Extending platinum-free interval (PFI) in partially platinum-sensitive (PPS) patients (pts) with recurrent ovarian cancer (ROC) treated with trabectedin (Tr) plus pegylated liposomal doxorubicin (Tr+PLD) versus PLD alone: Results from a PPS cohort of a phase III study.

Poveda, A.; Tjulandin, S.; Kong, B.; Roy, Moni; Chan, Sing; Filipczyk−Cisarż, Emilia; Hagberg, H; Lebedinsky, Claudia; Parekh, Trilok; Monk, B.J.

doi:10.1200/jco.2010.28.15_suppl.5012

Cited by 7 publications

(5 citation statements)

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“…A protocol-specified interim analysis of overall survival (OS) was conducted with 300 events (versus 520 required for the final OS analysis) showing a 15% reduction in the risk of death with the combination (HR = 0.85; P = 0.1506). An updated OS interim analysis was conducted, at the request of regulatory authorities, with an additional year of follow-up and 419 events, the results of which have been presented elsewhere [8, 11, 12]. The updated OS results confirmed and strengthened those reported previously in a more mature dataset (HR = 0.85; P = 0.092).…”

Section: Introductionsupporting

confidence: 59%

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

et al. 2011

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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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Section: Introductionsupporting

confidence: 59%

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

et al. 2011

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Section: Trabectedin–pld Combination In Relapsed Ovarian Carcinomamentioning

confidence: 74%

“…However, recent data indicate that patients with partial platinum-sensitive disease benefit from the combination of trabectedin and PLD compared with PLD alone, with superior progression-free survival and overall survival for the combination. 37 …”

Section: Discussionmentioning

confidence: 99%

“…Interestingly, a subgroup analysis of this study, reported at the 2010 ASCO meeting, suggested that patients with partial platinum-sensitive disease may benefit the most from this combination. 37 Indeed, 214 patients in this trial had partial platinum-sensitive disease. In this subgroup, the median progression-free survival was 7.4 months for patients treated in the combination arm (T + PLD) versus 5.5 months for patients treated with PLD alone.…”

Section: Trabectedin–pld Combination In Relapsed Ovarian Carcinomamentioning

confidence: 97%

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New developments in treatment of ovarian carcinoma: focus on trabectedin

Cassier¹

2010

CMR

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Trabectedin is a new marine-derived compound that binds the DNA minor groove and interacts with proteins of the DNA repair machinery. Trabectedin has shown promising single-agent activity in pretreated patients with soft tissue sarcoma, and ovarian and breast cancer, and combination with various other chemotherapeutic drugs seems feasible. Toxicities are mainly hematologic and hepatic, with Grade 3–4 neutropenia and thrombocytopenia observed in approximately 50% and 20% of patients, respectively, and Grade 3–4 elevation of liver enzymes observed in 35%–50% of patients treated with trabectedin. The recently reported results of a large Phase III trial comparing pegylated liposomal doxorubicin (PLD) alone with a combination of PLD and trabectedin in patients with recurrent ovarian cancer showed improved progression-free survival with the combination of trabectedin and PLD, albeit at the price of increased toxicity. Current research focuses on the identification of predictive factors for patients treated with trabectedin, as well as the development of other combinations.

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“…36 Interestingly, a subgroup analysis of this study, reported at the 2010 ASCO meeting, suggested that patients with partial platinum-sensitive disease may benefit the most from this combination. 37 Indeed, 214 patients in this trial had partial platinum-sensitive disease. In this subgroup, the median progression-free survival was 7.4 months for patients treated in the combination arm (T + PLD) versus 5.5 months for patients treated with PLD alone.…”

Section: Trabectedin-pld Combination In Relapsed Ovarian Carcinomamentioning

confidence: 99%

New developments in treatment of ovarian carcinoma: focus on trabectedin

Cassier¹

2010

CMAR

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Abstract:Trabectedin is a new marine-derived compound that binds the DNA minor groove and interacts with proteins of the DNA repair machinery. Trabectedin has shown promising single-agent activity in pretreated patients with soft tissue sarcoma, and ovarian and breast cancer, and combination with various other chemotherapeutic drugs seems feasible. Toxicities are mainly hematologic and hepatic, with Grade 3-4 neutropenia and thrombocytopenia observed in approximately 50% and 20% of patients, respectively, and Grade 3-4 elevation of liver enzymes observed in 35%-50% of patients treated with trabectedin. The recently reported results of a large Phase III trial comparing pegylated liposomal doxorubicin (PLD) alone with a combination of PLD and trabectedin in patients with recurrent ovarian cancer showed improved progression-free survival with the combination of trabectedin and PLD, albeit at the price of increased toxicity. Current research focuses on the identification of predictive factors for patients treated with trabectedin, as well as the development of other combinations.

show abstract

Extending platinum-free interval (PFI) in partially platinum-sensitive (PPS) patients (pts) with recurrent ovarian cancer (ROC) treated with trabectedin (Tr) plus pegylated liposomal doxorubicin (Tr+PLD) versus PLD alone: Results from a PPS cohort of a phase III study.

Cited by 7 publications

References 0 publications

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

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

New developments in treatment of ovarian carcinoma: focus on trabectedin

New developments in treatment of ovarian carcinoma: focus on trabectedin

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