10 / 13), respectively, and 1 (11.1 %), 2 (20 %) and 5 (38.46 %) patients, respectively had CR.

PFS was 9.1 months (6.13, 9.1 and 12.17 months, for the 3 groups, respectively) (P < 0.001).

OS was 14 months (9.17, 15.2, and 19.23 months, for the 3 groups, respectively) (P < 0.001).

Treatment-related adverse events were manageable with only 1 patient (3.1 %) suffering from grade 4 neutropenia.

Grade 3 hematological and non-hematological toxicities were neutropenia in 8 (25 %), and peripheral neuropathy in 4 (12.5 %) patients, respectively.

Conclusion : Weekly TC is active and well-tolerated in platinum-resistant and platinum-sensitive patients with recurrent EOC previously treated with TC given every 3 weeks.