Background:Irritable bowel syndrome is one of the most commonly encountered gastrointestinal disorders, for which there are no established diagnostic criteria. Thus, a diagnosis of IBS is made by exclusion of any organic diseases. Recently, important attempts for the positive diagnosis of irritable bowel syndrome by questionnaire surveys of physical symptoms have been made. We performed a questionnaire survey to evaluate the diagnostic value of the Manning criteria and to observe the major symptoms in irritable bowel syndrome.Methods:A symptom questionnaire which consisted of 22 items, including 6 cardinal symptoms of the Manning criteria, were answered by 172 outpatients who had gastrointestinal complaints. According to a final diagnosis based on independent clinical evaluation, all patients were categorized in three groups: irritable bowel syndrome group, nonulcer dyspepsia group and organic gastrointestinal disease group. The results of the questionnaire were analyzed for each group.Results:The sensitivity and specificity of the Manning criteria for the diagnosis of irritable bowel syndrome were 67% and 70% if three or more items were regarded as positive. The mean score and overall frequency of the Manning criteria were significantly higher in irritable bowel syndrome group than in nonulcer dyspepsia (p<0.01) or organic gastointestinal disease group (p<0.05) Among subgroups of the irritable bowel syndrome group, the pain-predominant subgroup showed a significantly higher score and overall frequency than the painless subgroup(p<0.05).Conclusions:The Manning criteria would be useful as a simple and reliable backup tool for the diagnosis of irritable bowel syndrome and seem to be more useful in pain-predominant subgroup. More detailed history-taking should prevent unnecessary extensive investigations for the diagnosis of irritable bowel syndrome.

BACKGROUND: Pertuzumab (P) in combination with trastuzumab (T) and docetaxel (D) is the approved first line SOC in patients with HER2 positive metastatic breast cancer and is approved neoadjuvantly in patients with HER2 positive stage Ib-IIIc breast cancer. Because of its role in heterodimerization with EGFR, P may cause adverse events associated with EGFR antagonists. Diarrhea is the most commonly reported AE due to P. Increased usage of P has generated clinical questions regarding the incidence and management of diarrhea. Here we report safety analyses of diarrhea from three P containing studies. METHODS: The safety population evaluated in this exploratory analysis included 804 patients from CLEOPATRA, 416 patients from NeoSphere, and 223 from TRYPHAENA. Diarrhea incidence, severity (NCI-CTCAE v3.0), and management in P containing arms were analyzed. RESULTS: The incidence and management of diarrhea in MBC (Table 1), EBC (Table 2): CLEOPATRA P+T+D n=408Pla+T+D n=396Incidence of Events n (%)All Grades279 (68)193 (49)≥ Grade 338 (9)20 (5)Median time to 1st event (days) all grades / Interquartile Range (IQR)8 (4,44)23 (6,82)Discontinuation of any study drug8 (0.2)2 (0.6)Treatment n (%)Antidiarrheal treatment164 (40)77 (19)  NeoSphere X4 followed by adjuvant FECx3TRYPHAENANeoadjuvant tx followed by T up to 1 yearT+D n=107P+T+D n=107P+T n=108P+D n=94FEC+P+T x3→P+T+D x3 n=72FEC x3 →P+T+D x3 n=75TCH+P x6 n=76Incidence of Events n (%) (neoadjuvant + adjuvant exposure)All Grades41 (38)55 (51)46 (43)53 (56)46 (64)47 (63)55 (72)≥ Grade 34 (4)7 (7)3 (3)5 (5)3 (4)4 (5)9 (12)Median time to 1st event (days) all grades / Interquartile Range (IQR)7 (4,24)8 (3,26)19 (4,117)6 (3,21)9 (4,30)69 (64,82)6 (3,21)Discontinuation of any study drug0000000Treatment n (%)Antidiarrheal treatment13 (12)23 (22)20 (19)28 (30)23 (32)22 (29)31 (41)pertuzumab(P)+trastuzumab(T)+docetaxel(D) FEC= 5FU, epirubicin, cyclophosphamide TCH= docetaxel,(T)carboplatin(C), trastuzumab(H) The overall incidence of diarrhea events is greatest in the first cycle containing P: in CLEOPATRA (P+T+D) 43%, in NeoSphere (P+T+D) 34%, (P+T) 21%, and in TRYPHAENA (FEC+P+T→P+T+D) 40%, (FEC→P+T+D c4) 46%, and (TCH+P) 55%. Of patients experiencing diarrhea, the median number of events (all grades) for patients receiving P+T+D in CLEOPATRA and NeoSphere was 2 and 1 respectively, and 2 for patients receiving TCH+P in TRYPHAENA. CONCLUSIONS: Diarrhea was common in all P containing arms but events were mostly low grade and occurred more often with the first cycle. Events and management were similar in the EBC and MBC setting. Approximately half of patients required antidiarrheal treatment. However, rates of study drug discontinuation due to diarrhea were low. Studies of treatment associated diarrhea management are planned. Citation Format: Swain SM, Schneeweiss A, Gianni L, Stein A, McNally V, Heeson S, Portera C, Yoo B, Cortes JC, Baselga J. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-14-14.

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BackgroundHepatitis C virus (HCV) is known to be a major cause of non-A, non-B hepatitis (NANBH) and is thought to be an important causative agent of serious liver disease. Recently the role of HCV in the development of various liver disease is suggested.MethodsSera from 222 patients with various liver diseases had been kept frozen at −20°C until the test. Anti-HCV was detected using the ABBOTT HCV EIA Test System (ABBOTT Co., America) following the manufacturer’s instructions. The assay uses a recombinant HCV antigen (C 100-3) synthesized in yeast.ResultsHCV antibodies (anti-HCV) were detected in 35 (31.5%) of 111 HBsAg-negative patients. The prevalence rate of anti-HCV was 61.9% (13 out of 21patients) in chronic hepatitis, 29.1% (14 out of 48) in liver cirrhosis, 26.3% (5 out of 19) in hepatocellular carcinoma and 13% (3 out of 23) in acute hepatitis was far less (3 out of 111 patients, 2.7%) than that of HBsAg-negative patients (p<0.01). In this group, anti-HCV was detected in 2 (5.1%) out of 39 liver cirrhosis, 1 (1.9%) out of 52 chronic hepatitis, among them 47 were biopsy-proven chronic active hepatitis, and none of 20 hepatocellular carcinoma.ConclusionsThese data suggest that, in Korea, 1) coinfection of HCV and HBV is infrequent, 2) HCV might be an important cause of HBsAg-negative chronic hepatitis, 3) HCV is seemed to be a less likely important factor associated with liver cirrhosis or hepatocellular carcinoma in HBsAg-negative patients, but further prospective study with a large population is necessary.

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