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Open Access Research article

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

Dimitrios Bafaloukos1, Helena Linardou1*, Gerasimos Aravantinos2, Christos Papadimitriou3, Aristotelis Bamias3, George Fountzilas4, Haralabos P Kalofonos5, Paris Kosmidis6, Eleni Timotheadou4, Thomas Makatsoris5, Epaminondas Samantas2, Evangelos Briasoulis7, Christos Christodoulou8, Pavlos Papakostas9, Dimitrios Pectasides10 and Athanasios M Dimopoulos3

Author Affiliations

1 1st Oncology Department, Metropolitan Hospital, Athens, Greece

2 3rd Oncology Clinic, Agii Anargiri Cancer Hospital, Athens, Greece

3 Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece

4 Department of Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece

5 Department of Oncology University of Patras Medical School, Patras, Greece

6 2nd Oncology Department, Hygeia Hospital, Athens, Greece

7 Department of Oncology, Ioannina University Hospital, Ioannina, Greece

8 2nd Oncology Department, Metropolitan Hospital, Athens, Greece

9 Department of Oncology, Ippokration Hospital, Athens, Greece

10 Department of Oncology, University General Hospital Attikon, Athens, Greece

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BMC Medicine 2010, 8:3  doi:10.1186/1741-7015-8-3

Published: 7 January 2010

Abstract

Background

Platinum-based combinations are the standard second-line treatment for platinum-sensitive ovarian cancer (OC). This randomized phase II study was undertaken in order to compare the combination of carboplatin and pegylated liposomal doxorubicin (LD) with carboplatin and paclitaxel (CP) in this setting.

Methods

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).

Results

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.

Conclusions

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.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12609000436279