Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients.

TitleFinal overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients.
Publication TypeJournal Article
Year of Publication2012
AuthorsWagner, U, Marth, C, Largillier, R, Kaern, J, Brown, C, Heywood, M, Bonaventura, T, Vergote, IB, Piccirillo, MC, Fossati, R, Gebski, V, Lauraine, EP
JournalBr J Cancer
Volume107
Start Page588
Issue4
Pagination591
Date Published08/2012
ISSN1532-1827
KeywordsAntineoplastic Combined Chemotherapy Protocols, Carboplatin, Disease-Free Survival, Doxorubicin, Female, Humans, Middle Aged, Paclitaxel, Platinum, Polyethylene Glycols, Recurrence, Treatment Outcome
Abstract

BACKGROUND: The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin-paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature.METHODS: Women with ROC relapsing > 6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here.RESULTS: A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio = 0.99 (95% confidence interval 0.85, 1.16); log-rank P = 0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P < 0.001).CONCLUSION: Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.

DOI10.1038/bjc.2012.307
Alternate JournalBr. J. Cancer
PubMed ID22836511
PubMed Central IDPMC3419956