PMID- 19114704
OWN - NLM
STAT- MEDLINE
DCOM- 20090226
LR  - 20241219
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 27
IP  - 5
DP  - 2009 Feb 10
TI  - Phase II trial of single-agent bevacizumab followed by bevacizumab plus 
      irinotecan at tumor progression in recurrent glioblastoma.
PG  - 740-5
LID - 10.1200/JCO.2008.16.3055 [doi]
AB  - PURPOSE: To evaluate single-agent activity of bevacizumab in patients with 
      recurrent glioblastoma. PATIENTS AND METHODS: Patients with recurrent 
      glioblastoma were treated with bevacizumab 10 mg/kg every 2 weeks. After tumor 
      progression, patients were immediately treated with bevacizumab in combination 
      with irinotecan 340 mg/m(2) or 125 mg/m(2) every 2 weeks, depending on use of 
      enzyme-inducing antiepileptic drugs. Complete patient evaluations were repeated 
      every 4 weeks. RESULTS: Forty-eight heavily pretreated patients were accrued to 
      this study. Thromboembolic events (12.5%), hypertension (12.5%), hypophosphatemia 
      (6%), and thrombocytopenia (6%) were the most common drug-associated adverse 
      events. Six patients (12.5%) were removed from study for drug-associated toxicity 
      (five thromboembolic events, one bowel perforation). Thirty-four patients (71%) 
      and 17 patients (35%) achieved radiographic response based on Levin and Macdonald 
      criteria, respectively. Median progression-free survival (PFS) was 16 weeks (95% 
      CI, 12 to 26 weeks). The 6-month PFS was 29% (95% CI, 18% to 48%). The 6-month 
      overall survival was 57% (95% CI, 44% to 75%). Median overall survival was 31 
      weeks (95% CI, 21 to 54 weeks). Early magnetic resonance imaging response (first 
      96 hours and 4 weeks) was predictive of long-term PFS, with the Levin criteria 
      being more predictive than Macdonald criteria. Of 19 patients treated with 
      bevacizumab plus irinotecan at progression, there were no objective radiographic 
      responses. Eighteen patients (95%) experienced disease progression by the second 
      cycle, and the median PFS was 30 days. CONCLUSION: We conclude that single-agent 
      bevacizumab has significant biologic and antiglioma activity in patients with 
      recurrent glioblastoma.
FAU - Kreisl, Teri N
AU  - Kreisl TN
AD  - Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, 
      Bethesda, MD 20892-8200, USA.
FAU - Kim, Lyndon
AU  - Kim L
FAU - Moore, Kraig
AU  - Moore K
FAU - Duic, Paul
AU  - Duic P
FAU - Royce, Cheryl
AU  - Royce C
FAU - Stroud, Irene
AU  - Stroud I
FAU - Garren, Nancy
AU  - Garren N
FAU - Mackey, Megan
AU  - Mackey M
FAU - Butman, John A
AU  - Butman JA
FAU - Camphausen, Kevin
AU  - Camphausen K
FAU - Park, John
AU  - Park J
FAU - Albert, Paul S
AU  - Albert PS
FAU - Fine, Howard A
AU  - Fine HA
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20081229
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 7673326042 (Irinotecan)
RN  - XT3Z54Z28A (Camptothecin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/administration & dosage/*therapeutic use/toxicity
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/administration & dosage/*therapeutic use
MH  - Antineoplastic Agents, Phytogenic/*administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bevacizumab
MH  - Brain Neoplasms/*drug therapy/mortality
MH  - Camptothecin/administration & dosage/*analogs & derivatives
MH  - Disease-Free Survival
MH  - Female
MH  - Glioblastoma/*drug therapy/mortality
MH  - Humans
MH  - Irinotecan
MH  - Male
MH  - Middle Aged
PMC - PMC2645088
COIS- Authors' disclosures of potential conflicts of interest and author contributions 
      are found at the end of this article.
EDAT- 2008/12/31 09:00
MHDA- 2009/02/27 09:00
PMCR- 2010/02/10
CRDT- 2008/12/31 09:00
PHST- 2008/12/31 09:00 [entrez]
PHST- 2008/12/31 09:00 [pubmed]
PHST- 2009/02/27 09:00 [medline]
PHST- 2010/02/10 00:00 [pmc-release]
AID - JCO.2008.16.3055 [pii]
AID - 63055 [pii]
AID - 10.1200/JCO.2008.16.3055 [doi]
PST - ppublish
SO  - J Clin Oncol. 2009 Feb 10;27(5):740-5. doi: 10.1200/JCO.2008.16.3055. Epub 2008 
      Dec 29.