G-CSF administration was allowed in case of G4 neutropenia, along with its prophylactic use in subsequent cycles. Chemotherapy was usually administered on an outpatient basis for a maximum of 12 cycles. Treatment was discontinued in case of disease progression, unacceptable toxicity, treatment delay longer than 2 weeks or patient refusal.
The study protocol was approved by the Ethic Committee of the Regina Elena selleck kinase inhibitor National Cancer Institute, the coordinating centre. A written informed consent was obtained from all the enrolled patients prior to any trial procedure. The project was carried out according to the Helsinki Declaration. Statistical analysis Primary objectives of the study were the evaluation of response rate (RR) and PFS, while safety and OS were secondary aims. The optimal Simon’s two-stage phase II design was used to determine the sample size [19]. An interim analysis was carried out when the first 13 assessable patients were recruited. If more than 3 responses were observed, 30 additional patients had to be
recruited; otherwise, the study had to be terminated. If more than 12 responses were observed in the BI 6727 ic50 43 patients, the regimen was considered sufficiently active with a significance level of 5% and power of 80% to be submitted for further evaluation. The enrolment of 41 patients ensured a sufficient number of events
required for statistical analysis. PFS and OS were analyzed according to the Kaplan-Meier method. Follow-up was updated to 30 April 2013. Results Patients characteristics Overall, 41 ovarian patients with recurrent, platinum-resistant disease were enrolled between March 2010 and December 2012. Main patient characteristics Lepirudin are listed in Table 1. Median age was 60 years (range, 32–75). Serous adenocarcinomas and poorly differentiated tumours were the most common histological subtypes (24.5%, equally represented), while stage III FIGO at the diagnosis was largely predominant (80%). By preset inclusion criteria, all the patients had received at least one previous platinum-based regimen and were platinum-resistant on study entry. Twenty three patients (56%) were defined platinum-refractory or resistant, while for 18 women (44%) the PFI fell in a 6 to 12 month interval (NVP-BGJ398 nmr partially platinum-sensitive). Thirty eight patients (93%) had been previously treated with at least two lines of chemotherapy. Eighteen women (44%) had received no less than two previous platinum-based regimens. All the patients had received paclitaxel, one also docetaxel. Thirty seven patients (90%) had also received liposomal doxorubicin. Table 1 Main patient characteristics Characteristic No.