PMID- 38264520
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240125
IS  - 1758-8340 (Print)
IS  - 1758-8359 (Electronic)
IS  - 1758-8340 (Linking)
VI  - 16
DP  - 2024
TI  - A phase II study evaluating the efficacy of enzalutamide and the role of liquid 
      biopsy for evaluation of ARv7 in mCRPC patients with measurable metastases 
      including visceral disease (Excalibur study).
PG  - 17588359231217958
LID - 10.1177/17588359231217958 [doi]
LID - 17588359231217958
AB  - BACKGROUND: Up to 30% of patients with metastatic castration-resistant prostate 
      cancer (mCRPC) develop visceral metastases, which are associated with a poor 
      prognosis. OBJECTIVES: Efficacy of enzalutamide in mCRPC patients with measurable 
      metastases, including visceral and/or extra-regional lymph nodes. METHODS: In 
      this phase II multicenter study, patients with mCRPC and measurable metastases 
      received enzalutamide as the first line. Primary endpoint: 3-month (mo) disease 
      control rate (DCR) defined as the proportion of patients with complete (CR) or 
      partial response (PR) or stable disease (SD) as per Response Evaluation Criteria 
      in Solid Tumors 1.1. Secondary endpoint: safety. Exploratory endpoint: the 
      association between ARv7 splicing variants in basal circulating tumor cell 
      (CTC)-enriched blood samples and treatment response/resistance using the AdnaTest 
      ProstateCancerSelect kit and the AdnaTest ProstateCancer Panel AR-V7. RESULTS: 
      From March 2017 to January 2021, 68 patients were enrolled. One patient never 
      started treatment. Median age: 72 years. A total of 52 patients (78%) received 
      enzalutamide as a first line for mCRPC. The median follow-up was 32 months. At 
      the 3-month assessment, 24 patients presented an SD, 1 patient achieved a CR, and 
      23 patients had a PR (3-mo-DCR of 72%). Discontinuations due to adverse events 
      (AEs), disease-related death, or disease progression occurred in 9%, 6%, and 48% 
      of patients. All patients reported at least one grade (G) 1-2 AE: the most common 
      were fatigue (49%) and hypertension (33%). Six G3 AEs were reported: two 
      hypertension, one seizure, one fatigue, one diarrhea, and one headache. Basal 
      detection of ARv7 was significantly associated with poor treatment response (p = 
      0.034) and a nonsignificant association (p = 0.15) was observed between ARv7 
      detection and response assessments. At month 3, ARv7 was detected in 57%, 25%, 
      and 15% of patients undergoing progressive disease, SD, and PR, respectively. 
      CONCLUSION: The study met its primary endpoint, showing the efficacy of 
      enzalutamide in men with mCRPC and measurable metastatic lesions in visceral 
      and/or lymph node sites. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: 
      NCT03103724. First Posted: 6 April 2017. First patient enrollment: 19 April 2017.
CI  - (c) The Author(s), 2024.
FAU - Sepe, Pierangela
AU  - Sepe P
AUID- ORCID: 0000-0002-0645-7293
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Via Giacomo Venezian 1, Milan 20133, Italy.
FAU - Procopio, Giuseppe
AU  - Procopio G
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
AD  - Programma Prostata, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
FAU - Pircher, Chiara Carlotta
AU  - Pircher CC
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
FAU - Basso, Umberto
AU  - Basso U
AD  - Oncology Unit 1, Department of Medical Oncology, Istituto Oncologico Veneto IOV 
      IRCCS, Padova, Italy.
FAU - Caffo, Orazio
AU  - Caffo O
AD  - Department of Medical Oncology, Santa Chiara Hospital, Trento, Italy.
FAU - Cappelletti, Vera
AU  - Cappelletti V
AD  - Department of Advanced Diagnostics, Fondazione IRCCS Istituto Nazionale Tumori di 
      Milano, Milan, Italy.
FAU - Claps, Melanie
AU  - Claps M
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
FAU - De Giorgi, Ugo
AU  - De Giorgi U
AUID- ORCID: 0000-0001-7520-2908
AD  - Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori 
      (IRST) Dino Amadori, Meldola, Italy.
FAU - Fratino, Lucia
AU  - Fratino L
AD  - Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano, 
      IRCCS, Aviano, Italy.
FAU - Guadalupi, Valentina
AU  - Guadalupi V
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
FAU - Miodini, Patrizia
AU  - Miodini P
AD  - Department of Advanced Diagnostics, Fondazione IRCCS Istituto Nazionale Tumori di 
      Milano, Milan, Italy.
FAU - De Marco, Cinzia
AU  - De Marco C
AD  - Department of Advanced Diagnostics, Fondazione IRCCS Istituto Nazionale Tumori di 
      Milano, Milan, Italy.
FAU - Perrucci, Bruno
AU  - Perrucci B
AD  - Oncology Department, ASST Istituti Ospitalieri, Cremona, Italy.
FAU - Mennitto, Alessia
AU  - Mennitto A
AD  - Department of Medical Oncology, University Hospital Maggiore della Carita, 
      Novara, Italy.
AD  - Medical Oncology, Department of Translational Medicine (DIMET), University of 
      Eastern Piedmont (UPO), Novara, Italy.
FAU - Santini, Daniele
AU  - Santini D
AD  - Oncologia Medica, Campus Bio-Medico University of Rome, Rome, Italy.
AD  - University of Rome La Sapienza, Roma, Italy.
FAU - Spina, Francesco
AU  - Spina F
AD  - Department of Hematology and Oncology, Niguarda Cancer Center, Ospedale Niguarda 
      Ca' Granda, Milan, Italy.
FAU - Stellato, Marco
AU  - Stellato M
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
FAU - de Braud, Filippo
AU  - de Braud F
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
AD  - Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
FAU - Verzoni, Elena
AU  - Verzoni E
AD  - Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 
      Milan, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT03103724
PT  - Journal Article
DEP - 20240122
PL  - England
TA  - Ther Adv Med Oncol
JT  - Therapeutic advances in medical oncology
JID - 101510808
PMC - PMC10804904
OTO - NOTNLM
OT  - ARv7
OT  - CTC
OT  - androgen receptor signaling inhibitor
OT  - enzalutamide
OT  - liquid biopsy
OT  - metastatic castration-resistant prostate cancer
OT  - overall survival
OT  - radiographic progression-free survival
OT  - visceral
EDAT- 2024/01/24 06:43
MHDA- 2024/01/24 06:44
PMCR- 2024/01/22
CRDT- 2024/01/24 03:53
PHST- 2023/06/07 00:00 [received]
PHST- 2023/11/15 00:00 [accepted]
PHST- 2024/01/24 06:44 [medline]
PHST- 2024/01/24 06:43 [pubmed]
PHST- 2024/01/24 03:53 [entrez]
PHST- 2024/01/22 00:00 [pmc-release]
AID - 10.1177_17588359231217958 [pii]
AID - 10.1177/17588359231217958 [doi]
PST - epublish
SO  - Ther Adv Med Oncol. 2024 Jan 22;16:17588359231217958. doi: 
      10.1177/17588359231217958. eCollection 2024.