Randomized phase II study of tegafur-uracil/leucovorin versus tegafur-uracil/leucovorin plus oxaliplatin after curative resection of high-risk stage II/III colorectal cancer (SOAC-1101 trial).

PURPOSE: This randomized phase II trial compared tegafur-uracil/leucovorin (UFT/LV) plus oxaliplatin (TEGAFOX) to UFT/LV as adjuvant chemotherapy for patients with high-risk stage II/III colorectal cancer. METHODS: From 2010 to April 2015, 159 patients who underwent curative resection were randomly assigned to receive TEGAFOX (85 mg/m2 oxaliplatin on days 1 and 15, 300 mg/m2/day UFT and 75 mg/day LV on days 1-28, every 35 days for five cycles) or UFT/LV. The primary study endpoint was disease-free survival. RESULTS: The 3-year disease-free survival rate was 84.2% in the TEGAFOX arm, versus 62.1% for UFT/LV. The stratified hazard ratio for disease-free survival for TEGAFOX compared to UFT/LV was 0.338 (P < 0.01). The incidence of any-grade adverse events was significantly higher in the TEGAFOX arm (96.1%) than in the UFT/LV arm (76.6%; P < 0.01). The rates of any-grade neutropenia, thrombocytopenia, aspartate aminotransferase/alanine aminotransferase elevation, and peripheral sensory neuropathy were higher in the TEGAFOX group, whereas the incidence of grade ≥ 3 adverse events did not differ between the groups. CONCLUSIONS: TEGAFOX is an additional adjuvant chemotherapy option for high-risk stage II/III colorectal cancer. TRIAL REGISTRATION: UMIN ID: 000007696, date of registration: April 10, 2012.

[A case of advanced gastric cancer with para-aortic lymph node metastases responding to S-1/CDDP chemotherapy that leads to a pathological complete response].

A 66-year-old man complaining of epigastralgia was referred to our hospital. We examined the patient and diagnosed advanced gastric cancer (ML, type 3, por, cT3, cN3, cH0, cP0, cM1[LYM], cStage IV). A poor outcome was predicted, so we attempted induction chemotherapy and expected tumor downstaging. We chose S-1/CDDP therapy. S-1 was administered orally for 21 days, followed by CDDP div on day 8. Total gastrectomy and lymph node dissection (D2+No. 12a, No. 13,16) was performed using Roux-en-Y reconstruction. Histological examination of the resected stomach and lymph nodes revealed no residual cancer cells, suggesting complete histological remission (grade 3) according to the Japanese classification of gastric carcinoma. The patient has been in good health without recurrence for 12 months after surgery.

Inhibitory remnant stomach motility by duodenal distention after B-I gastrectomy.

BACKGROUND/AIMS: Although control of gastric motility is a highly regulated process, B-I gastrectomy causes accelerated gastric emptying. We found few reports so far concerned with the mechanical effect of balloon distention of the duodenum on the remnant stomach in B-I dogs. METHODOLOGY: Four weeks after conventional distal gastrectomy with B-I reconstruction procedure, a balloon was inserted into the duodenum, and strain gauge force transducers (SGTs) were sutured onto the wall of the gastric remnant and duodenal serosa in beagles. After a two-week postoperative recovery period, gastro-duodenal motility was measured with SGTs prior to distention, during distention, and after evacuation of the balloon. The motility index (MI) was calculated every 30 minutes. RESULTS: Upon duodenal distention with 4 mL of water, motility of gastric remnant was significantly inhibited, however, no reduction in duodenal MI was observed. The response was maintained for as long as duodenal distension continued. Ninety minutes after evacuation of the balloon, MI returned to predistension levels. Increased plasma levels of cholecystokinin (CCK) were observed upon distention of the duodenal balloon. CONCLUSIONS: Motility of the remnant stomach in B-I dogs was inhibited by duodenal distension. Increased levels of plasma CCK during distention might play a role in this feedback mechanism.

High en bloc resection rate achieved by endoscopic mucosal resection with IT knife for early gastric cancer.

BACKGROUND/AIMS: Circumferential endoscopic mucosal resection (EMR) around lesions performed by an insulation-tipped diathermic knife (IT knife) increases en bloc resection rates, suggesting the possibility of expanding indications for EMR. METHODOLOGY: Clinical outcome of EMR performed by IT knife under general anesthesia was evaluated for 26 patients with 29 early gastric cancer. RESULTS: Successful en bloc resection rates obtained by the IT knife were 100, 87.5, 90.0 and 100% for lesions < or =10 mm in size, 11-20 mm, 21-30 mm, and > or =31 mm, respectively. They were significantly higher with the IT knife than those obtained by the conventional method (IT knife method: 93.1% vs. conventional method: 28.5%, p<0.0001). Two lesions were lateral margin positive, and in three cases invasion of lesions was observed as deep as the submucosa. Distal, total, and proximal gastrectomy with D2 lymphadenectomy, respectively, was provided in 3 cases; however, no lymph node involvement was found in any of the resected specimens. Bleeding and perforation were observed in 3 cases, respectively, however, no additional surgical treatment was required for these patients. CONCLUSIONS: EMR by means of the IT knife under general anesthesia can be performed safely and adequately. It is a useful treatment modality for early gastric cancer.

Effect of the anastomosis-site after Billroth I gastrectomy on the motility of the remnant stomach.

BACKGROUND/AIMS: Gastric emptying, in healthy individuals, is a highly regulated process, and plasma cholecystokinin plays a major role in its feedback regulation. However, the hormonal regulation of postprandial gastric emptying of the remnant stomach after distal gastrectomy with Billroth I reconstruction procedure has not been well described. The aim of this study is to characterize the gastroduodenal motility and gastric emptying of the two anastomosis-methods after Billroth I gastrectomy, while assessing the effect of cholecystokinin on the motility of the remnant stomach. METHODOLOGY: Two types of anastomosis (end-to-end, side (posterior wall)-to-end) after Billroth I gastrectomy were measured with strain gauge force transducers, and evaluated as to gastroduodenal motility, gastric emptying, gastrointestinal hormones (cholecystokinin, gastrin), and blood glucose associated with food administration. RESULTS: Remnant stomachs with side-to-end anastomosis showed superior motility as compared to those with end-to-end anastomosis. Plasma cholecystokinin was higher in the end-to-end anastomosis group. No differences as to gastric emptying, levels of plasma gastrin, or blood glucose were observed between the two groups. CONCLUSIONS: Plasma cholecystokinin may explain the difference in motility index between the two groups.