MP50-19 DOSE-FRACTIONATED ANTI-PSMA RADIOIMMUNOTHERAPY ( 177 LU-J591) FOR MCRPC (2016)

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) II1 Apr 2016MP50-19 DOSE-FRACTIONATED ANTI-PSMA RADIOIMMUNOTHERAPY (177LU-J591) FOR MCRPC Jaspreet S. Batra, Beerinder Karir, Kavya Pinto-Chengot, Yuliya S. Jhanwar, Shankar Vallabhajosula, Paul J. Christos, Gillian Hodes, Linda Lam, Ana Molina, Himisha Beltran, Stanley J. Goldsmith, David M. Nanus, Neil H. Bander, and Scott T. Tagawa Jaspreet S. BatraJaspreet S. Batra More articles by this author , Beerinder KarirBeerinder Karir More articles by this author , Kavya Pinto-ChengotKavya Pinto-Chengot More articles by this author , Yuliya S. JhanwarYuliya S. Jhanwar More articles by this author , Shankar VallabhajosulaShankar Vallabhajosula More articles by this author , Paul J. ChristosPaul J. Christos More articles by this author , Gillian HodesGillian Hodes More articles by this author , Linda LamLinda Lam More articles by this author , Ana MolinaAna Molina More articles by this author , Himisha BeltranHimisha Beltran More articles by this author , Stanley J. GoldsmithStanley J. Goldsmith More articles by this author , David M. NanusDavid M. Nanus More articles by this author , Neil H. BanderNeil H. Bander More articles by this author , and Scott T. TagawaScott T. Tagawa More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.453AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Phase 1 and 2 trials of single dose 177Lu-J591 are published. We conducted two phase 1 dose escalation studies of fractionated dose 177Lu-J591 to test hypothesis that higher cumulative radiation doses can be safely administered. METHODS Initially, phase 1 dose escalation study of 177Lu-J591 administered 2 doses 2 wks apart to determine recommended phase 2 dose (RP2D). Expansion cohorts at RP2Ds were enrolled and 2nd trial of escalating fractionated doses of 177Lu-J591 in combination with docetaxel 75 mg/m2 q3 wks performed to determine RP2D of the combo. Men with progressive mCRPC and normal neutrophil and platelet counts were included and 177Lu-J591 planar imaging performed. CTC (CellSearch) counts assessed before and after treatment in expansion cohorts and docetaxel combo study. RESULTS In single agent fractionated dose escalation 177Lu-J591 study, 48 pts. median age 73.05 (52.5-93.8), median PSA 45.38 (1.93-766.5), 52% elevated LDH, 47.9% elevated alk phos, 35.4% with prior chemo were treated. RP2Ds were 40 mCi/m2 or 45 mCi/m2 x2 with option for GCSF. Of 25 with available CTC counts, 14 declined, 8 remained stably favorable, and 3 increased. Of 12 with unfavorable counts, 8 converted at follow up, 2 decreased by 30 and 88% but remained ≥5, and 2 increased. 79.2% had accurate targeting of known disease sites on 177Lu-J591 imaging. Predictable, reversible myelosuppression with 19 Gr 4 thrombocytopenia [15 received transfusions], 9 (18.75%) Gr 4 neutropenia without fever. In combination with docetaxel, 15 men with median age 69.1 (49.3-80.8) were enrolled. RP2D was 40 mCi/m2 x2 doses (delivered with cycle 3). All 14 with baseline and post 177Lu-J591 CTC counts had decline or persistently favorable counts, with 7 of 10 with unfavorable counts converting to favorable. Of 11 scans analyzed to date, all had targeting. CONCLUSIONS Fractionated 177Lu-J591 well tolerated with subsequent PSA declines and predictable, reversible myelosuppression. Dose fractionation allows delivery of higher cumulative dose and also combination with docetaxel, with all subjects able to continue docetaxel with a 3-6 wk delay during temporary myelosuppression from RIT. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e680 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Jaspreet S. Batra More articles by this author Beerinder Karir More articles by this author Kavya Pinto-Chengot More articles by this author Yuliya S. Jhanwar More articles by this author Shankar Vallabhajosula More articles by this author Paul J. Christos More articles by this author Gillian Hodes More articles by this author Linda Lam More articles by this author Ana Molina More articles by this author Himisha Beltran More articles by this author Stanley J. Goldsmith More articles by this author David M. Nanus More articles by this author Neil H. Bander More articles by this author Scott T. Tagawa More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...