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Clinical Trial
. 2011 Jan;22(1):49-58.
doi: 10.1093/annonc/mdq353. Epub 2010 Jul 19.

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval

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

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval

S B Kaye 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; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy.

Patients and methods: a detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted.

Results: similar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357).

Conclusion: the superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.

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Figures

Figure 1.
Figure 1.
Flow chart of patients receiving platinum as further chemotherapy. PLD, pegylated liposomal doxorubicin.
Figure 2.
Figure 2.
Percentage of patients receiving subsequent platinum therapies per platinum-free interval. PFI, platinum-free interval (P < 0.0001).
Figure 3.
Figure 3.
Time to subsequent chemotherapy in the overall population (N = 672 patients). (A) All chemotherapy regimens. (B) Platinum-based regimens. C, number of censored patients; HR, hazard ratio; N, number of patients; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
Figure 4.
Figure 4.
Median overall survival from the administration of subsequent platinum-based therapy (all patients who received further platinum; n = 347). C, number of censored patients; HR, hazard ratio; N, number of patients; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
Figure 5.
Figure 5.
Median overall survival from the administration of subsequent platinum-based therapy per platinum sensitivity subset (all patients who received further platinum). (A) Platinum-resistant (PFI < 6 months; n = 86); (B) Partially platinum sensitive (PFI 6–12 months; n = 121); (C) Platinum sensitive (PFI > 12 months; n = 139). C, number of censored patients; HR, hazard ratio; P, log-rank test P value; PLD, pegylated liposomal doxorubicin.
Figure 6.
Figure 6.
Time to subsequent chemotherapy and median OS from the administration of platinum-based therapy as subsequent line in the platinum-free interval 6–12 subset. (A) Time to subsequent chemotherapy; (B) Overall survival. C, number of censored patients; HR, hazard ratio; P, log-rank test P value; PLD, pegylated liposomal doxorubicin; OS, overall survival.
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References

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