%0 Journal Article
%T A randomized phase II study of carboplatin plus pegylated liposomal doxorubicin versus carboplatin plus paclitaxel in platinum sensitive ovarian cancer patients: a Hellenic Cooperative Oncology Group study
%A Dimitrios Bafaloukos
%A Helena Linardou
%A Gerasimos Aravantinos
%A Christos Papadimitriou
%A Aristotelis Bamias
%A George Fountzilas
%A Haralabos P Kalofonos
%A Paris Kosmidis
%A Eleni Timotheadou
%A Thomas Makatsoris
%A Epaminondas Samantas
%A Evangelos Briasoulis
%A Christos Christodoulou
%A Pavlos Papakostas
%A Dimitrios Pectasides
%A Athanasios M Dimopoulos
%J BMC Medicine
%D 2010
%I BioMed Central
%R 10.1186/1741-7015-8-3
%X Patients with histologically confirmed recurrent OC, at the time of or more than 6 months after platinum-based chemotherapy, were randomized to six cycles of CP (carboplatin AUC5 + paclitaxel 175 mg/m2, d1q21) or CLD (carboplatin AUC5 + pegylated LD 45 mg/m2, d1q28).A total of 189 eligible patients (CP 96, CLD 93), with a median age of 63 years, median Performance Status (PS) 0 and a median platinum free interval (PFI) of 16.5 months, entered the study. Discontinuation due to toxicity was higher in the CP patients (13.5% versus 3%, P = 0.016). The overall response rate was similar: CP 58% versus CLD 51%, P = 0.309 (Complete Response; CR 34% versus 23%) and there was no statistical difference in time-to-progression (TTP) or overall survival (OS; TTP 10.8 months CP versus 11.8 CLD, P = 0.904; OS 29.4 months CP versus 24.7 CLD, P = 0.454). No toxic deaths were recorded. Neutropenia was the most commonly seen severe toxicity (CP 30% versus CLD 35%). More frequent in CLD were severe thrombocytopenia (11% versus 2%, P = 0.016), skin toxicity and Palmar-plantar erythrodysesthesia (PPE) grade 1-2 (38% versus 9%, P< 0.001), while grade 3 neurotoxicity and alopecia were higher in CP (7% versus 0%, P = 0.029, 20% versus 5%, P = 0.003). PS and PFI were independent prognostic factors for TTP and OS.The combination of pegylated LD with carboplatin is effective, showing less neurotoxicity and alopecia than paclitaxel-carboplatin. It thus warrants a further phase III evaluation as an alternative treatment option for platinum-sensitive OC patients.Australian New Zealand Clinical Trials Registry: ACTRN12609000436279Ovarian cancer (OC) remains the leading cause of death due to gynaecological malignancies [1]. The standard first-line treatment is a platinum-paclitaxel combination, achieving complete response rates of up to 50%. However, despite progress in first-line therapy, more than 60% of patients relapse and die from chemoresistant disease [2-4]. Therefore, the majority of patient
%U http://www.biomedcentral.com/1741-7015/8/3