Exploratory phase II trial in a multicenter setting to evaluate the clinical value of a chemosensitivity test in patients with gastric cancer (JACCRO-GC 04, Kubota memorial trial).

BACKGROUND: Although postoperative adjuvant chemotherapy with S-1, an oral fluoropyrimidine, has become a standard of care for gastric cancer in Japan, nonresponders may suffer from the cost and adverse reactions without clinical benefit. This multicenter exploratory phase II trial was conducted to see whether a chemosensitivity test, the collagen gel droplet embedded culture drug sensitivity test (CD-DST), can adequately select patients for chemotherapy. METHODS: The CD-DST using four different concentrations of 5-fluorouracil was conducted with resected specimens from preregistered patients who underwent gastrectomy with D2 or more extensive lymphadenectomy. Patients who were histopathologically confirmed to have stage II or greater disease without distant metastasis were eligible for final enrollment. All patients underwent protocol-specified adjuvant chemotherapy with S-1. Three-year relapse-free survival was compared between patients determined as sensitive by the CD-DST (responders) and those deemed insensitive (nonresponders). Appropriate cutoff values for in vitro growth inhibition were defined when the hazard ratio for relapse in responders and the log-rank P values were at their minimum. RESULTS: Of the 311 patients enrolled, 14 were ineligible and 27 failed to start the protocol treatment. The CD-DST failed in 64 other patients, and survival analyses were conducted with the remaining 206 patients (39 stage II disease, 155 stage III disease, and 12 stage IV disease). The outcome of patients who were determined to be responders was significantly superior to that of nonresponders regardless of the 5-fluorouracil concentrations, although no differences in clinicopathologic characteristics were observed between the two groups, except for age. CONCLUSIONS: The CD-DST identified those who benefit from adjuvant chemotherapy. It deserves further evaluation in the setting of a prospective randomized trial. ClinicalTrials.gov identifier: NCT00287755.

A secure technique of intracorporeal Roux-Y reconstruction after laparoscopic distal gastrectomy.

BACKGROUND: Laparoscopic distal gastrectomy [LDG] is a minimally invasive surgery for gastric carcinoma. The Billroth I method has been commonly employed to reconstruct alimentary tract after LDG. Conversely, Roux-Y reconstruction is employed far less commonly despite its merits. Technical difficulties, including a risk of twisting the Roux loop under limited vision through a laparoscope, have hampered Roux-Y reconstruction after LDG. METHODS: We performed LDG and intracorporeal Roux-Y reconstruction in 5 patients with early gastric cancer. The procedure included a functional end-to-end anastmosis of the stomach and jejunum, consisting of side-to-side approximation of jejunal loop to greater curvature of the gastric remnant with a laparoscopic stapling device followed by closure of the open end and simultaneous division of the jejunum with another stapler. RESULTS: Roux-Y reconstruction was successfully accomplished without torsion of the loop in all patients. CONCLUSIONS: By using the present technique, intracorporeal Roux-Y reconstruction after LDG can be accomplished without a risk of twisting the jejunal loop.