Correction to: Purse-string approximation vs. primary closure with a drain for stoma reversal surgery: results of a randomized clinical trial.

In the original publication, surname of first author is misspelt as "Amamo". It should be "Amano" as given in this Correction.

Purse-string approximation vs. primary closure with a drain for stoma reversal surgery: results of a randomized clinical trial.

PURPOSE: Stoma reversal carries a risk of surgical site infection (SSI). Purse-string approximation (PSA) has been reported as an attractive alternative to conventional primary wound closure for stoma reversal, but its efficacy is still under debate. METHODS: Patients undergoing elective stoma reversal were randomized to undergo PSA or primary closure with a drain (PCD). All patients received preoperative bowel cleansing and antimicrobial prophylaxis. The primary endpoint was the incidence of wound healing at the stoma site 30 days after surgery. The secondary endpoint was the 30-day SSI rate after surgery. RESULTS: A total of 159 patients (PCD group, n = 79; PSA group, n = 80) were eligible for this study. The incidence of wound healing at the stoma site was 92.4% in the PCD group and 62.5% in the PSA group [difference (95% confidence interval - 29.9% (- 42.9 to - 16.9%)]. The 30-day SSI rate at the stoma site, as the secondary endpoint, was 8.9% in the PCD group and 5.0% in the PSA group (P = 0.35). CONCLUSIONS: These results suggest that PCD may remain the standard procedure for stoma reversal surgery.

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

PURPOSE: To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. METHODS: Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. RESULTS: A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). CONCLUSION: The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

[The efficacy and safety of FOLFIRI or combined FOLFIRI and bevacizumab treatment as second-line chemotherapy for metastatic colorectal cancer patients aged 75 years and older].

The safety and efficacy of FOLFIRI as second-line chemotherapy for metastatic colorectal cancer patients ≥ 75 years was retrospectively evaluated. We analyzed 106 patients, who received FOLFIRI or a combination of FOLFIRI and bevacizumab following oxaliplatin-based first-line chemotherapy. The clinical characteristics and outcome in elderly patients ≥75 years(elderly[EP]group; n=18)were compared with those in patients aged<75 years(control group; n=88). The number of patients treated by a combination of FOLFIRI and bevacizumab in the EP group was lower than that in the control group (27.8% vs 55.7%; p=0.03). The comparison revealed no significant differences in response rate, progression-free survival, overall survival, and the frequency of overall adverse events after the start of second-line chemotherapy, although the frequency of anemia(Bgrade 3, p=0.07)and alopecia(grade 1/2, p=0.054)tended to be higher in the EP group than in the control group. Although this study retrospectively analyzed a limited number of patients, our results indicate that the safety and efficacy of FOLFIRI as second-line chemotherapy for metastatic colorectal cancer are almost equal in patients ≥ 75 years and those aged<75 years.

[Theoretical background of our original single-incision laparoscopic-assisted surgery technique for colon cancer via a periumbilical approach].

We assessed the theoretical background of our original single-incision laparoscopic-assisted surgery( SILS) technique involving a periumbilical approach. The subjects included 10 cases who underwent periumbilical SILS colectomy and had their surgical wounds photographed before and after skin incision between September 2009 and October 2010. Using an image analyzer, we estimated the theoretical oval area after a 3/4-circumferential periumbilical skin incision, the actual oval area after placement of the wound retractor, and the length of the skin incision. The mean oval area after the placement of the wound retractor was 2.9 times (range: 1.6-5.0 times) larger than that of the theoretical area. The square of the length of the skin incision positively correlated with the actual oval area created by placing the wound retractor( p=0.04, r=0.67). There were 5 patients, whose actual oval area was ≤700 mm2, and thus required additional radial skin incision( s)( 1 in 3 cases, 2 in 1 case and 3 in 1 case). When performing our original SILS via the periumbilical approach, the area of the actual surgical window can be predicted by measuring the distance from the center of the umbilicus to its edge.

[Effect of chemotherapy in primary tumor of MSI-H colon cancer aged 50 years or younger].

Microsatellite instability( MSI) in colorectal carcinoma is reportedly associated with resistance to 5-fluorouracil-based chemotherapy. Moreover, colorectal cancer patients aged ≤ 50 years could potentially have Lynch syndrome. In the present study, we examined 11 colorectal cancer patients with unresectable Stage IV disease who underwent resection of the primary tumor between January 2006 and December 2012. The relationship between the MSI status and the efficacy of first- line oxaliplatin-based chemotherapy was retrospectively examined. The MSI status included MSI-H in 1 patient, MSS-L in 2 patients, and MSS in 8 patients. The MSI-H in 1 patient was associated with familial adenomatous polyposis. Following chemotherapy, among 8 MSS patients, 3 showed stable disease (SD) and 1 showed partial response (PR). Moreover 2 MSH-L patients and 1 MSI-H patient showed progressive disease (PD) after chemotherapy. However, additional data collection is required to determine the effect of oxaliplatin-based chemotherapy for MSS-H or MSS-L colorectal patients aged ≤ 59 years.

Discrepancy between the NCI-CTCAE and DEB-NTC scales in the evaluation of oxaliplatin-related neurotoxicity in patients with metastatic colorectal cancer.

BACKGROUND: Several oxaliplatin-specific scales have been proposed in clinical practice to evaluate oxaliplatin-related neurotoxicity. We investigated whether there might be a discrepancy between the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and the Neurotoxicity Criteria of Debiopharm (DEB-NTC), the commonly used oxaliplatin-specific scales, in the evaluation of peripheral neurotoxicity. PATIENTS AND METHODS: The subjects were 42 patients with metastatic colorectal cancer who received more than 6 cycles of first-line therapy with modified FOLFOX6 and more than 6 cycles of second-line therapy with FOLFIRI. The median number and cumulative dose of oxaliplatin administrations were 10.5 (range 6-22) and 889.4 mg/m(2) (range 484.5-1875.0 mg/m(2)), respectively. The peripheral neurotoxicity was evaluated during mFOLFOX6 therapy and after its discontinuation using NCI-CTCAE ver. 3.0 and DEB-NTC. Data were collected prospectively and analyzed retrospectively. RESULTS: The concordance rate of the peripheral neurotoxicity grade determined by these criteria was low: 48.8% during mFOLFOX6 and 47.3% after discontinuation of therapy. The cumulative dose of oxaliplatin-related peripheral neurotoxicity in 50% of the patients was lower when evaluated by DEB-NTC for both grades 1 (P = 0.09) and 2 (P < 0.001). The cumulative rate of improvement from grade 2 to 1 (P < 0.001) and from grade 2 to 0 (P < 0.05) after discontinuation of mFOLFOX6 therapy was higher when NCI-CTCAE was used for the evaluation. CONCLUSION: We found a discrepancy between the NCI-CTCAE and DEB-NTC scales in the evaluation of oxaliplatin-related neurotoxicity and suggest that the concomitant use of NCI-CTCAE and DEB-NTC would be useful to maintain oxaliplatin-based chemotherapy at higher quality.

[A long-term survivor of colorectal cancer associated with multiple liver metastases and peritoneal carcinomatosis treated through a multidisciplinary approach].

Even in the era of new anticancer drugs, an optimal treatment strategy for colorectal cancer associated with liver metastasis and peritoneal carcinomatosis has yet to be established. Here we report the case of a long-term survivor with very advanced colon cancer who underwent repeated resective surgery and chemotherapy. This 69-year-old man underwent a Hartmann's procedure and the resection of peritoneal metastases of cancer of the rectosigmoid, which had infiltrated the retroperitoneum giving rise to multiple liver metastases and peritoneal carcinomatosis. The resection margin was positive for cancer. After 14 courses of a modified FOLFOX6 (mFOLFOX6) regimen, a partial response with no development of new lesions was obtained. Multiple partial hepatectomies were subsequently performed. After the completion of an additional 6 courses of mFOLFOX6, a positron-emission tomography (PET)/computed tomography (CT) examination demonstrated a hot spot in segment 4. This hot deposit disappeared after a further 8 courses of mFOLFOX6. The patient then underwent a left lateral segmentectomy for a newly developed lesion in segment 3, which was detected 2 years and 7 months after the first operation. The patient has remained free from recurrence for 2 years since his last operation.

[Clinical outcome of Stage IV colorectal cancer on the basis of the seventh edition of the TNM classification].

Recent advances in chemotherapy for stage IV colorectal cancer have improved clinical outcome. According to the seventh edition of the TNM classification of colorectal cancer, stage IV is classified into stage IVA and stage IVB. In this study, we assessed the clinical validity of this classification as a prognostic factor. The subjects were 170 patients with stage IV colorectal cancer(stage IVA, n=78; stage IVB, n=92)treated between January 2006 and December 2011 at our institute. Of 92 patients with stage IVB, peritoneal carcinomatosis alone was recognized in 21 patients. The median survival periods for patients with stage IVA and IVB were 29.2 and 16.1 months, respectively( p=0.13). The median survival period for patients with peritoneal carcinomatosis alone was 37.6 months, and there was no difference between survival in patients with stage IVA and those with peritoneal carcinomatosis alone. Our present results suggest that it may be reasonable and useful to classify peritoneal carcinomatosis alone into stage IVA instead of stage IVB in clinical practice.

[The clinical significance of serum anti-p53 antibody as a monitoring marker in colorectal cancer].

We examined alterations in the level of serum anti-p53 antibody(S-p53 Ab) in colorectal cancer patients who underwent curative resection and analyzed the usefulness of S-p53 Ab as a monitoring marker for postoperative observation. The measurement of S-p53 Ab was performed preoperatively and postoperatively in 16 stage II/III colorectal cancer patients with a high level of S-p53 Ab. A time course analysis of both S-p53 Ab and CEA levels was performed in 6 of these patients who were carcinoembryonic antigen (CEA) positive. The median S-p53 Ab level was 29.9 U/mL and the half-life of the S-p53 Ab level was 40.3 days. In 4(25%) cases, the level of S-p53 Ab recovered to within normal limits by 79-142 days. When the half-lives of S-p53 Ab and CEA were analyzed in 6 patients who were both S-p53 Ab and CEA positive, the half-lives of S-p53 Ab and CEA were 32.3 and 13.2 days, respectively. In the case of recurrence with liver metastasis after resection of ascending colon cancer, the S-p53 Ab level did not respond quickly while the CEA level increased. Therefore, it is difficult to use the level of S-p53 Ab as a marker for monitoring treatment, and priority should be given to the examination of CEA and imaging modality.

[Predictive value of Köhne's index on the efficacy of FOLFIRI regimen in the treatment of unresectable liver metastatsis of colorectal cancer].

The aim of this retrospective study was to analyze the predictive value of Köhne's index on the efficacy of FOLFIRI regimen in the treatment of unresectable liver metastasis of colorectal cancer. The subjects were 44 patients with unresectable liver metastasis from colorectal cancer treated with FOLFIRI regimen as second-line, for all of whom oxaliplatin-based regimen had previously failed. Bevacizumab was concomitantly used in 23 patients. Classification of the Köhne's index revealed high risk in 22 patients, intermediate risk in 7 patients, and low risk in 15 patients. The response rate was 13.6% in the patients with high risk(H group) and 27.3% in the patients with intermediate or low risk(non-H group)(p=0.45). The disease control rate was 50% in the H group and 68.2% in the non-H group (p=0.36). In the H group, the median progression -free survival time was 4.1 months and in the non-H group it was 7.1 months (p=0.33). Compared with the H group, the non-H group showed significantly better overall survival (10.8 months vs 23.9 months, p=0.03). None of the patients has received hepatectomy (conversion therapy). These results suggest that the predictive value of Köhne's index is limited in terms of the effect of shrinkage of liver metastases, including conversion therapy.

[Clinical outcomes in refractory colorectal cancer patients with wild-type K-ras treated with bevacizumab and oxaliplatin-based chemotherapy as a first-line treatment].

The clinical outcomes, including adverse events, in 34 unresectable advanced colorectal cancer patients with wild-type K-ras, who were treated with bevacizumab and oxaliplatin-based chemotherapy as a first-line treatment, were analyzed for confirmation of the effectiveness and safety of this treatment. The response rate of the patients was 44% (complete remission, 2 patients; and partial remission, 13 patients). The median progression-free survival and overall survival in these patients was 11.1 and 25.1 months, respectively. Adverse events of greater than grade 3 were observed in 18 patients. Of these patients, 10 exhibited grade 3/4 neutropenia, and 6 had peripheral neuropathy. Our results were similar to those of randomized phase III trials from abroad, including those using anti-epidermal growth factor receptor antibody, with respect to effectiveness and safety. Furthermore, patients with liver metastasis had poor prognosis compared to those with metastasis to organs other than the liver. Further analysis will be required to better understand these results.

[Adjuvant chemotherapy comprising modified FOLFOX6 after curative resection of synchronous or metachronous metastasis from colorectal cancer].

PURPOSE: This retrospective study evaluated the outcome of adjuvant chemotherapy comprising modified FOLFOX6 (mFOLFOX6) after potentially curative metastasectomy from colorectal cancer. PATIENTS AND METHODS: The subjects were 40 patients with colorectal cancer who underwent potentially curative metastatectomy without any prior chemotherapy between December 2003 and November 2011. Patient background, type of adjuvant chemotherapy, and prognosis were examined. RESULTS: Adjuvant chemotherapy was given in 30 patients (mFOLFOX6, n=26; oral fluoropyrimidines, n=4). The median relapse-free survival tended to be longer in patients treated with mFOLFOX6 compared to those treated with fluoropyrimidines (28.5 months vs 14.8 months; p=0.11). The median overall survival did not differ significantly between the 2 groups (37.9 months vs 31.3 months, p=0.56). When the analysis was restricted to patients treated with mFOLFOX6, no significant differences were found in relapse-free survival (p=0.46), overall survival (p=0.29), and frequency of adverse events during chemotherapy(Grade 3, p=0.32) between patients with synchronous metastasis(n=11) and those with metachronous metastasis (n=15). CONCLUSION: These results suggest that mFOLFOX6 might contribute to prolonging the time to relapse and that the timing of developing metastasis(synchronously or metachronously) may not have any effect on the outcome of adjuvant mFOLFOX6.

[Prediction of the efficacy of first-line oxaliplatin-based chemotherapy for unresectable liver metastases of colorectal cancer by Köhne's index].

PURPOSE: This retrospective study was undertaken to examine the usefulness of Köhne's index(KI) for predicting the efficacy of first-line oxaliplatin-based chemotherapy for unresectable liver metastases of colorectal cancer. PATIENTS AND METHODS: The subjects were 84 patients with unresectable liver metastases of colorectal cancer in whom first-line oxaliplatin- based chemotherapy was administered. The outcome of treatment was analyzed in relation to the KI. RESULTS: The patients were classified into 3 groups: high risk group (n=12), intermediate risk group (n=20), and low risk group (n=52). There were no significant differences between the groups with regard to response rate, disease control rate, disease-free survival, overall survival, and the rate of conversion to hepatic metastatectomy. CONCLUSION: Our results suggest that KI might not be useful for predicting the efficacy of first-line oxaliplatin-based chemotherapy for unresectable liver metastases of colorectal cancer.

[Clinical differences between palliative gastrectomy and reduction surgery for gastrectomy in curatively unresectable gastric cancer].

Surgical treatments for curatively unresectable gastric cancer include reduction surgery and palliative surgery(palliative gastrectomy and bypass operation). Both palliative gastrectomy and reduction surgery reduce the tumor volume. In this study, the clinical significance of these treatment methods was investigated. The subjects were 58 patients with unresectable gastric cancer for which surgery was performed as the primary treatment. Of these patients, 38 patients underwent reduction surgery and 20 patients underwent palliative surgery. On univariate analysis, age and gender were not significant. Pre-operative performance status(PS) in patients treated with reduction surgery was favorable compared to that in patients receiving palliative surgery(PS 0: 65.8 vs 40.0%, p=0.06). The administration rate of post-operative chemotherapy in patients treated with reduction surgery was higher than that in patients with palliative surgery (92.1 vs 65.0%, p<0.01). The median survival time in patients treated with reduction surgery was 18.2 months, while that in patients with palliative surgery was 11.0 months (p<0.01). These results indicated that reduction surgery was clinically different compared to palliative surgery in terms of the administration rate of post-operative chemotherapy and prognosis.

Impact of prior abdominal surgery on curative resection of colon cancer via minilaparotomy.

PURPOSE: To evaluate the impact of prior abdominal surgery on curative resection of colon cancer via a minilaparotomy approach. METHODS: Feasibility, safety, and oncological outcomes were evaluated retrospectively in 263 patients scheduled to undergo curative resection of colon cancer via a minilaparotomy approach, defined as a skin incision of ≤ 7 cm, between September 2000 and March 2009. RESULTS: Abdominal adhesions were found in 59 (77.6%) of 76 patients who had undergone prior abdominal surgery (PAS group) and in 4 (2.1%) of 187 patients who had not (control group). The success rate of the minilaparotomy approach was 92.1% in the PAS group and 97.3% in the control group (P = 0.08). The incidence of extending the minilaparotomy wound for adhesiolysis was significantly higher in the PAS group than in the control group (6.6% vs 0.5%; P < 0.01). The two groups did not differ significantly in terms of the types of surgery, pathological stage, body mass index, operative time, blood loss, incidence of postoperative complications, length of postoperative hospital stay, and disease-free survival. CONCLUSIONS: These results suggest that prior abdominal surgery might require an extension of the minilaparotomy incision but that it does not seem to contraindicate a minilaparotomy approach for curative colectomy.

Curative resection of transverse colon cancer via minilaparotomy.

Minilaparotomy has been reported to be a minimally invasive alternative to laparoscopically assisted surgery. We retrospectively evaluated the usefulness of minilaparotomy for the resection of transverse colon cancer, which has generally been considered difficult to resect laparoscopically. Patients for whom curative resection was attempted for transverse colon cancer (n = 21) or sigmoid colon cancer (n = 81) via minilaparotomy (skin incision, < or = 7cm) were analyzed. The 2 groups did not significantly differ in terms of success rate of minilaparotomy (90.5% versus 97.5%), age, sex, pathologic stage, body mass index, operative time (mean, 133.5 minutes versus 122.5 minutes), blood loss (119.7 mL versus 92.4 mL), number of lymph nodes harvested, incidence of postoperative complications (9.5% versus 12.3%), postoperative length of stay, and 5-year disease-free survival rate (86.6% versus 79.6%). Minilaparotomy is feasible, safe, and favorable in terms of early oncologic outcome in patients with transverse colon cancer as well as those with sigmoid colon cancer.

Experience of distal gastrectomy by minilaparotomy with laparoscopic-assistance for nonoverweight patients with T1N0-1 gastric cancer.

To evaluate the usefulness of laparoscopic assistance for curative distal gastrectomy by minilaparotomy, 19 patients (body mass index < or = 25.0 kg/m2) with T1NO-1 gastric cancer who underwent distal gastrectomy with a minilaparotomy (skin incision < or = 7 cm) with laparoscopic assistance (LA (+) group) were compared with 19 historic controls who underwent equivalent surgery by minilaparotomy without laparoscopic assistance (LA (--) group). The percentage of patients with blood loss more than 300 mL tended to be lower in the LA (+) group (5.3% versus 31.6%, P = 0.09). The first flatus passage was earlier (P = 0.04), serum C-reactive protein levels on postoperative day 1 were lower (P = 0.04), and white blood cell counts on postoperative day 1 tended to be lower (P = 0.07) in the LA (+) group. Minilaparotomy with laparoscopic assistance seems to be less invasive compared with pure minilaparotomy. This procedure is considered to be a simple alternative to standard laparoscopic-assisted distal gastrectomy in selected patients with T1NO-1 gastric cancer.

Significance of hepatic lymph node metastasis in patients with unresectable synchronous liver metastasis of colorectal cancer.

The frequency and significance of hepatic lymph node (HLN) metastasis were retrospectively evaluated in 43 patients with unresectable synchronous liver metastasis of colorectal cancer who underwent resection of the primary tumor and histopathologic evaluation of HLNs between March 1997 and August 2007. HLN metastasis was detected in 12 patients (27.9%). No significant correlations were observed between the presence of HLN metastasis and any of the 12 clinicopathologic factors examined. On multivariate analysis using the Cox proportional hazards model, the presence of HLN metastasis (P = 0.002), along with a large number (> or = 4) of regional lymph node metastases (P = 0.003), and nonuse of oxaliplatin-based chemotherapy (P = 0.005) were identified as independent risk factors for shorter survival. To establish a new therapeutic strategy for initially unresectable liver metastasis of colorectal cancer, HLNs should be examined histologically in patients undergoing resection of hepatic lesions when they are rendered resectable by effective chemotherapy.

Oncologic outcome of stages II/III colon cancer treated via minilaparotomy.

We analyzed clinicopathologic, surgical, and survival data on consecutive series of patients with stages II/III colon cancer for whom curative resection via minilaparotomy (skin incision, < or = 7 cm) was attempted between September 2002 and March 2009 to clarify the oncologic safety of this type of surgery. There were 64 men and 55 women; the median age was 70 years (range, 25-91 years). The median body mass index was 21.7 kg/ m2 (range, 15.1-28.9 kg/m2). The minilaparotomy approach was successful in 115 cases (96.6%). The cumulative 5-year disease-free and overall survival rates were 89.7% and 82.4%, respectively, in patients with stage II disease (n = 62) and were 68.4% and 82.4%, respectively, in patients with stage III disease (n = 57), all of which were compatible with those of the historical control patients who underwent conventional open surgery. Minilaparotomy approach for stages II/III colon cancer seems to be oncologically equivalent to conventional open surgery.