Combined modality therapy for pancreatic carcinoma - An Australian Pancreatic Cancer Group study of the addition of gemcitabine to concurrent infusional 5-fluorouracil and 3D conformal radiotherapy

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 4100-4100 ◽  
Author(s):  
D. Goldstein ◽  
G. Van Hazel ◽  
C. Underhill ◽  
D. Kotasek ◽  
J. Harvey ◽  
...  
2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4104-4104
Author(s):  
D. Goldstein ◽  
N. Spry ◽  
G. Van Hazel ◽  
C. Underhill ◽  
D. Kotasek ◽  
...  

4104 Background: This open-label Phase II study (B9E-AY-S168) examined whether CI 5FU plus 3D conformal planning RT is well tolerated and may be combined with G pre and post chemoradiotherapy in patients (pts) with pancreatic cancer (PC). Methods: Eligible pts were enrolled in two strata: (1) inoperable PC in head or body without metastases (LAD) or (2) resected PC at high risk of relapse (Surg). G was given at 1000 mg/m2 weekly for 3 wks followed by 1 wk rest and a 5–6 wk period of RT and concurrent CI 5FU (200 mg/m2/day). The defined target volume was treated to 54Gy in 30# of 1.8Gy (LAD) or 45Gy in 25# (Surg). After 4 wks rest, G was given for 12 wks. Results: 63 pts were enrolled: 39 females, 24 males; mean age 61 yr, range 31–79; 43% ECOG PS 0, 51% PS 1, 5% PS 2. Follow-up was 2 yr. 1- and 2-yr survival (KM) were 46% and 10% (LAD) and 59% and 27% (Surg). 1- and 2-yr local control (KM) were 48% and 21% (LAD) and 80% and 80% (Surg). The % planned dose delivered was (i) G pre RT: 87.6% (LAD)/94.6% (Surg); (ii) 5FU: 100.7%/96.4%; (iii) RT: 96.2%/99.5%; (iv) G post RT: 67.4%/65.3%. The baseline CA 19.9 level was significantly associated with a shorter TTPD (p=0.0002) and a shorter survival time (p=0.0071). Using Time Dependent Covariate analysis, CA 19.9 levels were strongly associated with TTPD and survival (both p < 0.0001); a person with a 10-fold higher level has a 1.95-fold higher risk of death over the next time period than their counterpart (95% CI: 1.53–2.49-fold). In 22 pts we found no statistically significant associations between outcome and mutations in K-RAS or TP53 or with microsatellite instability. Grade 3/4 hematological and non-hematological toxicity was reported by 29 (46%) and 42 pts (67%), respectively. There was one treatment-related death. Conclusions: This approach to treatment is safe and promising, with good local control for a substantial proportion of patients, and merits testing in a randomized trial. [Table: see text] [Table: see text]


1998 ◽  
Vol 5 (3) ◽  
pp. 227-234 ◽  
Author(s):  
William F. Regine ◽  
William J. John ◽  
Mohammed Mohiuddin

1993 ◽  
Vol 11 (3) ◽  
pp. 241-246 ◽  
Author(s):  
Howard W. Bruckner ◽  
Shalom Kalnicki ◽  
Jack Dalton ◽  
Gary K. Schwartz ◽  
Margaret R. Chesser ◽  
...  

1995 ◽  
Vol 19 (2) ◽  
pp. 264-269 ◽  
Author(s):  
Tvvin A. Rich ◽  
Douglas B. Evans

1993 ◽  
Vol 16 (3) ◽  
pp. 199-203 ◽  
Author(s):  
Howard W. Bruckner ◽  
Shalom Kalnicki ◽  
Jack Dalton ◽  
Harry Snady ◽  
Gary K. Schwartz ◽  
...  

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