PMID- 27654255
OWN - NLM
STAT- MEDLINE
DCOM- 20180124
LR  - 20181202
IS  - 1525-1438 (Electronic)
IS  - 1048-891X (Linking)
VI  - 26
IP  - 9
DP  - 2016 Nov
TI  - 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.
PG  - 1580-1585
AB  - 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) +/- 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/m 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%-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.
FAU - Herzog, Thomas J
AU  - Herzog TJ
AD  - *University of Cincinnati Medical Center, Cincinnati, OH; daggerCentrum Onkologii 
      Ziemi Lubelskiej, Lublin; and double daggerHolycross Cancer Center, Kielce, Poland;  section signLevine 
      Cancer Institute, Carolinas HealthCare System, Charlotte, NC; vertical lineEndocyte, Inc, West 
      Lafayette, IN; and  paragraph signMerck & Co, Inc, Kenilworth, NJ.
FAU - Kutarska, Elzbieta
AU  - Kutarska E
FAU - Bidzinsk, Mariusz
AU  - Bidzinsk M
FAU - Symanowski, Jim
AU  - Symanowski J
FAU - Nguyen, Binh
AU  - Nguyen B
FAU - Rangwala, Reshma A
AU  - Rangwala RA
FAU - Naumann, R Wendel
AU  - Naumann RW
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Int J Gynecol Cancer
JT  - International journal of gynecological cancer : official journal of the 
      International Gynecological Cancer Society
JID - 9111626
RN  - 0 (Antibiotics, Antineoplastic)
RN  - 0 (EC145)
RN  - 0 (Folic Acid Transporters)
RN  - 0 (Vinca Alkaloids)
RN  - 0 (liposomal doxorubicin)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 80168379AG (Doxorubicin)
RN  - 935E97BOY8 (Folic Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibiotics, Antineoplastic/administration & dosage/*adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols
MH  - Doxorubicin/administration & dosage/adverse effects/*analogs & derivatives
MH  - Female
MH  - Folic Acid/administration & dosage/adverse effects/*analogs & derivatives
MH  - Folic Acid Transporters/*metabolism
MH  - Humans
MH  - Middle Aged
MH  - Ovarian Neoplasms/*drug therapy/metabolism
MH  - Polyethylene Glycols/administration & dosage/adverse effects
MH  - Vinca Alkaloids/administration & dosage/*adverse effects
EDAT- 2016/10/26 06:00
MHDA- 2018/01/25 06:00
CRDT- 2016/09/23 06:00
PHST- 2016/10/26 06:00 [pubmed]
PHST- 2018/01/25 06:00 [medline]
PHST- 2016/09/23 06:00 [entrez]
AID - 10.1097/IGC.0000000000000806 [doi]
PST - ppublish
SO  - Int J Gynecol Cancer. 2016 Nov;26(9):1580-1585. doi: 
      10.1097/IGC.0000000000000806.