Sven Mahner1, Werner Meier2, Andreas du Bois3, Chris Brown4, Domenica Lorusso5, Tiziana Dell'Anna6, Jacques Cretin7, Hanne Havsteen8, Paul Bessette9, Alain G Zeimet10, Ignace Vergote11, Paul Vasey12, Eric Pujade-Lauraine13, Laurence Gladieff14, Annamaria Ferrero15. 1. Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Study Group (AGO) and University Medical Center Hamburg-Eppendorf, Germany. Electronic address: Sven.Mahner@gmx.de. 2. Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Study Group (AGO) and Evangelisches Krankenhaus Düsseldorf, Germany. 3. Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Study Group (AGO) and Kliniken Essen-Mitte, Germany. 4. ANZGOG-NHMRC, Sydney, Australia. 5. Multicenter Italian Trials in Ovarian Cancer and gynecologic malignancies group (MITO) and Istituto Nazionale dei Tumori, Milan, Italy. 6. Mario Negri Gynecologic Oncology Group (MANGO) and Ospedale San Gerardo, Monza, Italy. 7. Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Clinique Valdegourue, Nimes, France. 8. Nordic Society of Gynecological Oncology (NSGO) and Copenhagen University, Copenhagen, Denmark. 9. National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) and Universite de Sherbrooke, Sherbrooke, Canada. 10. Arbeitsgemeinschaft Gynäkologische Onkologie Österreich (AGO-Austria) and Innsbruck University, Innsbruck, Austria. 11. European Organisation for Research and Treatment of Cancer (EORTC) and University Hospital Leuven, Leuven, Belgium. 12. Australia New Zealand Gynecological Oncology Group (ANZGOG) and Wesley Medical Centre, Brisbane, Australia. 13. Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Universite Paris Descartes, Paris, France. 14. Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Institut Claudius Regaud, Toulouse, France. 15. Mario Negri Gynecologic Oncology Group (MANGO) and Ospedale Ordine Mauriziano di Torino, Turin, Italy.
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.
RCT Entities:
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.
Authors: Jessica Erriquez; Martina Olivero; Gloria Mittica; Maria Stella Scalzo; Marco Vaira; Michele De Simone; Riccardo Ponzone; Dionyssios Katsaros; Massimo Aglietta; Raffaele Calogero; Maria Flavia Di Renzo; Giorgio Valabrega Journal: Oncotarget Date: 2016-05-03
Authors: Anne-Christine Wong Te Fong; Parames Thavasu; Sladjana Gagrica; Karen E Swales; Martin O Leach; Sabina C Cosulich; Yuen-Li Chung; Udai Banerji Journal: Oncotarget Date: 2017-12-06