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

Sven Mahner, Werner Meier, Andreas Du Bois, Chris Brown, Domenica Lorusso, Tiziana Dell'Anna, Jacques Cretin, Hanne Havsteen, Paul Bessette, Alain G. Zeimet, Ignace Vergote, Paul Vasey, Eric Pujade-Lauraine, Laurence Gladieff, Annamaria Ferrero

Research output: Contribution to journalArticle

Abstract

Aim To perform a subset analysis of patients with very platinum-sensitive recurrent ovarian cancer (ROC) enrolled in the phase III CALYPSO trial. Patients and methods The international non-inferiority trial enrolled women with ROC that relapsed >6 months following first- or second-line platinum- and paclitaxel-based therapies. Patients were randomised to CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) and stratified by treatment-free interval (TFI). In this analysis, patients with a TFI > 24 months were analysed separately for progression free survival (PFS), the primary endpoint of CALYPSO, overall survival (OS) and safety. Results A total of 259 very platinum-sensitive patients were included (n = 131, CD; n = 128, CP). Median PFS was 12.0 months for the CD arm and 12.3 months for CP [HR = 1.05 (95% CI, 0.79-1.40); P = 0.73 for superiority] and median OS was 40.2 months for CD and 43.9 for CP [HR = 1.18 (95% CI 0.85-1.63); P = 0.33 for superiority]. Overall response rates were 42% and 38%, respectively (P = 0.46). Toxicities were more common with CP versus CD, including grade 3/4 neutropenia (40.8% versus 27.5%; P = 0.025), nausea (4.8% versus 3.1%; P = 0.47), allergic reaction (8% versus 3.1%; P = 0.082) sensory neuropathy (4.8% versus 2.3%; P = 0.27) and grade 2 alopecia (88% versus 9.2%; P <0.001). Grade 3/4 thrombocytopenia (12.2% versus 3.2%; P = 0.007) and mucositis (2.3% versus 0%; P = 0.089) were more common with CD. Grade 3/4 hand-foot syndrome occurred rarely with CD (3 patients versus 0 in CP arm; P = 0.089). Conclusion CP and CD were equally effective treatment regimens for patients with very platinum-sensitive ROC. The favourable risk-benefit profile suggests carboplatin-PLD as treatment of choice for these patients.

Original languageEnglish
Pages (from-to)352-358
Number of pages7
JournalEuropean Journal of Cancer
Volume51
Issue number3
DOIs
Publication statusPublished - 2015

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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    Mahner, S., Meier, W., Du Bois, A., Brown, C., Lorusso, D., Dell'Anna, T., Cretin, J., Havsteen, H., Bessette, P., Zeimet, A. G., Vergote, I., Vasey, P., Pujade-Lauraine, E., Gladieff, L., & Ferrero, A. (2015). Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in very platinum-sensitive ovarian cancer patients: Results from a subset analysis of the CALYPSO phase III trial. European Journal of Cancer, 51(3), 352-358. https://doi.org/10.1016/j.ejca.2014.11.017