Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study).

BACKGROUND: This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer. METHODS: Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8. RESULTS: Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups. CONCLUSIONS: Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.

Timing of relapse and outcome after curative resection for colorectal cancer: a Japanese multicenter study.

BACKGROUND: The aim of this multicenter study was to clarify the influence of timing of relapse after curative resection for colorectal cancer on prognosis. METHODS: We enrolled 5,230 consecutive patients who underwent curative resection for colorectal cancer at 14 hospitals from 1991 to 1996. All patients were intensively followed up. Time to relapse (TR) was classified into three groups as follows: group A, TR < or =1 year; group B, TR >1 year and < or =3 years, and group C, TR >3 years. The prognoses after relapse were compared among the three groups. RESULTS: Of the 5,230 patients, 906 experienced relapse (17.3%). The curative resection rates for recurrent tumors were 35.2% in group A, 46.6% in group B, and 45.1% in group C (p = 0.0045). There were significant differences in the prognoses after relapse among the three TR groups in patients with relapse to the liver (p = 0.0175) and in those with local relapses (p = 0.0021), but not in those with pulmonary or anastomotic recurrence. There were no differences in prognoses after relapse in any recurrence site among the three groups in patients who underwent curative resection for relapse. CONCLUSION: If patients can undergo curative resection for relapse, they receive a survival benefit regardless of the timing of relapse.

Repeated resection for intra-abdominal and retroperitoneal liposarcomas: long-term experience in a single cancer center in Japan.

Intra-abdominal or retroperitoneal liposarcomas are huge, and local recurrence is a common event. There is still no consensus concerning debulking or repeated resection. Twelve patients who had surgery for intra-abdominal or retroperitoneal liposarcomas at the Cancer Institute Hospital (Tokyo, Japan) during 1981-2002 were enrolled. Eight patients underwent complete resection, for a resectability rate of 67%. Combined resection of adjacent organs was necessary to obtain clear margins in 10 of the 12 patients (83%). A patient who underwent R2 resection survived 13.2 years in a dormant state without tumor regrowth. Resection of second (five patients), third (three patients), or seventh (one patient) for local recurrence or regrowth tumors was successfully performed. A patient survived 21.5 years after four R0 resections and three R2 resections. Our experience suggests that both near-total and repeated resection might improve survival benefit.

[Influence of primary disease factors on outcome after resection of colorectal liver metastases?].

The outcome after resection of hepatic metastases from colorectal cancer is influenced not only by factors of metastatic lesions but also those of primary disease. To clarify whether primary disease factors are predictive of post-resection outcome of colorectal liver metastases, 180 patients (male : female = 114 : 66; 61.1 +/-10.5 yrs; synchronous: metachronous = 95 : 85; colon: rectum = 124 : 56 who underwent surgery of colorectal liver metastases in Cancer Institute Hospital from 1995 to 2005 were recruited for analysis. Post-resection outcome of the patients with colorectal liver metastases was significantly influenced by 1) depth of invasion, 2) grade of lymph node metastasis , 3) number of metastatic lymph nodes and 4) Dukes stage of primary disease. The patients with lymph node metastases further than grade 3 showed median survival time of less than 2 years and did not survive longer than 5 years. Thus such condition seemed not warrant resective treatment for liver metastases. In case of synchronous metastatic disease, primary disease information, such as lymph node metastases, depth of invasion, and Dukes stage, were significant predictive factors after hepatectomy. Meanwhile, such factors did not show significant influence in the patients with metachronous liver metastases. In conclusion, influence of primary disease factors should be considered for deciding the indication of hepatectomy for colorectal liver metastases, especially when patients have synchronous lesions.

[Current status of sentinel node navigation surgery in colon cancer].

The feasibility of sentinel node (SN) mapping and its diagnostic reliability are now being determined in colorectal cancer, but the reports issued in 2000 or later suggest that they are promising with SN detection rates of 94-100% and overall diagnostic accuracy of regional lymph node status based on SN status of 86-100%. In particular, patients with a pT1 or pT2 colorectal cancer are suggested to be the best candidates for SN mapping, with diagnostic accuracy of almost 100%. On the contrary, the effects on recurrence and survival rates in colorectal cancer have not yet been verified between patients with and without micrometastasis in the SN. In accordance with the Japanese Classification of Colorectal Carcinoma, surgery for D2 (or D3) lymph node dissection have been routine in Japan for T1 or T2 colon cancers without any postoperative sequelae, and can harvest nearly all SNs without lymphatic mapping, because SNs are anatomically distributed in the paracolic and intermediate nodes. Patients with a T1 or T2 colon cancer are the best candidates for sentinel node navigation surgery (SNNS) as well as for laparoscopy-assisted colectomy (LAC). However, intraoperative colonofiberoscopy to inject a pigment tracer into the colic wall for lymphatic mapping is problematic to the LAC procedure thereafter. For this reason, SNNS might not be accepted widely in colon cancer surgery in the near future.