The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study.

PURPOSE: We previously reported the first evidence of oncological benefits from a Japanese phase II trial of oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer (the FACOS study). We herein report the long-term survival and persistent oxaliplatin-related peripheral sensory neuropathy (PSN) for patients enrolled in this trial. METHODS: Patients were scheduled to receive the mFOLFOX6 or CAPOX regimen in the adjuvant setting. The five-year overall survival (OS) rate and persistent PSN were evaluated. RESULTS: A total of 130 patients (mFOLFOX6, n = 73; CAPOX, n = 57) were eligible. The 5-year OS rate was 91.4%. No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25). The incidence of PSN during adjuvant treatment was 55.4% in grade 1 (G1), 30.0% in G2, and 4.6% in G3. No patients showed G3 PSN at 12 months, but G1 or G2 residual PSN after 5 years was observed in 21.8% (G1, 20%; G2, 1.8%). CONCLUSIONS: Updated results from the FACOS study support the benefits of oxaliplatin-based adjuvant chemotherapy in terms of the long-term survival among Japanese patients with stage III colon cancer. However, long-term persistent PSN occurs in about 20% of survivors, counterbalancing the favorable OS.

Usefulness of Machine Learning-Based Gut Microbiome Analysis for Identifying Patients with Irritable Bowels Syndrome.

Irritable bowel syndrome (IBS) is diagnosed by subjective clinical symptoms. We aimed to establish an objective IBS prediction model based on gut microbiome analyses employing machine learning. We collected fecal samples and clinical data from 85 adult patients who met the Rome III criteria for IBS, as well as from 26 healthy controls. The fecal gut microbiome profiles were analyzed by 16S ribosomal RNA sequencing, and the determination of short-chain fatty acids was performed by gas chromatography-mass spectrometry. The IBS prediction model based on gut microbiome data after machine learning was validated for its consistency for clinical diagnosis. The fecal microbiome alpha-diversity indices were significantly smaller in the IBS group than in the healthy controls. The amount of propionic acid and the difference between butyric acid and valerate were significantly higher in the IBS group than in the healthy controls (p < 0.05). Using LASSO logistic regression, we extracted a featured group of bacteria to distinguish IBS patients from healthy controls. Using the data for these featured bacteria, we established a prediction model for identifying IBS patients by machine learning (sensitivity >80%; specificity >90%). Gut microbiome analysis using machine learning is useful for identifying patients with IBS.

A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy.

PURPOSE: A phase II trial was conducted to investigate the benefit of oxaliplatin-based adjuvant chemotherapy in Japanese stage III colon cancer patients. METHODS: Eligible patients were scheduled to receive 12 cycles of mFOLFOX6 or 8 cycles of CAPOX in adjuvant settings. The primary endpoint was the 3-year disease-free survival (DFS). Cox proportional hazards regression was performed to identify risk factors for a worse DFS. RESULTS: A total of 130 patients, including 73 patients receiving mFOLFOX6 and 57 patients receiving CAPOX, were enrolled from 16 institutions between April 2010 and April 2014. The 3-year DFS was 82.2%, exceeding the expected primary endpoint of 81.7%. The 3-year DFS tended to be higher in patients receiving mFOLOFOX6 than in those receiving CAPOX (mFOLFOX6, 86.3%; CAPOX, 76.9%; P = 0.06). The 3-year DFS rates did not differ markedly based on the risk stratification (T1/T2/T3 N1 vs. T4 or N2) indicated by the IDEA COLLABORATION study (P = 0.22). In the multivariate analysis, stage IIIC (P = 0.046) and early discontinuation (P < 0.01) were identified as independent significant risk factors for a worse DFS. CONCLUSION: Our findings represent the first positive results in a Japanese phase II trial of adjuvant chemotherapy with mFOLFOX6/CAPOX. Early discontinuation within 2 months was an independent risk factor for a shorter DFS.

Diagnostic Performance and Patient Acceptance of Reduced-Laxative CT Colonography for the Detection of Polypoid and Non-Polypoid Neoplasms: A Multicenter Prospective Trial.

Purpose To evaluate the diagnostic accuracy and patient acceptance of reduced-laxative computed tomographic (CT) colonography without computer-aided detection (CAD) for the detection of colorectal polypoid and non-polypoid neoplasms in a population with a positive recent fecal immunochemical test (FIT). Materials and Methods Institutional review board approval and written informed consent were obtained. This multicenter prospective trial enrolled patients who had positive FIT results. Reduced-laxative CT colonography and colonoscopy were performed on the same day. Patients received 380 mL polyethylene glycol solution, 20 mL iodinated oral contrast agent, and two doses of 20 mg mosapride the day before CT colonography. The main outcome measures were the accuracy of CT colonography for the detection of neoplasms 6 mm or larger in per-patient and per-lesion analyses and a survey of patient perceptions regarding the preparation and examination. The Clopper-Pearson method was used for assessing the 95% confidence intervals of per-patient and per-lesion accuracy. Survey scores were analyzed by using the Wilcoxon and χ2 tests. Results Three hundred four patients underwent both CT colonography and colonoscopy. Per-patient sensitivity, specificity, positive predictive value, and negative predictive value of CT colonography for detecting neoplasms 10 mm or larger were 0.91 (40 of 44), 0.99 (255 of 258), 0.93 (40 of 43), and 0.98 (255 of 259), respectively; these values for neoplasms 6 mm or larger were 0.90 (71 of 79), 0.93 (207 of 223), 0.82 (71 of 87), and 0.96 (207 of 215), respectively. Per-lesion sensitivities for detection of polypoid and non-polypoid neoplasms 10 mm or larger were 0.95 (40 of 42) and 0.67 (six of nine), respectively; those for neoplasms 6 mm or larger were 0.90 (104 of 115) and 0.38 (eight of 21), respectively (P < .05 for both). Patient acceptance of preparation and examination with CT colonography was significantly higher than that with colonoscopy, and 62% (176 of 282) of patients would choose CT colonography as the first examination if they have a positive FIT result in the future. Conclusion Reduced-laxative CT colonography without CAD is accurate in the detection of polypoid neoplasms 6 mm or larger but is less accurate in the detection of non-polypoid neoplasms. Reduced-laxative CT colonography has high patient acceptance and is an efficient triage examination for patients with a positive FIT. © RSNA, 2016 Online supplemental material is available for this article.

Total intraoperative enteroscopy using a colonoscope for detecting the bleeding point.

We report a case of bleeding in the small intestine of a 59-year-old man that was successfully diagnosed and treated by total intraoperative enteroscopy. The patient was admitted to our hospital because of gastrointestinal bleeding. Gastroscopy, colonoscopy and mesenteric arteriography could not identify the bleeding point. Technetium-99m-labeled red blood cell scintigraphy suggested bleeding from the small intestine but could not reveal the precise lesion. As the patient presented melena and went into a state of shock, we performed emergency laparotomy with total intraoperative enteroscopy using a colonoscope. A small ulceration was found at the jejunum, and subsequently partial resection of the jejunum was performed. The lesion was diagnosed histopathologically as angiodysplasia. The patient recovered uneventfully and was discharged on the 24th postoperative day. Bleeding in the small intestine is rare and difficult to diagnose but it sometimes induces a severe condition. Total intraoperative enteroscopy using a colonoscope is effective for detecting the bleeding point in the small intestine and can be performed at most centers without special fiberscopes and techniques.

[Significance of the Yamamoto-Kohama mode of invasion in the prognosis of esophageal squamous cell carcinoma: relationship with reduced expression of involucrin protein].

The Yamamoto-Kohama (Y-K) mode of invasion is a useful indicator of the prognosis of squamous cell carcinoma (SCC) of the oral cavity. We have previously reported that the Y-K mode of invasion is related to lymph node metastasis in esophageal SCC. Therefore, to clarify the relationship between the Y-K mode of invasion and survival rate, we histologicaly evaluated specimens obtained by esophagectomy from patients who had not received induction therapy. The results indicated that the overall survival rate of patients with esophageal SCC was significantly lower in the Y-K 4D group. In addition, significantly lower expression of involucrin protein was observed in pStage III cases than in pStage II cases. As a consequence of the poor prognosis of pStage III SCC, it was suggested that involucrin expression was correlated with survival rate. In conclusion, the Y-K mode of invasion and involucrin expression are considered to be informative prognostic indicators in patients with esophageal SCC.

Experience with laparoscopic management of solitary symptomatic splenic cysts.

Aggressive laparoscopic procedures can be used to manage pathologic lesions of solid organs. We attempted laparoscopic management of solitary symptomatic splenic cysts in four patients--two men and two women--ranging in age from 19 to 63 years (mean, 35 years). The cysts involved the whole spleen in one case, the upper pole in one, and the lower pole in two. We performed laparoscopic splenectomy in one case and laparoscopic unroofing of the cyst wall in three. In two procedures we successfully used needlescopic instruments. The duration of surgery and the volume of intraoperative bleeding were 300 minutes and 200 mL, respectively, for the splenectomy, and an average of 170 minutes (range, 120-240) and minimum volume, respectively, for the unroofing. There were no intra- or postoperative complications related to the laparoscopic procedures. The postoperative hospital stay was 9 days for the patient who underwent splenectomy and an average of 5.6 days (range, 5-7) for the patients who underwent unroofing. Laparoscopic management of splenic cysts is technically feasible and safe and has the advantages of reduced postoperative pain, shortened convalescence, and improved cosmesis.