PMID- 19636002
OWN - NLM
STAT- MEDLINE
DCOM- 20090915
LR  - 20240322
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 27
IP  - 25
DP  - 2009 Sep 1
TI  - Phase II study of bevacizumab with concurrent capecitabine and radiation followed 
      by maintenance gemcitabine and bevacizumab for locally advanced pancreatic 
      cancer: Radiation Therapy Oncology Group RTOG 0411.
PG  - 4096-102
LID - 10.1200/JCO.2009.21.8529 [doi]
AB  - PURPOSE: The primary objective of this study was to assess the 1-year survival of 
      patients with locally advanced, unresectable pancreatic cancer treated with the 
      combination of bevacizumab, capecitabine, and radiation. Secondary end points 
      were toxicity, progression-free survival (PFS), and response rate (RR). PATIENTS 
      AND METHODS: Patients with locally advanced pancreatic cancer without duodenal 
      invasion were treated with 50.4 Gy per 28 fractions to the gross tumor with 
      concurrent capecitabine 825 mg/m(2) orally twice daily on days of radiation and 
      bevacizumab 5 mg/kg on days 1, 15, and 29 followed by maintenance gemcitabine 1 
      g/m(2) weekly for 3 weeks and bevacizumab 5 mg/kg every 2 weeks, both in 4-week 
      cycles until progression. Treatment plans were reviewed for quality assurance 
      (QA). RESULTS: Between January 2005 and February 2006, 82 eligible patients were 
      treated. The median and 1-year survival rates were 11.9 months (95% CI, 9.9 to 
      14.0 months) and 47% (95% CI, 36% to 57%). Median PFS was 8.6 months (95% CI, 6.9 
      to 10.5), and RR was 26%. Overall, 35.4% of patients had grade 3 or greater 
      treatment-related gastrointestinal toxicity (22.0% during chemoradiotherapy, 
      13.4% during maintenance chemotherapy). Unacceptable radiotherapy protocol 
      deviations (ie, inappropriately generous volume contoured) correlated with grade 
      3 or greater gastrointestinal toxicity during chemoradiotherapy (45% v 18%; 
      adjusted odds ratio, 3.7; 95% CI, 0.98 to 14.1; P = .05). CONCLUSION: The 
      addition of bevacizumab to chemoradiotherapy followed by bevacizumab and 
      gemcitabine resulted in a similar median survival to previous Radiation Therapy 
      Oncology Group studies in patients with locally advanced pancreatic cancer. 
      Prospective QA may help limit toxicity in future trials.
FAU - Crane, Christopher H
AU  - Crane CH
AD  - Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer 
      Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. ccrane@mdanderson.org
FAU - Winter, Kathryn
AU  - Winter K
FAU - Regine, William F
AU  - Regine WF
FAU - Safran, Howard
AU  - Safran H
FAU - Rich, Tyvin A
AU  - Rich TA
FAU - Curran, Walter
AU  - Curran W
FAU - Wolff, Robert A
AU  - Wolff RA
FAU - Willett, Christopher G
AU  - Willett CG
LA  - eng
SI  - ClinicalTrials.gov/NCT00114179
GR  - U10 CA32115/CA/NCI NIH HHS/United States
GR  - U10 CA21661/CA/NCI NIH HHS/United States
GR  - U10 CA37422/CA/NCI NIH HHS/United States
GR  - U10 CA037422/CA/NCI NIH HHS/United States
GR  - U10 CA021661/CA/NCI NIH HHS/United States
GR  - U10 CA032115/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20090727
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 (Angiogenesis Inhibitors)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - U3P01618RT (Fluorouracil)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/administration & dosage
MH  - Antibodies, Monoclonal/administration & dosage
MH  - Antibodies, Monoclonal, Humanized
MH  - Antimetabolites, Antineoplastic/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bevacizumab
MH  - Capecitabine
MH  - Chemotherapy, Adjuvant
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Disease-Free Survival
MH  - Female
MH  - Fluorouracil/administration & dosage/analogs & derivatives
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Pancreatectomy
MH  - Pancreatic Neoplasms/*drug therapy/mortality/pathology/*radiotherapy/surgery
MH  - Pancreaticoduodenectomy
MH  - Radiotherapy, Adjuvant
MH  - Time Factors
MH  - Treatment Outcome
MH  - Gemcitabine
PMC - PMC2734421
COIS- Authors' disclosures of potential conflicts of interest and author contributions 
      are found at the end of this article.
EDAT- 2009/07/29 09:00
MHDA- 2009/09/16 06:00
PMCR- 2010/09/01
CRDT- 2009/07/29 09:00
PHST- 2009/07/29 09:00 [entrez]
PHST- 2009/07/29 09:00 [pubmed]
PHST- 2009/09/16 06:00 [medline]
PHST- 2010/09/01 00:00 [pmc-release]
AID - JCO.2009.21.8529 [pii]
AID - 18529 [pii]
AID - 10.1200/JCO.2009.21.8529 [doi]
PST - ppublish
SO  - J Clin Oncol. 2009 Sep 1;27(25):4096-102. doi: 10.1200/JCO.2009.21.8529. Epub 
      2009 Jul 27.