PMID- 24488322
OWN - NLM
STAT- MEDLINE
DCOM- 20140715
LR  - 20140326
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 73
IP  - 4
DP  - 2014 Apr
TI  - Figitumumab in patients with refractory metastatic colorectal cancer previously 
      treated with standard therapies: a nonrandomized, open-label, phase II trial.
PG  - 695-702
LID - 10.1007/s00280-014-2391-2 [doi]
AB  - PURPOSE: Figitumumab (CP-751,871) is a human IgG2 monoclonal antibody that binds 
      and down-regulates insulin-like growth factor receptor-1 (IGF-1R) and inhibits 
      activation of this receptor by IGF-1 and IGF-2. This nonrandomized, open-label, 
      single-arm, phase II trial evaluated the antitumor activity and safety of 
      figitumumab in patients with metastatic colorectal cancer that was refractory to 
      >/=2 systemic therapies. METHODS: Cohorts A and B received intravenous figitumumab 
      20 and 30 mg/kg in 3-week cycles, respectively. Both received loading doses (20 
      or 30 mg/kg) on days 1 and 2 of cycle 1. The primary endpoint was 6-month 
      survival (null hypothesis for each cohort, H0: p6 mo surv = 0.45). Secondary 
      endpoints included progression-free survival (PFS), overall survival (OS), 
      objective response, safety, and pharmacokinetics. RESULTS: A total of 168 
      patients (Cohort A, n = 85; Cohort B, n = 83) received figitumumab. Estimated 
      6-month survival was 49.4 % (95 % CI 38.8-60.0) in Cohort A and 44.1 % (95 % CI 
      33.4-54.9) in Cohort B. Median OS was 5.8 and 5.6 months, respectively; median 
      PFS was 1.4 months in both cohorts. No objective partial or complete responses 
      occurred. The respective rates of treatment discontinuation due to 
      treatment-related adverse events (AEs) were 5 and 7 %. The most common grade 3/4 
      nonhematologic AEs in both cohorts were hyperglycemia and asthenia. No grade 4 
      hematologic laboratory abnormalities occurred. Most deaths were reported as due 
      to progressive disease; none were due to figitumumab. CONCLUSION: Six-month 
      survival data do not support further study of figitumumab 20 or 30 mg/kg in this 
      patient population.
FAU - Becerra, Carlos R
AU  - Becerra CR
AD  - Texas Oncology-Sammons Cancer Center at Baylor, 3410 Worth Street, Dallas, TX, 
      75246, USA, Carlos.Becerra@usoncology.com.
FAU - Salazar, Ramon
AU  - Salazar R
FAU - Garcia-Carbonero, Rocio
AU  - Garcia-Carbonero R
FAU - Thomas, Anne L
AU  - Thomas AL
FAU - Vazquez-Mazon, Federico J
AU  - Vazquez-Mazon FJ
FAU - Cassidy, James
AU  - Cassidy J
FAU - Maughan, Tim
AU  - Maughan T
FAU - Castillo, Manuel Gallen
AU  - Castillo MG
FAU - Iveson, Tim
AU  - Iveson T
FAU - Yin, Donghua
AU  - Yin D
FAU - Green, Stephanie
AU  - Green S
FAU - Bergsland, Emily K
AU  - Bergsland EK
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140201
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - VE267FC2UB (figitumumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/therapeutic use
MH  - Cohort Studies
MH  - Colorectal Neoplasms/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Staging
MH  - Survival Analysis
EDAT- 2014/02/04 06:00
MHDA- 2014/07/16 06:00
CRDT- 2014/02/04 06:00
PHST- 2013/12/20 00:00 [received]
PHST- 2014/01/13 00:00 [accepted]
PHST- 2014/02/04 06:00 [entrez]
PHST- 2014/02/04 06:00 [pubmed]
PHST- 2014/07/16 06:00 [medline]
AID - 10.1007/s00280-014-2391-2 [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2014 Apr;73(4):695-702. doi: 
      10.1007/s00280-014-2391-2. Epub 2014 Feb 1.