Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: Results from a subset analysis of the CALYPSO phase III trial

L. Gladieff, A. Ferrero, G. De rauglaudre, C. Brown, P. Vasey, A. Reinthaller, E. Pujade-Lauraine, N. Reed, D. Lorusso, S. Siena, H. Helland, L. Elit, S. Mahner

Research output: Contribution to journalArticle

Abstract

Background: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial. Patients and methods: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety. Results: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P <0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm). Conclusion: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.

Original languageEnglish
Pages (from-to)1185-1189
Number of pages5
JournalAnnals of Oncology
Volume23
Issue number5
DOIs
Publication statusPublished - May 2012

Keywords

  • CALYPSO
  • Carboplatin
  • Ovarian cancer
  • Paclitaxel
  • Partially platinum-sensitive
  • Pegylated liposomal doxorubicin

ASJC Scopus subject areas

  • Oncology
  • Hematology

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    Gladieff, L., Ferrero, A., De rauglaudre, G., Brown, C., Vasey, P., Reinthaller, A., Pujade-Lauraine, E., Reed, N., Lorusso, D., Siena, S., Helland, H., Elit, L., & Mahner, S. (2012). Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: Results from a subset analysis of the CALYPSO phase III trial. Annals of Oncology, 23(5), 1185-1189. https://doi.org/10.1093/annonc/mdr441