TY - JOUR
T1 - Postoperative intraperitoneal 5-fluoro-2′-deoxyuridine added to chemoradiation in patients curatively resected (R0) for locally advanced gastric and gastroesophageal junction adenocarcinoma
AU - Cohen, Deirdre J.
AU - Newman, Elliot
AU - Iqbal, Syma
AU - Chang, Richard Y.
AU - Potmesil, Milan
AU - Ryan, Theresa
AU - Donahue, Bernadine
AU - Chandra, Anurag
AU - Liu, Mengling
AU - Utate, Minerva
AU - Hiotis, Spiros
AU - Pachter, Leon H.
AU - Hochster, Howard
AU - Muggia, Franco
N1 - Funding Information:
ACKNOWLEDGMENT This study was supported by an FDA Orphan Products grant # FD-R-2150-04.
PY - 2012/2
Y1 - 2012/2
N2 - 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 R 0 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 R 0 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 R 0 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.
AB - 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 R 0 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 R 0 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 R 0 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.
UR - http://www.scopus.com/inward/record.url?scp=84856663517&partnerID=8YFLogxK
U2 - 10.1245/s10434-011-1940-8
DO - 10.1245/s10434-011-1940-8
M3 - Article
C2 - 21769462
AN - SCOPUS:84856663517
SN - 1068-9265
VL - 19
SP - 478
EP - 485
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
IS - 2
ER -