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

S. B. Kaye, N. Colombo, B. J. Monk, S. Tjulandin, B. Kong, M. Roy, S. Chan, E. Filipczyk-Cisarz, H. Hagberg, I. Vergote, C. Lebedinsky, T. Parekh, P. Santabárbara, Y. C. Park, A. Nieto, A. Poveda

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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.

Original languageEnglish
Pages (from-to)49-58
Number of pages10
JournalAnnals of Oncology
Volume22
Issue number1
DOIs
Publication statusPublished - 2011

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trabectedin
Platinum
Ovarian Neoplasms
Drug Therapy
Survival
liposomal doxorubicin

Keywords

  • Pegylated liposomal doxorubicin
  • Platinum-free interval
  • Relapsed ovarian cancer
  • Trabectedin

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval. / Kaye, S. B.; Colombo, N.; Monk, B. J.; Tjulandin, S.; Kong, B.; Roy, M.; Chan, S.; Filipczyk-Cisarz, E.; Hagberg, H.; Vergote, I.; Lebedinsky, C.; Parekh, T.; Santabárbara, P.; Park, Y. C.; Nieto, A.; Poveda, A.

In: Annals of Oncology, Vol. 22, No. 1, 2011, p. 49-58.

Research output: Contribution to journalArticle

Kaye, SB, Colombo, N, Monk, BJ, Tjulandin, S, Kong, B, Roy, M, Chan, S, Filipczyk-Cisarz, E, Hagberg, H, Vergote, I, Lebedinsky, C, Parekh, T, Santabárbara, P, Park, YC, Nieto, A & Poveda, A 2011, 'Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval', Annals of Oncology, vol. 22, no. 1, pp. 49-58. https://doi.org/10.1093/annonc/mdq353
Kaye, S. B. ; Colombo, N. ; Monk, B. J. ; Tjulandin, S. ; Kong, B. ; Roy, M. ; Chan, S. ; Filipczyk-Cisarz, E. ; Hagberg, H. ; Vergote, I. ; Lebedinsky, C. ; Parekh, T. ; Santabárbara, P. ; Park, Y. C. ; Nieto, A. ; Poveda, A. / Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval. In: Annals of Oncology. 2011 ; Vol. 22, No. 1. pp. 49-58.
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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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T1 - Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval

AU - Kaye, S. B.

AU - Colombo, N.

AU - Monk, B. J.

AU - Tjulandin, S.

AU - Kong, B.

AU - Roy, M.

AU - Chan, S.

AU - Filipczyk-Cisarz, E.

AU - Hagberg, H.

AU - Vergote, I.

AU - Lebedinsky, C.

AU - Parekh, T.

AU - Santabárbara, P.

AU - Park, Y. C.

AU - Nieto, A.

AU - Poveda, A.

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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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KW - Platinum-free interval

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KW - Trabectedin

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