Presentado Sabado 5 de Mayo :ABSTRTACT 5060 .
Author(s): J. del Campo, T. Ciuleanu, C. Sessa, A. M. Westermann, A. Roszak, S. Chan, T. Hogberg, P. Zintl, Y. C. Park, C. N. Krasner; Vall d'Hebron Hospital, Barcelona, Spain; Institutul Oncologic I. Chiricuta, Cluj-Napoca, Romania; Oncology Institute of Southern Switzerland, Ospedale Regionale Bellinzona e Valli, Bellinzona, Switzerland; Center Department of Medical Oncology, Amsterdam Zuidoost, Netherlands; Wielkopolsice Centrum Oncology, Poznan, Poland; Nottingham University Hospital, Nottingham, United Kingdom; Nordic Society of Gynaecological Oncology, Lund, Sweden; PharmaMar, Colmenar Viejo, Madrid, Spain; Johnson & Johnson Pharmaceutical Research and Development, New Jersey, NJ; Massachusetts General Hospital Gillette Center for Women's Cancer, Boston, MA
Abstract:
Background: A pooled analysis of efficacy with Tr as second/third line in 295 ROC pts demonstrated a median time to progression (TTP) of 4.6 months (mo) (McMeekin, ASCO 2007). Pts sensitive to platinum with a PFI > 6 m (PS), reached a TTP of 6.0 mo, and an overall response rate (ORR) of 36.4% (45.5% in pts with ≥ 2 prior lines). This subanalysis is focused in ROC pts with partially platinum sensitive (PPS) disease, i.e. relapsing between 6-12 m after the end of last prior platinum regimen (PFI:6-12 mo).
Methods: Of the 295 pts, 103 were PPS). Three Tr schedules were studied: weekly (0.58 mg/m2 3-h x3 q4w), and two every 3 weeks (1.3 mg/m2 3-h and 1.5 mg/m2 24-h), that were administered to 41%, 34% and 25% patients, respectively. Efficacy and safety in these patients are reported.
Results: Baseline characteristics: median age 58 years (35-80), ECOG PS 0/1: 72%/27%; papillary/serous histology 76%; histology grade 1-2/3: 28%/58%; liver involvement 35%. Treatment with Tr induced 4% complete responses (CR), 26% partial responses (PR), and 40% stable disease (SD); median response duration (RD:PR+CR) 5.2 mo.(95%CI: 3.9-5.8). Median TTP was 5.3 mo (95%CI: 3.8-6.2); 44% pts were progression free at 6 mo (95%CI: 34%-54%). In pts with liver metastases CR+PR was 36% with median TTP 5.3 mo (95%CI: 3.7-6.5). The most common adverse events were neutropenia and transaminase elevations, which were manageable and without serious clinical consequences.
Conclusions: Tr monotherapy is active in patients with ROC, including patients with PPS disease (PFI 6-12 mo), with a 30% ORR plus 40% SD, with a median TTP of 5.3 mo. Activity was retained in pts with liver metastasis, with 36% ORR and identical TTP. These single-agent results support the findings of the randomized phase III trial OVA-301 where trabectedin + PLD demonstrated superior clinical benefit over PLD alone in the overall population with particularly pronounced efficacy in the PPS cohort.