Phase II multicenter open-label study of carboplatin and pegylated liposomal doxorubicin in uterine and cervical malignancies

Lê LH, Swenerton KD, Elit L, Provencher DM, Stuart GCE, Le T, Lee U, Rodgers A, Pond GR, Oza AM. Phase II multicenter openlabel study of carboplatin and pegylated liposomal doxorubicin in uterine and cervical malignancies. Int J Gynecol Cancer 2005;15:799–806. The results of a multicenter phase II study investigating carboplatin and pegylated liposomal doxorubicin (PLD) in patients with recurrent/metastatic uterine and cervical malignancies (UCM) are presented here. Fifty-three subjects with measurable, untreated, advanced UCM were enrolled. Fifty-one were evaluable for response. Prior combined-modality treatment was permitted if a component of primary therapy. Patients received carboplatin AUC = 5 with PLD 35 mg/m2 intravenously once every 4 weeks. Overall response rate was 33% (35% stable disease). Overall survival (OS) at six months was 86% (95% CI 76%–96%). Six-month progression-free survival (PFS) was 43% (95% CI 30%–57%). Median PFS was 22.9 weeks (range 16.0–35.3) and median OS was 49.1 weeks (range 41.4–75.1). The most frequent grade 3-4 nonhematological adverse events were: abdominal pain (n = 7), fatigue (4), vomiting (4), nausea (3), and shortness of breath (3). There was 1 report of grade 3 hand-foot syndrome and none of grade 4. Twelve patients had first infusion reactions with only 1 discontinuing treatment. Grade 3-4 neutropenia occurred in 26/230 cycles (11.3%). There were no treatment-related deaths. The combination of carboplatin and PLD is well tolerated with sufficient activity to justify additional evaluation in clinical trials and might be suited to the addition of a taxane.