6533b7ddfe1ef96bd1274000
RESEARCH PRODUCT
Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer. Preliminary activity results of the MITO-2 phase III trial
Roberto SorioFrancesco CognettiGiuseppe SignorielloC. PisanoP. ScolloGiovanni ScambiaVittorio GebbiaSandro PignataDomenica LorussoAlessandro MorabitoEnrico BredaAntonella SavareseF. PerroneA. Vernaglia Lombardisubject
Oncologyarea under curveCancer Researchendocrine system diseasesmedicine.medical_treatmentneoplasmspolyethylene glycolsantibioticsPegylated Liposomal Doxorubicinsurvival analysischemistry.chemical_compoundpaclitaxelmiddle agedantineoplastic agentsNeoplasms Glandular and EpithelialhumansanthracyclinesAntibiotics AntineoplasticadultGeneral Medicineovarian neoplasmsfemale genital diseases and pregnancy complicationsagedovarian cancerfemaleOncologyPaclitaxelcarboplatinlipids (amino acids peptides and proteins)Anthracyclinesmedicine.drugmedicine.medical_specialtyantineoplasticantineoplastic combined chemotherapy protocolsglandular and epithelialdoxorubicinpegylated liposomal doxorubicinInternal medicineanthracyclines; carboplatin; ovarian cancer; paclitaxel; pegylated liposomal doxorubicin; adult; aged; antibiotics antineoplastic; antineoplastic agents; antineoplastic combined chemotherapy protocols; area under curve; carboplatin; doxorubicin; female; humans; middle aged; neoplasm staging; neoplasms glandular and epithelial; ovarian neoplasms; paclitaxel; polyethylene glycols; survival analysis; treatment outcomemedicineDoxorubicinneoplasm stagingAdvanced ovarian cancerChemotherapybusiness.industryCancermedicine.diseaseCarboplatinEndocrinologychemistrytreatment outcomebusinessOvarian cancerdescription
<i>Background:</i> Based on the efficacy of pegylated liposomal doxorubicin (PLD) in relapsed ovarian cancer, we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer. Because of limited phase I and II data on PLD plus carboplatin in this setting, we conducted an interim activity analysis. <i>Patients and Methods:</i> Patients with stage 1c-IV epithelial ovarian cancer were randomized to carboplatin AUC 5 plus either paclitaxel 175 mg/m<sup>2</sup> or PLD 30 mg/m<sup>2</sup> every 3 weeks for 6 cycles. The interim activity analysis was planned according to a single-stage phase II design with an auspicated 50% response rate; 50 patients eligible for response assessment were required. Response was defined according to RECIST (Response Evaluation Criteria in Solid Tumors). <i>Results:</i> A complete response was achieved in 14 patients (28%) and a partial response in 20 (40%), which produced an overall response rate of 68%. The activity exceeded the minimum required for study continuation. Stable disease was reported in an additional 10 patients (20%). <i>Conclusions:</i> The adopted schedule of PLD plus carboplatin demonstrates activity as a first-line treatment for advanced ovarian cancer.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2008-01-01 |