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.

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.

Size of anal squamous cell carcinomas at diagnosis: a retrospective case series.

Anal squamous cell carcinoma is more common in HIV-positive homosexual men than in the general population and prognosis worsens with increasing tumour size. To identify opportunities for earlier diagnosis, we aimed to determine size and visibility of anal squamous cell carcinoma at diagnosis. We conducted a retrospective review of medical records between 1992 and 2010 from one hospital radiotherapy centre, a major centre for HIV care, in Melbourne, Australia. Of 128 cases of anal squamous cell carcinoma, 24 (19%) were in HIV-positive men. At diagnosis, half (52%) of the tumours were externally visible and mean estimated tumour size was 36 mm (29 mm in HIV-positive and 38 mm in HIV-negative patients; p = 0.04) and 114/121 (94%) tumours were 1 cm or larger. The most frequent symptoms were bleeding (43%) and pain (36%) and mean duration of symptoms was 22 weeks. This suggests most anal squamous cell carcinoma were visible or palpable for some time before diagnosis, meaning that screening high-risk groups by anal inspection and palpation is plausible.