Purpose
Chemoradiation after surgery for locally advanced gastric cancer improves overall and relapse-free survival compared with
observation. However, locoregional recurrences remain high. Accordingly, we instituted this pilot/feasibility study, including
intraperitoneal 5-fluoro-2′-deoxyuridine (IP FUDR) as part of the treatment.
Methods
Gastric/gastroesophageal junction adenocarcinoma stage Ib–IV (M0) patients who underwent R0 resection were eligible and had IP catheters inserted at time of surgery. IP FUDR (3 g/dose/day) was given during study days
1–3 and 15–17 before combined 5-fluorouracil, leucovorin, and external beam radiation (45 Gy). Endpoints included toxicity,
completion rate, locoregional recurrence, and survival.
Results
Twenty-eight patients (22 men) were enrolled from 2002–2006 at two institutions; their median age was 59.5 years. After R0 resection, a median 22 (range, 8–102) lymph nodes were examined, and 22 patients had positive nodes. AJCC stages were IB
(n = 8), II (n = 10), IIIA (n = 5), IIIB (n = 1), and IV (n = 4). Full-dose IP FUDR and chemoradiation treatment was completed in 20 and 25 patients, respectively. At nearly 4-year
median follow-up, 11 patients were disease-free, 5 were alive with disease, 7 were dead of disease, and 1 was dead from other
cause; 4 have been lost to follow-up. Recurrences were local in one, intra-abdominal in six, distant in two, multiple sites
in two, and unknown in one. The median relapse-free survival is 65.3 months, and the median overall survival has not yet been
reached.
Conclusions
IP FUDR before chemoradiation after R0 gastric cancer resection is well tolerated without compromising completion of postoperative adjuvant treatment. Larger randomized
trials studying IP FUDR as part of gastric cancer multidisciplinary treatment are needed to prove efficacy in reducing regional
recurrence and improving survival.
Previously presented: 2007 ASCO Gastrointestinal Symposium, Orlando, Florida, 2007 ASCO Symposium, Chicago, Illinois.