@article {Herzog1580, author = {Thomas J. Herzog and El{\.z}bieta Kutarska and Mariusz Bidzi{\'n}sk and Jim Symanowski and Binh Nguyen and Reshma A. Rangwala and R. Wendel Naumann}, title = {Adverse Event Profile by Folate Receptor Status for Vintafolide and Pegylated Liposomal Doxorubicin in Combination, Versus Pegylated Liposomal Doxorubicin Alone, in Platinum-Resistant Ovarian Cancer: Exploratory Analysis of the Phase II PRECEDENT Trial}, volume = {26}, number = {9}, pages = {1580--1585}, year = {2016}, doi = {10.1097/IGC.0000000000000806}, publisher = {BMJ Specialist Journals}, abstract = {Objective This exploratory analysis evaluated the incidence of adverse events (AEs) by folate receptor (FR) status in the randomized, multicenter, open-label PRECEDENT study in women with platinum-resistant ovarian cancer receiving pegylated liposomal doxorubicin (PLD) {\textpm} the small-molecule drug conjugate vintafolide.Methods Women 18 years or older with platinum-resistant ovarian cancer were randomized 2:1 to vintafolide (2.5 mg intravenously, 3 times per week, weeks 1 and 3, every 28 days) + PLD (50 mg/m2 intravenously, day 1, every 28 days) or PLD alone (same dose/schedule). The expression of functionally active FR was evaluated by single-photon emission computed tomography with etarfolatide. Patients were categorized according to FR positivity: patients with all target lesions positive for FR expression (FR 100\%), patients with 1 or more but not all target lesions positive for FR expression (FR 10\%{\textendash}90\%), and patients with all lesions negative for FR expression (FR 0\%).Results Data on FR status were available for 94 patients: 38 were FR 100\%, 36 were FR 10\% to 90\%, and 20 were FR 0\%. Across all FR subgroups, the duration of treatment was longer, and the number of cycles was higher in combination-therapy arms than PLD-alone arms. Although the frequency of AEs was relatively consistent across subgroups, the FR 100\% subgroup had a higher incidence of patients with at least 1 AE for combination therapy versus PLD alone. No surprising safety signals were shown according to FR status. The incidence of grade 3 or 4 treatment-emergent drug-related AEs was generally low across all FR subgroups and treatment arms.Conclusions This exploratory analysis suggests that FR status does not influence the AE profile of vintafolide + PLD combination therapy or PLD alone in patients with platinum-resistant ovarian cancer. Future a priori analyses in larger populations are needed to confirm these findings.}, issn = {1048-891X}, URL = {https://ijgc.bmj.com/content/26/9/1580}, eprint = {https://ijgc.bmj.com/content/26/9/1580.full.pdf}, journal = {International Journal of Gynecologic Cancer} }