TY - JOUR
T1 - The GOFURTGO Study: AGITG Phase II Study of fixed dose rate gemcitabine-oxaliplatin integrated with concomitant 5FU and 3-D conformal radiotherapy for the treatment of localised pancreatic cancer
AU - Goldstein, D.
AU - Spry, Nigel
AU - Cummins, M.M.
AU - Brown, C.
AU - Van Hazel, Guy
AU - Carroll, S.
AU - Selva-Nayagam, S.
AU - Borg, M.
AU - Ackland, S.P.
AU - Wratten, C.
AU - Shapiro, J.
AU - Porter, I.W.T.
AU - Hruby, G.
AU - Horvath, L.
AU - Bydder, Sean
AU - Underhill, C.
AU - Harvey, J.
AU - Gebski, V.J.
PY - 2012
Y1 - 2012
N2 - BACKGROUND: Locally advanced inoperable pancreatic cancer (LAPC) has a poor prognosis. By increasing intensity of systemic therapy combined with an established safe chemoradiation technique, our intention was to enhance the outcomes of LAPC. In preparation for phase III evaluation, the feasibility and efficacy of our candidate regimen gemcitabine-oxaliplatin chemotherapy with sandwich 5-fluorouracil (5FU) and three-dimensional conformal radiotherapy (3DCRT) needs to be established.METHODS: A total of 48 patients with inoperable LAPC without metastases were given gemcitabine (1000 mgm(-2) d1 + d15 q28) and oxaliplatin (100 mgm(-2) d2 vertical bar d16 q28) in induction (one cycle) and consolidation (three cycles), and 5FU 200 mgm(-2) per day over 6 weeks during 3DCRT 54 Gy.RESULTS: Median duration of sustained local control (LC) was 15.8 months, progression-free survival (PFS) was 11.0 months, and overall survival was 15.7 months. Survival rates for 1, 2, and 3 years were 70.2%, 21.3%, and 12.8%, respectively. Global quality of life did not significantly decline from baseline during treatment, which was associated with modest treatment-related toxicity.CONCLUSION: Fixed-dose gemcitabine and oxaliplatin, combined with an effective and safe regimen of 5FU and 3DCRT radiotherapy, was feasible and reasonably tolerated. The observed improved duration of LC and PFS with more intensive therapy over previous trials may be due to patient selection, but suggest that further evaluation in phase III trials is warranted. British Journal of Cancer (2012) 106, 61-69. doi:10.1038/bjc.2011.526 www.bjcancer.com Published online vertical bar December 2011 (C) 2012 Cancer Research UK
AB - BACKGROUND: Locally advanced inoperable pancreatic cancer (LAPC) has a poor prognosis. By increasing intensity of systemic therapy combined with an established safe chemoradiation technique, our intention was to enhance the outcomes of LAPC. In preparation for phase III evaluation, the feasibility and efficacy of our candidate regimen gemcitabine-oxaliplatin chemotherapy with sandwich 5-fluorouracil (5FU) and three-dimensional conformal radiotherapy (3DCRT) needs to be established.METHODS: A total of 48 patients with inoperable LAPC without metastases were given gemcitabine (1000 mgm(-2) d1 + d15 q28) and oxaliplatin (100 mgm(-2) d2 vertical bar d16 q28) in induction (one cycle) and consolidation (three cycles), and 5FU 200 mgm(-2) per day over 6 weeks during 3DCRT 54 Gy.RESULTS: Median duration of sustained local control (LC) was 15.8 months, progression-free survival (PFS) was 11.0 months, and overall survival was 15.7 months. Survival rates for 1, 2, and 3 years were 70.2%, 21.3%, and 12.8%, respectively. Global quality of life did not significantly decline from baseline during treatment, which was associated with modest treatment-related toxicity.CONCLUSION: Fixed-dose gemcitabine and oxaliplatin, combined with an effective and safe regimen of 5FU and 3DCRT radiotherapy, was feasible and reasonably tolerated. The observed improved duration of LC and PFS with more intensive therapy over previous trials may be due to patient selection, but suggest that further evaluation in phase III trials is warranted. British Journal of Cancer (2012) 106, 61-69. doi:10.1038/bjc.2011.526 www.bjcancer.com Published online vertical bar December 2011 (C) 2012 Cancer Research UK
U2 - 10.1038/bjc.2011.526
DO - 10.1038/bjc.2011.526
M3 - Article
C2 - 22134511
VL - 106
SP - 61
EP - 69
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
ER -
