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Clinical Trial
. 2012 Jan 3;106(1):61-9.
doi: 10.1038/bjc.2011.526. Epub 2011 Dec 1.

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

D Goldstein  1 , N Spry, M M Cummins, C Brown, G A van Hazel, S Carroll, S Selva-Nayagam, M Borg, S P Ackland, C Wratten, J Shapiro, I W T Porter, G Hruby, L Horvath, S Bydder, C Underhill, J Harvey, V J Gebski; Australasian Gastro-Intestinal Trials Group
Collaborators, Affiliations
Clinical Trial

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

D Goldstein et al. Br J Cancer. .

Abstract

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 mg m(-2) d1 + d15 q28) and oxaliplatin (100 mg m(-2) d2 + d16 q28) in induction (one cycle) and consolidation (three cycles), and 5FU 200 mg m(-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.

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Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Patient disposition. Patients who withdrew from the study during a component are counted as started or completed <80% for that cycle, and counted according to reason for their withdrawal in subsequent components. Bar represents patients who completed all four components or reasons for early withdrawal. One out of seventeen patients who received ⩾80% of treatment did not complete according to specified time schedule.
Figure 3
Figure 3
Cumulative incidence of any grade 3/4 toxicity (n=47).
Figure 4
Figure 4
Kaplan–Meier curves of (A) sustained local control, (B) time to progression, and (C) overall survival in the current study of GemOx with 5FU–3DCRT (n=47); and (D) sustained local control, (E) time to progression, and (F) overall survival from our previous study of Gem with 5FU–3DCRT (n=41).
See this image and copyright information in PMC

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