Authors: Poveda, A.; Vergote, I.; Tjulandin, S.; Kong, B.; Roy, M.; Chan, S.; Filipczyk-Cisarz, E.; Hagberg, H.; Kaye, S. B.; Colombo, N.; Lebedinsky, C.; Parekh, T.; Gmez, J.; Park, Y. C.; Alfaro, V.; Monk, B. J.
Source: Annals of Oncology, Volume 22, Number 1, 2011 , pp. 39-48(10)
Publisher: Oxford University Press
Abstract:
Background: OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [612 months platinum-free interval (PFI)] is unclear.
Patients and methods: Within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup.
Results: Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) 0.65, 95% confidence interval (CI), 0.450.92; P 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR 0.59; 95% CI, 0.430.82; P 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR 0.63; P 0.0357; median 13.3 versus 9.8 months).
Conclusion: This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 612 months).
Publication date: 2011-01-01