The Conventional Technique Versus the No-touch Isolation Technique for Primary Tumor Resection in Patients With Colon Cancer (JCOG1006): A Multicenter, Open-label, Randomized, Phase III Trial.

OBJECTIVE: This phase III trial evaluated whether the no touch was superior to the conventional in patients with cT3/T4 colon cancer. BACKGROUND: No touch involves ligating blood vessels that feed the primary tumor to limit cancer cell spreading. However, previous studies did not confirm the efficacy of the no touch. METHODS: This open-label, randomized, phase III trial was conducted at 30 Japanese centers. The eligibility criteria were histologically proven colon cancer; clinical classification of T3-4, N0-2, andM0; and patients aged 20 to 80years. Patients were randomized (1:1) to undergo open surgery with conventional or the no touch. Patients with pathological stage III disease received adjuvant capecitabine chemotherapy. The primary endpoint was disease-free survival (DFS) according to the intention-to-treat principle. RESULTS: Between January 2011 and November 2015, 853 patients were randomized to the conventional group (427 patients) or the no touch group (426 patients). The 3-year DFS were 77.3% [95% confidence interval (CI) 73.1%-81.0%] and 76.2% (95% CI 71.9%-80.0%) in the conventional and no touch groups, respectively. The superiority of no touch was not confirmed: hazard ratio for DFS = 1.029 (95% CI 0.800- 1.324; 1-sided P = 0.59). Operative morbidity was observed in 31 of 427 conventional patients (7%) and 26 of 426 no touch patients (6%). All grade adverse events were similar between the conventional and no touch groups. No in-hospital mortality occurred in either group. CONCLUSION: The present study failed to confirm the superiority of the no touch.

Efficacy of thoracotomy and thoracoscopic-assisted esophageal surgery in conversion and salvage surgeries: a retrospective study.

BACKGROUND: The esophagus has no serosa; therefore, esophageal cancer may quickly invade its adjacent organs. In recent years, reports of conversion surgery (CS) and salvage surgery (SS) have described resection of esophageal cancer previously considered unresectable, with the addition of intensive preoperative chemotherapy or chemoradiotherapy. Currently, there is no established method for determining whether tumor excision is possible. Additionally, differences in surgical approaches between facilities may influence outcome after resection. However, the option for resection is considered a significant factor in determining a patient's prognosis. METHODS: Patients who were diagnosed with advanced-stage (T3 or higher) squamous cell carcinoma of the esophagus and subsequently underwent resection with CS or SS were included in the study. Resection was performed through a small thoracotomy using a thoracoscope. Clinicopathologic factors, such as complete resection rate (R0) and prognosis, were investigated. RESULTS: A total of 49 surgeries were conducted: 39 CS and 10 SS cases. The male-to-female ratio was 37:12. R0:R1:R2 equals 42:3:4, and the R0 resection rate was 85.7%. The 5-year survival rates for CS and SS cases were 69.2% and 32.1%, respectively. The 5-year survival rates for R0, R1, and R2 resections were 63.4%, 0.0%, and 25.0%, and those for R0 and R1 + 2 resections were 63.4% and 14.3%, respectively, indicating that the prognosis for R0 resection cases was significantly better (P = 0.001 and P = 0.001, respectively). Regarding chemotherapy for CS, 29 patients received 5-FU and cisplatin therapy, whereas 10 patients received 5-FU, cisplatin, and docetaxel (DCF) therapy. After 2015, the ratio of DCF was significantly high, and the R0 resection rate was 100% in patients who received DCF therapy. CONCLUSIONS: In this study, a satisfactory R0 rate was achieved using the magnifying effect of the thoracoscope while ensuring safety during thoracotomy. TRIAL REGISTRATION: This was a single-center cohort study wherein clinical data were retrospectively registered. This study was approved by the Chiba Cancer Center review board (H29-262). All procedures adhered to the ethical standards of the responsible committee on human experimentation and the Helsinki Declaration of 1964 and its later amendments.

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.

[A Study of Laparoscopic Stoma Creation for Patients with Colorectal Cancer].

There are few reports on laparoscopic stoma creation; we report here our experience with laparoscopic stoma creation. PATIENTS AND METHODS: Seven patients who underwent laparoscopic stoma creation between April 2019 and December 2019 were studied and their clinical outcome was evaluated retrospectively. Operation approach: We performed a colostomy in the transverse colon. At first, we insert a 12 mm first port into the site of stoma marking. And more, we insert three 5 mm ports on the opposite side of the first port. We remove the adhesions of the intestinal tract and create a colostomy. RESULT: We changed open method 2 cases out of 7 cases due to extensive adhesion. In laparoscopically, we had an operation time of 97 (42-130) minutes and a blood loss of 5(2-40) mL. We had no postoperative complications or stoma problems. CONCLUSION: Laparoscopic stoma creation was useful due to few postoperative complications and can be rapidly transferred to chemotherapy.

[Intracorporeal Anastomosis in Laparoscopic Colectomy with Blood Flow Confirmation by Fluorescence Angiography].

We verified the significance of intestinal blood flow evaluation by indocyanine green(ICG)fluorescence during intracorporeal anastomosis in laparoscopic colectomy which was performed from July 2019 to December 2019 in our institute. For 11 cases of intracorporeal anastomosis, we examined the patient background, surgical results such as operation time and blood loss, evaluation of intraoperative ICG blood flow, and perioperative complications. In all cases, after the mesentery treatment in the abdominal cavity and before the intestinal incision, the blood flow of the planned anastomosis site was evaluated by ICG fluorescence observation. No cases were required to be changed the anastomosis site. The average operation time was 240 minutes and the average blood loss was 10 mL. There were no perioperative complications such as anastomotic leakage, stenosis, bleeding, nor wound infection. It was suggested that the intraoperative evaluation of ICG blood flow during intracorporeal anastomosis in laparoscopic colectomy may contribute to the suppression of complications such as anastomotic leakage.

Inducing multiple antibodies to treat squamous cell esophageal carcinoma.

BACKGROUND: The positive response and the clinical usefulness of 14 serum antibodies in patients with esophageal squamous cell carcinoma (ESCC) were examined in this study. The Cancer Genome Atlas (TCGA) was used to investigate the frequency of gene expressions, mutations, and amplification of these 14 antigens and also the possible effects of antibody induction. METHODS: Blood serum derived from 85 patients with ESCC was collected and analyzed for the 14 antibodies using ELISA. The prognosis between positive and negative antibodies were then compared. The antibody panel included LGALS1, HCA25a, HCC-22-5, and HSP70. RESULTS: Patient serum was positive for all antibodies, except VEGF, with the positive rates ranging from 1.18 to 10.59%. Positive rates for LGALS1, HCA25a, HCC-22-5, and HSP70 were > 10%. TCGA data revealed that all antigen-related genes had little or no mutation or amplification, and hence an increase in gene expression affected antibody induction. The positive results from the panel accounted for the positive rate comparable to the combination of CEA and SCC. No significant association was observed between the presence of antibodies and disease prognosis. CONCLUSIONS: The detection rates of LGALS1, HCA25a, HCC-22-5, and HSP70 were 10% higher in patients with ESCC. Gene overexpression may be involved in such antibody production. These four antibodies were applied as a panel in comparison with conventional tumor markers. Moreover, it was confirmed that the combination of this panel and the conventional tumor markers significantly improved the positive rate.

[Laparoscopic Partial Colectomy for Transverse Colon Cancer after Open Laparotomy for Gastric Cancer Resection].

We report a case of transverse colon cancer resected by laparoscopic partial colectomy, followed by open gastrectomy. A man in his 70s was diagnosed with transverse colon cancer. He had a history of open gastrectomy for gastric lymphoma; thus, postoperative adhesions were expected in the upper abdomen. We performed a laparoscopic partial colectomy with gentle adhesiotomy, without injury. After preparation of the marginal vessels, blood flow towards the planned anastomotic line was confirmed by infrared observation after venous injection of indocyanine green. However, the initially planned oral anastomotic line did not show a blood supply; therefore, the anastomotic line was altered to a site of sufficient blood flow. In postlaparotomy cases, delicate handling and careful adhesiotomy are necessary in the laparoscopic approach due to the possibility of severe intraoperative injury resulting in conversion to open surgery. Furthermore, blood flow confirmation by fluorescence angiography is recommended in cases in which anatomical alterations might have occurred due to the previous operation.

[Significance of Surgery for Multidisciplinary Treatment Including Neoadjuvant Chemotherapy for Locally Advanced Colorectal Cancer].

Neoadjuvant chemotherapy has been performed for locally advanced colorectal cancer with invasion to other organs or lateral lymph node metastasis in to control local recurrence and distant metastasis. We evaluated the treatment results and the significance of surgery in 53 patients(36 rectal cancer cases and 17 sigmoid colon cancer cases)who underwent surgery after chemotherapy by XELOX plus bevacizumab for 3 months. As pretreatment diagnosis, 42 cases were T4b and 39 cases were lymph node positive. Combined resection was performed in 34 cases including 12 cases of total pelvic exenteration. Pathological diagnosis showed 27 cases of ypT4b and 34 cases of ypN0. Pathological curative resection was performed in 90.4%. Histological effect by chemotherapy was 31 cases in Grade(Gr)1a, 10 cases in Gr 1b, 8 cases in Gr 2, and 4 cases in Gr 3, respectively. The 5-year survival rate was 60.9% in Gr 1a or lower and 100% in Gr 1b or higher. Tumor markers( CEA and CA19-9)were reduced into normal range after neoadjuvant chemotherapy in all 4 patients with Gr 3. Pathological CR could not be predicted from clinical findings after neoadjuvant chemotherapy. It was suggested that neoadjuvant chemotherapy for locally advanced rectal cancer with invasion to other organs or lateral lymph node metastasis is useful for improving the prognosis, surgical resection is indispensable as a multidisciplinary treatment, and that the pathological therapeutic effect leads to prognosis prediction.

Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401.

BACKGROUNDS: Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer is safe and feasible. In contrast, no prospective study evaluating the safety and efficacy of laparoscopy-assisted total gastrectomy (LATG) or laparoscopy-assisted proximal gastrectomy (LAPG) has been completed. We conducted a single-arm confirmatory trial to evaluate the safety of LATG/LAPG for clinical stage I (T1N0/T1N1/T2N0) proximal gastric cancer. METHODS: The extent of lymphadenectomy was selected based on the Japanese Gastric Cancer Treatment Guidelines. The mini-laparotomy incision was required to be ≤ 6 cm. The primary endpoint was the proportion of grade 2-4 (CTCAE ver. 4.0) esophagojejunal anastomotic leakage. The planned sample size was 245 considering a threshold of 8% and one-sided alpha of 2.5%. RESULTS: Between April 2015 and February 2017, 244 eligible patients were enrolled. LATG/LAPG was performed in 195/49. The proportion of conversions was 1.7%. Clinical T1N0/T1N1/T2N0 was 212/9/23. The extents of lymphadenectomy were as follows: D1+: 229; D2: 15. The median operation time was 309 min (IQR 265-353). The median blood loss was 30 ml (IQR 10-86). Grade 2-4 esophagojejunal anastomotic leakage was 2.5% (6/244; 95% CI 0.9-5.3). The overall proportion of in-hospital grade 3-4 adverse events was 29% (71/244). The proportions of intraabdominal abscess and pancreatic fistula were 3.7% and 2.0%, respectively. There were no treatment-related deaths. CONCLUSIONS: This trial confirmed the safety of LATG/LAPG. After the non-inferiority of LADG is confirmed in our phase III trial (JCOG0912), LATG/LAPG is expected to be established as one of the standard treatments for clinical stage I gastric cancer.

Questionnaire survey on adjuvant chemotherapy for elderly patients after gastrectomy indicates their vulnelabilities.

BACKGROUND: In Japan, S-1 adjuvant chemotherapy for 1 year is the standard of care for the treatment of stage II and III patients under 80 years old with gastric cancer after curative operation. However, the feasibility of S-1 chemotherapy in patients over 80 years old has not yet been elucidated. METHODS: To clarify the current treatment situation and feasibility of S-1 treatment in patients over 80 years old, a questionnaire survey of the patients treated from January 2011 to December 2012 was conducted at 58 member institutions of the Stomach Cancer Study Group of the JCOG (Japan Clinical Oncology Group). RESULTS: Gastrectomy was performed in 15,573 patients of all ages, and 1,660 (10.7%) patients were over 80 years of age. Of these elderly patients, 661 (4.2%) were diagnosed as stage II and III. While S-1 adjuvant chemotherapy was recommended to 248 (37.5%) of the stageII/III patients, only 99 (15.0%) of them actually received S-1. Interestingly, the creatinine clearance rate was between 30 and 80 mL/min in 87 (87.9%) of the patients suggesting that S-1 dose modification should be considered. Moreover, S-1 compliance was poor in patients with more than 15% body weight loss. CONCLUSION: In general practice, surgery alone can be regarded as the standard of care for stage II and III gastric cancer patients over 80 years old. The feasibility and efficacy of S-1 adjuvant chemotherapy should be elucidated in a randomized control trial considering the vulnerabilities of the elderly.

Surgical treatment strategy for esophagogastric junction cancers based on the tumor diameter.

BACKGROUND: The number of patients with esophagogastric junction (EGJ) cancers has tended to increase. However, no clear consensus on the optimum treatment policy has yet been reached. METHODS: This study included patients diagnosed with adenocarcinoma of Sievert type II in whom resection was performed in our hospital. We performed a clinicopathological examination, and patients were divided into two groups by the tumor size: L group, tumor size ≥4 cm; and S group, tumor size < 4 cm. The clinical factors, such as nodal dissection and recurrence pattern, were then analyzed. RESULTS: A total of 48 patients were diagnosed with ECJ cancers. The average tumor size was 55.1 mm, and 32 cases (66.7%) had tumors ≥4 cm. Metastasis to the mediastinum was noted in 4 cases (12.5%) in the L group but none in the S group. Recurrence in the upper or middle mediastinum lymph nodes was noted in 3 cases (9.4%) in the L group. The 5-year overall survival rates were 49.7 and 83.9% in the L and S groups, respectively. CONCLUSIONS: As the tumor grows large, it is difficult to accurately judge EGJ on the image, and as a result it is difficult to understand the exact esophageal invasion distance of the tumor. Therefore, lymph node dissection including the upper mediastinum is considered vital, regardless of the degree of esophageal invasion.

[Treatment Results and Strategies for Early Gastric Cancer Patients Aged 80 Years or Older-How Should We Deal withNon -Curative ESD Cases ?]

With the aging population, the number ofearly gastric cancer patients aged 80 years or older is increasing. We clarified the outcome ofgastrectomy among early gastric cancer patients aged 80 years or older and examined the significance ofadditional gastrectomy for non-curative ESD cases. 1 ) Surgical outcomes in 90 cases ofearly gastric cancer patients aged 80 years or older with gastrectomy were analyzed. Gastrectomy was performed for patients up to 88 years of age and 84 cases (93.3%)were pStageⅠA. Three years and 5 years survival rates were 83.9% and 60.4%, respectively. The causes ofdeath included other disease in 28 cases, other cancer in 4 cases, and death associated with hospital stay in 1 case. 2 ) There were 28 non-curative ESD cases, including 6 T1a, 9 T1b1, and 13 T1b2. Among them, 8 additional gastrectomies were performed, but none were lymph node metastases and cancer residue at the proper muscle layer was identified in only 1 case. Three years and 5 years survival rates ofthe additional gastrectomy group were 100% and 60%, respectively. Although 2 years survival rate ofthe group without additional gastrectomy was 83.3%, there were no deaths due to gastric cancer. In elderly patients with early gastric cancer, considering the increasing the proportion deaths due to other diseases and the decreased quality of life after gastrectomy, the usefulness of additional gastrectomy for non-curative ESD is limited.

[Results of Neoadjuvant Chemotherapy with S-1 plus CDDP for Gastric Cancer-The Number of Therapeutic Coursers and Therapeutic Effects].

Neoadjuvant chemotherapy(NAC)with S-1 plus CDDP(SP)followed by gastrectomy has been used for the treatment of patients with locally advanced gastric cancer. We examined the number of treatment courses, histologic effects, ypStage, and prognosis to estimate the utility and define the best treatment course of SP NAC. The patients were divided into 1 course(A: 54 cases), 2 courses(B: 50 cases), and incomplete first course(C: 12 cases). The rates of Grade 2 or more in histological effect were 24.1% in group A, 34.0% in B, and 0% in C. Four patients achieved pathological CR(1 case in group A and 3 cases in group B). The pathological response by NAC was more effective in group B than in group A. In down-staging cases by NAC, survival curves were obtained according to ypStage. The 5-year survival rates in R0 cases were 67.0%in the effective therapeutic group and 51.0%in the non-effective group; the results being significantly different. According to the number of therapeutic courses of NAC, the 5-year survival rates were 57.9% in group A, 65.2% in group B, and 20.0% in group C, demonstrating a significantly better prognosis in group B. Although the pathological response appeared in 1 course, it was significant in 2 courses of NAC. The results indicate that the completion of at least 2 courses of NAC are necessary in locally advanced gastric cancer.

[Laparoscopic Gastro-Jejunostomy Using the Overlap Method after Subtotal Gastrectomy for Upper Gastric Cancer].

BACKGROUND: Due to an aging society, patients with gastric cancer are also getting older. Although total gastrectomy should be avoided for elderly patients, laparoscopic subtotal gastrectomy(LSTG)is a technically demanding procedure. Here, we present a safe procedure of gastro-jejunostomy using the overlap method. METHODS: After transection of the stomach using gastroscopy, an entry hole was created at the center of the staple line of the remnant stomach. The jejunum was anastomosed to the dorsal wall of the gastric remnant with a linear stapler, and the entry hole was closed by hand-sewn sutures. Nineteen patients with gastric cancer in the upper third of the stomach underwent LSTG using this technique, and the short-term clinical outcomes were analyzed retrospectively. RESULTS: The median operative time was 221 minutes(143-318), and the median blood loss was 10 mL(3-100). The median postoperative hospital stay was 7 days(6-13), and there were no complications related to anastomosis. CONCLUSIONS: The short-term clinical outcomes of the laparoscopic gastro-jejunostomy using the overlap method after LSTG reveal that this technique is safe and feasible to use for improving patient outcomes.

[A Case of Concurrent Robotic-Assisted Partial Nephrectomy and Laparoscopic Ileocecal Resection for Synchronous Cancer of the Kidney and Ascending Colon].

We report a case of synchronous cancer of the kidney and ascending colon that was resected concurrently using roboticassisted partialnephrectomy and laparoscopic ileocecalresection. A man in his 70s was diagnosed as having renaland ascending colon cancers. Thus, simultaneous resection was planned. First, robotic partial nephrectomy was performed via a transabdominalapproach by the urologicalsurgeon. After changing the position from semi-lateraldecubitus to supine, severalports were added and laparoscopic ileocecal resection was performed. Robotic and laparoscopic surgery was performed simultaneously, and the benefits of minimally invasive surgery were obtained.

A randomized phase II multicenter trial to explore efficacy of weekly intraperitoneal in comparison with intravenous paclitaxel administered immediately after gastrectomy to the patients with high risk of peritoneal recurrence: final results of the INPACT trial.

BACKGROUND: Intraperitoneal administration of paclitaxel had been considered a promising option to treat peritoneal metastasis, the most frequent pattern of recurrence in gastric cancer after D2 gastrectomy, but its safety and efficacy after gastrectomy had not been fully explored. METHODS: A phase II randomized comparison of postoperative intraperitoneal (IP) vs. intravenous (IV) paclitaxel was conducted. Patients with resectable gastric linitis plastica, cancer with minimal amount of peritoneal deposits (P1), or cancer positive for the peritoneal washing cytology (CY1) were eligible. After intraoperative confirmation of the above disease status and of resectability, patients were randomized to be treated either by the IP therapy (paclitaxel 60 mg/m2 delivered intraperitoneally on days 0, 14, 21, 28, 42, 49, and 56) or the IV therapy (80 mg/m2 administered intravenously using the identical schedule) before receiving further treatments with evidence-based systemic chemotherapy. The primary endpoint was 2-year survival rate. RESULTS: Of the 86 patients who were randomized intraoperatively, 83 who actually started the protocol treatment were eligible for analysis (n = 39, IP group; n = 44, IV group). The 2-year survival rate of the IP and IV groups was 64.1% (95% CI 47.9-76.9) and 72.3% (95% CI 56.3-83.2%), respectively (p = 0.5731). The IP treatment did not confer significant overall or progression-free survival benefits, and was associated with particularly poor performance in patients with residual disease, including the CY1 P0 population. CONCLUSIONS: We were unable to prove superiority of the IP paclitaxel over IV paclitaxel delivered after surgery to control advanced gastric cancer with high risk of peritoneal recurrence.

Multi-panel assay of serum autoantibodies in colorectal cancer.

BACKGROUND: Although serum p53 autoantibodies (s-p53-Abs) are induced even in the early stages of colorectal cancer, their positive rate is only approximately 20%. Therefore, we assessed the possibility of using other serum autoantibodies to increase the positive rates for detecting colorectal cancer. METHODS: Autoantibodies against 17 tumor antigens (p53, RalA, HSP70, Galectin1, KM-HN-1, NY-ESO-1, p90, Sui1, HSP40, CyclinB1, HCC-22-5, c-myc, PrxVI, VEGF, HCA25a, p62, and Annexin II) were evaluated in 279 patients with colorectal cancer and 74 healthy controls. Cutoff values were fixed at mean + 3 standard deviations of serum titers in healthy controls. RESULTS: Autoantibodies with the highest positive rates were p53 (20%), RalA (14%), HSP70 (12%), and Galectin1 (11%). Combination assays using multiple autoantibodies increased the positive rates based on the number of autoantibodies used. Positive rates of 56, 62, 66, 71, and 73% were obtained with 6, 9, 11, 14, and 17 antibodies, respectively, for the overall disease. Moreover, these autoantibodies showed relatively high positive rates even during stage 0/I disease (55 and 70% with 6 and 17 antibodies, respectively). CONCLUSION: The measurement of set of 17 autoantibodies allowed autoantibody profiling in patients with colorectal cancer. The combination assay of six tumor antigens (p53, RalA, HSP70, Galectin1, KM-HN-1, and NY-ESO-1) achieved a positive rate of 56%. Such high positive rates will be helpful for detecting colorectal cancer regardless of tumor stages.

[Clinicopathological Examination of Differentiated Gastric Cancer].

OBJECTIVE: The common type carcinoma of gastric cancer is divided into 3 groups, papillary adenocarcinoma(pap), well differentiated tubular adenocarcinoma(tub1)and moderately tubular adenocarcinoma(tub2). In this study, we tried to individualize treatments of them by evaluating their clinicopathological features. METHODS: Examined resected specimens were collected from 2000 to 2016. We compared among pap, tub1, and tub2 as the clincopathological features retrospectively. RESULTS: Histological diagnosis was confirmed to 55 cases with pap, 639 cases with tub1 and 718 cases with tub2. Comparing the ratio of lymph node metastasis(LNM)according to the depth of invasion, tub2 and pap show higher incidence of LNM than tub1 in T1b, T2, and T4(a+b). Tub2 and pap patients have larger number of LNM and worse 5 year survival rates than tub1 patients. CONCLUSION: We demonstrated that tub2 and pap may have higher malignancy and show earlier LNM than tub1. When we consider of endoscopic treatment, individualizataing tub1, tub2 and pap is important.

Panel of autoantibodies against multiple tumor-associated antigens for detecting gastric cancer.

Gastric cancer is the second leading cause of cancer death in the world, and effective diagnosis is extremely important for good outcome. We assessed the diagnostic potential of an autoantibody panel that may provide a novel tool for the early detection of gastric cancer. We analyzed data from patients with gastric cancer and normal controls in test and validation cohorts. Autoantibody levels were measured against a panel of six tumor-associated antigens (TAAs) by ELISA: p53, heat shock protein 70, HCC-22-5, peroxiredoxin VI, KM-HN-1, and p90 TAA. We assessed serum autoantibodies in 100 participants in the test cohort. The validation cohort comprised 248 participants. Autoantibodies to at least one of the six antigens showed a sensitivity/specificity of 49.0% (95% confidence interval [CI], 39.2-58.8%)/92.4% (95% CI, 87.2-97.6%), and 52.0% (95% CI, 42.2-61.8%)/90.5% (95% CI, 84.8-96.3%) in the test and validation cohorts, respectively. In the validation cohort, no significant differences were seen when patients were subdivided based on age, sex, depth of tumor invasion, lymph node metastasis, distant metastasis, peritoneal dissemination, or TNM stage. Patients who were positive for more than two antibodies in the panel tended to have a worse prognosis than those who were positive for one or no antibody. Measurement of autoantibody response to multiple TAAs in an optimized panel assay to discriminate patients with early stage gastric cancer from normal controls may aid in the early detection of gastric cancer.

Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial.

OBJECTIVE: The aim of the study was to confirm the noninferiority of mesorectal excision (ME) alone to ME with lateral lymph node dissection (LLND) in terms of efficacy. BACKGROUND: Lateral pelvic lymph node metastasis is occasionally found in clinical stage II or III lower rectal cancer, and ME with LLND is the standard procedure in Japan. ME alone, however, is the international standard surgical procedure for rectal cancer. METHODS: Eligibility criteria included histologically proven rectal cancer at clinical stage II/III; main lesion located in the rectum, with the lower margin below the peritoneal reflection; no lateral pelvic lymph node enlargement; Peformance Status of 0 or 1; and age 20 to 75 years. Patients were intraoperatively allocated to undergo ME with LLND or ME alone in a randomized manner. The primary endpoint was relapse-free survival, with a noninferiority margin for the hazard ratio of 1.34. Secondary endpoints included overall survival and local-recurrence-free survival. Analysis was by intention to treat. RESULTS: In total, 701 patients were randomized to the ME with LLND (n = 351) and ME alone (n = 350) groups. The 5-year relapse-free survival in the ME with LLND and ME alone groups were 73.4% and 73.3%, respectively (hazard ratio: 1.07, 90.9% confidence interval 0.84-1.36), with a 1-sided P value for noninferiority of 0.0547. The 5-year overall survival, and 5-year local-recurrence-free survival in the ME with LLND and ME alone groups were 92.6% and 90.2%, and 87.7% and 82.4%, respectively. The numbers of patients with local recurrence were 26 (7.4%) and 44 (12.6%) in the ME with LLND and ME alone groups, respectively (P = 0.024). CONCLUSIONS: The noninferiority of ME alone to ME with LLND was not confirmed in the intent-to-treat analysis. ME with LLND had a lower local recurrence, especially in the lateral pelvis, compared to ME alone.