Phase 2 Trial of Adjuvant Chemotherapy With S - 1 for Node-Positive Biliary Tract Cancer (N-SOG 09).

BACKGROUND: Nodal metastasis is a leading attributable factor of poor survival in biliary tract cancer (BTC), and adjuvant chemotherapy targeting this high-risk feature has not been attempted to date. This study aimed to test the efficacy of adjuvant S - 1 for patients with node-positive BTC. METHODS: This single-arm multicenter phase 2 trial enrolled patients who underwent resection for histologically proven node-positive BTC. In this trial, S - 1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 6 months. The primary end point of the trial was 3-year overall survival (OS), in which the result would be promising if the 90% confidence interval (CI) surpassed a threshold of 30% (alpha error, 0.1; beta error, 0.2). The secondary end points were relapse-free survival (RFS), feasibility, and toxicity. RESULTS: The trial included 50 patients with perihilar (n = 23) or distal (n = 20) cholangiocarcinoma, or gallbladder cancer (n = 7). The median numbers of positive lymph nodes and examined lymph nodes were respectively 2 and 15. The 3-year OS and RFS were respectively 50% (90% CI, 40.9-59.1%) and 32.0% (95% CI, 19.1-44.9%), with median survival times of 34.6 months (95% CI, 19.3-49.8 months) and 18.4 months (95% CI, 11.9-24.9 months). Although hematologic toxicity often occurred, grades 3 and 4 toxicity were rare. The completion rate of the test therapy was 64%, and the median relative dose intensity was 87.5% (interquartile range, 50-100%). CONCLUSION: Adjuvant chemotherapy with S - 1 may be promising for patients with node-positive BTC.

Pathological impact of transanal colorectal tube for obstructive colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) with acute colorectal obstruction (ACO) is an emergency. Transanal colorectal tube (TCT) use can be a safe single-stage surgery with laparoscopy-assisted colectomy; it offers long-term outcomes equivalent to emergency surgery for stage-II/III CRC with ACO. Self-expanding metallic stent use, another alternative, may have detrimental pathological and molecular effects, whereas the pathological impact of TCT placement remains unclear. We hypothesized that TCT placement might exert little damage on primary tumor. Hence, the current study analyzed the pathological impact of TCT placement for CRC with ACO compared to emergency surgery. METHODS: Data from consecutive patients with stage-II/III distal CRC with ACO who underwent surgery between January 2007 and December 2015 were retrospectively reviewed at two Japanese affiliate hospitals. Inflammatory and malignant potential-related parameters were analyzed by a single blinded pathologist. We extracted mRNA from tumor tissues to analyze inflammatory cytokines. RESULTS: Sixty-eight patients with stage-II/III distal CRC with ACO were identified (surgery: 25 patients; TCT: 43 patients). Baseline characteristics were well balanced between the two groups. TCT showed a significantly lower frequency of abscess (surgery vs TCT, 36.0% vs 11.6%; P = 0.017) and a lower tendency of pathological perforation (surgery vs TCT, 20.0% vs 4.7%, respectively; P = 0.091), compared to the surgery group. There were no significant intergroup differences in oncological factors, including perineural invasion (surgery vs TCT, 52.0% vs 62.8%; P = 0.383), microlymphatic involvement (surgery vs TCT, 52.0% vs 58.1%; P = 0.623), and microvascular involvement (surgery vs TCT, 32.0% vs 25.6%; P = 0.570). No significant intergroup differences were found in interleukin (IL)-6, IL-8, or IL-1ß gene expression levels (P = 0.580, 0.250, 0.941). CONCLUSIONS: TCT placement had no pathologically detrimental effects on the tumor or surrounding tissues and might be an attractive non-invasive strategy for cases of curative distal CRC with ACO.

Correction to: Pathological impact of transanal colorectal tube for obstructive colorectal cancer.

In Methods of Abstract, the word "2015" should be changed to "2011".

Phase II study of capecitabine plus oxaliplatin (CapOX) as adjuvant chemotherapy for locally advanced rectal cancer (CORONA II).

OBJECTIVE: This multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer. METHODS: Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CapOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1-14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety. RESULTS: A total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CapOX therapy. The completion rate of all eight cycles of CapOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57-86%) and 96% (95% CI 80-99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively. CONCLUSION: CapOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.

Neoadjuvant CAPOX and bevacizumab alone for locally advanced rectal cancer: long-term results from the N-SOG 03 trial.

BACKGROUND: Neoadjuvant chemotherapy (NAC) alone for locally advanced rectal cancer (LARC) remains an experimental treatment, and the efficacy in terms of long-term outcome has not been fully elucidated. The N-SOG 03 trial examined the safety and efficacy of neoadjuvant CAPOX and bevacizumab (Bev) without radiotherapy in patients with poor-risk LARC. METHODS: Thirty-two patients with MRI-defined LARC received neoadjuvant CAPOX and Bev followed by curative resection between 2010 and 2011. The overall survival (OS), progression-free survival (PFS), and local-relapse rate (LRR) were calculated using the Kaplan-Meier method, and the risk factors were evaluated by multivariate analysis using the Cox proportional hazard models. This trial is registered with UMIN, number 000003507. RESULTS: In the entire cohort, the 5-year OS was 81.3%. Because of disease progression during chemotherapy, 3 patients ultimately did not undergo curative surgery. As a result, 29 patients underwent R0/1 resection. Among these 29 patients, the 5-year OS, PFS, and LRR were 89.7%, 72.4% and 13.9%, respectively. In multivariate analysis, cT4b tumor was an independent poor prognostic factor for OS and LRR, and ypT4b tumor and absence of N down-staging were independent poor prognostic factors for PFS. CONCLUSIONS: Patients with cT4b tumor were not suitable for NAC alone. However, the long-term outcomes of the other patients were satisfactory, and NAC alone might be an option for treatment of LARC. N down-staging was likely to bring favorable PFS, even in patients with cStage III.

[A Case of Breast Cancer That Was Able to Accomplish Six Courses of TAC for Preoperative Chemotherapy Using Pegfilgrastim].

The present study reports the case of a 45-year-old pre-menopausal woman treated with 6courses of TAC chemotherapy by the pegfilgrastim for preoperative chemotherapy. The patient visited our hospital in February 2010 with the chief complaint of a mass in the right breast. A 40mm tumor in the outer lower area of the right breast and the axillary lymph nodes was palpable. Pathological findings revealed scirrhous carcinoma with an ER(+), PgR(+), HER2(1+), and Ki-67 80%profile. Pre-operatively, the patient underwent 6courses of triweekly TAC(docetaxel[75mg/m / 2], adriamycin[50mg/m2], cyclo- phosphamide[500mg/m2])chemotherapy. Pegfilgrastim(3.6m g)was subcutaneously injected on the next day of each course. The side effect of 6courses of TAC was stomatitis and low back pain(Grade 2). Relative dose intensity(RDI)was not reduced and there was no occurrence of febrile neutropenia(FN). Partial resection of the tumor was facilitated. Pathologically viable tumor cells still lay scattered in the range of 45 mm, and a ductal carcinoma in situ was seen. However, metastasis to axillary lymph nodes was not observed. Radiation therapy(50 Gy)was performed on the residual breast. There was no recurrence, and now she survival free with tamoxifen(20mg/day)of 8 years four months after operation. TAC with pegfilgrastim therapy could be an effective pre-operative chemotherapy regimen in breast cancer.

[Proactive Efforts by Medical Establishments to Support Working Cancer Patients and Formation of Comprehensive Employment Support Networks in Local Communities].

As part of proactive efforts to support working cancer patients at medical establishments, patients were given advice not to quit working after diagnosis and invited to a cancer counseling and support center. Further, medical treatment plans focusing on treatment period were presented prior to the start of treatment. These plans can be useful for cancer patients who seek support from their employers about changing their working conditions during treatment. Although these active support initiatives for newly diagnosed working cancer patients tended to contribute to a decrease in the rate of early job termination, the number of cancer patients who quit their work did not decrease significantly. There was a limit to work-related support at the clinical site. It is essential for many professionals to collaborate, such as clinicians, occupational health staff and working support professionals in the promotion of measures for balancing work and treatment for cancer patients. In the Tokai area, we set up the Cancer and Employment Workshop in 2015. We have been working to establish a local network to comprehensively support these patients.

Colorectal obstruction is a potential prognostic factor for stage II colorectal cancer.

BACKGROUND: Obstructive colorectal cancer (CRC) is an emergency situation with high morbidity and mortality, but long-term outcomes of stage II/III obstructive CRC remain unclear. The aim of this study was to evaluate prognostic factors, including colorectal obstruction. METHODS: Data were retrospectively reviewed from consecutive patients with stage II/III CRC who underwent curative surgery between January 2007 and December 2011 at two Japanese institutions. We analyzed overall survival (OS) and relapse-free survival (RFS), according to various prognostic factors including colorectal obstruction. RESULTS: In total, 979 patients with stage II/III CRC were identified for this study. Among these 979 patients, 94 patients showed colorectal obstruction (9.6%). In both stage II and stage III CRCs, colorectal obstruction showed significantly poorer OS and RFS compared to non-obstruction (5-year OS, obstruction vs. non-obstruction, stage II: 65.9 vs. 86.5%, P = 0.002; stage III: 55.9 vs. 73.6%, P = 0.007) (5-year RFS, obstruction vs. non-obstruction, stage II: 59.2 vs. 77.8%, P = 0.008; stage III 31.3 vs. 56.3%, P = 0.001). Multivariate analysis demonstrated colorectal obstruction as a significant independent and poor prognostic factor in terms of both OS (hazard ratio (HR) 2.469; 95% CI 1.339-4.545; P = 0.004) and RFS (HR 1.992; 95% CI 1.160-3.425; P = 0.012) for stage II CRC, as well as pT4 stage. On multivariate analysis for stage III CRC, colorectal obstruction was a significant predictor of poor RFS (HR 1.626; 95% CI 1.070-2.469; P = 0.023), but not poor OS. CONCLUSIONS: Colorectal obstruction is an independent poor prognostic factor for stage II CRC. Adjuvant chemotherapy might be feasible for stage II CRC with colorectal obstruction.

Effects of synbiotics on ileal microbiota.

BACKGROUND & OBJECTIVES: Despite advancements in molecular-based methods, the composition of the human ileal microbiota and the effects of synbiotics/probiotics on its microbes remain poorly understood. The aim of this study was to determine the composition of the mucus microbiota in the human ileum and to assess the effects of oral administration of synbiotics on the microbiota. METHODS: As part of a clinical trial for synbiotics treatment and surgical infection, ileal mucus was sampled when resection of the ileocecal portion was required. The microbiota composition was examined using 16S rRNA-targeted real-time-quantitative polymerase chain reaction. RESULTS: A total of 33 samples from the synbiotics group and 39 from the control group were analyzed. Total numbers of bacteria in the ileum were 108.5 cells/g in the synbiotics group and 108.4 cells/g in the control group, in which obligate anaerobes were dominant over facultative anaerobes. The level of Enterobacteriaceae was significantly lower in the synbiotics group than in the control group. The administered probiotics species Lactobacillus casei strain Shirota and Bifidobacterium breve strain Yakult were detected in 42 and 76 per cent of the synbiotics group, respectively. No significant correlations were observed between tumour stage/size and the various microbes present, except for a negative correlation between tumour size and Bifidobacterium. INTERPRETATION & CONCLUSIONS: The present analysis of a substantial number of samples from surgically resected intestines showed an abundance of obligate anaerobes as a characteristic feature of the ileal mucus microbiota. Our results also indicated that the synbiotics intervention induced a prominent reduction in Enterobacteriaceae in the ileal microbiota.

Phase II trial of neoadjuvant chemotherapy with S-1 and oxaliplatin plus bevacizumab for colorectal liver metastasis (N-SOG 05 trial).

PURPOSE: This Phase II trial evaluated the safety and efficacy of neoadjuvant chemotherapy (NAC) with S-1 and oxaliplatin (SOX) plus bevacizumab (Bev) in patients with colorectal liver metastasis (CRLM). METHODS: Patients with initially resectable CRLM received four cycles of SOX plus Bev as NAC. We adopted the R0 resection rate as the primary endpoint, and the threshold R0 resection rate was set at 80%. RESULTS: Between December 2010 and August 2014, 61 patients were enrolled in this study and all started NAC. The completion rate of NAC was 82.0%. Three patients (4.9%) developed severe liver dysfunction caused by NAC and one patient finally decided against resection. Three patients (4.9%) were judged as having progressive disease during or after NAC and did not undergo liver resection. Among 57 patients who underwent liver resection after NAC, three patients were diagnosed with CRLM by pre-treatment imaging modalities and received NAC although a final pathological diagnosis was another malignant disease or benign condition. Finally, 47 of the 54 patients (87.0%) with resected CRLM achieved R0 resection. The pathological complete response rate of the 54 patients was 13.0%, and 31.5% were judged as pathological responders. However, the R0 resection rate of 77.0% in the entire cohort did not meet the endpoint. CONCLUSIONS: NAC with SOX plus Bev has an acceptable toxicity profile and achieved a satisfactory pathological response. However, accuracy of pre-operative diagnoses and liver dysfunction caused by NAC were serious problems. Easy introduction of NAC for initially resectable CRLM should not be performed.

Laparoscopic subtotal cholecystectomy for severe cholecystitis.

BACKGROUND: The concept of laparoscopic subtotal cholecystectomy (LSC), without approaching Calot's triangle to avoid both laparotomy and serious complications, is not widely accepted. In this study, we evaluated the outcomes of LSC for severe cholecystitis when dissection of the cystic duct and cystic artery is hazardous. METHODS: From January 2004 to December 2013, 110 consecutive patients who underwent LSC without ligation of the cystic duct and vessels were enrolled in this retrospective study. Their clinical records, including operative records and outcomes, had been entered into a prospectively maintained database and were analyzed. RESULTS: The mean operating time and blood loss were 121 min and 33.8 ml, respectively. All LSCs were completed without conversion to an open procedure. No injuries to the bile duct or vessels were experienced. Postoperative complications occurred in ten (9.1%) patients, including subhepatic hematoma in 3, bile leakage in 3, and subhepatic abscess in 1. Patients recovered from complications without requiring re-operation. During follow-up periods (mean 30.7 months), symptomatic biliary stone diseases relapsed in three patients (2.7%) and were successfully treated by endoscopic management. CONCLUSIONS: LSC without an attempt to dissect Calot's triangle is a safe and feasible procedure that can avoid conversion to laparotomy.

Laparoscopic versus open surgery for complicated appendicitis in adults: a randomized controlled trial.

BACKGROUND: The aim of this study was to assess whether laparoscopic appendectomy (LA) for complicated appendicitis (CA) effectively reduces the incidence of postoperative complications and improves various measurements of postoperative recovery in adults compared with open appendectomy (OA). METHODS: This single-center, randomized controlled trial was performed in the Nagoya Daini Red Cross Hospital. Patients diagnosed as having CA with peritonitis or abscess formation were eligible to participate and were randomly assigned to an LA group or an OA group. The primary study outcome was development of infectious complications, especially surgical site infection (SSI), within 30 days of surgery. RESULTS: Between October 2008 and August 2014, 81 patients were enrolled and randomly assigned with a 1:1 allocation ratio (42, LA; 39, OA). All were eligible for study of the primary endpoint. Groups were well balanced in terms of patient characteristics and preoperative levels of C-reactive protein. SSI occurred in 14 LA group patients (33.3 %) and in 10 OA group patients (25.6 %) (OR 1.450, 95 % CI 0.553-3.800; p = 0.476). Overall, the rate of postoperative complications, including incisional or organ/space SSI and stump leakage, did not differ significantly between groups. No significant differences between groups were found in hospital stay, duration of drainage, analgesic use, or parameters for postoperative recovery except days to walking. CONCLUSION: These results suggested that LA for CA is safe and feasible, while the distinguishing benefit of LA was not validated in this clinical trial.

Efficacy of perioperative synbiotics treatment for the prevention of surgical site infection after laparoscopic colorectal surgery: a randomized controlled trial.

PURPOSE: The aim of this study was to assess the effect of perioperative oral administration of synbiotics on the surgical outcome in patients undergoing laparoscopic colorectal resection. METHODS: In this single-center randomized, controlled trial, patients scheduled to undergo elective laparoscopic colorectal surgery were eligible to participate and randomly assigned to a synbiotics group or a control group. The primary study outcome was the development of infectious complications, particularly surgical site infection (SSI), within 30 days of surgery. RESULTS: In this study, 379 patients were enrolled and randomly assigned (173 to the synbiotics group and 206 to the control group), of whom 362 patients (168 to the synbiotics group and 194 to the control group) were eligible for this study. SSI occurred in 29 (17.3%) patients in the synbiotics group and 44 (22.7%) patients in the control group (OR: 0.761, 95% CI 0.50-1.16; p = 0.20). Overall, the rate of postoperative complications, including anastomotic leakage, did not differ significantly between the two groups. Synbiotics treatment reversed the changes in fecal bacteria and organic acids after surgery and suppressed the increases in potentially pathogenic species, such as Clostridium difficile. CONCLUSION: The efficacy of perioperative administration of synbiotics was not validated as a treatment for reducing the incidence of infectious complications after laparoscopic colorectal resection. However, the microbial imbalance, in addition to the reduction in organic acids, could be improved by perioperative synbiotics treatment.

[Investigation of the neck swelling caused by accumulation of irrigation fluid during shoulder arthroscopy in the beach-chair position: second report].

BACKGROUND: Previously, we reported that pre- and postoperative measurement of the neck circumference might be an easy and useful measure for prediction of postoperative airway obstruction in shoulder arthroscopy. However, it is suggested that airway pressure to cause a cuff leak around the tracheal tube in a cuff deflated condition (cuff leak pressure) is a predictor of postoperative airway obstruction. We studied a correlation between the neck circumference and the cuff leak pressure. METHODS: Forty patients undergoing shoulder arthroscopy in the beach-chair position were included in this study. There were 30 male and 10 female patients. All patients' neck circumference and cuff leak pressure were compared pre- and postoperatively and with each other. RESULTS: There was a strong correlation between the increase of neck circumference and the increase of cuff leak pressure. CONCLUSIONS: The rate of increase in neck circumference shows the swelling of external tissue of the neck. However, it may not reflect the swelling of the internal tissue containing pharynx, larynx and retrotracheal space. Alternatively, pre- and postoperative measurement of the cuff leak pressure could be a more substantial predictor of postoperative airway obstruction than the rate of increase in neck circumference.

[Investigation of the neck swelling due to accumulation of irrigation fluid during shoulder arthroscopy in the beach-chair position].

BACKGROUND: The primary purpose of this study was to investigate the degree of neck swelling by accumulation of irrigation fluid during shoulder arthroscopy in the beach-chair position. METHODS: Twenty-one patients undergoing shoulder arthroscopy in the beach-chair position were included in this study. There were 16 male and 5 female patients, with a mean age of 58.7 +/- 16.1 years. All patients' weight and neck circumference were compared pre- and postoperatively and correlated to each other. RESULTS: There was a strong correlation between the increase rate of weight and the increase rate of neck circumference (r = 0.69, P < 0.05). CONCLUSIONS: Pre- and postoperative measurement of the neck circumference might be an easy and useful measure for prediction of postoperative airway obstruction.

Oral-to-rectum microbial transmission in orthopedic patients without a history of intestinal disorders.

The enrichment of oral taxa in the gut has recently been reported as a notable alteration in the microbial balance in patients with intestinal disorders. However, translocation in populations without such diseases remains controversial. In this study, we examined 49 pairs of tongue and rectal samples collected from orthopedic patients without a history of intestinal disorders to verify the presence of oral taxa in the rectal microbiota. The bacterial composition of each sample was determined using 16S rRNA gene sequencing and amplicon sequence variant (ASV) analysis. Although the bacterial compositions of the tongue and rectal microbiota were distinctly different, tongue ASVs were detected in 67.3% of the participants and accounted for 0.0%-9.37% of the rectal microbiota. Particularly, Streptococcus salivarius, Fusobacterium nucleatum, and Streptococcus parasanguinis were abundant in the rectal microbiota. According to the network analysis, tongue taxa, such as S. salivarius and S. parasanguinis, formed a cohabiting group with Klebsiella pneumoniae and Alistipes finegoldii in the rectal microbiota. The total abundance of tongue ASVs in the rectal microbiota was significantly higher in participants with older age, hypertension, and proton pump inhibitor (PPI) use. Our study presents an extensive translocation of oral taxa to the rectum of a population without intestinal disorders and suggests that aging, hypertension, and PPI use are associated with an increased abundance of oral taxa and potential pathogenic bacteria in the rectal microbiota.

Phase II trial of adjuvant chemotherapy with S-1 for colorectal liver metastasis.

BACKGROUND: This phase II trial was designed to evaluate the safety and efficacy of adjuvant chemotherapy with S-1 in patients with curatively resected liver metastasis from colorectal cancer. Results of an interim analysis of safety and short-term outcomes are reported. METHODS: Patients who underwent curative resection of liver metastasis from colorectal cancer received S-1 monotherapy (on days 1-28, followed by 14 days' rest, 8 cycles) as adjuvant chemotherapy. RESULTS: Among 62 patients enrolled between October 2008 and August 2010, a total of 60 patients were eligible for analysis. The most frequent grade 3 or higher hematologic toxicity involved neutropenia in three patients (5.0 %). Nonhematologic toxicities of grade 3 or higher were fatigue in 6.7 % of patients. Grade 4 enteritis occurred in one patient, but resolved promptly after withdrawal of S-1 therapy. The completion rate of the eight scheduled cycles of chemotherapy was 58.3 %. The most common reasons for withdrawal of treatment was the detection of early relapse in 16 patients (64 %). When the 16 patients who had recurrence during adjuvant treatment were excluded from analysis, 79.5 % of the remaining 44 patients completed the scheduled treatment. Early recurrence within 1 year after curative liver resection occurred in 21 patients (35 %). The most common site was the remnant liver in 14 patients. CONCLUSIONS: Orally administered S-1 after curative liver resection has an acceptable toxicity profile and a high rate of completion of the therapy. S-1 can be safely used and might be a viable treatment option in an adjuvant setting.

Neoadjuvant oxaliplatin and capecitabine and bevacizumab without radiotherapy for poor-risk rectal cancer: N-SOG 03 Phase II trial.

OBJECTIVE: This Phase II trial was designed to evaluate the safety and efficacy of neoadjuvant oxaliplatin and capecitabine and bevacizumab without radiotherapy in patients with poor-risk rectal cancer. METHODS: Patients with magnetic resonance imaging-defined poor-risk rectal cancer received neoadjuvant oxaliplatin and capecitabine and bevacizumab followed by total mesorectal excision or more extensive surgery. RESULTS: Between February 2010 and December 2011, 32 patients were enrolled in this study. The completion rate of the scheduled chemotherapy was 91%. Reasons for withdrawal were refusal to continue therapy in two patients and disease progression in one, with two of these three patients not undergoing surgery. Among the 29 patients who completed the scheduled chemotherapy, one refused surgery within 8 weeks after the completion of chemotherapy, which was the period stipulated by the protocol, and another had rectal perforation, requiring urgent laparotomy. As a result, the completion rate of this experimental treatment was 84%. Of the 30 patients who underwent surgery, the R0 resection rate was 90% and a postoperative complication occurred in 43%. A pathological complete response was observed in 13% and good tumor regression was exhibited in 37%. CONCLUSIONS: Neoadjuvant oxaliplatin and capecitabine plus bevacizumab for poor-risk rectal cancer caused a high rate of anastomotic leakage and experienced a case with perforation during chemotherapy, both of which were bevacizumab-related toxicity. Although the short-term results with the completion rate of 84.4% and the pathological complete response rate of 13.3% were satisfactory, we have to reconsider the necessity of bevacizumab in neoadjuvant chemotherapy (UMIN number, 000003507).

Clinical and oncologic safety of laparoscopic surgery for obstructive left colorectal cancer following transanal endoscopic tube decompression.

BACKGROUND: Little information has been available concerning the safety of laparoscopic resection of obstructive colorectal cancer after transanal endoscopic tube decompression (TETD). The aim of this study was to assess the short- and long-term outcomes of laparoscopic surgery following TETD for such advanced colorectal cancer. METHODS: A retrospective review was performed of 40 patients with obstructive left colorectal cancer whose distended bowels were treated with TETD before laparoscopic surgery, between January 2001 and March 2011 (TETD group). The elective surgery resulted in potentially curative resection of the tumor in all cases. Their clinical records were compared to those of 80 matched controls with nonobstructive left colorectal cancer resected laparoscopically during the same period (control group). RESULTS: Operative time, blood loss, and the rate of conversion to laparotomy were comparable between the two groups. There were no significant between-group differences in morbidity rates. Five-year overall survival rates in the TETD and control groups were 71.9 and 75.4%, respectively, with no statistical difference. Disease-free survival rates after 5 years were also similar (TETD group, 64.5% vs. control group, 66.3%). There were no significant differences between the two groups in recurrence rates and patterns. CONCLUSION: These results suggest that laparoscopic surgery following TETD is clinically and oncologically safe and could be a treatment of choice for obstructive left colorectal cancer.

Multicenter phase II study of modified FOLFOX6 as neoadjuvant chemotherapy for patients with unresectable liver-only metastases from colorectal cancer in Japan: ROOF study.

BACKGROUND: Neoadjuvant chemotherapy for unresectable colorectal liver metastases can reduce tumor size, which sometimes leads to curative resection. The aim of the present study was to identify and describe patients with initially unresectable liver-only metastases from colorectal cancer who obtained sufficient chemotherapeutic benefit that eventually lead to the removal of the metastatic diseases in the liver. METHODS: A phase II multicenter cooperative study was conducted in 38 medical institutions using modified FOLFOX6 (mFOLFOX6) as neoadjuvant chemotherapy from January 2008 to June 2009. Patients with liver-only metastases from colorectal cancer that was deemed not optimally resectable by liver surgeons received mFOLFOX6 as preoperative neoadjuvant chemotherapy for 6-8 cycles. Patients were reassessed for resectability after 6 cycles of mFOLFOX6. Surgery was carried out 3-6 weeks after chemotherapy. The primary endpoint was the rate of macroscopic curative surgery including liver resection. RESULTS: 36 patients (23 male/13 female, ECOG performance status 0-1) were enrolled. The median age of the patients was 62.5 years; 78% (28 patients) had 5 or more metastatic tumors, and 50% (18 patients) had metastatic tumors over 5 cm diameter. The mFOLFOX6 regimen was safety administered resulting in 18 partial responses (50%), 12 stable disease, and 4 progressive disease. There was no grade 3/4 neurotoxicity. Fourteen patients (38.9%) underwent surgery (R0: 13; R1: 1). Of these, thirteen patients (36.1%) underwent R0 surgery. CONCLUSIONS: Our data suggest that mFOLFOX6 has a high response rate in patients with liver-only metastases from colorectal cancer, allowing for R0 resection of liver metastases in a proportion of patients initially not judged to be optimally resectable.