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.

TitleCarboplatin 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.
Publication TypeJournal Article
Year of Publication2015
AuthorsMahner, S, Meier, W, du Bois, A, Brown, C, Lorusso, D, Dell'Anna, T, Cretin, J, Havsteen, H, Bessette, P, Zeimet, AG, Vergote, IB, Vasey, PA, Pujade-Lauraine, E, Gladieff, L, Ferrero, A
JournalEur J Cancer
Volume51
Issue3
Pagination352-8
Date Published2015 Feb
ISSN1879-0852
KeywordsAdult, Aged, Aged, 80 and over, Carboplatin, Chemotherapy, Adjuvant, Cystadenocarcinoma, Serous, Doxorubicin, Drug Resistance, Neoplasm, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Middle Aged, Ovarian Neoplasms, Paclitaxel, Platinum Compounds, Polyethylene Glycols, Recurrence
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.

DOI10.1016/j.ejca.2014.11.017
Alternate JournalEur. J. Cancer
PubMed ID25534295