Long-term results of minimally invasive transanal surgery for rectal tumors in 249 consecutive patients.

PURPOSE: To delineate the long-term results of minimally invasive transanal surgery (MITAS) for selected rectal tumors. METHODS: We analyzed data, retrospectively, on consecutive patients who underwent MITAS between 1995 and 2015, to establish the feasibility, excision quality, and perioperative and oncological outcomes of this procedure. RESULTS: MITAS was performed on 243 patients. The final histology included 142 cancers, 47 adenomas, and 52 neuroendocrine tumors (NET G1). A positive margin of 1.6% and 100% en bloc resection were achieved. The mean operative time was 27.4 min. Postoperative morbidity occurred in 7% of patients, with 0% mortality. The median follow-up was 100 months (up to ≥ 5 years or until death in 91.8% of patients). Recurrence developed in 2.9% of the patients. The 10-year overall survival rate was 100% for patients with NET G1 and 80.3% for those with cancer. The 5-year DFS was 100% for patients with Tis cancer, 90.6% for those with T1 cancer, and 87.5% for those with T2 or deeper cancers. MITAS for rectal tumors ≥ 3 cm resulted in perioperative and oncologic outcomes equivalent to those for tumors < 3 cm. CONCLUSION: MITAS is feasible for the local excision (LE) of selected rectal tumors, including tumors ≥ 3 cm. It reduces operative time and secures excision quality and long-term oncological outcomes.

Management of inguinal lymph node metastases from rectal and anal canal adenocarcinoma.

AIM: The surgical treatment of inguinal lymph node (ILN) metastases secondary to anorectal adenocarcinoma remains controversial. This study aimed to clarify the surgical treatment and management of ILN metastasis according to its classification. METHODS: This retrospective, multi-centre, observational study included patients with synchronous or metachronous ILN metastases who were diagnosed with rectal or anal canal adenocarcinoma between January 1997 and December 2011. Treatment outcomes were analysed according to recurrence and prognosis. RESULTS: Among 1181 consecutively enrolled patients who received treatment for rectal or anal canal adenocarcinoma at 20 referral hospitals, 76 (6.4%) and 65 (5.5%) had synchronous and metachronous ILN metastases, respectively. Among 141 patients with ILN metastasis, differentiated carcinoma, solitary ILN metastasis and ILN dissection were identified as independent predictive factors associated with a favourable prognosis. No significant difference was found in the frequency of recurrence after ILN dissection between patients with synchronous (80.6%) or metachronous (81.0%) ILN metastases. Patients who underwent R0 resection of the primary tumour and ILN dissection had a 5-year survival rate of 41.3% after ILN dissection (34.1% and 53.1% for patients with synchronous and metachronous ILN metastases, respectively, P = 0.55). CONCLUSION: The ILN can be appropriately classified as a regional lymph node in rectal and anal canal adenocarcinoma. Moreover, aggressive ILN dissection might be effective in improving the prognosis of low rectal and anal canal adenocarcinoma with ILN metastases; thus, prophylactic ILN dissection is unnecessary.

Robotic low anterior resection for rectal cancer with side-to-end anastomosis in a patient with anal stenosis.

BACKGROUND: Colorectal anastomosis using the double stapling technique (DST) has become a standard procedure. However, DST is difficult to perform in patients with anal stenosis because a circular stapler cannot be inserted into the rectum through the anus. Thus, an alternative procedure is required for colorectal anastomosis. CASE PRESENTATION: A 78-year-old woman presented with bloody stool. Colonoscopy and computed tomography revealed advanced low rectal cancer without lymph node or distant metastasis. We initially planned to perform low anterior resection using a double stapling technique or transanal hand-sewn anastomosis, but this would have been too difficult due to anal stenosis and fibrosis caused by a Milligan-Morgan hemorrhoidectomy performed 20 years earlier. The patient had never experienced defecation problems and declined a stoma. Therefore, we inserted an anvil into the rectal stump and fixed it robotically with a purse-string suture followed by insertion of the shaft of the circular stapler from the sigmoidal side. In this way, side-to-end anastomosis was accomplished laparoscopically. The distance from the anus to the anastomosis was 5 cm. The patient was discharged with no anastomotic leakage. Robotic assistance proved extremely useful for low anterior resection with side-to-end anastomosis. CONCLUSION: Performing side-to-end anastomosis with robotic assistance was extremely useful in this patient with rectal cancer and anal stenosis.

Outcomes of stapler repair with anastomosis for stoma prolapse.

PURPOSE: The published data on the outcomes of an operative repair for stoma prolapse are limited. This study aimed to clarify the long-term outcomes of stapler repair with anastomosis for stoma prolapse. METHODS: Twenty-four patients (15 men, median age 64 years, range 33-88 years) undergoing 25 stapler repairs with anastomosis were prospectively registered, and their medical records were retrospectively reviewed. RESULTS: The median length of prolapse was 10 cm (range 5-22). Stoma prolapse repair was performed by means of 16 loop colostomies, four end colostomies, three loop ileostomies, and one end ileostomy. A stapler was used 4.6 times on average (range 4-8). The average operative time and bleeding were 40.8 (range 15-75) min and 40 (range 0-214) mL, respectively. No mortality and morbidity were observed after surgery. A recurrence of stoma prolapse was reported in only one of 25 repairs (4%) at the proximal limb of loop ileostomy during a median follow-up period of 1 year (range 1-120 months). However, a new stoma prolapsed in one untreated limb of loop stoma. CONCLUSIONS: Stapler repair with anastomosis is a safe and minimally invasive treatment option for stoma prolapse with a low recurrence. However, the effectiveness of reparing stoma prolapse on the proximal limb of loop ileostomy might be limited.

Transvaginal peritoneocele repair with anterior levatorplasty for patients with a rectocele and an enterocele.

Enteroceles and rectoceles are often identified as the cause of a vaginal mass and pelvic discomfort. The combination of a rectocele and an enterocele as pelvic organ prolapses is not infrequent; however, there are few reports on possible simultaneous treatments of these two conditions. We report a new and simple procedure for repairing an enterocele during a transvaginal anterior levatorplasty with posterior colporrhaphy for a rectocele repair. This technique involves making an excision in the peritoneal sac, with high ligation, and attaching the uterine cervix and/or cardinal ligament to the upper most part of the approximation of the levator muscles, to reinforce and lift the deep peritoneal sac. This procedure allows for transvaginal repair of both an enterocele and a rectocele. The enterocele is visualized by applying barium to the posterior vaginal wall during defecography.

Factors affecting R0 resection of colorectal cancer with synchronous peritoneal metastases: a multicenter prospective observational study by the Japanese Society for Cancer of the Colon and Rectum.

BACKGROUND: In Japan, R0 resection has been recommended for colorectal cancer patients with peritoneal metastases confined to the adjacent peritoneum and those with a few metastases to the distant peritoneum. R0 resection for M1c disease has drawn attention in Western countries and is currently considered an acceptable therapeutic option in the US National Comprehensive Cancer Network guidelines. However, clinical factors that affect the choice of R0 resection are unknown. METHODS: This multicenter, prospective, observational study was conducted by the Japanese Society for Cancer of the Colon and Rectum. Colorectal cancer patients with synchronous peritoneal metastases were enrolled at 28 institutions in Japan from October 2012 to December 2016. To determine factors affecting R0 resection and R1 resection with intended R0 resection, stepwise logistic regression analyses were performed on clinical factors including age, sex, performance status (PS), body mass index, peritoneal cancer index (PCI) score, presence of ascites, presence of distant metastases, and primary tumor site. RESULTS: R0/R1 resection was performed in 36 (31/5; 25%) of 146 patients. No distant metastases [odds ratio (OR) 52.9; 95% confidence interval (CI) 13.3-210.1; p < 0.0001], low PCI score (1-6) (OR 20.0; 95% CI 4.8-83.4; p < 0.0001), and high PS (0) (OR 2.40; 95% CI 0.66-8.68; p = 0.18) were independent factors affecting R0/R1 resection. PCI score and PS were also independent factors affecting R0/R1 resection in M1c patients without non-peritoneal distant metastases (n = 59). CONCLUSION: Distant metastases, PCI score, and PS are three factors which affect R0 resection for M1c disease.

Exfoliated cancer cells during intersphincteric resection for very low rectal cancer.

PURPOSE: To investigate the frequency of exfoliated cancer cells and the efficacy of rectal washout during intersphincteric resection (ISR) in patients not receiving chemoradiotherapy (CRT) for very low rectal cancer. METHOD: The subjects of this prospective study were 16 consecutive patients who underwent ISR without CRT for very low rectal cancer. Brushing cytology of the posterior anorectal wall was performed twice in each step of the ISR procedure and the samples were sent for blind cytological examination to identify exfoliated cancer cells. RESULTS: Exfoliated cancer cells were identified in 9 of 13 patients (69%) preoperatively. The number of cancer cells identified after abdominal total mesorectal dissection decreased significantly from 94% (15/16) to 25% (4/16) after transanal irrigation with 2000 mL saline (p < 0.001). No cancer cells were identified after swabbing the anal wall following transanal dissection with purse-string closure of the distal stump. No suture-line recurrence was found during a median follow-up duration of 6 years. CONCLUSION: Exfoliated cancer cells, confirmed in 94% of patients after total mesorectal excision, could be eliminated by performing rectal irrigation after clamping the rectum proximal to the tumor and swabbing the anorectal wall during ISR.

Short- and long-term outcomes of robotic surgery for rectal cancer: a single-center retrospective cohort study.

PURPOSE: This study aimed to clarify the short- and long-term outcomes of robotic surgery with or without lateral lymph node dissection (LLND) for rectal cancer at Fujita Health University Hospital, Aichi, Japan, during a self-pay period. METHODS: We retrospectively evaluated 115 consecutive patients who underwent robotic surgery for rectal cancer between September 2009 and March 2018, with a median follow-up period of 48 months. Total mesorectal excision was completed by two certified surgeons using a da Vinci S, Si, or Xi Surgical System with an entirely robotic single-docking technique. The surgical and pathological outcomes, morbidity, and oncological results were examined. RESULTS: Lateral lymph node dissection was performed in 26 patients (22.6%). Neither conversion to open surgery nor perioperative blood transfusion occurred. Ten patients (8.7%) experienced Clavien-Dindo grade III postoperative complications. Pathologically, both the distal and radial margins were negative in all cases. The 5-year relapse-free survival rates for stages I, II, III, and IV were 93.5%, 100%, 83.8%, and not reached, respectively. CONCLUSIONS: Even in the period before coverage by the health insurance system, robotic surgery for rectal cancer performed by experienced surgeons was safe and technically feasible, with favorable perioperative results and long-term oncological outcomes, including rates of the relapse-free survival.

Analysis of gender-based differences among surgeons in Japan: results of a survey conducted by the Japan Surgical Society. Part. 2: personal life.

PURPOSE: To assess the true conditions and perceptions of the personal lives of men and women working as surgeons in Japan. METHODS: In 2014, all e-mail subscribed members of the Japan Surgical Society (JSS, n = 29,861) were invited to complete a web-based survey. The questions covered demographic information, work environment, and personal life (including marital status, childcare, and nursing care for adult family members). RESULTS: In total, 6211 surgeons (5586 men and 625 women) returned the questionnaires, representing a response rate of 20.8%. Based on the questionnaire responses, surgeons generally prioritize work and spend most of their time at work, although women with children prioritize their family over work; men spend significantly fewer hours on domestic work/childcare than do their female counterparts (men 0.76 h/day vs. women 2.93 h/day, p < 0.01); and both men and women surgeons, regardless of their age or whether they have children, place more importance on the role of women in the family. CONCLUSIONS: The personal lives of Japanese surgeons differed significantly according to gender and whether they have children. The conservative idea that women should bear primary responsibility for the family still pertains for both men and women working as surgeons in Japan.

Analysis of gender-based differences among surgeons in Japan: results of a survey conducted by the Japan Surgical Society. Part 1: Working style.

PURPOSE: To assess the working styles of men and women working as surgeons in Japan. METHODS: In July, 2014, the Japan Surgical Society invited all their members (n = 29,861), through an internet campaign, to participate in a nationwide survey of surgeons. The items investigated in this descriptive study included demographic information and working styles, based on a questionnaire. RESULTS: In total, 6211 surgeons participated (response rate 20.8%, 5586 men and 625 women). The largest age stratum was 40-49 years for men and 30-39 years for women. Overall, respondents identified their labor contract, including salary and work hours, as the highest priority for improvement. Women with children were more likely to be part-time employees, work fewer hours, and take fewer house calls/on-calls than their male counterparts. Moreover, women of all ages earned a lower annual income than men, irrespective of whether they had children. Perception scores for discrimination related to work and promotion were significantly higher among women than men (p < 0.01 and p = 0.011, respectively). CONCLUSIONS: A significant difference in working style was observed between men and women working as surgeons in Japan.

Clinicopathological Factors Associated with Recurrence and Prognosis after R0 Resection for Stage IV Colorectal Cancer with Peritoneal Metastasis.

BACKGROUND/AIMS: Peritoneal metastasis (PM) is a well-known predictor of poor prognosis. This study aims at identifying factors affecting recurrence and prognosis after R0 resection for colorectal cancer (CRC) with synchronous PM. METHODS: A multi-institutional, retrospective analysis of 172 patients with R0 surgery for CRC with PM was conducted. Clinicopathological variables were analyzed for their significance in contributing toward recurrence and prognosis. RESULTS: Lymph node (LN) metastasis was an independent factor affecting recurrence as indicated by logistic regression analyses. The following factors were independent predictors of poor prognostic using the Cox proportional hazard model: LN metastasis, no postoperative adjuvant chemotherapy, five or fewer dissected LNs, and preoperative high serum carbohydrate antigen 19-9 levels. Of the patients undergoing postoperative adjuvant chemotherapy, no significant differences were observed in recurrence rate and disease-free interval between those with intensive adjuvant chemotherapy and those with non-intensive chemotherapy. After R0 surgery for PM, 90 patients (76.3%) experienced recurrence by 18 months, and hematogenous recurrence occurred significantly more often than peritoneal recurrence. CONCLUSION: Harvesting of more than 5 LNs and administration of postoperative adjuvant chemotherapy after R0 surgery are recommended for prognosis improvement. Intensive follow-up should be performed within 18 months after R0 surgery for CRC with synchronous PM.

Prognoses and treatment strategies for synchronous peritoneal dissemination of colorectal carcinoma.

PURPOSE: We devised a simple dichotomous classification system and showed sufficient reproducibility to indicate treatment strategies for peritoneal metastasis of colorectal cancer. METHODS: We included 67 patients with peritoneal metastasis of colorectal cancer and classified them according to the largest lesion size, number of lesions and number of regional peritoneal metastases. The oncological data were recorded and compared. RESULTS: According to the univariate analyses, the prognoses were significantly better in patients with ≤3 disseminated lesions than in those with ≥4, and in patients with disseminated lesions in only one region than in those with ≥2 lesions. A multivariate analysis showed that primary tumor resection and the presence of peritoneal metastases in only one region were favorable factors for the patient survival. Patients with disseminated lesions in only one region (localized group) and those with nonlocalized lesions had three-year survival rates of 45.6 and 12.2 %, respectively. Finally, primary tumor resection improved the prognoses in both the localized and nonlocalized groups. CONCLUSIONS: Colorectal cancer patients were categorized into localized and nonlocalized groups according to the number of regions with peritoneal metastasis, and significant prognostic associations were demonstrated. Subsequent analyses of the oncological data suggested that primary tumor resection contributes to an improved prognosis in all patients with synchronous peritoneal metastases.

Effects of robotic rectal surgery on sexual and urinary functions in male patients.

PURPOSES: This study prospectively assessed the sexual and urinary functions, as well as factors influencing these functions, in patients who underwent open or robotic surgery for rectal cancer. METHODS: Forty-five consecutive male patients who underwent rectal resection for rectal cancer were prospectively enrolled in this study. Their sexual and urinary functions were assessed through self-administered questionnaires comprising the International Index of Erectile Function (IIEF; sexual function) and the International Prostate Symptom Score (IPSS; urinary function) before and at 3, 6, and 12 months after surgery. RESULTS: Fifteen patients who underwent robotic surgery and 22 who underwent open surgery were finally analyzed in this study. The total IIEF score and the individual score items did not change at 3, 6 or, 12 months after open or robotic surgery compared with the preoperative values. However, a univariate analysis revealed that age affected the urinary function 12 months after surgery, while both univariate and multivariate analyses revealed that postoperative complications affected the sexual function 12 months after surgery. CONCLUSIONS: In this non-randomized comparison, the postoperative sexual and urinary functions were comparable between patients who underwent open rectal surgery and those who underwent robotic rectal surgery. Postoperative complications were a risk factor for sexual dysfunction, while age was a risk factor for urinary dysfunction.

[Clinical Significance of Lateral Lymph Node Dissection for Stage â £ Low Rectal Cancer].

We reviewed the clinical records of 81 patients with stage Ⅳ low rectal carcinoma (LRC) (25 Cur B surgeries and 56 Cur C surgeries) to evaluate the effectiveness of lateral lymph node dissection (LLND) by comparing the treatment outcomes with those of patients with stage Ⅲ LRC. Mesenteric lymph node metastasis was a risk factor for local recurrence in a multivariate analysis. There were no significant differences in the frequency of lateral node metastasis, local recurrence rate, or prognosis between Cur B and stage Ⅲ LRC patients. We suggest that LLND effectively improves prognosis as well as local control in Cur B patients. In Cur C patients, prognosis was poor regardless of lateral node metastasis. However, in patients with lateral node metastasis, there were no significant differences in between the Cur C (25.0%), Cur B, and stage Ⅲ groups, suggesting that LLND improves local control in Cur C patients with lateral node metastasis. Although the local recurrence rate was high (71.4%) in Cur C patients without lateral node metastasis, fewer lateral lymph nodes were harvested in these patients than in those with lateral node metastasis. Our results indicate that further examination of the local control effects of LLND in Cur C patients is necessary.

When is local excision appropriate for "early" rectal cancer?

Local excision is increasingly performed for "early stage" rectal cancer in the US; however, local recurrence after local excision has become a controversial issue in Western countries. Local recurrence is considered to originate based on the type of tumor and procedure performed, and in surgical margin-positive cases. This review focuses on the inclusion criteria of "early" rectal cancers for local excision from the Western and Japanese points of view. "Early" rectal cancer is defined as T1 cancer in the rectum. Only the tumor grade and depth of invasion are the "high risk" factors which can be evaluated before treatment. T1 cancers with sm1 or submucosal invasion <1,000 µm are considered to be "low risk" tumors with less than 3.2 % nodal involvement, and are considered to be candidates for local excision as the sole curative surgery. Tumors with a poor tumor grade should be excluded from local excision. Digital examination, endoscopy or proctoscopy with biopsy, a barium enema study and endorectal ultrasonography are useful for identifying "low risk" or excluding "high risk" factors preoperatively for a comprehensive diagnosis. The selection of an initial local treatment modality is also considered to be important according to the analysis of the nodal involvement rate after initial local treatment and after radical surgery.

Intraluminal exfoliated cancer cells and effectiveness of bowel ligatures during sigmoidectomy for sigmoid colon cancer.

PURPOSES: To establish the efficiency of bowel ligatures in colon cancer surgery, focusing on the extent to which exfoliated cancer cells are shed in the colonic lumen during sigmoidectomy. METHODS: Twenty consecutive patients who underwent sigmoidectomy for sigmoid colon cancer were prospectively randomized into two groups: the "ligatures group", in which bowel ligatures were placed, 3, 5, 10 cm from the tumor proximally and distally before dissection; and the "no ligatures group", in which the corresponding sites were ligated only immediately before taking the specimen out. Each colonic segment ligated was irrigated with saline and samples were sent for blind cytological examination. RESULTS: Cancer cells were found in the colonic segment where the tumor was located, in 18 of 20 samples. The frequency of free cancer cells decreased from 50 to 0 % (p < 0.04) in the distal 3-5 cm colonic segment and from 80 to 20 % (p < 0.03) in the proximal colonic segment after performing bowel ligatures. Free cancer cells were confirmed in 1 of 10 samples at both colonic segments 5-10 cm from the tumor, even after bowel ligatures. CONCLUSIONS: Intraluminal exfoliated cancer cells could be eliminated by placing bowel ligatures during sigmoidectomy. Measures should be considered to eliminate exfoliated cancer cells during colectomy, even after placing bowel ligatures.

Risk factors for surgical site infection in Japanese patients with ulcerative colitis: a multicenter prospective study.

PURPOSE: A prospective, multicenter, observational study was performed to investigate the risk factors of surgical site infection (SSI) in patients with ulcerative colitis (UC). METHODS: From 2009 to 2010, perioperative clinicopathological data were collected from patients who had undergone surgery for UC within the research period, for up to 6 consecutive months in 13 hospitals in Japan. The primary outcome was the development of SSI. RESULTS: A total of 195 patients with UC who underwent colorectal surgery were enrolled. SSI was diagnosed in 38 (19.5 %) patients, in the form of incisional infection in 23 (11.8 %), organ/space infection in 16 (8.2 %), and both in 1 (0.5 %). There were no significant risk factors associated with an increased risk of development of incisional SSI. An American Society of Anesthesiologists physical status of ≥ 3 was indicated as the only significant risk factor for organ/space SSI (P = 0.02) compared with other factors, such as a neutrophil count of >100 × 10(2)/mm(3), albumin level of <3.5 g/dl, perioperative packed red blood cell transfusion, fair or poor colonic cleanliness, and therapeutic use of antibiotics. CONCLUSION: Poor general physical status was the significant independent risk factor for organ/space SSI in patients with UC in Japan.

Relapse of minimal change disease following the third mRNA COVID-19 vaccination: a case report and literature review.

Mass vaccination is the most important strategy to terminate the coronavirus disease 2019 (COVID-19) pandemic. Reports suggest the potential risk of the development of new-onset or relapse of minimal change disease (MCD) following COVID-19 vaccination; however, details on vaccine-associated MCD remain unclear. A 43-year-old man with MCD, who had been in remission for 29 years, developed nephrotic syndrome 4 days after receiving the third dose of the Pfizer-BioNTech vaccine. His kidney biopsy revealed relapsing MCD. Intravenous methylprednisolone pulse therapy followed by oral prednisolone therapy was administered, and his proteinuria resolved within 3 weeks. This report highlights the importance of careful monitoring of proteinuria after COVID-19 vaccination in patients with MCD, even if the disease is stable and no adverse events occurred during previous vaccinations. Our case report and literature review of COVID-19 vaccine-associated MCD indicated that MCD relapse tends to occur later after vaccination and slightly more often following the second and subsequent vaccine doses than new-onset MCD.

Hypereosinophilia-associated acute intradialytic hypotension: a report of three cases and literature review.

Occasionally, patients undergoing dialysis develop acute severe hypotension that requires interruption of dialysis within minutes of initiating every dialysis session. Although the underlying causes of recurrent intradialytic hypotension are evaluated extensively, including dialysis-associated allergic reactions or other possible causes, the definitive cause is sometimes missed. Dialysis is a life-sustaining procedure; therefore, prompt identification and management of the underlying cause of dialysis intolerance are crucial. Herein, we report three cases of patients undergoing dialysis who presented with hypereosinophilia-associated acute intradialytic hypotension. All three patients developed acute severe hypotension within minutes after the start of every dialysis session. The prescriptions for dialysis were changed, but episodes of intradialytic hypotension persisted. Pretreatment with methylprednisolone given intravenously before the dialysis session was also ineffective. All patients had hypereosinophilia (> 1500/µL) of different etiology. Eosinophil-lowering therapy with 0.5 mg/kg of prednisolone given orally daily was initiated, and all of them could restart dialysis without any hypotensive episodes within a few days. Our case report and literature review indicated that hypereosinophilia, regardless of its etiology, could result in severe acute hypotension shortly after the start of dialysis session. The oral administration of prednisolone daily was highly effective on hypereosinophilia-associated intradialytic hypotension, while pretreatment with intravenous corticosteroid therapy just before dialysis had no effect. Hypereosinophilia-associated acute intradialytic hypotension is an under-recognized condition; therefore, clinicians need to be aware of this clinical entity and initiate effective treatment strategies. We also provide a brief summary of previously published cases.

Phase II clinical study of modified FOLFOX7 (intermittent oxaliplatin administration) plus bevacizumab in patients with unresectable metastatic colorectal cancer-CRAFT study.

PURPOSE: Continuous treatment with FOLFOX therapy is associated with peripheral nerve toxicity, and to improve this inconvenient side effect various methods of administration are being investigated. A regimen of intermittent oxaliplatin administration by continuous infusion therapy, i.e., modified FOLFOX7 (mFOLFOX7) + bevacizumab, was designed with the goal of alleviating severe peripheral nerve disorders and hematological toxicity. A phase II clinical study was conducted to evaluate the efficacy and safety of this regimen. METHODS: Previously untreated patients were assigned to mFOLFOX7 (oxaliplatin 85 mg/m(2), levofolinate [l-LV] 200 mg/m(2), 5-fluorouracil [5-FU] 2400 mg/m(2)) + bevacizumab (5 mg/kg) administered every 2 weeks for 8 cycles, maintenance without oxaliplatin for 8 cycles, and reintroduction of mFOLFOX7 + bevacizumab for 8 cycles or until disease progression. Progression free survival (PFS) following the first dose (PFS 1) and following reintroduction of oxaliplatin (PFS 2) were used as indices for assessing the efficacy of intermittent administration. RESULTS: Fifty-two patients were enrolled, with median age of 64 years (range, 36-74). Median PFS 1 was 11.8 months (95 % confidence interval [CI], 9.5 to 13.7), median time to treatment failure was 10.3 months (95 % CI, 5.6 to 12.1), percentage of patients with neutropenia of grade 3 or higher was 7.8 %, and percentage with peripheral nerve disorders was 3.9 %. Response rate was 50 %, and 84.4 % of patients who started modified simplified LV5FU2 + bevacizumab were reintroduced to oxaliplatin. CONCLUSION: By excluding 5-FU bolus administration and administering bevacizumab continuously the mFOLFOX7 + bevacizumab regimen with preplanned withdrawal of oxaliplatin showed high tolerability and prevented severe peripheral neuropathy and neutropenia without reducing efficacy.