PMID- 24558510
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140221
LR  - 20211021
IS  - 1934-7820 (Print)
IS  - 1934-7987 (Electronic)
IS  - 1934-7820 (Linking)
VI  - 7
IP  - 1
DP  - 2014 Jan
TI  - Accelerated fraction radiotherapy with capecitabine as neoadjuvant therapy for 
      borderline resectable pancreatic cancer.
PG  - 15-22
AB  - BACKGROUND: A standard neoadjuvant regimen has not been defined for borderline 
      resectable (BR) pancreatic cancer. This phase II trial was designed to determine 
      the safety of accelerated fraction radiotherapy (AFRT) with capecitabine in 
      patients with BR pancreatic cancer. METHODS: The patients had newly diagnosed BR 
      adenocarcinoma of the pancreas and normal organ function. Intensity-modulated (n 
      = 11) or 3D conformal (n = 2) radiotherapy was given to a dose of 50 Gy in 2.5-Gy 
      fractions with capecitabine 825 mg/m(2) twice on radiation days. The primary 
      outcome was the frequency of severe treatment-related adverse events (AEs). The 
      study was stopped before planned interim analysis because of 2 severe (grades 4 
      and 5) gastric ulcerations. RESULTS: Thirteen patients were enrolled with a 
      median age of 66 years. All patients completed treatment. Seven (54%) experienced 
      grade 3+ treatment-related AEs. Severe gastric ulceration occurred in 2 patients 
      despite receipt of >/=43 Gy to only 1% (2-3 cm(3)) of the stomach. Lymphopenia (n = 
      7) was the only other severe AE that occurred in >1 patient. In 7 of the 13 
      patients, disease had progressed outside the pancreas at restaging. Five of the 
      13 underwent resection, and all had >10% viable tumor. Median progression-free 
      survival (PFS) was 2.4 months (95% CI 1.9-5.9), and median survival was 9.1 
      months (95% CI 5.9-not reached). Among those who underwent resection, median PFS 
      was 13.0 months (95% CI 4.4-not reached). Median survival was not reached. 
      CONCLUSIONS: Given the limited efficacy signal and severe gastric ulcerations, we 
      do not recommend this regimen for pancreatic cancer. We also do not recommend the 
      use of high doses per fraction outside a clinical trial.
FAU - Chakraborty, Samhita
AU  - Chakraborty S
AD  - Cancer Center ; Department of Medicine Division of Hematology/Oncology.
FAU - Morris, Monica M
AU  - Morris MM
AD  - Cancer Center ; Department of Radiation Oncology.
FAU - Bauer, Todd W
AU  - Bauer TW
AD  - Cancer Center ; Department of Surgery Division of Hepatobiliary Surgery.
FAU - Adams, Reid B
AU  - Adams RB
AD  - Cancer Center ; Department of Surgery Division of Hepatobiliary Surgery.
FAU - Stelow, Edward B
AU  - Stelow EB
AD  - Cancer Center ; Department of Pathology.
FAU - Petroni, Gina
AU  - Petroni G
AD  - Cancer Center ; Department of Biostatistics University of Virginia 
      Charlottesville, VA.
FAU - Sanoff, Hanna K
AU  - Sanoff HK
AD  - Cancer Center ; Department of Medicine Division of Hematology/Oncology ; 
      Department of Medicine Division of Hematology/Oncology University of North 
      Carolina Chapel Hill, NC.
LA  - eng
GR  - P30 CA016086/CA/NCI NIH HHS/United States
PT  - Journal Article
PL  - United States
TA  - Gastrointest Cancer Res
JT  - Gastrointestinal cancer research : GCR
JID - 101300691
PMC - PMC3924761
EDAT- 2014/02/22 06:00
MHDA- 2014/02/22 06:01
PMCR- 2014/01/01
CRDT- 2014/02/22 06:00
PHST- 2013/06/13 00:00 [received]
PHST- 2013/09/25 00:00 [accepted]
PHST- 2014/02/22 06:00 [entrez]
PHST- 2014/02/22 06:00 [pubmed]
PHST- 2014/02/22 06:01 [medline]
PHST- 2014/01/01 00:00 [pmc-release]
AID - 0184 [pii]
PST - ppublish
SO  - Gastrointest Cancer Res. 2014 Jan;7(1):15-22.