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Clinical Trial
. 2011 Jan;22(1):39-48.
doi: 10.1093/annonc/mdq352. Epub 2010 Jul 19.

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial

A Poveda  1 , I Vergote  2 , S Tjulandin  3 , B Kong  4 , M Roy  5 , S Chan  6 , E Filipczyk-Cisarz  7 , H Hagberg  8 , S B Kaye  9 , N Colombo  10 , C Lebedinsky  11 , T Parekh  12 , J Gómez  11 , Y C Park  12 , V Alfaro  11 , B J Monk  13
Affiliations
Clinical Trial

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial

A Poveda et al. Ann Oncol. 2011 Jan.

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 [6-12 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), 0.45-0.92; 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, 0.43-0.82; 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 6-12 months).

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Figures

Figure 1.
Figure 1.
Progression-free survival for the partially platinum-sensitive population (OVA-301 study). independent radiology review of all measurable patients (primary end point). HR, hazard ratio; N, number of patients; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
Figure 2.
Figure 2.
Updated interim analysis of overall survival for OVA-301 study (cut-off, 31 May 2009). (A) All randomized patients. (B) Partially platinum-sensitive population. HR, hazard ratio; N, number of patients; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
Figure 3.
Figure 3.
Overall survival adjusted by continuous platinum-free interval (OVA-301 study, cut-off, 31 May 2009). HR, hazard ratio; P, Cox regression P value; PLD, pegylated liposomal doxorubicin.
Figure 4.
Figure 4.
Time from randomization to subsequent platinum-based therapy in the partially platinum-sensitive subpopulation (OVA-301 study, PFI 6- to 12-month subset, n = 121). HR, hazard ratio; N, number of patients; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
Figure 5.
Figure 5.
Overall survival from subsequent platinum-based therapy in the partially platinum-sensitive population (OVA-301 study, PFI 6- to 12-month subset; n = 121). Censored: PLD arm (21%); trabectedin/PLD arm (42%). HR, hazard ratio; N, number of patients; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
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Comment in

References

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