[Results of Watch and Wait after Chemoradiotherapy for Locally Advanced Rectal Cancer].

BACKGROUND: Watch and wait(W & W)for rectal cancer after chemoradiotherapy(CRT)is attracting attention. PURPOSE: To examine regimens and indications from the results of follow-up of cases undergoing W & W in our department. MATERIALS AND METHODS: CRT(SOX therapy 2-5 cycles, 45 Gy)was performed on patients with lower rectal cancer over a period of 2016 to 2020, and 7 patients with clinical complete response(cCR)were followed up. RESULTS: With a median follow-up of 33 months(10-74), 4 of 7 patients(57.1%)remained in cCR. Two patients had local relapse more than a year after the start of treatment, were able to undergo salvage surgery, and are alive after surgery. Patients with lateral lymph node metastasis before CRT had para-aortic lymph node metastasis at 8 months. CONCLUSIONS: Patients with maintained cCR were those with localized, node-negative disease. On the other hand, in patients with lymph node metastasis, including lateral metastasis, it was not possible to perform salvage surgery due to distant metastasis. Careful case selection and follow-up are necessary in the future.

[A Case of the Huge GIST in the Transverse Colon Mesentery with Intra-Tumoral Hemorrhage and Jejunal Infiltration].

A 38-year-old woman was admitted to our hospital due to severe anemia. CT showed a 13×12 cm tumor with moderately enhanced wall thickening in the right upper abdomen. The huge tumor located adjacent to the jejunum and compressed the right transverse colon. Hemorrhagic necrosis and air were observed within the tumor, suspecting tumor penetration into the jejunum. The patient was diagnosed with abdominal GIST with jejunal infiltration. Laparotomy revealed a 13× 11 cm solid mass with intra-tumoral hemorrhage and invasion into the jejunum, located in the transverse mesocolon. Tumor resection combined with partial jejunectomy and transverse colectomy were performed. Immunohistochemical findings of the resected specimen was positive for c-kit and DOG-1, and the MIB-1 positive rate was 10%. Three weeks after the operation, re-anastomosis was performed due to transverse colon anastomotic stricture. She was discharged 45 days after first operation. Currently, 9 months after the operation, patient has been prescribed imatinib and is alive without recurrence.

Analysis of Circulating DNA to Assess Prognoses for Metastatic Colorectal Cancer Patients Treated with Regorafenib Dose-Escalation Therapy: A Retrospective, Exploratory Analysis of the RECC Trial.

INTRODUCTION: Regorafenib is a multi-kinase inhibitor approved for patients with metastatic colorectal cancer (mCRC) who were previously treated with standard therapies. A few reports showed the impact of KRAS mutation on therapeutic efficacy of regorafenib. Only one study reported poor prognoses for patients treated with regorafenib who had large amounts of circulating cell-free DNA (cfDNA). In the present study, we evaluated the impact of KRAS mutations in tissue or plasma and amounts of cfDNA on prognoses of mCRC patients treated with regorafenib. METHOD: This is a biomarker investigation of the RECC study, which evaluated efficacy of regorafenib dose-escalation therapy. Plasma samples were obtained just before initiation of treatment with regorafenib. KRAS mutations were evaluated using tissue and plasma samples. cfDNA was extracted from plasma samples and quantified. RESULTS: Forty-five patients were enrolled in this biomarker study. Median progression-free survival (PFS) and overall survival (OS) of patients without KRAS mutations in tissues were 1.9 months (95% confidence interval [CI] 1.7-2.0) and 8.9 months (95% CI: 6.5-11.2), and those of patients with KRAS mutations were 1.4 months (95% CI: 1.3-1.5) and 6.8 months (95% CI: 5.0-8.5). Median PFS and OS of patients with plasma KRAS mutations were 1.9 months (95% CI: 1.8-1.9) and 7.0 months (95% CI: 5.3-8.7), respectively. Median PFS and OS of patients without plasma KRAS mutations were 1.7 months (95% CI: 1.1-2.3) and 8.9 months (95% CI: 6.7-11.2), respectively. Prior to administration of regorafenib, KRAS mutations were detected in 6 of 16 (37.5%) patients who had no tissue KRAS mutations. Median OS of patients with high cfDNA concentration (>median) was significantly poorer than that of patients with low cfDNA. CONCLUSION: KRAS mutations in the tissue or plasma have no impact on efficacy of regorafenib. KRAS emerging mutations were observed in quite a few patients. Large amounts of cfDNA may indicate poorer prognoses for patients receiving late-line regorafenib chemotherapy.

[A Case of Pancreatic Tail Cancer Causing Gastrointestinal Hemorrhage Due to Transverse Colon Invasion].

An 81-year-old woman was admitted to our hospital due to frequent bleeding and hemorrhagic shock. Blood tests revealed anemia and contrast-enhanced abdominal CT revealed a pancreatic tail tumor with a diameter of 60 mm. The boundary between pancreatic tumor and the transverse colon, stomach and spleen was unclear, and invasion of the transverse colon as well as the stomach and spleen was suspected. Hemorrhage due to colon invasion of the pancreatic tail cancer and intra-tumoral hemorrhage were suspected. Due to persistent bleeding, the patient had emergency surgery to control bleeding. The pancreatic tail tumor invaded not only the colon but also stomach and spleen, distal pancreatectomy, partial gastrectomy and splenectomy was performed in combination with resection of the transverse colon, and transverse colon colostomy. We report a case of gastrointestinal bleeding caused by transverse colon invasion of pancreatic tail cancer, which resulted in emergency surgery.

[A Case of Perihilar Cholangiocarcinoma with Postoperative Hepatic Encephalopathy Due to Portosystemic Shunt Treated by Percutaneous Embolization].

An 83-year-old woman developed jaundice, and was diagnosed as perihilar cholangiocarcinoma. Abdominal contrast- enhanced CT revealed coexisting portosystemic shunt between portal vein and inferior vena cava, however, her blood ammonia level was normal. She underwent right hemihepatectomy and caudate lobectomy combined with extrahepatic bile duct resection and portal vein resection. Postoperatively, hyperammonemia refractory to conservative treatment was observed. The blood ammonia level increased to 180µg/dL and she was suffered from grade Ⅲ hepatic encephalopathy on the 20th postoperative day. CT showed an increase in the diameter of the portosystemic shunt, while there was only a slight increase in the remnant left lobe of the liver. These findings indicated that hepatic encephalopathy was caused by increased portosystemic shunt blood flow and decreased portal venous flow. Hepatic encephalopathy was rapidly improved by percutaneous transhepatic portosystemic shunt obliteration.

Efficacy and safety of regorafenib dose-escalation therapy for Japanese patients with refractory metastatic colorectal cancer (RECC study).

BACKGROUND: Regorafenib significantly improves overall survival in previously treated metastatic colorectal cancer patients. However, various toxicities, such as hand-foot skin reaction (HFSR), fatigue, and liver dysfunction have limited the use of regorafenib. These toxicities appear soon after treatment initiation. The ReDOS study demonstrated the effectiveness of a weekly dose-escalation therapy of regorafenib starting with a lower daily dose; however, its usefulness in Asian subjects is unknown. We conducted a phase II study to evaluate the safety and survival benefit of regorafenib dose-escalation therapy for Japanese patients. METHODS: Patients with sufficient organ function, who had previously received more than two lines of chemotherapy were included. Regorafenib was started at 80 mg/day and escalated to 120 mg/day in Week 2 and 160 mg/day in Week 3, if no severe drug-related toxicities were observed. The primary endpoint was cancer progression-free survival (PFS). Tumor response and progression were assessed radiologically every 8 weeks. This study was registered in the University Hospital Medical Information Network (UMIN#UMIN000028933). RESULTS: 57 patients were enrolled and all started regorafenib at 80 mg/day. 32 patients (56.1%) were subsequently escalated to 120 mg/day and 19 (33.3%) to 160 mg/day. Only 8 patients (14.0%) discontinued treatment because of adverse events. Median PFS was 1.9 months. Median overall survival was 8.9 months, the response rate was 0%, and the disease control rate was 31.6%. The most frequent adverse event greater than grade 3 was hypertension (19.3%), followed by HFSR (14.0%). CONCLUSIONS: Regorafenib dose-escalation therapy is well tolerated with PFS-like regorafenib standard therapy.

Biweekly TAS-102 and bevacizumab as third-line chemotherapy for advanced or recurrent colorectal cancer: a phase II, multicenter, clinical trial (TAS-CC4 study).

BACKGROUND: TAS-102 improves overall survival (OS) of patients with refractory colorectal cancer (CRC), resulting in median progression-free survival (PFS) of 2.0 months (RECOURSE trial). Subsequently, a combination of TAS-102 and bevacizumab was shown to extend median PFS by 3.7 months. However, approximately half of these patients experience grade 3/4 neutropenia. In this study, we evaluated whether biweekly TAS-102 and bevacizumab therapy has efficacy equal to that of conventional TAS-102 and bevacizumab therapy and whether it reduces adverse hematological effects. METHODS: This phase II, investigator-initiated, open-label, single-arm, multicenter study was conducted in Japan. Eligible patients had previously received first- and second-line chemotherapy for metastatic CRC. TAS-102 (35 mg/m2) was given twice daily on days 1-5 and days 15-19 in a 4-week cycle, and bevacizumab (5 mg/kg) was administered by intravenous infusion for 30 min every 2 weeks. The primary end point was progression-free survival (PFS), and secondary end points were time-to-treatment failure (TTF), response rate (RR), OS, and safety. RESULTS: 44 patients with metastatic colorectal cancer were enrolled in this study. Median PFS was 4.6 months (95% confidence interval [95% CI] 3.6-5.3) and median OS was 10.5 months (95% CI 9.6-11.4). A partial response was observed in 2 patients (4.5%, 95% CI 0.4-16.0%). The most common adverse event above grade 3 was neutropenia (7 patients, 15.9%, 95% CI 7.6-29.7%). CONCLUSIONS: Biweekly TAS-102 and bevacizumab therapy as third-line chemotherapy appears as effective as conventional TAS-102 and bevacizumab therapy, and this approach reduces adverse hematological effects.

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

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

Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy in patients with metastatic colorectal cancer (VOICE trial).

PURPOSE: The aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned intermittent oxaliplatin strategy in metastatic colorectal cancer (mCRC). METHODS: Patients with untreated mCRC were administered CAPOX (130 mg/m2 oxaliplatin on day 1, 2000 mg/m2/day capecitabine on days 1-14, every 21 days) + bevacizumab (7.5 mg/kg) every 3 weeks for five cycles, maintenance treatment without oxaliplatin for five cycles, and CAPOX + bevacizumab reintroduction for five cycles or upon tumor progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety. RESULTS: Forty-seven patients who fulfilled the inclusion criteria were enrolled in the evaluation of efficacy and safety. Median PFS was 14.1 months (95% confidence interval [CI], 8.6-19.5), and median TTF was 12.3 months (95% CI, 10.3-14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%. CONCLUSION: CAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief five-cycle induction therapy, five-cycle maintenance therapy with capecitabine plus bevacizumab, and five-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients. TRIAL REGISTRATION: UMIN ID: 000,005,732, date of registration: June 7, 2011.  https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006695.

Preoperative Neutrophil-to-Lymphocyte Ratio may Predict Postoperative Pneumonia in Stage I-III Gastric Cancer Patients After Curative Gastrectomy: A Retrospective Study.

BACKGROUND: Several studies have demonstrated that diverse systemic inflammatory-based prognostic parameters predict a poor prognosis in patients with gastric cancer. However, few studies have focused on the relationships between postoperative complications and systemic inflammatory-based prognostic parameters after curative gastrectomy. We investigated the relationships between postoperative complications and these parameters and assessed the clinical utility of the parameters as predictors of postoperative complications in patients with stage I-III gastric cancer. METHODS: We retrospectively reviewed 300 patients who underwent curative gastrectomy for stage I-III gastric cancer. All postoperative complications were classified as infectious or noninfectious. We evaluated the relationships between postoperative complications and clinical factors, including systemic inflammatory-based prognostic parameters. RESULTS: In total, 101 patients (33.7%) had postoperative Clavien-Dindo grade II-IV complications, and 54 (18.0%) patients developed infectious complications including pancreatic fistula, pneumonia, anastomotic leak, intra-abdominal abscess, and cholecystitis. The relationships between postoperative complications and systemic inflammatory-based prognostic parameters were evaluated by the areas under the receiver operating characteristic curves. Postoperative pneumonia was identified as the most sensitive complication to the systemic inflammatory-based prognostic parameters. Multivariate analysis revealed that preoperative neutrophil-to-lymphocyte ratio (odds ratio, 14.621; 95% confidence interval, 1.160-184.348; p = 0.038) was an independent predictor of pneumonia. CONCLUSIONS: Preoperative neutrophil-to-lymphocyte ratio may be a useful predictor of postoperative pneumonia in patients with stage I-III gastric cancer after curative gastrectomy.

Combination of TAS-102 and bevacizumab as third-line treatment for metastatic colorectal cancer: TAS-CC3 study.

BACKGROUND: TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial. Subsequently, the combination of TAS-102 and bevacizumab was shown to extend the median PFS (C-TASK FORCE study). However, the study included patients who received second- and third-line treatment. Our study exclusively examined patients receiving this combination as a third-line treatment to investigate the clinical impact beyond cytotoxic doublets. METHODS: This investigator-initiated, open-label, single-arm, multi-centered phase II study was conducted in Japan. Eligible CRC patients were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin in first- and second-line therapy. TAS-102 (35 mg/m2) was given orally twice daily on days 1-5 and 8-12 in a 4-week cycle, and bevacizumab (5 mg/kg) was administered by intravenous infusion every 2 weeks. The primary endpoint was PFS and the secondary endpoints were time-to-treatment failure, response rate, overall survival (OS), and safety. RESULTS: Between June 2016 and August 2017, 32 patients were enrolled. All patients previously received bevacizumab. The median PFS was 4.5 months; the median overall survival was 9.3 months. Partial response was observed in two patients. The most common adverse events above grade 3 were neutropenia followed by thrombocytopenia. There were no non-hematological adverse events above grade 3 and no treatment-related deaths occurred. CONCLUSIONS: This study met its primary endpoint of PFS, which is comparable to the results of the C-TASK FORCE study. The TAS-102 and bevacizumab combination has the potential to be a therapeutic option for third-line treatment of metastatic CRC.

A Novel Parameter Identified Using Indocyanine Green Fluorescence Angiography may Contribute to Predicting Anastomotic Leakage in Gastric Cancer Surgery.

BACKGROUND: Anastomotic leak is one of the most serious postoperative complications, and intraoperative adequate perfusion plays a key role in preventing its development in gastric cancer surgery. This study aimed to investigate the relationships between anastomotic leak and the parameters defined by an assessment of intraoperative anastomotic perfusion using a near-infrared indocyanine green (ICG) fluorescence system and to evaluate the usefulness of this ICG fluorescence assessment in gastric cancer surgery. METHODS: We retrospectively reviewed data of 100 patients who underwent gastric cancer surgery. In a visual assessment based on fluorescence intensity, we classified ICG fluorescence image patterns as homogeneous, heterogeneous, or faint. In a chronological assessment, the first or second time point of ICG fluorescence appearance on one or the other side of the anastomosis was defined as FT or ST, respectively. The time difference in ICG fluorescence appearance between FT and ST was defined as TD. The relationships between anastomotic leak and the evaluated clinical factors, including the parameters identified by the ICG fluorescence assessment, were evaluated using univariate or multivariate analysis. RESULTS: Although no signs of leak were found by surgeons' subjective judgments, four patients developed postoperative anastomotic leak of Clavien-Dindo grade III or IV. Multivariate analysis revealed that TD was an independent predictor of anastomotic leak (odds ratio 35.361, 95% confidence interval 1.489-839.923, p = 0.027). CONCLUSIONS: A novel parameter identified using near-infrared ICG fluorescence assessment may be useful to predict anastomotic leak in gastric cancer surgery. TRIAL REGISTRATION: UMIN Clinical Trials Registry: #UMIN000030747 ( https://www.umin.ac.jp/ctr/index.htm ).

Oxaliplatin-induced increase in splenic volume: experiences from multicenter study in Japan.

BACKGROUND: Chemotherapy with oxaliplatin is known to induce sinusoidal obstruction syndrome (SOS). In a previous single-center study, we reported that oxaliplatin-induced increase in splenic volume (SV) is strongly indicative of SOS, and that this increase in SV persisted for > 1 year after completing chemotherapy. The aim of this study was to confirm the oxaliplatin-induced SV change in a multicenter study in patients with stage III colon cancer in Japan. METHODS: We enrolled 59 patients who underwent curative resection for stage III colon cancer in the FACOS study in a phase II multi-center clinical study. Participants received mFOLFOX6 or CAPOX as adjuvant chemotherapy. SV change was assessed three times by computed tomographic volumetry: before surgery, on completion of adjuvant chemotherapy, and 1 year after completing adjuvant chemotherapy. RESULTS: SV on completing and 1 year after chemotherapy was significantly higher than that before surgery (P < 0.001). Oxaliplatin-induced SOS persisted for > 1 year after the completion of adjuvant chemotherapy in half of the patients. There was no difference in 3-year disease-free survival with respect to the presence or absence of increased SV. An increase in SV was observed in 72% of patients treated with mFOLFOX6 and 94% of patients treated with CAPOX (P = 0.13). CONCLUSION: This study can be verified the findings observed in our previous single-center study, oxaliplatin-based adjuvant chemotherapy was associated with an increase in SV. Furthermore, this increase can persist for > 1 year. The continuous presence of SOS may have a negative impact on prognosis in patients that develop recurrent disease.

Etiology and management of low anterior resection syndrome based on the normal defecation mechanism.

Low anterior resection syndrome (LARS) commonly develops after an anal sphincter-preserving operation (SPO). The etiology of LARS is not well understood, as the anatomical components and physiological function of normal defecation, which may be damaged during the SPO, are not well established. SPOs may damage components of the anal canal (such as the internal anal sphincter, longitudinal conjoint muscle, or hiatal ligament), either mechanically or via injury to the nerves that supply these organs. The function of the rectum is substantially impaired by resection of the rectum, division of the rectococcygeus muscle, and/or injury of the nervous supply. When the remnant rectum is small and does not function properly, an important functional role may be played by the neorectum, which is usually constructed from the left side of the colon. Hypermotility of the remnant colon may affect the manifestation of urge fecal incontinence. To develop an SPO that minimizes the risk of LARS, the anatomy and physiology of the structures involved in normal defecation need to be understood better. LARS is managed similarly to fecal incontinence. In particular, management should focus on reducing colonic motility when urge fecal incontinence is the dominant symptom.

[Transverse Colectomy with D2 Lymph Node Dissection with a Small Incision Using Body Surface 3D-Simulation CT Colonography].

BACKGROUND: Laparoscopic transverse colectomy is technically difficult. In mini-laparotomy surgery, colectomy for midtransverse colon cancer can easily be performed, but exact D2 lymph node dissection is very difficult for a variety of vessels in the transverse colon. Using 3D-CT imaging, we present a case of D2 lymph node dissection where mini-laparotomy transverse colectomy was performedby a small incision similar to that usedin laparoscopic surgery. METHOD: The patient was a 60-yearoldwoman with early transverse colon cancer, which was locatedin the mid-transverse colon. Surgical treatment was plannedfor pT1b(1.5mm)andpVM1 in pathological findings after EMR. Using CT colonography(CTC), the location of the primary tumor was identified. Using simulation CTC(sCTC), composedof CTC and 3D imaging of the arteries andveins, the dominant artery was identified and D2 lymph node dissection was simulated. In addition, body surface 3D imaging and permeable surface 3D imaging of the abdominal trunk were performed. Using body surface 3D-sCTC, composedof sCTC and body surface 3D imaging, the minimum incision to enable D2 lymph node dissection was simulated. RESULT: Using sCTC, it was identified that the dominant artery was the right branch of the middle colic artery(MCA Rt)andthe accompanying vein was branchedfrom the gastrocolic trunk(GCT). D2 lymph node dissection to separate the branching root of MCA Rt and the accompanying vein was simulated. Next, surgical incision was simulated using body surface 3D-sCTC. Because the branching roots of MCA Rt andGCT were locatedabout 5 cm cranial from the upper rim of the navel, a 7 cm upper abdominal midline incision was designed in addition to a 2 cm umbilical incision. Mini-laparotomy transverse colectomy with a 7 cm incision was performedin accordance with the simulation. The operation time was 2 hours and5 1 minutes, andbloodloss was due to occult bleeding. The patient was discharged 7 days after surgery without complications, and the final diagnosis was pT1bN0M0, StageⅠwith no recurrence for 4 years and2 months after surgery. The cranial incision from the upper rim of the navel has shrank about 3 cm, and the umbilical incision is not noticeable. CONCLUSION: D2 lymph node dissection of minilaparotomy transverse colectomy can be a treatment option for early transverse colon cancer through using body surface 3DsCTC.

An increase in the neutrophil-to-lymphocyte ratio during adjuvant chemotherapy indicates a poor prognosis in patients with stage II or III gastric cancer.

BACKGROUND: The neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR) are associated with poor prognoses in patients with gastric cancer; however, few studies have focused on the dynamic changes in these ratios during the treatment of patients with gastric cancer. Here, we assessed the clinical utility of changes in these ratios as prognostic indicators in patients with stage II or III gastric cancer who received adjuvant chemotherapy. METHODS: We retrospectively reviewed 100 patients who received S-1 adjuvant chemotherapy at ≥70% of the relative dose intensity, and their NLRs and PLRs were evaluated at different times: prior to gastrectomy and upon commencement and termination of adjuvant chemotherapy. To assure the clinical utility of the changes in NLR and PLR as prognostic indicators, other clinical factors were assessed as well. RESULTS: Disease recurred in 35 patients as follows: lymph node metastasis (17 patients, 17.0%), peritoneal metastasis (12 patients, 12.0%), and hematogenous metastasis (6 patients, 6.0%); 24 patients died. An increase in the NLR during adjuvant chemotherapy with S-1 was identified as an independent indicator associated with overall survival (hazard ratio [HR] 6.736, 95% confidence interval [CI] 2.420-18.748; P < 0.001), and relapse-free survival (HR 5.309, 95% CI 2.585-10.901; P < 0.001). CONCLUSION: An increase in the NLR during S-1 adjuvant chemotherapy may be a useful prognostic indicator in patients with stage II or III gastric cancer.

Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (The FACOS study).

PURPOSE: Adjuvant chemotherapy with oxaliplatin combined with a fluoropyrimidine derivative is widely accepted as standard therapy for patients with stage III colon cancer, since few clinical data are available for Japanese patients. The FACOS trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) and XELOX regimens in Japanese colon cancer patients. METHODS: Twelve cycles of mFOLFOX6 or 8 cycles of XELOX were given to patients with eligibility: stage III curatively resected colon cancer, performance status of 0-1, age from 20 to 75 years, and adequate organ function. The primary endpoint was 3-year disease-free survival. Secondary endpoints were the incidence of adverse events (AEs) and the completion rate of study therapy. RESULTS: From April 2010 to April 2014, a total of 132 patients were enrolled. Safety was analyzed in 130 patients, with finalized data from 73 patients receiving mFOLFOX6 and 57 patients receiving XELOX. A total of 130 patients (100%) experienced AEs (any grade), and 52 patients (40.0%) experienced AEs of grade ≥ 3. No significant difference in the frequency of grade ≥ 3 AEs was observed between mFOLFOX6 and XELOX groups. Continuation of the planned cycle rate of protocol treatment was 69.9% in the mFOLFOX6 group and 68.4% in the XELOX group. Treatment was discontinued because of AEs in 14 patients (19.2%) in the mFOLFOX6 group and 8 (14.0%) in the XELOX group. Mean relative dose intensity for oxaliplatin was 78.0% in the mFOLFOX6 group and 82.8% in the XELOX group. CONCLUSION: As adjuvant chemotherapy for stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.

Early anal gland adenocarcinoma with a characteristic submucosal tumor-like appearance: a case report.

BACKGROUND: The clinical findings of early anal gland carcinoma (AGC) have not been well delineated because AGC is a rare malignancy usually diagnosed at an advanced stage. Knowledge of the characteristic findings will be helpful for both diagnosis and determination of the treatment options for early AGC. CASE PRESENTATION: A 62-year-old man was referred to our hospital for treatment of a rectal submucosal tumor (SMT) detected during a medical checkup at another hospital. Trans-sacral resection of the tumor was performed under the diagnosis of a rectal benign cyst. Pathological examination of the resected tumor showed a mucin-producing adenoma. About 14 months later, a new cystic lesion was found by follow-up examination, and trans-sacral resection of the tumor was performed again. The second pathological diagnosis was a mucinous adenocarcinoma with a possible remnant tumor at the local site. After providing sufficient informed consent, the patient underwent intersphincteric resection (ISR) of the rectum to preserve anal function. The final diagnosis was mucinous adenocarcinoma of the anal gland, T1N0M0. The patient remained alive without recurrence or complications for 6 years 7 months postoperatively. CONCLUSION: We have herein reported a case of early AGC with a characteristic SMT-like appearance. Because the anal gland is located within both the submucosal layer and the internal sphincter muscle, ISR may be selected when the tumor is limited to inside the gland.

[Partial Gastrectomy for Elderly Patients with Early-Stage Gastric Cancer].

The aim of this study was to assess the impact of partial gastrectomy on postoperative outcomes in elderly patients with gastric cancer. Sixty -three consecutive elderly patients aged 75 years and older with histologically proven Stage ⅠA gastric adenocarcinoma who underwent partial gastrectomy(PG, n=7)or normal gastrectomy(NG, n=56)were investigated. PG was performed by segmental gastrectomy or local gastrectomy due to poor performance status, severe comorbidities, and social background instead of normal gastrectomy(distal, proximal, and total gastrectomy). Both body mass index(BMI)and body weight changes 12 months postoperatively were significantly higher in those who underwent PG(20.5 kg/m2 vs 18.4 kg/m2, p=0.043; and 96.6% vs 86.4%, p=0.016)despite being statistically similar preoperatively. The 5-year cause-specific survival rate of those who underwent PG was 100% excluding relapse cases. The 5-year overall survival rates were 86% in those who underwent PG and 67%in those who underwent NG, although they differed significantly. Partial gastrectomy may be a valid surgical procedure that may yield better prognosis compared to that with normal gastrectomy for elderly patients with Stage ⅠA gastric cancer.

[D2 Lymph Node Dissection in Mini-Laparotomy Transverse Colectomy Using Non-Contrast Simulation CT Colonography].

BACKGROUND AND PURPOSE: It is reported that simulation computed tomography colonography(S-CTC), which combines CTC and 3-dimensional(3D)vascular imaging, is useful in colorectal cancer surgery. However, it is difficult to create 3D vascular images using non-contrast CT. Laparoscopic transverse colectomy is said to be technically difficult. Mini-laparotomy surgery for mid-transverse colon cancer is quite easy to perform. However, exact D2 lymph node dissection is very difficult. We present a case of D2 lymph node dissection during mini-laparotomy transverse colectomy performed using S-CTC, which involves the creation of 3D vascular images using non-contrast CT. PATIENT AND METHOD: The patient was a 77-year-old man with transverse colon cancer located in the mid-transverse colon, cT2N0M0, Stage Ⅰ. He had coexisting chronic renal failure. Non-contrast CT was performed prior to surgery, and the images were processed using workstation Zaiostation2. RESULTS: Both the artery and the vein created from non-contrast CT could be visualized clearly until the marginal vessels. Using noncontrast S-CTC in combination with CTC and 3D artery imaging, it was identified that the dominant artery was the left branch of the middle colic artery(MCA Lt), while the right branch of the MCA(MCA Rt)and accessory MCA(AMCA)were 10 cm or more apart. The fusion of 3D artery and vein imaging made it evident that the vein accompanying MCA Lt branched from the superior mesenteric vein. Using non-contrast S-CTC, D2 lymph node dissection, dissection of the branching root of MCA Lt and the vein at the same level was simulated. Thus, mini-laparotomy transverse colectomy was performed through a 7 cm incision, in accordance with the simulation. CONCLUSION: Non-contrast S-CTC was useful for performing D2 lymph node dissection during mini-laparotomy transverse colectomy.