PMID- 26780387
OWN - NLM
STAT- MEDLINE
DCOM- 20170501
LR  - 20231006
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Print)
IS  - 1464-4096 (Linking)
VI  - 118
IP  - 4
DP  - 2016 Oct
TI  - Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients 
      with metastatic castration-resistant prostate cancer.
PG  - 590-7
LID - 10.1111/bju.13412 [doi]
AB  - OBJECTIVE: To determine the safety and clinical efficacy of two anti-angiogenic 
      agents, bevacizumab and lenalidomide, with docetaxel and prednisone. PATIENTS AND 
      METHODS: Eligible patients with metastatic castration-resistant prostate cancer 
      enrolled in this open-label, phase II study of lenalidomide with bevacizumab (15 
      mg/kg), docetaxel (75 mg/m(2) ) and prednisone (10 mg daily). Docetaxel and 
      bevacizumab were administered on day 1 of a 3-week treatment cycle. To establish 
      safety, lenalidomide dosing in this combination was escalated in a conventional 3 
      + 3 design (15, 20 and 25 mg daily for 2 weeks followed by 1 week off). Patients 
      received supportive measures including prophylactic pegfilgrastim and enoxaparin. 
      The primary endpoints were safety and clinical efficacy. RESULTS: A total of 63 
      patients enrolled in this trial. Toxicities were manageable with most common 
      adverse events (AEs) being haematological, and were ascertained by weekly blood 
      counts. Twenty-nine patients (46%) had grade 4 neutropenia, 20 (32%) had grade 3 
      anaemia and seven (11%) had grade 3 thrombocytopenia. Despite frequent 
      neutropenia, serious infections were rare. Other common non-haematological grade 
      3 AEs included fatigue (10%) and diarrhoea (10%). Grade 2 AEs in >10% of patients 
      included anorexia, weight loss, constipation, osteonecrosis of the jaw, rash and 
      dyspnoea. Of 61 evaluable patients, 57 (93%), 55 (90%) and 33 (54%) had PSA 
      declines of >30, >50 and >90%, respectively. Of the 29 evaluable patients, 24 
      (86%) had a confirmed radiographic partial response. The median times to 
      progression and overall survival were 18.2 and 24.6 months, respectively. 
      CONCLUSIONS: With appropriate supportive measures, combination angiogenesis 
      inhibition can be safely administered and potentially provide clinical benefit. 
      These hypothesis-generating data would require randomized trials to confirm the 
      findings.
CI  - Published 2016. This article is a U.S. Government work and is in the public 
      domain in the USA.
FAU - Madan, Ravi A
AU  - Madan RA
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Karzai, Fatima H
AU  - Karzai FH
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Ning, Yang-Min
AU  - Ning YM
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Adesunloye, Bamidele A
AU  - Adesunloye BA
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Huang, Xuan
AU  - Huang X
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Harold, Nancy
AU  - Harold N
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Couvillon, Anna
AU  - Couvillon A
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Chun, Guinevere
AU  - Chun G
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Cordes, Lisa
AU  - Cordes L
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Sissung, Tristan
AU  - Sissung T
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Beedie, Shaunna L
AU  - Beedie SL
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Dawson, Nancy A
AU  - Dawson NA
AD  - Lombardi Comprehensive Cancer Center, Georgetown University, Washington, D.C., 
      USA.
FAU - Theoret, Marc R
AU  - Theoret MR
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - McLeod, David G
AU  - McLeod DG
AD  - Center for Prostate Disease Research, Walter Reed National Military Medical 
      Center, Bethesda, MD, USA.
FAU - Rosner, Inger
AU  - Rosner I
AD  - Center for Prostate Disease Research, Walter Reed National Military Medical 
      Center, Bethesda, MD, USA.
FAU - Trepel, Jane B
AU  - Trepel JB
AD  - Developmental Therapeutics Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Lee, Min-Jung
AU  - Lee MJ
AD  - Developmental Therapeutics Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Tomita, Yusuke
AU  - Tomita Y
AD  - Developmental Therapeutics Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Lee, Sunmin
AU  - Lee S
AD  - Developmental Therapeutics Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Chen, Clara
AU  - Chen C
AD  - Radiology and Imaging Sciences, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Steinberg, Seth M
AU  - Steinberg SM
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Arlen, Philip M
AU  - Arlen PM
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Gulley, James L
AU  - Gulley JL
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
FAU - Figg, William D
AU  - Figg WD
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA. wdfigg@helix.nih.gov.
FAU - Dahut, William L
AU  - Dahut WL
AD  - Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer 
      Institute, Bethesda, MD, USA.
LA  - eng
GR  - Z01 BC010547-05/Intramural NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20160219
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - F0P408N6V4 (Lenalidomide)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/*therapeutic use
MH  - Antineoplastic Agents, Hormonal/*therapeutic use
MH  - Bevacizumab/*therapeutic use
MH  - Humans
MH  - Lenalidomide
MH  - Male
MH  - Middle Aged
MH  - Prednisone/*therapeutic use
MH  - Prostatic Neoplasms, Castration-Resistant/*drug therapy
MH  - Thalidomide/*analogs & derivatives/therapeutic use
PMC - PMC6387685
MID - NIHMS1008564
OTO - NOTNLM
OT  - angiogenesis inhibition
OT  - combinationation therapy
OT  - docetaxel coimbination
OT  - metastatic castration resistant prostate cancer
OT  - prostate cancer
COIS- Conflict of Interest None declared.
EDAT- 2016/01/19 06:00
MHDA- 2017/05/02 06:00
PMCR- 2019/02/24
CRDT- 2016/01/19 06:00
PHST- 2016/01/19 06:00 [entrez]
PHST- 2016/01/19 06:00 [pubmed]
PHST- 2017/05/02 06:00 [medline]
PHST- 2019/02/24 00:00 [pmc-release]
AID - 10.1111/bju.13412 [doi]
PST - ppublish
SO  - BJU Int. 2016 Oct;118(4):590-7. doi: 10.1111/bju.13412. Epub 2016 Feb 19.